Online Ephedra

This article is about the use of species of Ephedra in medicine. For botanical information, see Ephedra (genus). Species of Ephedra have traditionally been used by indigenous people for a variety of medicinal purposes, and are a likely candidate for the Soma plant of Indo-Iranian religion. Also known as ma huang, it was used in traditional Chinese medicine up to 5,000 years ago, probably for the treatment of asthma and hay fever. In the late 1900s, it was used as a stimulant and a dieting aid. Due to the risk of adverse effects on the cardiovascular system, Western medical professionals recommend against the consumption of any ephedra.[1] Contents [hide] 1 Chemistry 2 Effects 3 Safety 4 Regulatory history in the United States 5 In professional sports 6 See also 7 External links 8 References [edit] Chemistry The alkaloids ephedrine and pseudoephedrine are the active constituents of the plant. Pseudoephedrine is used in over-the-counter decongestants. Ephedrine is used to treat low blood pressure, but alternatives with reduced cardiovascular risk have replaced it for treating asthma. It is also considered a performance-enhancing drug and is prohibited in most competitive sports. Some species in the Ephedra genus have zero alkaloid content and are therefore essentially inert, however the most commonly used species, Ephedra sinica, has a total alkaloid content of 1–3% by dry weight. Ephedrine constitutes 40–90% of the alkaloid content, with the remainder consisting of pseudoephedrine and the demethylated forms of each [2]. [edit] Effects Ephedra is both a stimulant (similar to adrenaline) and a thermogenic. It stimulates the brain, increases heart rate, constricts blood vessels (increasing blood pressure), and expands bronchial tubes (making breathing easier). Its thermogenic properties cause an increase in metabolism, evidenced by an increase in body heat. Side effects of ephedra may include irritability, nervousness, dizziness, trembling, headache, vomiting and hyperthermia. Chemical dependence may also develop. [edit] Safety Please expand and improve this section as described on this article's talk page or at Requests for expansion, then remove this message. Just like other stimulants such as Ritalin[3], in high doses ephedra can cause heart attacks, stroke, and seizures[4]. Yet, because ephedra is unregulated and because its primary use is now for weight-loss, there is additional concern about safety due to dieters taking more than the recommended amount, hoping to lose weight faster. The FDA maintains that "[ephedra] is dangerous at any dose"[5]. But there are many people including experienced users of ephedra[6] who don't agree with the FDA. One popular website with a focus on ephedra puts questions the FDA's recommendation, asking, "If ephedra is as dangerous as the FDA claims it is, given that the Chinese have been using it for 5,000 years, shouldn't they have experienced enough adverse events to be wary of it? If the FDA is so forceful in its opinion that any amount of natural ephedra is harmful, why does it allow you to buy Big Pharma's synthetic versions of ephedra, 240mg pseudoephedrine[7] and 25mg ephedrine[8] without a prescription? Unless natural ephedra is more dangerous than its synthetic form, it's disingenuous to prohibit the sale of natural ephedra if the synthetic form can be sold without a prescription!"[9] Ephedra and pseudoephedrine are precusors to methamphetamine. After ephedra was restricted, sales of pseudoephedrine soared. Sales of decongestants such as Sudafed now have restrictions and are monitored. [edit] Regulatory history in the United States Beginning in the 1990s, concerns about the safety of Ephedra and Ephedra-based products began to be publicly raised in the United States. Concentrated mixtures were found in weight control products marketed as "dietary supplements". Sympathomimetic amines such as ephedrine raise heart rate and blood pressure and can be particularly hazardous to those with pre-existing cardiac problems. After receiving over 800 reports of "adverse events", the country's federal Food and Drug Administration (FDA) proposed regulations in 1997 for a warning label, and a limited dose of 8mg (no more than 24mg per day).[10] After various petitions for and against the regulations, (including complaints about the accuracy of dosage and lack of quality control in the dietary supplement industry [11]) the FDA hired the RAND Corporation to do a study in 2002, [12] and eventually linked 155 deaths to Ephedra, most of them caused by cardiac problems and strokes.[citation needed] In May 2003, the health food store General Nutrition Center announced that they would stop carrying ephedra-containing products as of June 2003. [9] The FDA must approve all drugs before they may be sold in the United States. It considers the risks and benefits of medications for specific medical conditions, may require a doctor's prescription, make labeling requirements, or ban the drug entirely. The burden of proof for safety is on the manufacturer. The Dietary Supplement Health and Education Act of 1994 creates a class of substances known as dietary supplements, which are not subject to pre-approval, and for which the burden of proof is on the government if it wishes to restrict availability. As a traditional herb, Ephedra qualifies as a dietary supplement. On December 30, 2003, the FDA announced a ban (effective 12 April 2004) on the uncontrolled sale of dietary supplements containing Ephedra, citing "an unreasonable risk of illness or injury"[citation needed] from the use of the drug. The active ingredients ephedrine and pseudoephedrine remained available as an ingredient in some over the counter (OTC) medications that are clearly labeled in accordance with FDA regulations. Chemicals created in a laboratory do not qualify as dietary supplements, even if they are the same as those found in natural products. Many advocates maintained that Ephedra was safe in low doses typical of traditional herbal preparations, and that the adverse cardiovascular effects were associated with higher doses. The Nutraceutical Corporation of Park City, Utah, which had been selling a relatively low dose (10mg, compared to 40mg-100mg doses also on the market) sued the FDA. On 14 April 2005, Utah federal district judge Tena Campbell ruled in favor of the company.[13] The ruling stated that because of the 1994 law and Ephedra's status as a dietary supplement, the FDA did not have the statutory authority to require the manufacture to prove that the product offered a benefit, and that it had failed to meet its burden of proof that the 10mg dose posed a sufficient risk. Nutraceutical said that it did not plan to re-introduce Ephedra, and that it had brought the suit merely to protect its other product lines from overzealous regulation by the FDA. The FDA said that it considered further research into the dose-dependent safety of Ephedra to be unethical, given the lack of benefit (other than for short-term weight loss [14]) and potential risk.[15] Critics renewed calls to reform the 1994 dietary supplement law.[16] [17] The state of California banned Ephedra dietary supplements in January 2004, followed by New York and Illinois. These laws are not affected by the federal court decision. [18] [edit] In professional sports In the 1994 FIFA World Cup, the Argentine footballer Diego Armando Maradona tested positive for ephedrine in a doping control for using one dietary supplement product containing the substance. The Japanese motorcycle racer Noriyuki Haga tested positive for it in 2000, being disqualified from two races and banned from two more as a result. The U.S. National Football League banned players from using ephedra as a dietary supplement in 2001 after the death of Minnesota Vikings offensive tackle Korey Stringer. The substance is also banned by the National Basketball Association.[19] Baseball pitcher Steve Bechler of the Baltimore Orioles died in 2003 after taking the supplement that same year. [10] Later that year, his widow filed a $600 million wrongful death lawsuit against the manufacturer.[20] NFL player Todd Sauerbrun of the Denver Broncos was suspended for the first month of the 2006 season after testing positive for the banned supplement ephedra. [edit] See also Ephedra (also known as Ma huang, Chinese Ephedra and epitonin) is the worlds oldest medicine. The Chinese discovered ephedra more than 5000 years ago. Research has shown that ephedra increases metabolism and helps promote weight loss, relaxes the air passages in the lungs to help treat asthma and cough, promotes perspiration to help a person recover from a minor cold and helps promote urination to help relieve edema. Ephedra has been widely researched for its thermogenic (fat burning) properties. Research has show that ephedra helps promote the loss of fat while helping spare lean muscle tissue, a highly sought-after property that prescription diet medications still have not been able to reproduce. Herbal Phen-Fen, a popular herbal formulation used for dieting, is a combination of ephedra and St. Johns Wort. The ECA Stack (ephedra, caffeine, aspirin) has been used by bodybuilders to burn fat, and increase energy. -------------------------------------------------------------------------------- Safety For FDA information on ephedra, please see the ephedra.com FDA page. As ephedra is a stimulant and a thermogenic, it should NOT be used by people / in situations where these properties might be harmful. There are some common sense rules about using ephedra: Do not use ephedra if you have any medical problems as the use of a stimulant might overtax your system. Do not use ephedra if your activity / environment will prevent you from dissipating heat. Your body core temperature might exceed safe levels. And do not take more than the manufacturer's recommended amount. What this means is: If you have a heart condition, do not take ephedra. And if you plan to wear clothes to raise your body temperature, do not take ephedra. And do not think that playing baseball on a hot muggy day will counteract these two common sense conditions and make it okay to take ephedra. -------------------------------------------------------------------------------- Some other common names and terms that people use when searching for information on ephedra: ephedra sinica, ma huang, ephedrine, pseudoephedrine, buy ephedra, efedra, efedrine, mahuang, mahung, guarana, diets, weight loss, asthma, metabolife, energizers, alkaloids, amphetamines, BAT, metabolism, brown fat, brown adipose tissue, caffeine, calories, eca, eac, stack, ecstasy, energy, engergizing, energizer, extreme power plus, fat burners, fat burning, guarana, herbs, herbal, phen-fen, java trim, metabolic, metabolism, metabolite, metabomax, mormon tea, mowrey, natural trim, obesity, omnitrim, overweight, pep, redux, ripped, squaw tea, stacker, stimulants, thermogenesis, thermogenics, thermo-lift, xenadrine, ultimate xphoria, xtc, speed, bronchodilator Email Due to liability concerns, we can not provide any health information regarding ephedra. Also, we no longer have time to respond to individual emails. If you want to share your thoughts about ephedra and your right to being able to buy it, please visit the ephedra forum on yahoo. Thank you for your interest in ephedra.com . Home FAQ Alternatives Diet Drugs Good Karma! News & Research FDA on ephedra Links Patented Formulas Forum Laws Opinion Disclaimer: ephedra.com accepts no responsibility and will not be held liable for the information provided here. The information is intended for educational purposes only, without any assurance of accuracy, and should not be relied upon or used as legal or medical advice. Do not use this information as a substitute for the advice of a licensed health care provider in diagnosing or treating a health problem. Always check with your doctor or pharmacist before making any decisions regarding your health and well-being. Copyright © 2006, ephedra.com This first comment was written just before the FDA's 2004 ban on ephedra. But it is still very applicable, considering the FDA is once again trying to ban ephedra! While ephedra.com does not promote the