phentermine prescribing guidelines florida

0000002991 00000 n All rights reserved. The amount of medicine that you take depends on the strength of the medicine. This medication has been linked to physical dependence, which means a patient may become addicted to it. The Drug Enforcement Administration (DEA) has made 2 changes related to . The journals or printed bills of the respective chambers should be consulted for official purposes. 0000001146 00000 n Law Implemented Florida Statutes 458.336. It is often prescribed to be taken in the morning, before or after breakfast. Your email address will not be published. 104 0 obj <> endobj Keep from freezing. In some cases, the side effects were life-threatening and led to the death of a patient. ]c,'303:20/) @d` )2 Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. It is obvious that these symptoms can make the entire program useless. The written prescription must be dated and signed by the prescribing practitioner on the day when issued. 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 HB 423 - ARNP/PA Controlled Substance Prescribing. Later on, between 1940 and 1960, Phentermine was combined with other medications to improve its effectiveness. If the prescriber is not available to verify a prescription, the pharmacist may dispense the controlled substance but may insist that the person to whom the controlled substance is dispensed provide valid photographic identification. https://www.uptodate.com/contents/search. We comply with the HONcode standard for trustworthy health information. 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. Phentermine is approved for use for up to 12 weeks. 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. Because of the potential for serious adverse reactions in nursing infants, 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. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F 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. 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. Do not keep outdated medicine or medicine no longer needed. = Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). 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. Primary Pulmonary Hypertension (PPH) a rare, frequently fatal disease of the lungs has been reported to occur in patients receiving a combination of Phentermine with fenfluramine or dexfenfluramine. But weight management can take time. Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. History.s. the unsubscribe link in the e-mail. 0000005652 00000 n JC. These are all promoted as weight loss pills that assist obese individuals. information highlighted below and resubmit the form. 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. The doctor also looks at the patients medical history for any pre-existing medical conditions that the medication should not be taken with. A physician will usually start with a physical examination to determine if the patients health is in a state that will not be negatively affected when taking this drug. Facts & Comparisons eAnswers. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [see ClinicalPharmacology (12.3)]. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. 458.336, Florida Statutes - Drugs to treat obesity; rules establishing guidelines; Rule 64B8-9.012, Florida Administrative Code - Standards for the Prescription of Obesity . 2020; doi:10.4093/dmj.2020.0258. Do not double doses. privacy practices. The following information includes only the average doses of this medicine. Burguera B, et al. Animal reproduction studies have not been conducted with Phentermine. 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 . Section 458.336, F.S. %%EOF 188, ch. Copyright 2000- 2023 State of Florida. i h,T h,T +h,T h,T 6B*CJ aJ mH nH ph u+h,T h,T B*CJ H*aJ mH nH ph u(h,T h,T B*CJ aJ mH nH ph u +h,T h,T 5B*CJ aJ mH nH ph u ~ P r 2 i $ hhhh hd 1$ 5$ 7$ 8$ 9D H$ `ha$gd,T $d 1$ 5$ 7$ 8$ 9D H$ a$gd,T " $ hhhh hd 1$ 5$ 7$ 8$ 9D @&H$ `ha$gd,T i gd,T $d x 1$ 5$ 7$ 8$ 9D H$ a$gd,T 2 1h:p,T / =!"#$% @ @ @ N o r m a l CJ _HaJ mH sH tH D A@ D D e f a u l t P a r a g r a p h F o n t R i R T a b l e N o r m a l 4 Review/update the 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)]. History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension), During or within 14 days following the administration of monoamine oxidase inhibitors, Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, Effect on the ability to engage in potentially hazardous tasks [see, Withdrawal effects following prolonged high dosage administration [see, Development of primary pulmonary hypertension [see, Development of serious valvular heart disease [see, Effects on the ability to engage in potentially hazardous tasks [see, The risk of an increase in blood pressure [see, the potential for developing tolerance and actions if they suspect development of tolerance [see, the risk of dependence and the potential consequences of abuse [see. grants the Board of Medicine the authority to adopt rules to establish the practice guidelines for drugs used to treat obesity. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of Phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Talk with your doctor before starting an exercise program. It isnt prescribed on request, but rather when a healthcare provider notices it may be beneficial for a specific patient to lose weight in order to improve their overall health or to decrease the risk of certain health concerns. Publications, Help Searching Click here for an email preview. Losing weight during pregnancy can harm both a mother and her baby. Javascript must be enabled for site search. If a patient would like to take other supplements, they should consult their doctor first. Acidification of the urine increases Phentermine excretion. There is a problem with Common side effects of phentermine include: Phentermine is one of the most prescribed weight-loss medicines. 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. This content does not have an English version. To provide you with the most relevant and helpful information, and understand which (phentermine hydrochloride) orally disintegrating tablet C IV . 