0000003317 00000 n Long-term efficacy and safety of anti-obesity treatment: Where do we stand? 97-264. The first use of Phentermine as a drug to help treat obesity dates back to 1938. 188 . However in the presence of topiramate, Phentermine Cmax and AUC increase 13% and 42%, respectively. The following adverse reactions are described, or described in greater detail, in other sections: The following adverse reactions to Phentermine have been identified: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events. Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. HVMs8WQl eLg*&{dd $_;lm |NggK6,M]gu\.BNB. %%EOF 893.049(1)(d), (e),f.s. Available for Android and iOS devices. In addition to its function as an appetite suppressant, Phentermine drugs also act as energy boosters. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. It is often prescribed to be taken in the morning, before or after breakfast. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. 2020; doi:10.4093/dmj.2020.0258. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. The amount of weight loss associated with the use of an anorectic drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. 121 0 obj <>/Filter/FlateDecode/ID[<5D80FCFEE48BF540827EEA7155FB4128>]/Index[104 35]/Info 103 0 R/Length 85/Prev 180155/Root 105 0 R/Size 139/Type/XRef/W[1 2 1]>>stream If you are a Mayo Clinic patient, this could Do not double doses. Copyright 2000- 2023 State of Florida. Phentermine (as resin complex): Usual dosage is 15 or 30 mg once daily. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. Notwithstanding subsection (1), a pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of the prescribed medication for any medicinal drug other than a medicinal drug listed in Schedule II, in compliance with the provisions of s. The legal owner of any stock of controlled substances in a pharmacy, upon discontinuance of dealing in controlled substances, may sell said stock to a manufacturer, wholesaler, or pharmacy. Safety and effectiveness in pediatric patients have not been established. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Committee PDF Prescribing Information - Qsymia (Phentermine and Topiramate extended Dosage form: tablet The written prescription must be dated and signed by the prescribing practitioner on the day when issued. Numerous side effects have been linked to the use of Phentermine. privacy practices. PDF Reference ID: 3115694 - Food and Drug Administration These rules and statutes . L^%0:T'xHGi,KGyVfZ5WI6&ZU1/VqM4.ct\i2gTAtQV%[$*/tbn"xS8JU$bljsI2)bs_/FouVGwCqX';z{0REZbSX,bXWPS#Bf|il#o'y`?jv{;!bS F#vPGzD"1~5~F%mW9YlGIQVYOS~kojbdQS!>|@Ph Rule 4731-11-04. Click here for an email preview. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. (A) A prescriber may utilize a schedule III or IV controlled substance for the treatment of obesity only if it has an F.D.A approved indication for this purpose and then only in accordance with all of the . It is not uncommon for patients to experience a change in their sexual interest. %%EOF You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. It can help weight loss by making you less hungry. All trademarks are the property of their respective owners. Florida HB 423 - ARNP/PA Controlled Substance Prescribing - FANA 35 0 obj <>stream For example, it can be be used with healthy eating, physical activity and behavior change. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. This combination of ingredients was branded as Fen-Phen. Management of acute Phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. 0 Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of Phentermine hydrochloride (equivalent to 30 mg of Phentermine base). . 1591 0 obj <>stream A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. Taking Phentermine depends on the brand and preparation of the drug. Why is phentermine a controlled substance? 79-12; s. 2, ch. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. The promotion of this brand as a diet pill started in 1990. If you miss a dose of this medicine, take it as soon as possible. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . (1) A pharmacist, in good faith and in the course of professional practice only, may dispense controlled substances upon a written or oral prescription of a practitioner . Joint Administrative Procedures Committee (JAPC), Joint Committee on Public Counsel Oversight(JCPO), Joint Legislative Auditing Committee (JLAC), Joint Legislative Budget Commission (JLBC), Joint Select Committee on Collective Bargaining (JSCB), Office of Program Policy Analysis & Government Accountability (OPPAGA), Florida Legislative Committee on Intergovernmental Relations (LCIR), Joint Legislative Committee on Everglades Oversight (JCEO), Joint Legislative Sunset Committee (JCSC), Copyright 1995-2023 The Florida Legislature . The Administration's plan is to