use of ephedra, it does seek to preserve our freedom of choice. With our sympathy going out to the unfortunate few that did not abuse ephedra but may have suffered an adverse reaction, the following is the opinion of ephedra.com. It's all about the money! Where is the responsible reporting by the news industry when you need it? It started out as a few bad apples (abusers). Then the greedy litigating ambulance chasers saw a way to make money and created a parade of greedy copycat opportunists. And to help sway the opinions of juries, they encouraged everyone they could, especially the news industry, to jump on the ephedra bashing bandwagon. And the pharmaceutical industry took notice. They knew that ephedra (as is true with many natural remedies) was competing with their drug sales. And they figured that by spending a little money on hyping the problems of ephedra (no natural or manufactured remedy is perfect) and some more money in buying off politicians to manipulate the FDA (class action lawsuits had emptied the pockets of the ephedra product manufacturers - the only competing force that would have prevented this), they could get ephedra banned. And they would stand to make a killing from increased sales of their unnatural concoctions. And while we only see the tip of the iceberg - the FDA trying to "protect us" - what we really have is the FDA being manipulated by the industry they supposedly oversee. With the proposed FDA ban, there are more ephedra bashing news articles than ever. So it looks like the news industry wants a piece of ephedra too! Why sell any old news when what really sells is sensationalized bad news! Leave it to the news industry to take the easy road and help throw stones at ephedra rather than investigate, expose the truth and help defend our freedom of choice from the selfish interests that stand to profit from this ban! Say hello to being manipulated and good-by to our freedom of choice! To provide a contrary perspective, ephedra.com provides this page as a resource for published news (and opinion) articles that don't bash ephedra. (If you want to see the bashing articles, just do a search on any search engine for 'ephedra news'.) [ Please click here to send this page to the editors of your local newspapers. ] Consumer advocate, Tim Bolen, has an interesting theory regarding the news media's motivations for bashing ephedra: The anti-EPHEDRA campaign, I believe, was a scam orchestrated by the real quackbusters operating out of that New York ad agency. The whole thing is a well-designed hoax to overturn gains we've made in dietary supplement legislation. All those newspaper articles, and the article in some magazines, etc., weren't the result of investigative journalism - they were PLACED in those publications, by the New York ad agency, as a condition of continued drug advertising in those publications. Why do I think so? Look at the publications in which those articles ran, and you'll see that a significant portion of those pub's income comes from drug ads. Writers and Editors like to get paid. Cancellation of drug ads for the next issue means lay-offs on the editorial staff, right this minute. Historical news on ephedra 4/27/2004 - Not All Ephedra Products Banned by FDA -- Is Politics the Reason? PR Newswire 3/2004 - Is the FDA Gambling with Your Health? by Frank Lampe, Conscious Choice January 2004 - The FDA's latest herbal scapegoat: Ephedra, The many benefits of herbal ephedra Idaho Observer 12/30/03 - Chinese Point Finger and Laugh at Stupid Americans from http://www.thepowerstore.com "Ephedra is gone but it's NOT because it is inherently dangerous. It's because of mass hysteria, misinformation, and class-action lawsuits." 2/21/03 - The Alleged Role of Ephedra in the Death of a Professional Baseball Player Baylor University Department of Health, Human Performance & Recreation If you find a published news article or opinion that doesn't bash ephedra (that's not posted here), please email us the link to it! We will try to post it. Thanks in advance! -------------------------------------------------------------------------------- Other ephedra Articles of Interest: 12/4/03 - National Institutes of Health - Office of Dietary Supplements Ephedra and Ephedrine Alkaloids for Weight Loss and Athletic Performance 3/29/03 - FDA Docket: 95N-0304 Dietary Supplements Containing Ephedrine Alkaloids -------------------------------------------------------------------------------- Supporting information for the above opinion: Jan. 20, 2004 - Chicago Tribune Current published article showing the character of our government officials (with all due respect for our great country), confirming that It's All About the Money - for big business! U.S. stalls U.N. plan to fight obesity (Reuters Health) Research information: Sources of political funding for and against ephedra Ephedra: Guidelines For Dosage And Label Warnings October 2000 The following guidelines for dosage levels and label warnings for ephedra have now been adopted by all of the trade associations for herbal product manufacturers. These guidelines were first drafted in March 1994 by the American Herbal Products Association (AHPA) in close collaboration with the National Nutritional Foods Association (NNFA) and the Utah Natural Products Association (UNPA). This current version was revised in January 2000, and was adopted in August 2000 by the Consumer Health Products Association (CHPA). Serving (dosage) limits Products are not to contain in excess of 25 mg of total ephedrine alkaloids per serving; usage instructions should limit daily consumption to 100 mg of total ephedrine alkaloids. Labeling The label of the goods should bear an adequate cautionary statement, which shall at a minimum include the following language, or comparable language: Not intended for use by anyone under the age of 18. Do not use this product if you are pregnant or nursing. Consult a health care professional before using this product if you have heart disease, thyroid disease, diabetes, high blood pressure, psychiatric condition, difficulty in urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAOI) or any other prescription drug, or you are using an over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products). Exceeding recommended serving will not improve results and may cause serious adverse health effects. Discontinue use and call a health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms. The product label shall list the amount of ephedrine alkaloids per serving. Herbs of Commerce conformity Label identification must be in conformity with the standard common name listed in Herbs of Commerce. Synthetic ingredients Neither finished consumer goods nor raw materials used in their manufacture are to contain any synthetically derived ephedrine alkaloids or their salts (e.g., ephedrine sulfate; pseudoephedrine hydrochloride; phenylpropanolamine hydrochloride). Marketing No claims shall be made that the product may be useful to achieve an altered state of consciousness, euphoria, or as a "legal" alternative for an illicit drug. Note : On February 6th, 2004 The Food and Drug Administration (FDA) issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra) because such supplements present an unreasonable risk of illness or injury. The rule became effective 60 days from the date of publication. On April 14, 2005 a Federal District Court in Utah under Judge Tena Campbell struck down a U.S. Food and Drug Administration ban on ephedra. The ruling is specific only to Utah, although it calls into question the FDA ban in general. The suit in question was brought by the dietary supplement manufacturing company Nutraceutical Corporation. The decision specifically questioned the ability of the FDA to ban ephedra completely without conclusively demonstrating danger at low doses . Although most evidence around the risks associated with ephedra use is based on higher doses or combination use with caffeine, a universal ban was implemented by the FDA, as it would be unethical to conduct human studies of lower doses in order to establish safety. Therefore, Judge Campbell felt there is inadequate safety data at lower doses. This places the FDA in a bind under current dietary supplement regulatory law - it suspects dangers at low doses, but cannot seek to prove these dangers . It remains unclear whether ephedra will find its way back onto shelves, despite widespread acknowledgement of significant safety risks, including serious potential cardiovascular events or death . Ephedra sinica , a species of ephedra (Ma huang), contains the alkaloids ephedrine and pseudoephedrine, which have been found to induce central nervous system stimulation, bronchodilation, and vasoconstriction. In combination with caffeine, ephedrine appears to elicit weight loss (in trials of 1-12 months duration). However, studies of ephedra or ephedrine monotherapy have been equivocal. The majority of human trials of weight loss have been small with methodological weaknesses including large dropout rates due to adverse effects, and incomplete reporting of blinding or randomization. Numerous trials have documented the efficacy of ephedrine in the management of asthmatic bronchoconstriction and hypotension. However, commercial preparations of non-prescription supplements containing ephedra have not been systematically studied for these indications. Major safety concerns have been associated with ephedra or ephedrine use, including hypertension, tachycardia, CNS excitation, arrhythmia, myocardial infarction, and stroke. In 1997, due to over 800 U.S. reports of serious toxicity (and many more worldwide) including at least 22 deaths in adolescents and young adults, the U.S. Food and Drug Administration (FDA) adopted a policy that ephedra-containing products must: (1) be labeled with all possible adverse effects, including death; (2) contain no more than 8mg of ephedrine per serving; and (3) be used for no more than seven days. The FDA also proposed a maximum daily dose of 24mg, and a ban on ephedra-caffeine combination products (these proposed limits were subsequently withdrawn). In 2002, Samenuk et al. identified 926 cases of possible ephedra toxicity reported to the Adverse Reaction Monitoring System of the FDA between 1995-1997. In 37 patients, use of ephedra was temporally related to stroke (16 patients), myocardial infarction (10), or sudden death (11). Autopsies performed in patients who experienced sudden death showed a normal heart in one, coronary atherosclerosis in three, and cardiomyopathies in three. In 36 of the 37 patients, use of ephedra was reported to be within the manufacturers' dosing guidelines. In 2003, a report was prepared by Shekelle et al. on behalf of the RAND Southern California Evidence-based Practice Center for the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. This study reviewed available clinical trials, as well as more than 1,500 adverse event reports to the FDA and adverse event reports to the manufacturer Metabolife. Although most prospective trials were not sufficiently large and most adverse event reports were not sufficiently detailed, the authors identified three deaths, two myocardial infarctions, two cerebrovascular accidents, one seizure, and three psychiatric cases that were considered to be "sentinel events" (i.e., strongly tied to ephedra use within 24 hours without other plausible explanations). In addition, 50 other possible sentinel events were identified. A 2003 analysis by Bent et al. in Annals of Internal Medicine found that products containing ephedra account for 64% of all adverse reactions to herbs in the United States, but only represent 0.82% of herbal product sales. The relative risk for an adverse reaction in a person using ephedra compared with other herbs was extremely high, ranging from 100 (95% CI, 83 to 140) for kava to 720 (95% CI, 520 to 1100) for Ginkgo biloba . It was concluded that ephedra use poses a greatly increased risk of adverse reactions compared with other herbs. A 2003 analysis published in Neurology also found increased risk of stroke associated with ephedra-containing products. Despite widely publicized safety concerns and the highly publicized 2003 death of