The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Schedule. 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. However, the medication does have a considerable street value. It is not uncommon for patients to experience a change in their sexual interest. 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. 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. 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 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. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. 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. xref 188, ch. 0000000909 00000 n Patients who have been on a Phentermine program should not suddenly stop using the drug. 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. Do not double doses. 0000001920 00000 n 893.04 Pharmacist and practitioner.. Chapter 893 DRUG ABUSE PREVENTION AND CONTROL Entire Chapter. Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. 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. All rights reserved. Studies have not been performed with Phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. Click here for an email preview. 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. For a more comprehensive list of drug and nutraceuticals which interact with phentermine hydrochloride, refer to our phentermine drug interactions data. 0000002991 00000 n CRIMES. It can help weight loss by making you less hungry. %%EOF ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F PDF Prescribing Laws and Rules for Florida Licensed Physicians Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. This combination of ingredients was branded as Fen-Phen. If your dose is different, do not change it unless your doctor tells you to do so. Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. 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 information highlighted below and resubmit the form. A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required. Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. Controlled substances for the treatment of obesity. Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID-19, plus expertise on managing health. For oral dosage form (disintegrating tablets): Adults and children 17 years of age and olderOne tablet once a day, taken in the morning. Accessed Oct. 11, 2022. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Acidification of the urine increases Phentermine excretion. Precaution should be taken if a patient has any existing health concerns as the drug may cause further harm to their body. Apart from these brand names, other brands that contain the drug as part of their multi-ingredient formula also exist and the most popular one is Qsymia. Low dose + low risk factors . JC. Management of acute Phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. 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 aforementioned statute and rule do not specifically rule out a patient evaluation taking place . Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. The possible origins of the increased weight loss due to the various drug effects are not established. 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. 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. Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. The following information includes only the average doses of this medicine. 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. Intravenous phentolamine (Regitine, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage. Phentermine is related chemically and pharmacologically to the amphetamines. Fatigue and depression usually follow the central stimulation. information highlighted below and resubmit the form. Children 15 years of age and youngerUse is not recommended. Children 16 years of age and youngerUse is not recommended. 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. "@Hw4`tqCA\+ q [AF]` b L ! Obesity has been linked to many different diseases, including type 2 diabetes and cardiovascular disease. The full name and address of the prescribing practitioner and the practitioners federal controlled substance registry number shall be printed thereon. PDF Prescription Drug Time and Dosage Limit Laws - CDC the unsubscribe link in the e-mail. Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. Available for Android and iOS devices. Phentermine (Oral Route) Proper Use - Mayo Clinic 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 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. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. You may opt-out of email communications at any time by clicking on 75-18; s. 12, ch. ]c,'303:20/) @d` )2 Or it can help you feel full longer. 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. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. Tak YJ, et al. Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. 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. Safety and effectiveness in pediatric patients have not been established. other information we have about you. 0 2020; doi:10.4093/dmj.2020.0258. But weight management can take time. After the tablet has melted, swallow or take a sip of water. The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. information and will only use or disclose that information as set forth in our notice of Also, it may cause certain side effects to become much worse. Duromine is not funded by Pharmac, so patients pay $160-$200 per month when they present a standard prescription of 30mg daily - in addition to the GP consultation fee. Do not keep outdated medicine or medicine no longer needed. In some cases, the use of this drug in combination with other pills may cause the effects of other drugs to increase. 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. Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. (3) In any case of dispensing hereunder, the amount or . 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)]. 1591 0 obj <>stream 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. 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. As mentioned above, new mothers should avoid using this medication when breastfeeding. This bill allows ARNPs and PAs to prescribe controlled substances under existing supervision and protocol requirements, and subject to a formulary to be developed by a committee under the Board of Nursing. Therefore, coadministration of Phentermine and these drug products is not recommended. health information, we will treat all of that information as protected health 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. (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 . Last updated on Mar 22, 2023. The journals or printed bills of the respective chambers should be consulted for official purposes. 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. One of the most important things to consider is the fact that the drug should never be accompanied by an MAO inhibitor. Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. 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. Doctors used it to help patients who experience certain health issues caused by obesity to lose weight and improve the symptoms they are experiencing. