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. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Place the tablet on the top of your tongue right after removing it from the bottle. Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. What You Should Know Before Taking Phentermine, Frequently Asked Questions About Phentermine, refer to our phentermine drug interactions data, Frequently Asked Questions about phentermine, https://www.drugs.com/ingredient/phentermine.html, http://www.rxlist.com/adipex-p-drug/patient-avoid-while-taking.htm, http://www.everydayhealth.com/drugs/phentermine, https://www.ncbi.nlm.nih.gov/pubmed/27664021, https://www.ncbi.nlm.nih.gov/pubmed/26584649, https://www.ncbi.nlm.nih.gov/pubmed/26446094, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4560177/, https://www.ncbi.nlm.nih.gov/pubmed/25911503, Feeling like they are going to faint, often accompanied by chest pain, Fluttering in the patients chest, as well as pounding heartbeats. 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. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 893.04 Pharmacist and practitioner.. In most cases, the drug is prescribed to users in periods of 12 weeks. https://www.uptodate.com/contents/search. Studies have not been performed with Phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. 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. 458.336, Florida Statutes - Drugs to treat obesity; rules establishing guidelines; Rule 64B8-9.012, Florida Administrative Code - Standards for the Prescription of Obesity . 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. 99-8; s. 2, ch. Accessed Oct. 11, 2022. hb```e````a`d`@ f(fcfILLvL~. 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). 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. Follow all directions on your prescription label and read all medication guides or instruction sheets. 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. For oral dosage form (disintegrating tablets): Adults and children 17 years of age and olderOne tablet once a day, taken in the morning. Taking Phentermine depends on the brand and preparation of the drug. Any time such prescriptions are made for children, the prescribing physician must obtain a written informed consent from the parent or legal guardian of the minor patient in addition to complying with the other guidelines and standards set forth in this rule. Six years after the approval, a similar drug, called Aminorex, were released in Europe with the same purpose of helping obese individuals. Available for Android and iOS devices. hX}(I 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. 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. These are all promoted as weight loss pills that assist obese individuals. 90-2; s. 1436, ch. Mid-range score: large amounts of medication in accordance with recommended guidelines.Low dose + high risk factors . 0000000828 00000 n 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. Statutes, Video Broadcast See DrugAbuse and Dependence (9.3). Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). Accessed Oct. 11, 2022. HB 423 - ARNP/PA Controlled Substance Prescribing. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). privacy practices. In some cases, patients have also found that Phentermine interacts with drugs that contain Tranylcypromine, Henelzine, Isocarboxazid, Diethylpropion, Phendimetrazine, Amphetamine, and Benzphetamine. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. Being extremely irritable and confused, or experienced unusual behavior or thoughts. Cumulative urinary excretion of Phentermine under uncontrolled urinary pH conditions was 62% to 85%. hbbd``b`z$@D`]"@DeX- Bb V ``LA\F*? FULL PRESCRIBING of the risk of hypertensive crisis. Schedule. It also isn't for people who are pregnant, may become pregnant or are breastfeeding. 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)]. If the federal government fails to oversee how the money is spent, advocates worry it will be wasted. In some cases, the use of Phentermine has also led to the development of symptoms that are related to erectile dysfunction. 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. Phentermine also is offered combined with topiramate for weight loss (Qsymia). All rights reserved. ]c,'303:20/) @d` )2 0000000596 00000 n xref If a patient would like to take other supplements, they should consult their doctor first. Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. A prescription for a controlled substance listed in Schedule II may not be refilled. The doctor also looks at the patients medical history for any pre-existing medical conditions that the medication should not be taken with. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. Phentermine (as resin complex): Usual dosage is 15 or 30 mg once daily. The possible origins of the increased weight loss due to the various drug effects are not established. It is not known if Phentermine is excreted in human milk; however, other amphetamines are present in human milk. However, the medication does have a considerable street value. Doctors used it to help patients who experience certain health issues caused by obesity to lose weight and improve the symptoms they are experiencing. information is beneficial, we may combine your email and website usage information with But weight management can take time. Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. information highlighted below and resubmit the form. the unsubscribe link in the e-mail. . The journals or printed bills of the respective chambers should be consulted for official purposes. JC. 2021; doi:10.1007/s13679-020-00422-w. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. 1558 0 obj <>/Filter/FlateDecode/ID[<7182559B062CF74D9CEE71C953F61692>]/Index[1530 62]/Info 1529 0 R/Length 121/Prev 89015/Root 1531 0 R/Size 1592/Type/XRef/W[1 2 1]>>stream hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ Drugs to treat obesity; rules establishing guidelines. @ d As phentermine is similar to amphetamine, it is a controlled drug (class C5) and has the potential for abuse. Numerous side effects have been linked to the use of Phentermine. For oral dosage form (tablets): Adults and children 17 years of age and older. 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 Other initial symptoms may include angina pectoris, syncope or lower extremity edema. 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)]. Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for the possible presence of pulmonary hypertension. Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. This brand is manufacturedby Teva Pharmaceuticals (formerly GATE Pharmaceuticals). Accessed Oct. 11, 2022. If you are a Mayo Clinic patient, this could Patients should be advised to report immediately any deterioration in exercise tolerance. The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. |. Average users lose 3-5% of their initial body weight as shown in studies. Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. Statutes, Video Broadcast It is obvious that these symptoms can make the entire program useless. We comply with the HONcode standard for trustworthy health information. It is not uncommon for patients to experience a change in their sexual interest. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. . 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). Advertising revenue supports our not-for-profit mission. The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Current Obesity Reports. Rule 4731-11-04. 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 name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. Disclaimer: The information on this system is unverified. Rx only. Phentermine is approved for use for up to 12 . https://fco.factsandcomparisons.com/. Fatigue and depression usually follow the central stimulation. 138 0 obj <>stream 35 0 obj <>stream 100 TABLETS The directions for the use of the controlled substance prescribed in the prescription. This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. 0000000909 00000 n Late evening medication should be avoided because of the possibility of resulting insomnia. Phentermine is a popular prescription drug that is often used to treat obesity. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). 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. The bill provides important new requirements for prescribers to generate and transmit all prescriptions electronically upon licensure renewal or by July 1, 2021, whichever is earlier. 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. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. This content does not have an Arabic version. . 2012 Florida Statutes. Phentermine Hydrochloride Tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The initial symptom of PPH is usually dyspnea. s. 4, ch. 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. . BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. The dosage varies from 15mg to 37.5mg per day. Portions of this document last updated: Feb. 01, 2023. The strength and dosage of Phentermine depend on the brand that is prescribed and the patients specific condition. Initial U.S. Approval: 1959 -----INDICATIONS AND USAGE----- Suprenza is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of . The recommended maximum dosage of Phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years. trailer Ideally, patients should take it on an empty stomach. 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. 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. To provide you with the most relevant and helpful information, and understand which Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). Drugs to treat obesity; rules establishing guidelines. Click here for an email preview. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F Review/update the Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. Take this medicine only as directed by your doctor. 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 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. Phentermine is approved for use for up to 12 weeks. Of course, it is taken orally. Taking too much Phentermine can be harmful to the patients body. Unfortunately, patients experienced a variety of side effects, which included severe heart toxicity and hypertension. These practice guidelines can be found in Rule 64B8-9.012, F.A.C. 21 0 obj <> endobj Each tablet contains the following inactive ingredients: starch, lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate and blue sugar spheres. 0000002991 00000 n The amount of medicine that you take depends on the strength of the medicine. Today, Phentermine can still be obtained through the doctors prescription in the majority of countries around the world. hYr ~{L(QdK4^bdsO_d;a BXO--p,!4!,WhfM/@c Committee You may opt-out of email communications at any time by clicking on 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. W0Qxe {>x??