a U.S. major league baseball pitcher thought to be related to ephedra, prior to the ban on ephedra, 14% of individuals using non-prescription weight-loss products in the U.S. continued to take ephedra or ephedrine-containing products. back to top Synonyms 4-hydroxy-3-(3-methyl-2-butenyl)phenyl beta-D-glucopyranoside, (nebrodenside A), Amsania, brigham tea, budshur, cao Ma huang (Chinese), chewa, Chinese ephedra, Chinese joint fir, desert herb, E. altissima, E. americana, E. anti-syphilitica, E. distacha, E. distachya, E. equisetina (Mongolian Ephedra), E. geradiana, E. helvetica, E. intermedia (intermediate ephedra), E. likiangensis, E. major, E. minuta, E. monosperma, E. nevadensis, E. przewalskii, E. sinica, E. shennungiana, E. trifurca, E. viridis, E. vulgaris, Ephedraceae (family), ephedra alkaloids, Ephedra distachya, Ephedra intermedia, Ephedra nebrodensis, Ephedra przewalskii, Ephedra regeliana, Ephedra sinica Ephedra soup medicines, Ephedrae herba, ephedrine, ephedrine hydrochloride, ephedrine sulphate, ephedroid, epicatechin, epitonin, European ephedra, herba ephedrae, horsetail, hum, huma, Indian joint fir, intermediate ephedra, joint fir, khama, mahoang, mahuang, "Mao" (Chinese), mao-kon, mahuuanggen, methylephedine, methylephedrine, methylpseudoephedine, Mexican tea, m;ocirc;c tac ma hoang, Mongolian ephedra, Mormon tea, mu-tsei-ma-huang, muzei mu huang, natural ecstasy, neuropeptide Y, norephedrine, norpseudoephedrine, O-coumaric acid beta-D-glucopyranoside, (nebrodenside B), O-coumaric acid glucoside, phok, popotillo, pseudoephedrine, san-ma-huang, sea grape, shrubby, soma, song tue ma hoang, squaw tea, teamster's tea, trun aa hoang, tsao-ma-huang, tutgantha, yellow astringent, yellow horse, zhong Ma huang. Note : There are approximately 40 species of ephedra. Multi-ingredient preparations containing ephedra : Acceleration, AllerClear, AllerPlus, Andro Heat, Better BodyEnergy for Life, Bio Trim, Biovital Plus, Bladderwrack-Dandelion Virtue, Breathe-Aid Formula, Breath Easy, Cordephrine XC, Diet Fuel, Dymetadrine Xtrem, EPH-833, Ephedra Plus, Thermogen, Guarana-Gotu Kola Virtue, Herba Fuel, Herbal Decongestant Expectorant Capsules, Herbalife - Thermojetics Original Green, Mao-Bushi-Saishin-To, Metabolife 356, Metabolift, Metaboloss, MetaboTRIM, Naturafed, Naturally Ripped, Naturatussin 1, Nettle-Reishi Virtue, Power Thin, ProLab Stoked, Pro-Ripped Ephedra, Respa-Herb, Respiratory Support Formula, Ripped Fuel, SinuCheck, SinuClear, SnoreStop, Thermadrene, Thermic Blast, Thermicore, Thermo Cuts, ThermoDiet, Ultra Diet Pep, Xenadrine RFA-1. back to top Evidence These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. Uses based on scientific evidence Grade* Weight loss Ephedra contains the chemical ephedrine, which appears to cause weight loss when used in combination with caffeine, based on the available scientific evidence. The results of research on ephedrine alone without caffeine are unclear. The amounts of ephedrine in commercially available products has widely varied. A Bronchodilator (asthma) Ephedra contains the chemicals ephedrine and pseudoephedrine which are bronchodilators (expand the airways to assist in easier breathing). It has been used and studied to treat asthma and chronic obstructive pulmonary disease in both children and adults. Other treatments such as beta-agonist inhalers (for example, albuterol) are more commonly recommended due to safety concerns with ephedra or ephedrine. B Allergic nasal symptoms (used as a nose wash) Preliminary study suggests that ephedrine nasal spray, a chemical in ephedra, may help treat symptoms of nasal allergies. Additional research is needed before a recommendation can be made. C Low blood pressure Chemicals in ephedra can stimulate the heart, increase heart rate, and raise blood pressure: Ephedrine, a component of ephedra, is sometimes used in hospitals to help control blood pressure. However, the effects of over-the-counter ephedra supplements taken by mouth are not well described in this area. C Sexual arousal One small study suggests that ephedra may increase sexual arousal in women. Further well designed research is needed to confirm these results. C Key to grades A Strong scientific evidence for this use B Good scientific evidence for this use C Unclear scientific evidence for this use D Fair scientific evidence against this use (it may not work) F Strong scientific evidence against this use (it likely does not work) Grading rationale Uses based on tradition or theory The below uses are based on tradition or scientific theories. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. Acute coryza (rhinitis), anaphylaxis (a severe allergic reaction), anti-inflammatory, antiviral, appetite suppressant, athletic performance enhancer, bed-wetting, body building, chills, colds, congenital myasthenic syndrome, cough, decongestant, depression, diuretic, dyspnea (shortness of breath), edema, energy enhancer, euphoria, fevers, flu, gonorrhea, gout, hay fever, hives, increased sweating, joint pain, kidney disease, lack of perspiration, metabolic enhancement, myasthenia gravis, narcolepsy, nasal congestion, nephritis, performance enhancement, runny nose, shortness of breath, stimulation of energy, syphilis, stimulant, upper respiratory tract infections, urticaria (rash), uterine stimulant, water retention. back to top Dosing The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy. Standardization Standardization involves measuring the amount of certain chemicals in products to try to make different preparations similar to each other. It is not always known if the chemicals being measured are the "active" ingredients. There is wide variability in the alkaloid content of different preparations of ephedra. A 1998 study by Gurley et al. examined the pseudoephedrine and ephedrine content of nine commercially available nutritional supplements containing Ephedra sinica . Significant variations in content were found for pseudoephedrine ranging from 0.52-9.46mg and for ephedrine from 1.08-13.54mg per recommended dose. A 1992 study by Liu et al. was conducted by collecting 22 different ephedra products from herbal shops throughout Taiwan. A four-fold difference was found in the amounts of the various alkaloids, ranging from 0.536-2.308%. Average ephedra supplement content is 1% of the crude plant. Different ephedra species, yielding markedly different quantities of active alkaloids, are all sold as Ma huang in China, leading to difficulties for consumers trying to find standardized products. Ephedra sinica plants grown in northern China often have a different morphology and alkaloid content from the same species grown in southern China. Adult Dosing (18 years or older): Note : The United States Federal Government announced on Tuesday December 30, 2003 that it is banning the sale of ephedra early in 2004. Consumers are urged to stop using the herbal weight control supplement immediately as it has been linked to numerous adverse health effects including death. Controversy regarding dosing : There is disagreement regarding the optimal form and dose of ephedra. Traditionally, herbalists have recommended a wide range of doses, which are typically higher than U.S. Food and Drug Administration (FDA) recommendations. In the past, the FDA has recommended a maximum of 8mg up to every six hours (total daily dose of 24mg) for up to seven days. However, doses up to 25mg of total ephedra alkaloids four times daily have been recommended by some experts, and doses in some studies have been as high as 50-100mg of ephedra three times daily. Over-the-counter drugs containing ephedra generally contain warning labels advising adults to take 12.5-25mg every four to six hours, and not to exceed 150mg in 24 hours. Weight loss : In the past, the FDA has recommended no greater than 8mg every six hours for up to seven days. Doses used in some clinical trials have been 25-50mg three times daily. Pediatric Dosing (younger than 18 years): Ephedrine is not recommended in children due to the risk of toxicity and death. Purified ephedrine has been given to children older than two years of age in doses of 2-3mg/kg/day divided into 4-6 daily doses in hospital settings. back to top Safety The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects. Allergies Persons with a known allergy to ephedra, ephedrine or pseudoephedrine (Sudafed®) should avoid ephedra. Side Effects and Warnings The Food and Drug Administration (FDA) has collected thousands of reports of serious toxicity (including over 100 deaths). On December 30, 2003, U.S. federal officials announced plans to ban the sale of dietary supplements containing ephedra, due to continued and growing health concerns. The FDA notified more than 60 companies that market ephedra products, and issued a consumer warning. On February 6 th , 2004 The FDA issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra) because such supplements present an unreasonable risk of illness or injury. The rule became effective 60 days from the date of publication. Some people may experience abdominal discomfort (nausea, vomiting, diarrhea, loss of appetite, constipation), anxiety, dizziness, headache, tremor, insomnia, dry mouth, delirium, or fainting. Ephedra may also cause irritability, euphoria, hallucinations, seizures, or stroke, as well as low potassium levels in the blood, exaggerated reflexes, weakness, muscle aches, muscle damage, depression, mania, agitation, suicidal ideas, or Parkinson's disease-like symptoms. Persons with prior strokes or transient ischemic attacks (TIAs/"mini-strokes"), tremor, or insomnia should avoid ephedra. Individuals with a history of a psychiatric illness, especially if treated with monoamine oxidase inhibitors (MAOIs), must first discuss ephedra with a qualified healthcare provider before taking supplements. Examples of MAOIs include isocarboxazid (Marplan®), phenelzine (Nardil®), and tranylcypromine (Parnate®). Ephedra can cause chest tightness, irregular heart rhythms, damage to the heart muscle, high blood pressure, heart attack, inflammation of the heart, fluid retention in the lungs, breathing difficulties, dilated cardiomyopathy left ventricular systolic dysfunction, coronary dissection, thrombosis, or cardiac arrest. Ephedra should be used with extreme caution in persons with a history of heart disease, heart rate disorders, or high blood pressure. Other side effects may include liver damage, kidney stones, difficulty passing urine or pain when urinating, increased urine production, or contractions of the uterus. These potential effects may limit the use of ephedra by people with kidney disease or enlarged prostate. Individuals with thyroid gland disorders or glaucoma should use ephedra cautiously. In theory, ephedra may lower blood sugar levels. Caution is advised in patients with diabetes or hypoglycemia, and in those taking drugs, herbs, or supplements that affect blood sugar. Serum glucose levels may need to be monitored by a qualified healthcare provider, and medication adjustments may be necessary. When used for prolonged periods, even at recommended doses, ephedra may lead to weight loss, difficulty sleeping, anxiety, obsessive compulsive disorder (OCD) flare, high blood pressure, dry mouth, irregular heart rhythms, and heart damage. It has been recommended that ephedra, Ma huang, use be stopped at least one week prior to major surgical or diagnostic procedures.

