endstream endobj 105 0 obj <> endobj 106 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/Type/Page>> endobj 107 0 obj <>stream Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. This documentation contains information regarding prescribing in Florida and is an effort to highlight Florida laws and rules related to prescribing in one doc ument. health information, we will treat all of that information as protected health Chapter 893 DRUG ABUSE PREVENTION AND CONTROL Entire Chapter. RPYcn@b[%XYK'Q %[.()GTkJ WCf.-i>n-oIzE*D40f#Gp'LcddmE8;>u?X"tO 1]M={4,ReC8E8Z Q1Lt$-XpFCrTJ The Board of Medicine shall adopt rules to establish practice guidelines for physicians to safely prescribe phentermine, fenfluramine, and other drugs used to treat obesity. |. The drug is also available in regular capsules that are taken orally with a glass of water. Javascript must be enabled for site search. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. CIV Cumulative urinary excretion of Phentermine under uncontrolled urinary pH conditions was 62% to 85%. The drug is classified under a certain chemical class known as amphetamine as it has a similar pharmacology value to other drugs classified in the class. Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Drugs of this class used in obesity are commonly known as anorectics or anorexigenics. It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Long-term efficacy and safety of anti-obesity treatment: Where do we stand? Some patients experience an increase in sexual interest, while others notice that they have a lower libido. https://fco.factsandcomparisons.com/. Phentermine also is offered combined with topiramate for weight loss (Qsymia). This website is a resource which lists doctors and clinics who may offer phentermine or appetite suppressants for patients they deem qualified. If we combine this information with your protected Do not crush, break, or chew it. Drug classes: Anorexiants, CNS stimulants. FULL PRESCRIBING of the risk of hypertensive crisis. endstream endobj 1531 0 obj <>/Metadata 26 0 R/Pages 1528 0 R/StructTreeRoot 41 0 R/Type/Catalog>> endobj 1532 0 obj <>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 0/Tabs/S/TrimBox[0.0 0.0 630.0 702.0]/Type/Page>> endobj 1533 0 obj <>stream Common side effects of phentermine include: Phentermine is one of the most prescribed weight-loss medicines. Florida HB 423 - ARNP/PA Controlled Substance Prescribing - FANA Law Implemented Florida Statutes 458.336. Swallow the extended-release capsule whole. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. 14 0000001146 00000 n 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, under the following conditions: Oral prescriptions must be promptly reduced to writing by the pharmacist or recorded electronically if permitted by federal law. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). ]c,'303:20/) @d` )2 Each tablet contains the following inactive ingredients: starch, lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate and blue sugar spheres. 1591 0 obj <>stream Opioid settlement billions flow to states, as advocates worry about Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. After the tablet has melted, swallow or take a sip of water. Moreover, it is strongly recommended to avoid or limit the alcohol intake. Also, it may cause certain side effects to become much worse. Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly. Adults Exogenous Obesity Oral. Rule 4731-11-04 - Ohio Administrative Code | Ohio Laws Management of acute Phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day. Publications, Help Searching 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. A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. Comprehensive review of current and upcoming anti-obesity drugs. The limited usefulness of agents of this class, including Phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below. JC. 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 127: VA Prescription Monitoring Program. If the prescription is for an animal, the species of animal for which the controlled substance is prescribed. In 1968, three years after its release, Aminorex was withdrawn. Average users lose 3-5% of their initial body weight as shown in studies. Phentermine Hydrochloride Tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index 30 kg/m2, or 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Rulemaking Authority 458.336 FS. The name of the prescribing practitioner. 0000003240 00000 n Lomaira: One tablet three times a day, taken 30 minutes before meals. Phentermine is used as part of a short-term plan, along with a low calorie diet, for weight reduction. This brand is manufacturedby Teva Pharmaceuticals (formerly GATE Pharmaceuticals). Follow your doctor's dosing instructions very carefully. The journals or printed bills of the respective chambers should be consulted for official purposes. Dosage form: tablet Animal reproduction studies have not been conducted with Phentermine. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Doctors often combined the use of Phentermine with diuretics, thyroid hormone medicines and digitalis. 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. the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. The Board of Medicine shall adopt rules to establish practice guidelines for physicians to safely prescribe phentermine, fenfluramine, and other drugs used to treat obesity. Numerous side effects have been linked to the use of Phentermine. Talk with your doctor before starting an exercise program. Each written prescription prescribed by a practitioner in this state for a controlled substance listed in Schedule II, Schedule III, or Schedule IV must include both a written and a numerical notation of the quantity of the controlled substance prescribed on the face of the prescription and a notation of the date, with the abbreviated month written out on the face of the prescription. 