Also available as phentermine hydrochloride; dosage expressed in terms of phentermine hydrochloride. Patients must be instructed on how much Phentermine to take, and when and how to take it [see Dosage and Administration (2)]. Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. Billions of dollars are headed to state and local governments to address the opioid crisis. 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. Committee 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. Do not crush, break, or chew it. All rights reserved. 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. Animal reproduction studies have not been conducted with Phentermine. The date on which the prescription for such controlled substance was filled. include protected health information. Required fields are marked *. 2007-156; s. 5, ch. 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)]. Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. 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. JC. Or it can help you feel full longer. Later on, between 1940 and 1960, Phentermine was combined with other medications to improve its effectiveness. The FDA has categorized this drug as X for pregnancy, which means it should not be used during pregnancy under any circumstances. |. The number of the prescription, as recorded in the prescription files of the pharmacy in which it is filled. There is a problem with Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. Phentermine: Package Insert - Drugs.com 0000001920 00000 n Children 15 years of age and youngerUse is not recommended. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. hbbd``b`z$@D`]"@DeX- Bb V ``LA\F*? Obesity has been linked to many different diseases, including type 2 diabetes and cardiovascular disease. 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. Symptoms of extremely high blood pressure, such as uneven heartbeats, chest pain, blurred vision, anxiety and a severe headache. . Accessed Oct. 11, 2022. Ask your healthcare professional how you should dispose of any medicine you do not use. The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited. Place the tablet on the top of your tongue right after removing it from the bottle. 0000021285 00000 n 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 . 0000001488 00000 n Phentermine is most commonly prescribed to patients who experience negative health effects to excessive amounts of body weight. 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. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . Burguera B, et al. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. xref Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. (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 . Do not crush, break, or chew it. Phentermine should never be taken after 6 pm in the afternoon as it causes insomnia. It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. Committee Losing weight during pregnancy can harm both a mother and her baby. Children 16 years of age and youngerUse is not recommended. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. 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. NDC 42806-810-01 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)]. 64b8-9 Mayo Clinic does not endorse companies or products. 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. Over 12 weeks, it can be as high as 9-10%. 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)]. 0000000016 00000 n Children 16 years of age and youngerUse is not recommended. 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. 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. (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 . Phentermine Hydrochloride Tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. It is obvious that these symptoms can make the entire program useless. Florida Regulations 64B8-9.012: Standards for the Prescription of Drugs As phentermine is similar to amphetamine, it is a controlled drug (class C5) and has the potential for abuse. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Like other weight-loss medicines ordered by providers, phentermine is meant to be only part of a weight-loss plan. Use caution when administering Phentermine to patients with renal impairment. 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. Doctors often prescribe a dose of 5-HTP and vitamin B12 with a Phentermine prescription in order to enhance its effects and to relieve some side effects. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F Copyright: Merative US L.P. 1973, 2023. Your email address will not be published. Copyright 2000- 2023 State of Florida. This is a label given to drugs that can be misused. These rules and statutes . grants the Board of Medicine the authority to adopt rules to establish the practice guidelines for drugs used to treat obesity. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. This content does not have an Arabic version. Rulemaking Authority 458.336 FS. CIV The possible origins of the increased weight loss due to the various drug effects are not established. This medication has been linked to physical dependence, which means a patient may become addicted to it. Fatigue and depression usually follow the central stimulation. 458.336 Drugs to treat obesity; rules establishing guidelines.. Pharmacist and practitioner. Adults and children 17 years of age and older. Concomitant use of alcohol with phentermine may result in an adverse drug reaction. 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). Phentermine is related chemically and pharmacologically to the amphetamines. 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). Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. Such prescriptions must contain the date of the oral authorization. A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom prescribed. endstream endobj startxref Portions of this document last updated: Feb. 01, 2023. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). Each tablet contains the following inactive ingredients: starch, lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate and blue sugar spheres. Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. 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. The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years. 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 has the chemical name of ,,-Dimethylphenethylamine hydrochloride. Dosage form: tablet . Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. 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. Unfortunately, the answer is no in most cases. This content does not have an English version. The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. HVMs8WQl eLg*&{dd $_;lm |NggK6,M]gu\.BNB. If we combine this information with your protected 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. 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 Won Son J, et al. The most common brand of Phentermine is a product known as Adipex, but officially called Adipex-P. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. The journals or printed bills of the respective chambers should be consulted for official purposes. 893.04 Pharmacist and practitioner.. Do not double doses. Studies have not been performed with Phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. Such controlled substances may be sold only upon an order form, when such an order form is required for sale by the drug abuse laws of the United States or this state, or regulations pursuant thereto. The initials of the pharmacist filling the prescription and the date filled. The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. https://www.uptodate.com/contents/search. In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg Phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg Phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of Phentermine. Florida HB 423 - ARNP/PA Controlled Substance Prescribing - FANA 188 . The Topamax is added to Phentermine in order to intensify its effects and to help patients lose weight faster. information submitted for this request. But weight management can take time. "@Hw4`tqCA\+ q [AF]` b L ! 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. Statutes & Constitution :View Statutes : Online Sunshine Take phentermine exactly as prescribed by your doctor. PDF Volume 25, Number 8 September 2011 Drugs & Therapy 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 . 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. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. It can help weight loss by making you less hungry. 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. But the rate of misuse seems to be low. 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. Florida has received national attention for the large num- the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Cumulative urinary excretion of Phentermine under uncontrolled urinary pH conditions was 62% to 85%. 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. Following the administration of Phentermine, Phentermine reaches peak concentrations (Cmax) after 3 to 4.4 hours. Available for Android and iOS devices. Phentermine (as resin complex): Usual dosage is 15 or 30 mg once daily. IBM Micromedex. Please consult with your physician before you make any decisions regarding your health. Phentermine is approved for use for up to 12 . 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. Prescribing controlled substances via telehealth - HHS.gov
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