MayoClinic.com Bookstore Diseases & ConditionsDrugs & SupplementsTreatment DecisionsHealthy LivingAsk a SpecialistHealth Tools Home Log in Register now RSS DRUGS & SUPPLEMENTS Advertising and sponsorship policy Aug 11, 2006 DENVER - A federal appeals panel appeared to support the FDA's basis for banning ephedra and to reject a Utah court opinion that the prohibition runs afoul of dietary supplements law. At a Monday hearing in Denver, judges for the 10th Circuit Court of Appeals questioned two key conclusions of the Utah court: that the FDA lacked the scientific evidence to show the amphetamine-like substance is dangerous at any dose, and that the agency was wrong to weigh the risks and benefits before deciding ephedra supplements pose an unreasonable risk of injury or illness. Those arguments were reiterated Monday by Jonathan Emord, an attorney for Park City-based Nutraceutical Corp., the company that in April 2004 convinced U.S. District Judge Tena Campbell the ban was flawed. The appeals court, however, wasn't so agreeable. "How can you determine unreasonable risk without that balancing act?" asked Justice Paul J. Kelly Jr. When Emord insisted federal law does not require supplement makers to show any benefit before selling their products, Kelly pounced. "Are you suggesting that just because it's a supplement, they can put out stuff that poisons people?" Emord countered that there is no evidence ephedra-based supplements, when taken in doses of 10 milligrams a day or less, is harmful, much less poisonous. He noted that the ban specifically excludes tea and other foods that contain ephedra. And he emphasized that salt and water are toxic at some level. "But we can't just willy-nilly ban those things," Emord said. Even FDA attorney Christine Kohl acknowledged there are no clinical studies showing low doses of ephedra pose an unreasonable risk of illness or injury. But she argued that is because current law does not require supplements be proved safe before they can be marketed. With no such research to rely on, the FDA did the next best thing, Kohl said. The agency hired an expert to examine studies on epinephrine, a drug in the same pharmacological class as ephedra. The FDA also relied on some 19,000 reports of "adverse incidents" involving ephedra supplements, such as heart failure, high blood pressure and death. Emord argued the report submitted by the FDA's expert did not meet the standard necessary to ban a dietary supplement. But Kelly seemed uncomfortable with Emord's suggestion that, when it comes to whether science supports an all-out ban on ephedra, the court - not the FDA - should judge the quality of the research. After the hearing, Emord shrugged off suggestions that the panel was unsympathetic to his arguments, saying he has learned not to read too much into the judges' questions. But he warned that, should Campbell's ruling be overturned, the FDA would be free to ban everything from peanut butter to Vitamin C. "The principle in this case is vital," he said. "If the government wins, we will all be at the mercy of the FDA." lfantin@sltrib.com EPHEDRA Uses: BIOLEAN® is a unique combination of Chinese herbal extracts and pharmaceutical-grade amino acids specifically designed to help raise overall health, participate in individual life extension programs, and enhance athletic performance. It has been shown to be extremely effective in promoting the healthy loss of excess body fat while helping to maintain lean body mass and potent energy levels. BIOLEAN, when used as a daily nutritional supplement, has also been shown to stimulate immune function in individuals with blunted sympathetic nervous systems, especially overweight and obese persons. It acts as a positive stimulator to immune functions involved in protection from environmental and dietary carcinogens. Components in BIOLEAN are known to cause fat loss through thermogenic activity and altered fuel metabolism resulting from sympathomimetic response to stimulation of beta receptors in adipose and muscle cells. The positive immune response, though not completely understood, is at least partially attributable to beta stimulation in adipocytes and the adaptogenic and tonifying activity of certain herbal extracts. This has been demonstrated in their long history of use in traditional Chinese herbal medicine as well as current scientific research which points to, among other possibilities, the extremely potent antioxidant properties found in some of the component plants, most notably in Green Tea and Schizandrae extracts. BIOLEAN may increase athletic performance and endurance through three pathways: 1) increased oxygen uptake in the lungs as a result of expanding bronchial passages; 2) enhanced mental acuity and response resulting from sympathetic nervous system stimulus; and 3) increasing the employment of fatty acids as fuel in muscle mitochondria while simultaneously sparing muscle glycogen and nitrogen. The herbal extracts in BIOLEAN are produced in a unique and exclusive process which is proprietary to this product. Instead of creating extracts based on a set quantity of one particular active within many which may be present in any particular plant, BIOLEAN components are concentrated to maintain the natural and complete spectrum of biologically active factors, in the same ratio presented by the unprocessed plant. Directions: AM Serving - Adults take one white tablet and two green tablets with low calorie food. PM Serving - Adults may take one green tablet with low calorie food. If using BIOLEAN dietary supplement for the first time, limit daily intake to one white tablet and one green tablet on days one and two, and one white tablet and two green tablets on day three. Needs vary with each individual. This product has a maximum of 25mg concentrated ephedrine group alkaloids per serving in the form of herbal extracts. Warnings: Not for use by children under the age of 18. If you are pregnant or nursing, if you have heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAOI) or any other prescription drug or over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products), consult a health professional before using this product. Exceeding recommended serving may cause serious adverse effects. Taking this product with other stimulants such as caffeine may cause serious side effects. Discontinue use and call a health professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms. Phenylketonurics: Contains phenylalanine. The maximum recommended daily dosage of ephedrine for a healthy, human adult is 100 mg, for not more than 12 weeks. Ingredients: Calcium (as calcium carbonate, dicalcium phosphate anhydrous), Ephedra Alkaloids (as ma haung), Caffeine (as green tea leaf), Schizandrae berry, Rehmannia root, Hawthorne berry, Jujube seed, Alisma root, Angelicae dahuricae root, Epemidium, Poria Cocos, Rhizoma rhei, Angelicae sinensis root, Codonopsis root, Euconium bark, Notoginseng root, L-phenylalanine, L-tyrosine, L-carnitine 85%, Cellulose, Stearic acid, Starch, Sodium lauryl sulfate, Hydroxypropyl cellulose, Magnesium stearate, Crosscarmelose sodium and Silicon dioxide. How Supplied: One box contains 28 packets (28 daily servings), with one white tablet and three green tablets per packet. This article is about the use of species of Ephedra in medicine. For botanical information, see Ephedra (genus). Species of Ephedra have traditionally been used by indigenous people for a variety of medicinal purposes, and are a likely candidate for the Soma plant of Indo-Iranian religion. Also known as ma huang, it was used in traditional Chinese medicine up to 5,000 years ago, probably for the treatment of asthma and hay fever. In the late 1900s, it was used as a stimulant and a dieting aid. Due to the risk of adverse effects on the cardiovascular system, Western medical professionals recommend against the consumption of any ephedra.[1] Contents [hide] 1 Chemistry 2 Effects 3 Safety 4 Regulatory history in the United States 5 In professional sports 6 See also 7 External links 8 References [edit] Chemistry The alkaloids ephedrine and pseudoephedrine are the active constituents of the plant. Pseudoephedrine is used in over-the-counter decongestants. Ephedrine is used to treat low blood pressure, but alternatives with reduced cardiovascular risk have replaced it for treating asthma. It is also considered a performance-enhancing drug and is prohibited in most competitive sports. Some species in the Ephedra genus have zero alkaloid content and are therefore essentially inert, however the most commonly used species, Ephedra sinica, has a total alkaloid content of 1–3% by dry weight. Ephedrine constitutes 40–90% of the alkaloid content, with the remainder consisting of pseudoephedrine and the demethylated forms of each [2]. [edit] Effects Ephedra is both a stimulant (similar to adrenaline) and a thermogenic. It stimulates the brain, increases heart rate, constricts blood vessels (increasing blood pressure), and expands bronchial tubes (making breathing easier). Its thermogenic properties cause an increase in metabolism, evidenced by an increase in body heat. Side effects of ephedra may include irritability, nervousness, dizziness, trembling, headache, vomiting and hyperthermia. Chemical dependence may also develop. [edit] Safety Please expand and improve this section as described on this article's talk page or at Requests for expansion, then remove this message. Just like other stimulants such as Ritalin[3], in high doses ephedra can cause heart attacks, stroke, and seizures[4]. Yet, because ephedra is unregulated and because its primary use is now for weight-loss, there is additional concern about safety due to dieters taking more than the recommended amount, hoping to lose weight faster. The FDA maintains that "[ephedra] is dangerous at any dose"[5]. But there are many people including experienced users of ephedra[6] who don't agree with the FDA. One popular website with a focus on ephedra puts questions the FDA's recommendation, asking, "If ephedra is as dangerous as the FDA claims it is, given that the Chinese have been using it for 5,000 years, shouldn't they have experienced enough adverse events to be wary of it? If the FDA is so forceful in its opinion that any amount of natural ephedra is harmful, why does it allow you to buy Big Pharma's synthetic versions of ephedra, 240mg pseudoephedrine[7] and 25mg ephedrine[8] without a prescription? Unless natural ephedra is more dangerous than its synthetic form, it's disingenuous to prohibit the sale of natural ephedra if the synthetic form can be sold without a prescription!"[9] Ephedra and pseudoephedrine are precusors to methamphetamine. After ephedra was restricted, sales of pseudoephedrine soared. Sales of decongestants such as Sudafed now have restrictions and are monitored. [edit] Regulatory history in the United States Beginning in the 1990s, concerns about the safety of Ephedra and Ephedra-based products began to be publicly raised in the United States. Concentrated mixtures were found in weight control products marketed as "dietary supplements". Sympathomimetic amines such as ephedrine raise heart rate and blood pressure and can be particularly hazardous to those with pre-existing cardiac problems. After receiving over 800 reports of "adverse events", the country's federal Food and Drug Administration (FDA) proposed regulations in 1997 for a warning label, and a limited dose of 8mg (no more than 24mg per day).[10] After various petitions for and against the regulations, (including complaints about the accuracy of dosage and lack of quality control in the dietary supplement industry [11]) the FDA hired the RAND Corporation to do a study in 2002, [12] and eventually linked 155 deaths to Ephedra, most of them caused by cardiac problems and strokes.[citation needed] In May 2003, the health food store General Nutrition Center announced that they would stop carrying ephedra-containing products as of June 2003. [9] The FDA must approve all drugs before they may be sold in the United States. It considers the risks and benefits of medications for specific medical conditions, may require a doctor's prescription, make labeling requirements, or ban the drug entirely. The burden of proof for safety is on the manufacturer. The Dietary Supplement Health and Education Act of 1994 creates a class of substances known as dietary supplements, which are not subject to pre-approval, and for which the burden of proof is on the government if it wishes to restrict availability. As a traditional herb, Ephedra qualifies as a dietary supplement. On December 30, 2003, the FDA announced a ban (effective 12 April 2004) on the uncontrolled sale of dietary supplements containing Ephedra, citing "an unreasonable risk of illness or injury"[citation needed] from the use of the drug. The active ingredients ephedrine and pseudoephedrine remained available as an ingredient in some over the counter (OTC) medications that are clearly labeled in accordance with FDA regulations. Chemicals created in a laboratory do not qualify as dietary supplements, even if they are the same as those found in natural products. Many advocates maintained that Ephedra was safe in low doses typical of traditional herbal preparations, and that the adverse cardiovascular effects were associated with higher doses. The Nutraceutical Corporation of Park City, Utah, which had been selling a relatively low dose (10mg, compared to 40mg-100mg doses also on the market) sued the FDA. On 14 April 2005, Utah federal district judge Tena Campbell ruled in favor of the company.