0000001039 00000 n 0000003317 00000 n 75-18; s. 12, ch. hb```e````a`d`@ f(fcfILLvL~. Phentermine is approved for use for up to 12 . See DrugAbuse and Dependence (9.3). The dosage may be adjusted to the patients need. The FDA has categorized this drug as X for pregnancy, which means it should not be used during pregnancy under any circumstances. Last updated on Mar 22, 2023. Each tablet contains the following inactive ingredients: starch, lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate and blue sugar spheres. other information we have about you. Safety and effectiveness in pediatric patients have not been established. Adults and children 17 years of age and older. 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). 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. To provide you with the most relevant and helpful information, and understand which the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Carefully follow the dosing instructions for the form you are using. Tak YJ, et al. %PDF-1.6 % Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. Fatigue and depression usually follow the central stimulation. Phentermine hydrochloride USP is a sympathomimetic amine anorectic. 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 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. hbbd``b` @IHpA\> . 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). This website is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. %%EOF The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Phentermine is used as part of a short-term plan, along with a low calorie diet, for weight reduction. Chapter 893 DRUG ABUSE PREVENTION AND CONTROL Entire Chapter. 14 It works as a psychostimulant drug that stimulates the central nervous system to release norepinephrine from the hypothalamus. Controlled substances for the treatment of obesity. Some patients experience an increase in sexual interest, while others notice that they have a lower libido. It is an appetite suppressant with the added ability to help the body produce more energy from fat cells. It can help weight loss by making you less hungry. Your email address will not be published. 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. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. Doctors used it to help patients who experience certain health issues caused by obesity to lose weight and improve the symptoms they are experiencing. 0000003240 00000 n Moreover, it is strongly recommended to avoid or limit the alcohol intake. Follow your doctor's dosing instructions very carefully. law states . However, it caused a chronic condition known as pulmonary hypertension, which led to the death of many patients. In 1968, three years after its release, Aminorex was withdrawn. Should a patient realize he/she has missed a dose within a reasonable timeframe after the doses timing, it is acceptable to take it once they remember it. Take phentermine exactly as prescribed by your doctor. Also, it may cause certain side effects to become much worse. 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. Comprehensive review of current and upcoming anti-obesity drugs. %PDF-1.6 % Adults and children 17 years of age and older15 to 30 milligrams (mg) once a day, taken at approximately 2 hours after breakfast. All rights reserved. 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. 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. Taking too much Phentermine can be harmful to the patients body. If we combine this information with your protected While discussing the use of Phentermine with the doctor, a patient is provided a list of lifestyle changes to implement while using this product. After the tablet has melted, swallow or take a sip of water. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). If we combine this information with your protected Management of acute Phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. 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. In order to use Phentermine, the doctor needs to prescribe the drug for a specific patient. 0000000016 00000 n There are reports of patients who have increased the dosage of these drugs to many times than recommended. Long-term efficacy and safety of anti-obesity treatment: Where do we stand? Or it can help you feel full longer. Primary Pulmonary Hypertension (PPH) a rare, frequently fatal disease of the lungs has been reported to occur in patients receiving a combination of Phentermine with fenfluramine or dexfenfluramine. CRIMES. FULL PRESCRIBING of the risk of hypertensive crisis. Doses are normally taken before breakfast, or 1 to 2 hours after breakfast. 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 . Obesity has been linked to many different diseases, including type 2 diabetes and cardiovascular disease. The most common brand of Phentermine is a product known as Adipex, but officially called Adipex-P. The drug is usually prescribed at the lowest possible dose to new users, which is 15mg per day. The full name and address of the prescribing practitioner and the practitioners federal controlled substance registry number shall be printed thereon. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. While this drug may sound like a wonder pill, patients should ensure they know are familiar with the precautions, interactions, side effects and other important details before they start taking it. The medication has been classified as a controlled substance in most countries and is also classified as a schedule IV prescription drug. 2012 Florida Statutes. https://www.micromedexsolutions.com. History-New 12-4-97, Amended 2-17-98, 8-8-22. 