Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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 . Drug classes: Anorexiants, CNS stimulants. 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. 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. The combined drug is approved for long-term use. the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. 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. 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. Chapter 893 Section 04 - 2012 Florida Statutes - The Florida Senate include protected health information. Dosage form: tablet 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). Florida has received national attention for the large num- the unsubscribe link in the e-mail. (phentermine hydrochloride) orally disintegrating tablet C IV . It is not known if Phentermine is excreted in human milk; however, other amphetamines are present in human milk. One of the most important things to consider is the fact that the drug should never be accompanied by an MAO inhibitor. 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. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). Statutes & Constitution :View Statutes : Online Sunshine 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 . There are reports of patients who have increased the dosage of these drugs to many times than recommended. The amount of medicine that you take depends on the strength of the medicine. History.s. Section 458.336, F.S. 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. Mayo Clinic does not endorse companies or products. 90-2; s. 1436, ch. Accessed Oct. 11, 2022. The name of the prescribing practitioner. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. 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. One should bear in mind that Phentermine is not only a drug to help reduce the baseline body weight of patients, but it also reduces a patients risk of developing certain health diseases. The initials of the pharmacist filling the prescription and the date filled. Comprehensive review of current and upcoming anti-obesity drugs. While discussing the use of Phentermine with the doctor, a patient is provided a list of lifestyle changes to implement while using this product. 0000000909 00000 n The Drug Enforcement Administration (DEA) has made 2 changes related to . 893.04 Pharmacist and practitioner.. Duromine is not funded by Pharmac, so patients pay $160-$200 per month when they present a standard prescription of 30mg daily - in addition to the GP consultation fee. Thus, in order to make the most of this drug, patients need make some effort too. Safety and effectiveness in pediatric patients have not been established. In some cases, the use of Phentermine has also led to the development of symptoms that are related to erectile dysfunction. xb```f``ZAb 1av K3gI{$*i p400t UD J@X$Ybv k=:,fb[ a`x @ ! Rule 4731-11-04. You may opt-out of email communications at any time by clicking on Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. 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. Keep from freezing. Phentermine. 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)]. For oral dosage form (extended-release capsules): Adults and children 16 years of age and olderOne capsule once a day, taken before breakfast or 10 to 14 hours before sleeping. The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. We comply with the HONcode standard for trustworthy health information. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. 2019; doi:10.1016/j.mayocp.2018.11.020. 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. To provide you with the most relevant and helpful information, and understand which The MAO inhibitors (Monoamine Oxidase Inhibitors) are used to treat depression, especially a specific type called atypical depression. Phentermine is for people with obesity or overweight who haven't been able to lose enough weight with diet and exercise alone to improve their health. Do not double doses. 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. 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 is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Symptoms of extremely high blood pressure, such as uneven heartbeats, chest pain, blurred vision, anxiety and a severe headache. Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. Like other weight-loss medicines ordered by providers, phentermine is meant to be only part of a weight-loss plan. 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. This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. Drugs to treat obesity; rules establishing guidelines. 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. 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. Accessed Oct. 11, 2022. 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. As mentioned above, new mothers should avoid using this medication when breastfeeding. Committee Phentermine hydrochloride/topiramate. Statutes, Video Broadcast @ d Swallow the extended-release capsule whole. Follow all directions on your prescription label and read all medication guides or instruction sheets. Adults Exogenous Obesity Oral. Florida Board of Medicine Electronic Prescribing Requirements Drug information provided by: Merative, Micromedex. It is important to follow these instructions religiously. Phentermine Hydrochloride Tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day. Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. History.s. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. Controlled substances for the treatment of obesity. Requirements may be altered [see Warnings and Precautions (5.9)]. 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. Review/update the 893.04 Pharmacist and practitioner.. Do not crush, break, or chew it. PDF Volume 25, Number 8 September 2011 Drugs & Therapy After 12 weeks, the patient needs to take a break from the product as it may lead to physical dependence. 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. Carefully follow the dosing instructions for the form you are using. Taking Phentermine depends on the brand and preparation of the drug. Publications, Help Searching 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. . Ideally, patients should take it on an empty stomach. 