[13] The ruling stated that because of the 1994 law and Ephedra's status as a dietary supplement, the FDA did not have the statutory authority to require the manufacture to prove that the product offered a benefit, and that it had failed to meet its burden of proof that the 10mg dose posed a sufficient risk. Nutraceutical said that it did not plan to re-introduce Ephedra, and that it had brought the suit merely to protect its other product lines from overzealous regulation by the FDA. The FDA said that it considered further research into the dose-dependent safety of Ephedra to be unethical, given the lack of benefit (other than for short-term weight loss [14]) and potential risk.[15] Critics renewed calls to reform the 1994 dietary supplement law.[16] [17] The state of California banned Ephedra dietary supplements in January 2004, followed by New York and Illinois. These laws are not affected by the federal court decision. [18] [edit] In professional sports In the 1994 FIFA World Cup, the Argentine footballer Diego Armando Maradona tested positive for ephedrine in a doping control for using one dietary supplement product containing the substance. The Japanese motorcycle racer Noriyuki Haga tested positive for it in 2000, being disqualified from two races and banned from two more as a result. The U.S. National Football League banned players from using ephedra as a dietary supplement in 2001 after the death of Minnesota Vikings offensive tackle Korey Stringer. The substance is also banned by the National Basketball Association.[19] Baseball pitcher Steve Bechler of the Baltimore Orioles died in 2003 after taking the supplement that same year. [10] Later that year, his widow filed a $600 million wrongful death lawsuit against the manufacturer.[20] NFL player Todd Sauerbrun of the Denver Broncos was suspended for the first month of the 2006 season after testing positive for the banned supplement ephedra. [edit] See also The following guidelines for dosage levels and label warnings for ephedra have now been adopted by all of the trade associations for herbal product manufacturers. These guidelines were first drafted in March 1994 by the American Herbal Products Association (AHPA) in close collaboration with the National Nutritional Foods Association (NNFA) and the Utah Natural Products Association (UNPA). This current version was revised in January 2000, and was adopted in August 2000 by the Consumer Health Products Association (CHPA). Serving (dosage) limits Products are not to contain in excess of 25 mg of total ephedrine alkaloids per serving; usage instructions should limit daily consumption to 100 mg of total ephedrine alkaloids. Labeling The label of the goods should bear an adequate cautionary statement, which shall at a minimum include the following language, or comparable language: Not intended for use by anyone under the age of 18. Do not use this product if you are pregnant or nursing. Consult a health care professional before using this product if you have heart disease, thyroid disease, diabetes, high blood pressure, psychiatric condition, difficulty in urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAOI) or any other prescription drug, or you are using an over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products). Exceeding recommended serving will not improve results and may cause serious adverse health effects. Discontinue use and call a health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms. The product label shall list the amount of ephedrine alkaloids per serving. Herbs of Commerce conformity Label identification must be in conformity with the standard common name listed in Herbs of Commerce. Synthetic ingredients Neither finished consumer goods nor raw materials used in their manufacture are to contain any synthetically derived ephedrine alkaloids or their salts (e.g., ephedrine sulfate; pseudoephedrine hydrochloride; phenylpropanolamine hydrochloride). Marketing No claims shall be made that the product may be useful to achieve an altered state of consciousness, euphoria, or as a "legal" alternative for an illicit drug. EPHEDRA Uses: BIOLEAN® is a unique combination of Chinese herbal extracts and pharmaceutical-grade amino acids specifically designed to help raise overall health, participate in individual life extension programs, and enhance athletic performance. It has been shown to be extremely effective in promoting the healthy loss of excess body fat while helping to maintain lean body mass and potent energy levels. BIOLEAN, when used as a daily nutritional supplement, has also been shown to stimulate immune function in individuals with blunted sympathetic nervous systems, especially overweight and obese persons. It acts as a positive stimulator to immune functions involved in protection from environmental and dietary carcinogens. Components in BIOLEAN are known to cause fat loss through thermogenic activity and altered fuel metabolism resulting from sympathomimetic response to stimulation of beta receptors in adipose and muscle cells. The positive immune response, though not completely understood, is at least partially attributable to beta stimulation in adipocytes and the adaptogenic and tonifying activity of certain herbal extracts. This has been demonstrated in their long history of use in traditional Chinese herbal medicine as well as current scientific research which points to, among other possibilities, the extremely potent antioxidant properties found in some of the component plants, most notably in Green Tea and Schizandrae extracts. BIOLEAN may increase athletic performance and endurance through three pathways: 1) increased oxygen uptake in the lungs as a result of expanding bronchial passages; 2) enhanced mental acuity and response resulting from sympathetic nervous system stimulus; and 3) increasing the employment of fatty acids as fuel in muscle mitochondria while simultaneously sparing muscle glycogen and nitrogen. The herbal extracts in BIOLEAN are produced in a unique and exclusive process which is proprietary to this product. Instead of creating extracts based on a set quantity of one particular active within many which may be present in any particular plant, BIOLEAN components are concentrated to maintain the natural and complete spectrum of biologically active factors, in the same ratio presented by the unprocessed plant. Directions: AM Serving - Adults take one white tablet and two green tablets with low calorie food. PM Serving - Adults may take one green tablet with low calorie food. If using BIOLEAN dietary supplement for the first time, limit daily intake to one white tablet and one green tablet on days one and two, and one white tablet and two green tablets on day three. Needs vary with each individual. This product has a maximum of 25mg concentrated ephedrine group alkaloids per serving in the form of herbal extracts. Warnings: Not for use by children under the age of 18. If you are pregnant or nursing, if you have heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAOI) or any other prescription drug or over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products), consult a health professional before using this product. Exceeding recommended serving may cause serious adverse effects. Taking this product with other stimulants such as caffeine may cause serious side effects. Discontinue use and call a health professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms. Phenylketonurics: Contains phenylalanine. The maximum recommended daily dosage of ephedrine for a healthy, human adult is 100 mg, for not more than 12 weeks. Ingredients: Calcium (as calcium carbonate, dicalcium phosphate anhydrous), Ephedra Alkaloids (as ma haung), Caffeine (as green tea leaf), Schizandrae berry, Rehmannia root, Hawthorne berry, Jujube seed, Alisma root, Angelicae dahuricae root, Epemidium, Poria Cocos, Rhizoma rhei, Angelicae sinensis root, Codonopsis root, Euconium bark, Notoginseng root, L-phenylalanine, L-tyrosine, L-carnitine 85%, Cellulose, Stearic acid, Starch, Sodium lauryl sulfate, Hydroxypropyl cellulose, Magnesium stearate, Crosscarmelose sodium and Silicon dioxide. How Supplied: One box contains 28 packets (28 daily servings), with one white tablet and three green tablets per packet. The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products. Why to buy diet pills ? Beacuse they are the most popular obesity solution, usually combined with an appropriate weight loss plan. People buy diet pills and make them so popular because Obesity is a chronic disease that affects many people. As in other chronic conditions, such as diabetes or high blood pressure, to use diet pills for a long-term use may be helpful. Want to buy diet pills ? here are the types: Prescription & non- prescription. Diet pills with a prescription: When you want to buy diet pills and you need a Prescription, it usually contain a sympathomimetic amine, which is similar to an amphetamine. The sympathomimetic amine stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite. After you buy diet pills from this kind - the process usually leads to fat burning and weight loss. You can buy diet pills with a prescription using an online web prescription and then the most popular ones are : orlistat (Xenical), Phentermine (Adipex) , Sibutramine (Meridia, Reductil) and diethylpropion (tenuate). Diet Pills without a prescription: You can buy diet pills without the need of prescription, and it usually contains a formula of some ingredients that can be based on supplements and herbs. When you buy pills with no prescription - the formula contains special herbs (Hoodia, green tea, guarana, yerba mate and many others) mixed with other vitamins & minerals such vitamin A, B, magnesium, calcium, chrome etc. These special herbs increase metabolism, reduce appetite and help your body to burn fat and lose weight. You can also buy diet pills with no prescription also through the internet. you can find them in many brand names, while each product can be different by its ingredients and their mixture. You can buy diet pills without prescription as OTC (Over-the-counter) drugs or as supplements. Want to get results in your weight loss? Don't know which diet pill to choose? The prescription free diet pills market is huge and if you don't want to get confused – you must determine your purposes. Don't forget that all products are herbal based and don't need prescription or doctor consultation. Our dietitian reviewed the web, searching for the "best Mixed" prescription-free diet pill, containing the best ingredients according to their category: • Control appetite – when you want to reduce your hunger and eat less • Block carbohydrate – when you feel the desire for carbs and want to reduce it • Increase metabolism – helping your body to burn more fat • Increase energy – when you want to have more energy that will help you burn more fat We ranked V in each category that the product is helping and V V when the product is best in this category. Then we collected responses from users like you in order to see what really worked for them. We did not rank products with Ephedrine because According to the FDA, ephedrine can cause serious side effects and may be harmful for your body. We got into 4 leading prescription free products that are best in results for losing weight. Prescription free diet pills Rank Best Choice 2 3 4 Diet Pill Brand Phentirmine HCL Lipitrex Dietrine Carb blocker Hoodia Control appetite V V V V Block carbohydrates V V Increase metabolism V V Increase energy V V V V Major Ingredients • Dicalium phosphate • Bitter orange • Guarana Learn more • CLA (conjugated linoleic acid) • PinnoThin - obtained from a special oriental pine tree nut • Citrus Aurantium Extract (bitter orange) • Chromium Learn more • Phase 2® - nutritional ingredient derived from the white kidney bean through a proprietary process Learn more • Famous south African Hoodia Gordonii planet Learn more Dietitian Score 9.6 9.4 8.8 8.6 Users Score 9.6 9.8 9 8.9 Monthly cost $ (When you buy 3 months supply) 33$ 56$ 30$ 30$ Products description – all of them are prescription free and herbal based only: Rank 1 - Our best Choice – Phentirmine HCL Phentirmine HCL is specially formulated to provide effects similar to the most prescription weight loss medication. The Phentirmine HCL is a pharmaceutical grade appetite suppressant that promoted less hunger while promoting more energy and metabolism. main ingredients : Bitter orange – is also known as citrus aurantium or neroli. Bitter orange has bee used in Traditional Chinese Medicine to stimulate gastrointestinal functions, Bitter orange contains several substances known to stimulate metabolic rate, which should increase calorie burning. Guarana -Caffeine is the effective ingredient in guarana plant seeds. Guarana may have a mild appetite suppressant effect over the short term. Guarana will increase your metabolism, and will help you to burn more fat. Best usage when You want to eat less but you must also increase your metabolism and energy in order to help the body burn more fat. Click here to buy phentirmine HCL. Rank 2 - Lipitrex Lipitrex is a formula that will help you control over your cravings and begin to reduce calories by eliminating those tempting, empty calorie foods. Studies have confirmed that the ingredients found in Lipitrex are capable of curbing appetite, while promoting a positive reduction of embarrassing body fat! main ingredients : PinnoThin - This natural ingredient, obtained from a special oriental pine tree nut, can help stimulate the release of a hunger-suppressing hormone help you control your appetite CLA (conjugated linoleic acid) is a natural fatty acid that interferes with a specific enzyme in your body that is responsible for depositing and storing fat, Decreases abdominal fat and helps your body to build lean muscle tissue. Citrus Aurantium Extract (bitter orange) - This natural fruit has been extensively studied for its ability to provide increases in the body’s metabolic rate Chromium - helping to regulate glucose (sugar) levels in the blood stream, and believed to play a role in the burning of fat and promoting lean body tissue. Vitamin B-5, B-6 and Caffeine - help to burn dietary fats and carbohydrates Best usage when Your endless appetite is the real problem, and you want to focus in eating less - in order to lose weight. Click here to buy Liprtrex. Rank 3 – Dietrine Carb Blocker Dietrine Carb Blocker is a 100% safe and stimulant free natural product that will allow you to indulge on occasion without having to feel guilty about eating starchy foods. Dietrine Carb Blocker Is designed to Block Carbohydrates, Control Carb Cravings, Boost Energy levels and Block Fats from your body. It works by "neutralizes" the digestive enzyme alpha amylase before it can convert starch into glucose and then fat. Main ingredient : Phase 2® is an amazing, non-stimulant, all-natural nutritional ingredient that is derived from the white kidney bean through a proprietary process Best usage when You want to get control on your carb craving which will then make the weight loss diet easy. Click here to buy Dietrine Carb Blocker. Rank 4 – Hoodia 750 Hoodia 750 is an all natural appetite suppressant that helps kill the appetite, suppress food cravings, reduce calorie intake and help you lose weight by not overeating. Ingredients : Hoodia 750 is made of pure famous South-African Hoodia Goorodnii planet. Hoodia Goorodnii works by tricking the brain into thinking the body is full even if it is not. When a person eats, the body produces glucose which sends a signal to the hypothalamus of the brain to tell it that the body received food, thus the body feels less hunger. Hoodia acts just like glucose, eliminating the feeling of hunger for extanded periods of time. Best usage when You want to decrease your appetite, using the Hoodia planet' like millions have done before. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. Suggested Citation: Shekelle P, Morton, S., Maglione M, et al. Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects. Evidence Report/Technology Assessment No. 76 (Prepared by Southern California Evidence-based Practice Center, RAND, under Contract No 290-97-0001, Task Order No. 9). AHRQ Publication No. 03-E022. Rockville, MD: Agency for Healthcare Research and Quality. February 2003. Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review prior to their release. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. We welcome written comments on this evidence report. They may be sent to: Director, Center for Practice and Technology Assessment, Agency for Healthcare Research and Quality, 6010 Executive Blvd., Suite 300, Rockville, MD 20852. Carolyn M. Clancy, M.D. Director Agency for Healthcare Research and Quality Jean Slutsky, P.A., M.S.P.H. Acting Director, Center for Practice and Technology Assessment Agency for Healthcare Research and Quality Acknowledgment We would like to thank Dr. Lori Love and Ms. Constance J. Hardy of the Food and Drug Administration for providing us with adverse event reports related to ephedra. We thank Dr. Catherine MacLean, a rheumatologist, and Dr. Barbara Vickrey, a neurologist, for providing advice on cases related to their fields. We thank Drs. Karen Miotto, a psychiatrist, and Martin Iguchi, a psychologist, for review of psychiatric case reports. We thank Ms. Birgit Danila, MA, for translation of Danish studies. Summary Overview At the direction of the funding agencies (National Institute of Health Office of Dietary Supplements (ODS), the National Center for Complementary and Alternative Medicine (NCCAM), and the Agency for Healthcare Research and Quality (AHRQ)), and in consultation with our Technical Expert Panel, we addressed research questions regarding the efficacy of herbal ephedra and ephedrine for weight loss and athletic performance through a comprehensive literature review and synthesis of evidence. We assessed the safety of these products through review of clinical trials. Meta-analysis was performed where appropriate. In addition, we reviewed herbal ephedra- and ephedrine-related adverse events reports on file with the U.S. Food and Drug Administration (FDA), published case reports, and reports to a manufacturer of ephedra-containing products. It is expected that the results of this review will be used to direct further research. Reporting the Evidence The following questions were provided to us by the funding agencies and guided this evidence report. Weight Loss What is the evidence for efficacy of ephedra-containing dietary supplement products in weight loss, over a sustained period of time? Can efficacy for weight loss be attributed to ephedra alone, or ephedra in combination with other ingredients (e.g., caffeine)? Does ephedra have additive effects with other agents? What dosage levels of ephedra are necessary to achieve weight loss? Athletic Performance What is the evidence for efficacy of ephedra-containing dietary supplement products in terms of energy enhancement and enhancement of athletic performance, over a sustained period of time? Can efficacy for energy enhancement and enhancement of athletic performance be attributed to ephedra alone, or ephedra in combination with other ingredients (e.g., caffeine) that produce energy enhancement and/or enhancement of athletic performance? Does ephedra have additive effects with other agents? What dosage levels of ephedra are necessary to achieve energy enhancement and enhancement of athletic performance? Safety Assessment Does use of ephedra-containing dietary supplement products over a sustained period of time increase the risk of cardiovascular disease (CVD) or other serious and life-threatening events in specific populations? What populations are at risk of CVD and other life-threatening events through use of ephedra over a sustained period of time? Can the risk for adverse events in these populations be attributed to ephedra alone, or in combination with other ingredients (e.g., caffeine)? Does ephedra have additive effects with other agents? What dosage levels of ephedra produce risk of CVD or other life-threatening events? Do ephedra-containing dietary supplement products alter physiologic markers of cardiovascular function? What are the metabolic actions of ephedra, so as to explain its beneficial and adverse effects? In addition to answering these 15 questions about ephedra-containing dietary supplement products, we were also asked to synthesize the available information on the same questions for the purified alkaloid, ephedrine. After searching published reports, journal articles, conference presentations, and various sources of unpublished studies, we identified 52 controlled clinical trials of ephedrine or herbal ephedra for weight loss or athletic performance in humans. The Food and Drug Administration provided us with copies of over 1,000 adverse event reports (AERs) related to herbal ephedra and 125 AERs related to ephedrine. These reports often included interviews with patients and/ or family members, extensive medical records, and copies of product labels. We identified 70 case reports in the literature and received a disk of 15,951 reports containing 18,502 cases from Metabolife, a manufacturer of ephedra products. Methodology Efficacy. Data for the efficacy analysis were abstracted from reports of controlled trials onto a specially designed form containing questions about the study design, the number of patients and comorbidities, dosage, adverse events, the types of outcome measures, and the time from intervention until outcome measurement. We selected the variables for abstraction with input from the project's technical experts. Two physicians, working independently, each extracted data from the same reports and resolved disagreements by consensus. In selecting studies for the meta-analysis of weight loss efficacy, we considered only those trials of at least eight weeks treatment duration. Our technical expert panel judged that shorter treatment durations were insufficient to assess weight loss. In selecting studies on athletic performance, we found that these studies varied widely with respect to intervention. Because of this heterogeneity, we compared and contrasted these studies in a narrative review, rather than performing a statistical synthesis. The effects of ephedra/ephedrine on weight loss were examined in six different types of comparisons: (1) ephedrine versus placebo; (2) ephedrine plus caffeine versus placebo; (3) ephedrine plus caffeine versus ephedrine; (4) ephedrine versus other active treatment; (5) ephedra versus placebo; and (6) ephedra plus herbs containing caffeine versus placebo. The last comparison subgroup contained only a single trial; thus, effect sizes were estimated only for the first five. The effect size was calculated by dividing the outcome of a study (e.g., difference in weight loss per month between the two groups) by its standard deviation, which produces a unitless measure that is useful when comparing studies that assess outcomes (such as weight) that are similar but are measured differently (e.g., weight loss in pounds versus change in body mass index). Effect sizes were pooled separately for each of the five comparison subgroups. In addition, we used meta-regression to conduct a cross-subgroup synthesis on the effect sizes of the subgroups with a placebo comparison: ephedrine versus placebo; ephedrine plus caffeine versus placebo; and ephedra plus herbs containing caffeine versus placebo. Safety. We reviewed each report of a controlled trial (regardless of treatment duration) for data on adverse events. Adverse events were recorded onto a spreadsheet that identified each study arm, the description of the adverse event as listed in the original article, and the numbers