}# cGCSGGC[G(P A@3'i~ (2[n! Registration is accomplished by completing and returning the dispensing physician registration form. The risks include, but are not limited to: See also, for example, Adverse Reactions (6) and Use in SpecificPopulations (8). The journals or printed bills of the respective chambers should be consulted for official purposes. HB 423 (by Rep. Pigman) was signed into law on April 14, 2016. Do not crush, break, or chew it. Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. This is a label given to drugs that can be misused. Other brands of this drug include Suprenza, Phentercot, Acxion, Elvenir, Terflamex, Panbesy, Duromine, Fentermina, Phentermin, PHentermine and Lomaira. Each brand has its own way of manufacturing the drug and, in some cases, combines it with other chemicals to make it more effective or to add additional features to its use. The written prescription must be dated and signed by the prescribing practitioner on the day when issued. Children 15 years of age and youngerUse is not recommended. law states . It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. Carefully follow the dosing instructions for the form you are using. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. The MAO inhibitors (Monoamine Oxidase Inhibitors) are used to treat depression, especially a specific type called atypical depression. These rules and statutes . . Required fields are marked *. All rights reserved. Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of Phentermine with fenfluramine or dexfenfluramine for weight loss. (1) A pharmacist, in good faith and in the course of professional practice only, may dispense controlled substances upon a written, oral, or electronic prescription of a practitioner, under the following conditions: (a) Oral prescriptions must be promptly reduced to writing by the pharmacist or recorded . In order to determine the effectiveness of certain pharmaceuticals, supplements and other substances, clinical trials and scientific research are often conducted among a group of volunteers. For more FAQs, please see our full archive of Frequently Asked Questions about phentermine and related prescription appetite suppressants. 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 hbbd``b` @IHpA\> . Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. (In combination with a healthy diet and exercise plan). Phentermine is related chemically and pharmacologically to the amphetamines. the unsubscribe link in the e-mail. For a more comprehensive list of drug and nutraceuticals which interact with phentermine hydrochloride, refer to our phentermine drug interactions data. This content does not have an English version. The usual adult dose is one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. SECTION 04. Apart from not combining Phentermine with the MAO inhibitors, a patient should also first ensure they are not allergic to Phentermine before they take it. Do not keep outdated medicine or medicine no longer needed. The dose of this medicine will be different for different patients. Rule 4731-11-04 | Controlled substances for the treatment of obesity. Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. 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. 104 0 obj <> endobj Moreover, it is strongly recommended to avoid or limit the alcohol intake. grants the Board of Medicine the authority to adopt rules to establish the practice guidelines for drugs used to treat obesity. Copyright 2000- 2023 State of Florida. 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 date on which the prescription for such controlled substance was filled. 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 initials of the pharmacist filling the prescription and the date filled. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. Florida. Burguera B, et al. NDC 42806-810-01 RPYcn@b[%XYK'Q %[.()GTkJ WCf.-i>n-oIzE*D40f#Gp'LcddmE8;>u?X"tO 1]M={4,ReC8E8Z Q1Lt$-XpFCrTJ History.s. Losing weight during pregnancy can harm both a mother and her baby. Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. 14 Adults and children 17 years of age and older15 to 30 milligrams (mg) once a day, taken at approximately 2 hours after breakfast. Advertising revenue supports our not-for-profit mission. 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. Publications, Help Searching Javascript must be enabled for site search. 0000003317 00000 n In addition to its function as an appetite suppressant, Phentermine drugs also act as energy boosters. The safety and efficacy of combination therapy with Phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. 0000000016 00000 n The first use of Phentermine as a drug to help treat obesity dates back to 1938. 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. Controlled substances for the treatment of obesity. Any pharmacist who dispenses by mail a controlled substance listed in Schedule II, Schedule III, or Schedule IV is exempt from the requirement to obtain suitable identification for the prescription dispensed by mail if the pharmacist has obtained the patients identification through the patients prescription benefit plan. 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. 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. Even patients who are overweight and pregnant at the same time are not allowed to use this product. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. information and will only use or disclose that information as set forth in our notice of