0 There is a problem with There is a problem with Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Phentermine: Package Insert - Drugs.com Review/update the All rights reserved. Patients with a larger body weight may need to take a larger dose, depending on whether they have any health concerns that may be worsened by the usage of a larger dose. Skip to Navigation | Skip to Main Content | Skip to Site Map. The following information includes only the average doses of this medicine. 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. 2009-202. 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 The FDA in the United States first approved the use of Amphetamine as a drug that can be used to suppress a patients appetite in 1959. 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. 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. While these are the most common side effects of the drug, they are not the only consequences associated with the intake of this medication. Tak YJ, et al. 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. After the tablet has melted, swallow or take a sip of water. . Rulemaking Authority 458.336 FS. 0000001039 00000 n Concomitant use of alcohol with Phentermine may result in an adverse drug reaction. Some of these include: As with many other prescription drugs, Phentermine can also interact with certain medications. If the federal government fails to oversee how the money is spent, advocates worry it will be wasted. SE, which stands for Electronic Florida Online Reporting of Controlled Sub-stances Evaluation program. hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ The dosage varies from 15mg to 37.5mg per day. For example, it can be be used with healthy eating, physical activity and behavior change. 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. Mayo Clinic offers appointments in Arizona, Florida and Minnesota and at Mayo Clinic Health System locations. health information, we will treat all of that information as protected health hb```e````a`d`@ f(fcfILLvL~. 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. Follow your doctor's dosing instructions very carefully. The doctor also looks at the patients medical history for any pre-existing medical conditions that the medication should not be taken with. other information we have about you. 0000003240 00000 n Copyright 2000- 2023 State of Florida. 0000002493 00000 n These practice guidelines can be found in Rule 64B8-9.012, F.A.C. - 7 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. Florida HB 423 - ARNP/PA Controlled Substance Prescribing - FANA Over 12 weeks, it can be as high as 9-10%. Phentermine also is offered combined with topiramate for weight loss (Qsymia). 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. Search: PHENTERMINE BMI GUIDELINES - United States Department of Justice 99-8; s. 2, ch. 0000000828 00000 n |. 14 Facts & Comparisons eAnswers. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. Phentermine is a popular prescription drug that is often used to treat obesity. The journals or printed bills of the respective chambers should be consulted for official purposes. If we combine this information with your protected The date on which the prescription for such controlled substance was filled. Losing weight during pregnancy can harm both a mother and her baby. Long-term efficacy and safety of anti-obesity treatment: Where do we stand? Prescribing Information - Qsymia (Phentermine and Topiramate extended . Ask your healthcare professional how you should dispose of any medicine you do not use. 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 <]>> 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 Y$iqzZz\vlt1a;svw&aBS8Z(HGCkr&_Qxt97t,GWceTL^QqX(%8_A2'"%tD'DNz"G*"Tc. 0000001920 00000 n Prescribing phentermine - Medical Protection 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. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. hWmo8+jE'"m{F This content does not have an English version. 458.336 Drugs to treat obesity; rules establishing guidelines.. Phentermine is related chemically and pharmacologically to the amphetamines. Use of Phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. 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. 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. Your doctor may occasionally change your dose. Being extremely irritable and confused, or experienced unusual behavior or thoughts. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. Advertising revenue supports our not-for-profit mission. 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. 35 0 obj <>stream 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. 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 . Mayo Clinic does not endorse companies or products. The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. Chapter 458 Section 336 - 2011 Florida Statutes - The Florida Senate Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Patients must be instructed on how much Phentermine to take, and when and how to take it [see Dosage and Administration (2)]. The drug is mainly an appetite suppressant, thus making a patient feel fuller after (and between) meals and making the patient more likely to consume foods that have lower amounts of calories. 2020; doi:10.4093/dmj.2020.0258. L^%0:T'xHGi,KGyVfZ5WI6&ZU1/VqM4.ct\i2gTAtQV%[$*/tbn"xS8JU$bljsI2)bs_/FouVGwCqX';z{0REZbSX,bXWPS#Bf|il#o'y`?jv{;!bS F#vPGzD"1~5~F%mW9YlGIQVYOS~kojbdQS!>|@Ph See DrugAbuse and Dependence (9.3). Opioid settlement billions flow to states, as advocates worry about Phentermine is approved for use for up to 12 . All trademarks are the property of their respective owners. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Fatigue and depression usually follow the central stimulation. It is vital to talk with the doctor before using Phentermine with other products. 21 15 SECTION 04. Why is phentermine a controlled substance? Burguera B, et al. The drug is usually prescribed at the lowest possible dose to new users, which is 15mg per day. It also isn't for people who are pregnant, may become pregnant or are breastfeeding. Patients who have been on a Phentermine program should not suddenly stop using the drug. Phentermine is used as part of a short-term plan, along with a low calorie diet, for weight reduction. Take the disintegrating tablet with or without food. This medication has been linked to physical dependence, which means a patient may become addicted to it. Phentermine also is offered combined with topiramate for weight loss (Qsymia). privacy practices. 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. Portions of this document last updated: Feb. 01, 2023.