of subjects and adverse events in each arm. We then compared event rates in the ephedra or ephedrine groups to those in the placebo groups. We conducted a meta-analysis on those adverse event symptoms for which appreciable numbers of events were noted in the controlled trials. Adverse event reports compiled by the Food and Drug Administration (FDA) concerning ephedra or ephedrine were also reviewed by our physician reviewers. Within the time and resource constraints of this report, we reviewed all available reports of death, myocardial infarction (heart attack), cerebral vascular accident (stroke), seizure, and serious psychiatric illness filed prior to September 30, 2001. We also reviewed published case reports as well as event reports filed with Metabolife, a manufacturer of ephedra-containing products. After screening, all case reports were subjected to a review. Based on input from our technical expert panel and the literature on methods to assess adverse event reports, we identified three important criteria for inclusion of such reports: Documentation of an adverse event that met our selection criteria. Documentation that the person having the adverse event took an ephedra-containing supplement or ephedrine within 24 hours prior to the event (for cases of death, myocardial infarction, stroke, or seizure). Documentation that alternative explanations for the adverse event were investigated and were excluded with reasonable certainty. We classified cases that met all three of these criteria as "sentinel events." Cases in which the event might have had other possible causes but the pharmacology of ephedrine could have contributed were classified as "possible sentinel events." Cases of death, myocardial infarction, cerebral vascular accident, and seizure were reviewed by internists, with additional review (as indicated) by a cardiologist, neurologist, or rheumatologist. Psychiatric cases were reviewed by a psychiatrist specializing in addictions and a psychologist with expertise in substance abuse. The criterion for use within 24 hours was not required for psychiatric cases. Findings Efficacy for Weight Loss. We identified 46 controlled trials that assessed use of ephedra or ephedrine used for weight loss. Of these, 20 were excluded from pooled analysis because they had a treatment duration of less than eight weeks. Six additional trials were excluded for a variety of other reasons. Of the remaining 20 trials included in the meta-analysis, only five tested herbal ephedra-containing products. Together, these 20 trials assessed 678 persons who consumed either ephedra or ephedrine. The majority of studies of both ephedra and ephedrine are plagued by methodological problems (particularly, high attrition rates) that might contribute to bias. These methodological limitations must be considered when interpreting any conclusions regarding the efficacy of these products. Nevertheless, the evidence we identified and assessed supports an association between short-term use of ephedrine, ephedrine plus caffeine, or dietary supplements that contain ephedra with or without herbs containing caffeine and a statistically significant increase in short-term weight loss (compared to placebo). Adding caffeine to ephedrine modestly increases the amount of weight loss. There is no evidence that the effect of ephedra-containing dietary supplements with herbs containing caffeine differs from that of ephedrine plus caffeine: Both result in weight loss that is approximately two pounds per month greater than that with placebo, for up to four to six months. No studies have assessed the long-term effects of ephedra-containing dietary supplements or ephedrine on weight loss; the longest duration of treatment in a published study was six months. Efficacy for Physical Performance Enhancement. The effect of ephedrine on athletic performance was assessed in seven studies. No studies have assessed the effect of herbal ephedra-containing dietary supplements on athletic performance. The few studies that assessed the effect of ephedrine on athletic performance have, in general, included only small samples of fit individuals (young male military recruits) and have assessed the effects only on very short-term immediate performance. Thus, these studies did not assess ephedrine as it is used in the general population. The data support a modest effect of ephedrine plus caffeine on very short-term athletic performance. No studies have assessed the sustained use of ephedrine on performance over time. The only study that assessed the additive effects of these agents reported that ephedrine must be supplemented with caffeine to affect athletic performance. Safety Issues. The data on adverse events were drawn from clinical trials and case reports published in the literature, submitted to the FDA, and reported to Metabolife, a manufacturer of ephedra-containing supplement products. The strongest evidence for causality should come from clinical trials; however, in most circumstances, such trials do not enroll sufficient numbers of patients to adequately assess the possibility of rare outcomes. Such was the case with our review of ephedrine and ephedra-containing dietary supplements. Even in aggregate, the clinical trials enrolled only enough patients to detect a serious adverse event rate of at least 1.0 per 1,000. For rare outcomes, we reviewed case reports, but a causal relationship between ephedra or ephedrine use and these events cannot be assumed or proven. Evidence from controlled trials was sufficient to conclude that the use of ephedrine and/or the use of ephedra-containing dietary supplements or ephedrine plus caffeine is associated with two to three times the risk of nausea, vomiting, psychiatric symptoms such as anxiety and change in mood, autonomic hyperactivity, and palpitations. The majority of case reports are insufficiently documented to make an informed judgment about a relationship between the use of ephedrine or ephedra-containing dietary supplements and the adverse event in question. For prior consumption of ephedra-containing products, we identified two deaths, three myocardial infarctions, nine cerebrovascular accidents, three seizures, and five psychiatric cases as sentinel events; for prior consumption of ephedrine, we identified three deaths, two myocardial infarctions, two cerebrovascular accidents, one seizure, and three psychiatric cases as sentinel events. We identified 43 additional cases as possible sentinel events with prior ephedra consumption and seven additional cases as possible sentinel events for prior ephedrine consumption. About half the sentinel events occurred in persons aged 30 years or younger. Classification as a sentinel event does not imply a proven cause and effect relationship. We did not assess the plethora of additional symptoms that have been reported in the published literature and the FDA Medwatch file for ephedra-containing dietary supplements and ephedrine products. Future Research Our analysis of the evidence reveals numerous gaps in the literature regarding the efficacy and safety of ephedra-containing dietary supplements. First, long-term assessments of the effectiveness of herbal ephedra or ephedrine for promoting weight loss are lacking. We identified no study with a treatment duration longer than six months. To improve health outcomes and reduce the risk of morbidities associated with being overweight, sufficient weight loss (5 to 10 percent of body weight) and long-term weight maintenance are necessary. Therefore, the benefit of ephedrine or herbal ephedra-containing dietary supplements for health outcomes is unknown. Evidence regarding the effect of herbal ephedra or ephedrine on physical performance that reflects its use in the general population (repeated or long-term use by a representative sample) is also needed. In order to assess a causal relationship between ephedra or ephedrine consumption and serious adverse events, a hypothesis-testing study is needed. Continued analysis of case reports cannot substitute for a properly designed study to assess causality. A case-control study would probably be the study design of choice. ### Get access to the Members Message Forum where you can discuss the best & cheapest sources to easily obtain prescription medication and join our Members Chat sessions. No waiting rooms No Appointments Private & Secure Learn the secrets of buying from Foreign Pharmacies This info does not contain outdated resources, you are getting real-time updated information! Order your medication from the privacy of your own home Sources for almost every medication available Only the most reliable, reputable, and proven sources are listed Pharmacies monitored and updated daily for customer satisfaction Get access to this information now and place your first order today for only $24.95! Lortab This page contains drug information on Lortab. The information provided includes the following: what is Lortab the possible side effects of Lortab what happens if you miss a dose of Lortab what happens if you overdose with Lortab the most important information about Lortab how to use Lortab other drugs that may affect Lortab what to avoid while using Lortab Generic Name: acetaminophen and hydrocodone (ah see ta MIH no fen and hye dro KOE done) Brand Names: Anexsia, Anolor DH5, Bancap HC, Dolacet, Lorcet 10/ 650, Lorcet HD, Lorcet Plus, Lortab, Lortab 10, Lortab 5/ 500, Lortab 7.5/ 500, Lortab Elixir, Norco, T-Gesic, Vicodin, Vicodin ES, Vicodin HP, Zydone What is the most important information I should know about acetaminophen and hydrocodone? • Hydrocodone is habit forming. It is possible become physically and/ or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if acetaminophen and hydrocodone is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. • Avoid alcohol while taking acetaminophen and hydrocodone. Alcohol can increase drowsiness and dizziness caused by the medication, possibly resulting in unconsciousness and death. Also, acetaminophen can be damaging to the liver when taken with alcohol. • Acetaminophen and hydrocodone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and hydrocodone is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor. • Acetaminophen and hydrocodone may cause constipation. Drink plenty of water (six to eight full glasses a day) to lessen this side effect. Increased fiber in the diet may also help to alleviate constipation. What is acetaminophen and hydrocodone? • Hydrocodone (related to codeine) is in a class of drugs called narcotic analgesics. It relieves pain. • Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone. • Together, acetaminophen and hydrocodone are used to relieve moderate-to-severe pain. • Acetaminophen and hydrocodone may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking acetaminophen and hydrocodone? • Before taking this medication, tell your doctor if you have · a history of alcohol or drug abuse; · kidney disease; · liver disease; · asthma; · urinary retention; · an enlarged prostate; · hypothyroidism; · seizures or epilepsy; · gallbladder disease; · a head injury; or · Addison's disease. • You may not be able to take acetaminophen and hydrocodone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. • Acetaminophen and hydrocodone is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. • Acetaminophen and hydrocodone passes into breast milk and may affect a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. • If you are younger than 18 years of age or older than 60 years of age, you may be more likely to experience side effects from acetaminophen and hydrocodone. Your doctor may prescribe a lower dose. How should I take acetaminophen and hydrocodone? • Take acetaminophen and hydrocodone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Take each dose with a full glass of water. • Take acetaminophen and hydrocodone with food or milk if it causes stomach upset. • To ensure that you get a correct dose, measure the liquid form of acetaminophen and hydrocodone with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one. • Hydrocodone is habit forming. It is possible become physically and/ or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if acetaminophen and hydrocodone is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. • Acetaminophen and hydrocodone may cause constipation. Drink plenty of water (six to eight full glasses a day) to lessen this side effect. Increased fiber in the diet may also help to alleviate constipation. • Store acetaminophen and hydrocodone at room temperature away from moisture and heat. What happens if I miss a dose? • Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking the next dose. What happens if I overdose? • Seek emergency medical attention if an overdose is suspected. • Symptoms of an acetaminophen and hydrocodone overdose may include slow breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cold and clammy skin, small pupils, nausea, vomiting, and sweating. What should I avoid while taking acetaminophen and hydrocodone? • Avoid alcohol while taking acetaminophen and hydrocodone. Alcohol can increase drowsiness and dizziness caused by the medication, possibly resulting in unconsciousness and death. Also, acetaminophen can be damaging to the liver when taken with alcohol. • Acetaminophen and hydrocodone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and hydrocodone is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor. • Use caution when driving, operating machinery, or performing other hazardous activities. Hydrocodone may cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities. • Other products may also contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Do not take any other products that contain acetaminophen without first talking to your doctor. Too much acetaminophen can be dangerous. What are the possible side effects of acetaminophen and hydrocodone? • If you experience any of the following serious side effects, stop taking acetaminophen and hydrocodone and seek emergency medical attention or contact your doctor immediately: · an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); · slow, weak breathing; · seizures; · cold, clammy skin; · severe weakness or dizziness; · unconsciousness; · yellowing of the skin or eyes; or · unusual fatigue, bleeding, or bruising. • Other, less serious side effects may be more likely to occur. Continue to take acetaminophen and hydrocodone and talk to your doctor if you experience · constipation; · dry mouth, nausea, vomiting, or decreased appetite; · dizziness, tiredness, or lightheadedness; · muscle twitches; · sweating; · itching; · decreased urination; or · decreased sex drive. • Hydrocodone is habit forming. It is possible become physically and/ or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if acetaminophen and hydrocodone is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. What other drugs will affect acetaminophen and hydrocodone? • Do not take acetaminophen and hydrocodone if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. • Acetaminophen and hydrocodone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and hydrocodone is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor. • Other products may also contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Do not take any other products that contain acetaminophen without first talking to your doctor. Too much acetaminophen can be dangerous. • Drugs other than those listed here may also interact with acetaminophen and hydrocodone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products. Where can I get more information? • Your pharmacist has additional information about acetaminophen and hydrocodone written for health professionals that you may read. -------------------------------------------------------------------------------- In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow #10 and FD&C Yellow #6 as coloring and natural and artificial flavoring. CLINICAL PHARMACOLOGY Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Pharmacokinetics The behavior of the individual components is described below. Hydrocodone Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-(alpha)- and 6-(beta)-hydroxymetabolites. See OVERDOSAGE for toxicity information. Acetaminophen Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information. INDICATIONS AND USAGE Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) is indicated for the relief of moderate to moderately severe pain. CONTRAINDICATIONS This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone. WARNINGS Respiratory Depression At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Infants may have increased sensitivity to the respiratory depressant effects of opioids (see PRECAUTIONS , Pediatric Use ). If use of Lortab Elixir in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring. Head Injury and Increased Intracranial Pressure The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. PRECAUTIONS General Special Risk Patients As with any narcotic analgesic agent, Lortab Elixir should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Cough Reflex Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Lortab Elixir are used postoperatively and in patients with pulmonary disease. Information for Patients Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided. Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Physicians should instruct patients and caregivers to read the patient information leaflet, which appears as the last section of the labeling. Laboratory Tests In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. Drug Interactions Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen oral solution may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. Drug/Laboratory Test Interactions Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether hydrocodone has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Hydrocodone has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Acetaminophen has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow. Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Lortab Elixir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. These signs usually appear during the first few days of life. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Labor and Delivery Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). The effect of hydrocodone, if any, on the later growth, development, and functional maturation of the child is unknown. Nursing Mothers Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in the pediatric population below the age of two years have not been established. Use of Lortab Elixir in the pediatric population is supported by the evidence from adequate and well controlled studies of hydrocodone and acetaminophen combination products in adults with additional data which support the development of metabolic pathways in children two years of age and over (see DOSAGE AND ADMINISTRATION for pediatric dosage information). Geriatric Use Clinical studies of hydrocodone bitartrate and acetaminophen oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen oral solution and observed closely. ADVERSE REACTIONS Potential effects of high dosage are also listed in the OVERDOSAGE section. Cardio-renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension. Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma. Endocrine: Hypoglycemic coma. Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting. Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention. Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia. Hypersensitivity: Allergic reactions. Musculoskeletal: Skeletal muscle flaccidity. Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression (see OVERDOSAGE ), shortness of breath. Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Skin: Cold and clammy skin, diaphoresis, pruritus, rash. DRUG ABUSE AND DEPENDENCE Controlled Substance Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) is classified as a Schedule III controlled substance. Abuse and Dependence Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution appropriate to the use of other oral narcotic medications. However, psychological dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen oral solution are used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. OVERDOSAGE Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Signs and Symptoms Toxicity from hydrocodone poisoning includes the opioid triad of loss of consciousness, pinpoint pupils, and respiratory depression (Cheyne-Stokes respiration, cyanosis, decrease in respiratory rate and/or tidal volume). Convulsions may occur. The toxic dose of acetaminophen for adults is 10 grams. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams. Early symptoms following a potentially hepatotoxic overdose of acetaminophen may include diaphoresis, general malaise, nausea, and vomiting. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Other signs and symptoms of overdose of this product include bradycardia, cold and clammy skin, extreme somnolence progressing to stupor or coma, hypoglycemic coma, hypotension, renal tubular necrosis, skeletal muscle flaccidity, thrombocytopenia. In severe overdosage, apnea; circulatory collapse; cardiac arrest; dose-dependent, potentially fatal hepatic necrosis; and death may occur. Treatment A single or multiple overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endo-tracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration. Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously. Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals. Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration. DOSAGE AND ADMINISTRATION Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of Lortab Elixir (providing 0.135 mg/kg of hydrocodone bitartrate and 9 mg/kg of acetaminophen). Dosing should be based on weight whenever possible. Lortab (pronounced LOR-tab) is used to relieve moderate to moderately severe pain. You should not take Lortab Elixir if you are allergic to hydrocodone or acetaminophen. The most common side effects of Lortab Elixir are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Take this medicine as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Uses Lortab Elixir is an analgesic used to relieve moderate to moderately severe pain. Lortab Elixir is a combination product containing hydrocodone (hye-droe-KO-done) bitartrate and acetaminophen (a-seat-a-MIN-oh-fen). Hydrocodone is a narcotic pain reliever and a cough suppressant. Acetaminophen is a non-narcotic pain reliever and fever reducer. A narcotic analgesic and acetaminophen used together may provide better pain relief than either product used alone. If you have any questions, please call your doctor or pharmacist. General Cautions Do not take this drug if you have allergies or unusual reactions to narcotic pain relievers or acetaminophen because it is likely that you may also be allergic to Lortab Elixir. This product may inhibit your mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while you are taking this product. This medicine may not be right for you. Check with your doctor or pharmacist, if you: are pregnant. are nursing. are taking other medications; narcotic pain relievers; allergy medicines; antidepressant medicines; acetaminophen-containing medicines or other medicines that cause central nervous system depression, including alcohol. have other medical problems: a history of drug or alcohol abuse; recent head injury; emphysema, asthma, or other chronic lung disease; liver disease, kidney disease; underactive thyroid, Addison's disease, enlarged prostate or difficulty urinating. Proper Use Take this medicine as directed by your doctor. Do not share it with anyone else. This medicine can cause drug dependence and has the potential for abuse. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you think that this medicine is not working properly after taking it for some time, do not increase the dose. Check with your doctor or pharmacist. Dosing The dose of this medication will be different for different patients. Follow the directions provided by your doctor. The following information includes only the average doses of this medication. If your dose is different, do not change doses unless your doctor tells you to do so. BODY WEIGHT APPROXIMATE AGE DOSE Every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day) 12 to 15 kg 27 to