end the COVID-19 public health emergency on May 11, 2023. Precaution should be taken if a patient has any existing health concerns as the drug may cause further harm to their body. The goal of the drug is to help patients lose weight and increase energy since the withdrawal symptoms of include fatigue and weight gain through an increase in appetite, the product is rendered a waste of the patients time and money. Children 15 years of age and youngerUse is not recommended. Phentermine is related chemically and pharmacologically to the amphetamines. See Drug Abuse and Dependence (9) and Overdosage (10). In some cases, especially when the health concern is not too serious, the doctor may prescribe the drug at lower doses spread throughout the day, instead of advising the patient to take one single dose every day. The possibility of an association between valvular heart disease and the use of Phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken Phentermine alone. This content does not have an Arabic version. Mayo Clinic Proceedings. Statutes, Video Broadcast Tablets containing 37.5 mg Phentermine hydrochloride (equivalent to 30 mg Phentermine base). As phentermine is similar to amphetamine, it is a controlled drug (class C5) and has the potential for abuse. It is vital to talk with the doctor before using Phentermine with other products. Many patients find that if their doctor gradually lowers their dose, for example from 37.5mg per day down to 15mg per day for the last few days, they experience fewer withdrawal symptoms and are able to keep the weight off later. When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. Last updated on Mar 22, 2023. Rule 4731-11-04 | Controlled substances for the treatment of obesity. It is a class IV controlled substance because of its serious side effects and addiction potential. 104 0 obj <> endobj The possibility of an association between PPH and the use of Phentermine alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken Phentermine alone. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. 893.04 Pharmacist and practitioner.. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). Acidification of the urine increases Phentermine excretion. Phentermine - Henry Meds Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. It should also not be taken within 14 days after taking an MAO inhibitor. It has the chemical name of ,,-Dimethylphenethylamine hydrochloride. 0000001039 00000 n Generic name: Phentermine hydrochloride Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. Javascript must be enabled for site search. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. (phentermine hydrochloride) orally disintegrating tablet C IV . The prescription of such weight loss enhancers is not generally appropriate for children. 21 0 obj <> endobj Florida Board of Medicine Electronic Prescribing Requirements The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Yes, you need a prescription for phentermine. potentially hazardous activities such as operating machinery or driving FULL PRESCRIBING INFORMATION in the presence of other risk factors (e.g., controlled hypertension, 333-33-100411 Tasks 35 Phentermine is a Schedule IV controlled substance. Drug information provided by: Merative, Micromedex. When mental impairment is present while taking Phentermine, a patient is also advised not to drive to avoid the risk of being involved in an accident. History.s. In some cases, the use of this drug in combination with other pills may cause the effects of other drugs to increase. Animal reproduction studies have not been conducted with Phentermine. The date on which the prescription for such controlled substance was filled. The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. Some preparations of the formula, however, have been classified as schedule II drugs. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. The initial symptom of PPH is usually dyspnea. (3) In any case of dispensing hereunder, the amount or . One should bear in mind that Phentermine is not only a drug to help reduce the baseline body weight of patients, but it also reduces a patients risk of developing certain health diseases. Review/update the Your email address will not be published. |. Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Even after the period that the drug has been prescribed for, the doctor will often recommend to gradually stop using the Phentermine to avoid the withdrawal symptoms. Patients must be informed about the risks of use of Phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. Tak YJ, et al. PDF label - Food and Drug Administration 2007-156; s. 5, ch. While suffering from any of these health concerns may be a cause for concern, it does not mean a patient will not be able to use Phentermine at all. Publications, Help Searching endstream endobj 22 0 obj <> endobj 23 0 obj <> endobj 24 0 obj <>/ProcSet[/PDF/Text]/ExtGState<>>> endobj 25 0 obj <> endobj 26 0 obj <> endobj 27 0 obj <> endobj 28 0 obj <> endobj 29 0 obj <> endobj 30 0 obj <> endobj 31 0 obj <> endobj 32 0 obj <>stream Phentermine is a schedule IV medication (only available by prescription) frequently used for generalized weight loss by acting as an appetite suppressant. hbbd``b` @IHpA\> . Requirements may be altered [see Warnings and Precautions (5.9)]. Take this medicine only as directed by your doctor. hYr ~{L(QdK4^bdsO_d;a BXO--p,!4!,WhfM/@c One of the most important things to consider is the fact that the drug should never be accompanied by an MAO inhibitor. Phentermine is used as part of a short-term plan, along with a low calorie diet, for weight reduction. 0000000016 00000 n Committee The use of Topamax and Phentermine is actually an FDA-approved combination. 90-2; s. 1436, ch. Thus, in order to make the most of this drug, patients need make some effort too. Such prescriptions must contain the date of the oral authorization. The FDA in the United States first approved the use of Amphetamine as a drug that can be used to suppress a patients appetite in 1959. The structural formula is as follows: Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. 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. This includes prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems. The most common brand of Phentermine is a product known as Adipex, but officially called Adipex-P. Schedule. Take the disintegrating tablet with or without food. ZeS{$d!YS,|C~E;h4DJS?|{x}~ ?`2F. hb```e````a`d`@ f(fcfILLvL~. 0000002736 00000 n In some cases, the doctor may prescribe Phentermine in smaller doses and advise the patient to take it up to three times in a single day. Accessed Oct. 11, 2022. <]>> Florida Statutes Definitions Index (2022), Table Tracing Session Laws to Florida Statutes (2022), Index to Special and Local Laws (1971-2022), Index to Special and Local Laws (1845-1970). Search: PHENTERMINE BMI GUIDELINES - United States Department of Justice REGULATION OF PROFESSIONS AND OCCUPATIONS. the unsubscribe link in the e-mail. Phentermine (Oral Route) Proper Use - Mayo Clinic 75-18; s. 12, ch. Keep from freezing. Adults Exogenous Obesity Oral. Due to its status as a controlled substance, the sale, distribution, and possession of this drug . Children 16 years of age and youngerUse is not recommended. Place the tablet on the top of your tongue right after removing it from the bottle. For oral dosage form (extended-release capsules): Adults and children 16 years of age and olderOne capsule once a day, taken before breakfast or 10 to 14 hours before sleeping. Phentermine hydrochloride/topiramate. If you are allergic to other stimulants, amphetamines, cold medications or diet pills, you have a higher risk of being allergic to these pills too. RPYcn@b[%XYK'Q %[.()GTkJ WCf.-i>n-oIzE*D40f#Gp'LcddmE8;>u?X"tO 1]M={4,ReC8E8Z Q1Lt$-XpFCrTJ Chapter 893 Section 04 - 2012 Florida Statutes - The Florida Senate Take phentermine exactly as prescribed by your doctor. "@Hw4`tqCA\+ q [AF]` b L ! Do not keep outdated medicine or medicine no longer needed. See DrugAbuse and Dependence (9.3). CIV NDC 42806-810-01 Javascript must be enabled for site search. Unfortunately, patients experienced a variety of side effects, which included severe heart toxicity and hypertension. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). Patients must be instructed on how much Phentermine to take, and when and how to take it [see Dosage and Administration (2)]. History.s. Mayo Clinic College of Medicine and Science, Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Graduate Medical Education, Mayo Clinic School of Continuous Professional Development, Mayo Clinic on Incontinence - Mayo Clinic Press, NEW Mayo Clinic on High Blood Pressure - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press, Financial Assistance Documents Minnesota. Patients who have been on a Phentermine program should not suddenly stop using the drug. Copyright 2000- 2023 State of Florida. @ d Patients should be advised to report immediately any deterioration in exercise tolerance. Phentermine has been linked to many complications; knowing these details will help patients minimize their risk of experiencing such unwanted scenarios. Doctors often combined the use of Phentermine with diuretics, thyroid hormone medicines and digitalis. 0 Phentermine is one of the substances that have been researched thoroughly, thus its effects have been proven effective and the claims that are made about this drug are backed by scientific evidence. Systemic exposure of Phentermine may increase up to 91%, 45%, and 22% in patients with severe, moderate, and mild renal impairment, respectively [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].

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