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. other information we have about you. 0000002493 00000 n If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). 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. 2012 Florida Statutes. = During the COVID-19 public health emergency (PHE), authorized providers can prescribe controlled substances via telehealth, without the need for an in-person medical evaluation. The recommended maximum dosage of Phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). Section 458.336, F.S. Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Common side effects of phentermine include: Phentermine is one of the most prescribed weight-loss medicines. health information, we will treat all of that information as protected health SECTION 04. Phentermine is most commonly prescribed to patients who experience negative health effects to excessive amounts of body weight. 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. hb```e````a`d`@ f(fcfILLvL~. Phentermine: Package Insert - Drugs.com Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. Phentermine is used as part of a short-term plan, along with a low calorie diet, for weight reduction. Review/update the Numerous side effects have been linked to the use of Phentermine. By doing this, the metabolism is revved up along with an . 0000021285 00000 n 458.336 Drugs to treat obesity; rules establishing guidelines.. NDC 42806-810-01 In some cases, the use of Phentermine has also led to the development of symptoms that are related to erectile dysfunction. However in the presence of topiramate, Phentermine Cmax and AUC increase 13% and 42%, respectively. 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. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Mayo Clinic does not endorse companies or products. Diabetes & Metabolism Journal. 21 15 A prescription for a controlled substance listed in Schedule II may be dispensed only upon a written prescription of a practitioner, except that in an emergency situation, as defined by regulation of the Department of Health, such controlled substance may be dispensed upon oral prescription but is limited to a 72-hour supply. OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. PDF Volume 25, Number 8 September 2011 Drugs & Therapy All trademarks are the property of their respective owners. History.s. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. Florida has received national attention for the large num- (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 . . xb```f``ZAb 1av K3gI{$*i p400t UD J@X$Ybv k=:,fb[ a`x @ ! Required fields are marked *. trailer privacy practices. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Chapter 458 Section 336 - 2011 Florida Statutes - The Florida Senate 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. As phentermine is similar to amphetamine, it is a controlled drug (class C5) and has the potential for abuse. Do not crush, break, or chew it. 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. The strength and dosage of Phentermine depend on the brand that is prescribed and the patients specific condition. 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)]. Advertising revenue supports our not-for-profit mission. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. 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. Cumulative urinary excretion of Phentermine under uncontrolled urinary pH conditions was 62% to 85%. Taking Phentermine depends on the brand and preparation of the drug. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). All rights reserved. PDF Reference ID: 3115694 - Food and Drug Administration Phentermine. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. History-New 12-4-97, Amended 2-17-98, 8-8-22. 104 0 obj <> endobj Carefully follow the dosing instructions for the form you are using. Burguera B, et al. 2009-202. Swallow the tablet whole. These rules and statutes . Rx only. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. 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. Chapter 893 Section 04 - 2012 Florida Statutes - The Florida Senate 893.04 Pharmacist and practitioner.. Phentermine Hydrochloride Tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. In order to help patients reduce their risk of developing these diseases when they are obese, doctors usually prescribe Phentermine. Today, Phentermine can still be obtained through the doctors prescription in the majority of countries around the world. 90-2; s. 1436, ch. 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. Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Different brands manufacture, distribute and sell Phentermine drugs. Talk with your doctor before starting an exercise program. 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 chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. In some cases, the side effects were life-threatening and led to the death of a patient. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [see ClinicalPharmacology (12.3)]. 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. 138 0 obj <>stream The medication has been classified as a controlled substance in most countries and is also classified as a schedule IV prescription drug. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. The doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. Phentermine hydrochloride/topiramate. Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. 0000001146 00000 n A prescription for a controlled substance listed in Schedule II may not be refilled. These practice guidelines can be found in Rule 64B8-9.012, F.A.C. REGULATION OF PROFESSIONS AND OCCUPATIONS. 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. Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Being extremely irritable and confused, or experienced unusual behavior or thoughts. . This content does not have an English version. Swallow the extended-release capsule whole. Doses are normally taken before breakfast, or 1 to 2 hours after breakfast. It should also not be taken within 14 days after taking an MAO inhibitor. <]>> The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. Rule 4731-11-04 | Controlled substances for the treatment of obesity. hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ 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 (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 . Mayo Clinic does not endorse companies or products. Florida Board of Medicine Electronic Prescribing Requirements Drug information provided by: Merative, Micromedex. %PDF-1.6 % 79-12; s. 2, ch. 14 Perreault L. Obesity in adults: Drug therapy. Pharmacist and practitioner. Review/update the PDF label - Food and Drug Administration It is often prescribed to be taken in the morning, before or after breakfast. Metric conversions are as follows: pounds 2.2 = kg; inches x 0.0254 = meters. There shall appear on the face of the prescription or written record thereof for the controlled substance the following information: The full name and address of the person for whom, or the owner of the animal for which, the controlled substance is dispensed.
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