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. A pharmacist may not knowingly fill a prescription that has been forged for a controlled substance listed in Schedule II, Schedule III, or Schedule IV. Pharmacists may order the medicinal drug products set forth in each rule subject to the following terms and limitations: . NDC 42806-810-01 The possible role of Phentermine in the etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. Cumulative urinary excretion of Phentermine under uncontrolled urinary pH conditions was 62% to 85%. Phentermine is related chemically and pharmacologically to the amphetamines. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. 21 0 obj <> endobj Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. Different brands manufacture, distribute and sell Phentermine drugs. But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. 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. Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. The risks include, but are not limited to: See also, for example, Adverse Reactions (6) and Use in SpecificPopulations (8). 90-2; s. 1436, ch. Skip to Navigation | Skip to Main Content | Skip to Site Map. include protected health information. 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. The combined drug is approved for long-term use. Symptoms of extremely high blood pressure, such as uneven heartbeats, chest pain, blurred vision, anxiety and a severe headache. 893.04 Pharmacist and practitioner.. Why is phentermine a controlled substance? This does not only include prescription drugs but also: Common drugs that are known to interact with Phentermine include Dopamine, Venlafaxine, Linezolid, Ephedrine, Isoproterenol, Epinephrine, Norepinephrine and a Phenylephrine injection. Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Phentermine (as resin complex): Usual dosage is 15 or 30 mg once daily. https://fco.factsandcomparisons.com/. endstream endobj startxref The drug has two primary functions in the human body, which is the reason why it is always accompanied by these lifestyle changes. Phentermine hydrochloride/topiramate. Phentermine is a Schedule 4 drug. It is a class IV controlled substance because of its serious side effects and addiction potential. Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. 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. Any controlled substance listed in Schedule III or Schedule IV may be dispensed by a pharmacist upon an oral prescription if, before filling the prescription, the pharmacist reduces it to writing or records the prescription electronically if permitted by federal law. Also available as phentermine hydrochloride; dosage expressed in terms of phentermine hydrochloride. Prescribing Standards: In addition to the laws and rules directly related to the prescription and prescribing, there are other standards which should be followed as well. Portions of this document last updated: Feb. 01, 2023. Javascript must be enabled for site search. Unfortunately, patients experienced a variety of side effects, which included severe heart toxicity and hypertension. Late evening medication should be avoided because of the possibility of resulting insomnia. This website is a resource which lists doctors and clinics who may offer phentermine or appetite suppressants for patients they deem qualified. 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. Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). As much as 33% of the U.S. adult population are considered to be obese. The pharmacist may dispense the controlled substance, in the exercise of her or his professional judgment, when the pharmacist or pharmacists agent has obtained satisfactory patient information from the patient or the patients agent. Rx only. privacy practices. For oral dosage form (tablets): Adults and children 17 years of age and older. . 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)]. Following the administration of Phentermine, Phentermine reaches peak concentrations (Cmax) after 3 to 4.4 hours. 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. 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. For example, it can be be used with healthy eating, physical activity and behavior change. 1591 0 obj <>stream Below is a chart of body mass index (BMI) based on various heights and weights. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. 0000000596 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. This content does not have an Arabic version. 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. 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. Current Obesity Reports. The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years. Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. Phentermine doctors network. Adults Exogenous Obesity Oral. Dosage form: tablet It is advised to stay in strict adherence with the instructions and dosage information a doctor prescribes to the patient in order to avoid dangerous side effects. Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. 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. Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. Pursuant to Board of Medical Examiners Rule 540-X-4-.05, dispensing physicians are required to register with the Board. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2), limit the dosage of Phentermine to 15 mg daily [see Dosage and Administration (2.2)]. Your doctor may occasionally change your dose. Schedule. 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. It is important to follow these instructions religiously. Taking Phentermine depends on the brand and preparation of the drug. <]>> 0000002736 00000 n Other brands of this drug include Suprenza, Phentercot, Acxion, Elvenir, Terflamex, Panbesy, Duromine, Fentermina, Phentermin, PHentermine and Lomaira. Accessed Oct. 11, 2022. Make sure your hands are dry before touching the tablet. The doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. Some of these include: As with many other prescription drugs, Phentermine can also interact with certain medications. Code R. 64B8-11.001 Advertising weight loss treatment shall be considered false, deceptive, or misleading if it contains representations that: (e) Suggest that weight loss is effortless or magical.
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