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 is for people with obesity or overweight who haven't been able to lose enough weight with diet and exercise alone to improve their health. 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. 90-2; s. 1436, ch. Unfortunately, patients experienced a variety of side effects, which included severe heart toxicity and hypertension. It helps patients lose weight by suppressing their appetite and boosting their energy levels, thus leading to a more active lifestyle and greater calorie burn. 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. 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. Florida Board of Medicine Electronic Prescribing Requirements 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, Biliopancreatic diversion with duodenal switch (BPD/DS), Endoscopic Sleeve Gastroplasty (Gastric Sleeve), Biliopancreatic diversion with duodenal switch. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. hYr ~{L(QdK4^bdsO_d;a BXO--p,!4!,WhfM/@c Search: phentermine guidelines - United States Department of Justice Phentermine - Henry Meds l 4 a ( k ( N o L i s t ( z ) . 188 . Controlled substances for the treatment of obesity. 0 The strength and dosage of Phentermine depend on the brand that is prescribed and the patients specific condition. (phentermine hydrochloride) orally disintegrating tablet C IV . If the federal government fails to oversee how the money is spent, advocates worry it will be wasted. Affixed to the original container in which a controlled substance is delivered upon a prescription or authorized refill thereof, as hereinafter provided, there shall be a label bearing the following information: The name and address of the pharmacy from which such controlled substance was dispensed. 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 . Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. See DrugAbuse and Dependence (9.3). 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. Phentermine (Oral Route) Proper Use - Mayo Clinic 0000005652 00000 n other information we have about you. 0000001920 00000 n A pharmacist may not dispense more than a 30-day supply of a controlled substance listed in Schedule III upon an oral prescription issued in this state. PDF Prescribing Laws and Rules for Florida Licensed Physicians Chapter 458 Section 336 - 2011 Florida Statutes - The Florida Senate Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. 2007-156; s. 5, ch. Even patients who are overweight and pregnant at the same time are not allowed to use this product. <]>> hWmo8+jE'"m{F Statutes, Video Broadcast It has the chemical name of ,,-Dimethylphenethylamine hydrochloride. hbbd``b`z$@D`]"@DeX- Bb V ``LA\F*? You may opt-out of email communications at any time by clicking on Take the disintegrating tablet with or without food. HB 423 (by Rep. Pigman) was signed into law on April 14, 2016. Phentermine is approved for use for up to 12 . Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Of course, it is taken orally. information and will only use or disclose that information as set forth in our notice of The use of Topamax and Phentermine is actually an FDA-approved combination. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. 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. The PDMP was created in the 2009 session of the Florida legislature to encourage safer prescribing of controlled substances and reduce drug abuse and diversion within the state. %PDF-1.6 % SECTION 04. Phentermine has not been studied in patients with eGFR less than 15 mL/min/1.73m2, including end-stage renal disease requiring dialysis; avoid use in these populations. If the doctor finds that the patient is a good candidate for Phentermine, they may prescribe a certain dose and provide specific details on dosage and lifestyle choices that should accompany the use of this medicine. Statutes & Constitution :View Statutes : Online Sunshine 0000000828 00000 n The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. Some patients need to take the drug an hour before they eat breakfast, while others are advised to take it approximately one to two hours after breakfast. (d) each prescription writtenby a practitioner in this statefor a controlledsubstance listed in schedule ii, schedule iii, or schedule iv must include a writtenand a numerical notation of the quantity of the controlled substance prescribed and a notation of the datein numerical, month/day/year format, or with the abbreviated month writtenout, or the month writtenout in . 0000021285 00000 n information submitted for this request. Both the law and the rule for treating obesity outline practice guidelines for the safe use of phentermine, fenfluramine, and ot her drugs used to . 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. To avoid trouble with sleeping, take the last dose of the day about 4 to 6 hours before bedtime, unless your doctor tells you otherwise. https://www.uptodate.com/contents/search. Avoid use of Phentermine in patients with eGFR less than 15 mL/min/1.73m2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Other brands of this drug include Suprenza, Phentercot, Acxion, Elvenir, Terflamex, Panbesy, Duromine, Fentermina, Phentermin, PHentermine and Lomaira. Patients who have been on a Phentermine program should not suddenly stop using the drug. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). The dose of this medicine will be different for different patients. This equates to a weight loss of 10-20 pounds for a 200 pound . The amount of medicine that you take depends on the strength of the medicine. hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ Adults and children 17 years of age and older15 to 30 milligrams (mg) once a day, taken at approximately 2 hours after breakfast. Committee Since Phentermine is a drug that contains chemical compounds, it is important to know about all of the risks that are involved with its use and precautions a person should be aware of before the consumption. the unsubscribe link in the e-mail. Take this medicine only as directed by your doctor. So some health care providers might order it for longer use. %%EOF the unsubscribe link in the e-mail. 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. It can help weight loss by making you less hungry. It is not uncommon for patients to experience a change in their sexual interest. Click here for an email preview. By doing this, the metabolism is revved up along with an . Before starting with consumption of this medication, patients should get informed about potential adverse effects to be able to determine whether a newly-developed symptom is a sign of a health issue or just a side effect associated with Phentermine. 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. Mayo Clinic Proceedings. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. Copyright: Merative US L.P. 1973, 2023. If the drug is taken too late in the day, it may also cause insomnia. The doctor also looks at the patients medical history for any pre-existing medical conditions that the medication should not be taken with. include protected health information. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. The combined drug is approved for long-term use. The directions for the use of the controlled substance prescribed in the prescription. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Drugs to treat obesity; rules establishing guidelines. Patients must be informed that Phentermine hydrochloride is a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity, and that coadministration of Phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5.1)]. PDF Reference ID: 3115694 - Food and Drug Administration Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. 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 Patients should be advised to report immediately any deterioration in exercise tolerance. Late evening medication should be avoided because of the possibility of resulting insomnia. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Generic name: Phentermine hydrochloride 75-18; s. 12, ch. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. For oral dosage form (disintegrating tablets): Adults and children 17 years of age and olderOne tablet once a day, taken in the morning. In fact, one study conducted at the Duke University School of Medicine found that apart from the Phentermines ability to effectively reduce body weight, it can also help improve a patients health-related quality of life. Phentermine was later provided to patients in combination with dexfenfluramine and fenfluramine as a more powerful appetite suppressant that could also act as a fat burner. The written prescription must be dated and signed by the prescribing practitioner on the day when issued. Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. Pursuant to Board of Medical Examiners Rule 540-X-4-.05, dispensing physicians are required to register with the Board. By: Susan St. John Pursuant to Section 456.44(3)(a), Florida Statutes, and Rule 64B-9.013(3)(a), Florida Administrative Code, a practitioner must evaluate a patient by taking a complete medical history and performing a physical examination prior to prescribing a controlled substance to a patient. All rights reserved. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. Patients are advised to report any symptoms or diseases they may have before the doctor prescribes the drug this may include high blood pressure and kidney problems, as well as any type of diabetes and thyroid disorders. NDC 42806-810-01 The dosage varies from 15mg to 37.5mg per day. Committee In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with anorectic drugs lost more weight on the average than those treated with placebo and diet. Over 12 weeks, it can be as high as 9-10%. Taking more than the prescribed amount of Phentermine can lead to an overdose, which means if a patient misses a dose, they should never try to make up for it by taking more than the prescribed amount at the next dose. PDF label - Food and Drug Administration Today, Phentermine can still be obtained through the doctors prescription in the majority of countries around the world. Do not crush, break, or chew it. Children 16 years of age and youngerUse is not recommended. %PDF-1.6 % What to offer the 99% of patients with severe obesity who do not undergo bariatric surgery? Doctors used it to help patients who experience certain health issues caused by obesity to lose weight and improve the symptoms they are experiencing. . Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Phentermine for weight loss - Mayo Clinic Available for Android and iOS devices. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). Other initial symptoms may include angina pectoris, syncope or lower extremity edema. (In combination with a healthy diet and exercise plan). 893.04 Pharmacist and practitioner.. Phentermine is approved for use for up to 12 weeks. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes.