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` &^ History-New 12-4-97, Amended 2-17-98, 8-8-22. Facts & Comparisons eAnswers. Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. Phentermine is not recommended for use in pediatric patients 16 years of age. 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). hWmo8+jE'"m{F Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Common side effects of phentermine include: Phentermine is one of the most prescribed weight-loss medicines. All rights reserved. Some of the studies that have linked Phentermine to positive results in humans include: The main active ingredient is known as Phentermine Hydrochloride. Take the disintegrating tablet with or without food. xb```f``ZAb 1av K3gI{$*i p400t UD J@X$Ybv k=:,fb[ a`x @ ! CRIMES. HVMs8WQl eLg*&{dd $_;lm |NggK6,M]gu\.BNB. Comprehensive review of current and upcoming anti-obesity drugs. hbbd``b` @IHpA\> . In most cases, the drug is prescribed to users in periods of 12 weeks. 893.04 Pharmacist and practitioner.. This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. 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. Your doctor may occasionally change your dose. health information, we will treat all of that information as protected health These are all promoted as weight loss pills that assist obese individuals. 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. Precaution should be taken if a patient has any existing health concerns as the drug may cause further harm to their body. Make sure your hands are dry before touching the tablet. The prescription of such weight loss enhancers is not generally appropriate for children. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. Like other weight-loss medicines ordered by providers, phentermine is meant to be only part of a weight-loss plan. This website is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Accessed Oct. 11, 2022. It is not known if Phentermine is excreted in human milk; however, other amphetamines are present in human milk. 1530 0 obj <> endobj Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). Pharmacists may order the medicinal drug products set forth in each rule subject to the following terms and limitations: . 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 In some cases, the use of Phentermine has also led to the development of symptoms that are related to erectile dysfunction. 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. The Drug Enforcement Administration (DEA) has made 2 changes related to . 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. Also available as phentermine hydrochloride; dosage expressed in terms of phentermine hydrochloride. trailer This search engine indexes the Drug Enforcement Administration Diversion Control Program Web Site (www.deadiversion.usdoj.gov) only. %PDF-1.6 % If you are a Mayo Clinic patient, this could The use of Topamax and Phentermine is actually an FDA-approved combination. HB 423 - ARNP/PA Controlled Substance Prescribing. But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. Talk with your doctor before starting an exercise program. 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 0000003240 00000 n Lomaira: One tablet three times a day, taken 30 minutes before meals. . By doing this, the metabolism is revved up along with an . Medically reviewed by Drugs.com. Mayo Clinic offers appointments in Arizona, Florida and Minnesota and at Mayo Clinic Health System locations. 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. In some cases, especially when the health concern is not too serious, the doctor may prescribe the drug at lower doses spread throughout the day, instead of advising the patient to take one single dose every day. The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. The journals or printed bills of the respective chambers should be consulted for official purposes. If your dose is different, do not change it unless your doctor tells you to do so. 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. NDC 42806-810-01 The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Keep from freezing. 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 . The possible origins of the increased weight loss due to the various drug effects are not established. Swallow the tablet whole. Do not crush, break, or chew it. 0000002736 00000 n Fatigue and depression usually follow the central stimulation. There are reports of patients who have increased the dosage of these drugs to many times than recommended. The FDA has categorized this drug as X for pregnancy, which means it should not be used during pregnancy under any circumstances. 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. privacy practices. Copyright: Merative US L.P. 1973, 2023. Section 458.336, F.S. This combination of ingredients was branded as Fen-Phen. Skip to Navigation | Skip to Main Content | Skip to Site Map. s. 4, ch. For a more comprehensive list of drug and nutraceuticals which interact with phentermine hydrochloride, refer to our phentermine drug interactions data. Registration is accomplished by completing and returning the dispensing physician registration form. But the rate of misuse seems to be low. The combined drug is approved for long-term use. 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. The dosage varies from 15mg to 37.5mg per day. These rules and statutes . 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. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. 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. 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. Tablets containing 37.5 mg Phentermine hydrochloride (equivalent to 30 mg Phentermine base). Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. 35 0 obj <>stream In order to use Phentermine, the doctor needs to prescribe the drug for a specific patient. 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. Acidification of the urine increases Phentermine excretion. 0000002493 00000 n Controlled substances for the treatment of obesity. Being extremely irritable and confused, or experienced unusual behavior or thoughts. REGULATION OF PROFESSIONS AND OCCUPATIONS. 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. 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. Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Taking too much Phentermine can be harmful to the patients body. Phentermine HCl Tablets, USP 37.5 mg 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. Thus, in order to make the most of this drug, patients need make some effort too. ZeS{$d!YS,|C~E;h4DJS?|{x}~ ?`2F. 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 Unfortunately, patients experienced a variety of side effects, which included severe heart toxicity and hypertension. Accessed Oct. 11, 2022. 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. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. Phentermine is not to be used while pregnant or breastfeeding under any circumstances. We comply with the HONcode standard for trustworthy health information. the unsubscribe link in the e-mail. include protected health information. Due to its status as a controlled substance, the sale, distribution, and possession of this drug . 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. Diabetes & Metabolism Journal. Obesity has been linked to many different diseases, including type 2 diabetes and cardiovascular disease. 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. Phentermine. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Use caution when administering Phentermine to patients with renal impairment. Dosage should be individualized to obtain an adequate response with the lowest effective dose. 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). The drug is usually prescribed at the lowest possible dose to new users, which is 15mg per day. health information, we will treat all of that information as protected health Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. IBM Micromedex. Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. The directions for the use of the controlled substance prescribed in the prescription. 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 doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. 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. 0000001920 00000 n Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. 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. The initial symptom of PPH is usually dyspnea. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. The first use of Phentermine as a drug to help treat obesity dates back to 1938. They inhibit the activity of an entire enzyme family known as monoamine oxidase. Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. 458.336, Florida Statutes - Drugs to treat obesity; rules establishing guidelines; Rule 64B8-9.012, Florida Administrative Code - Standards for the Prescription of Obesity . FULL PRESCRIBING of the risk of hypertensive crisis. Phentermine doctors network. A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom prescribed. Advertising revenue supports our not-for-profit mission. The amount of medicine that you take depends on the strength of the medicine. Rulemaking Authority 458.336 FS. 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 It depends on supplements a patient would like to take. 2012 Florida Statutes. 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. 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. W0Qxe {>x??}# cGCSGGC[G(P A@3'i~ (2[n! 0000000909 00000 n However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. As phentermine is similar to amphetamine, it is a controlled drug (class C5) and has the potential for abuse. Each tablet contains the following inactive ingredients: starch, lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate and blue sugar spheres. 127: VA Prescription Monitoring Program. Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. 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 prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Over 12 weeks, it can be as high as 9-10%. Patients who have been on a Phentermine program should not suddenly stop using the drug. These practice guidelines can be found in Rule 64B8-9.012, F.A.C. (3) In any case of dispensing hereunder, the amount or . 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. 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. 0000002991 00000 n 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 Ideally, patients should take it on an empty stomach. The combined drug is approved for long-term use. Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. Phentermine has been linked to many complications; knowing these details will help patients minimize their risk of experiencing such unwanted scenarios. Numerous side effects have been linked to the use of Phentermine. Intravenous phentolamine (Regitine, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. 75-18; s. 12, ch. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. Late evening medication should be avoided because of the possibility of resulting insomnia. 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 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. Committee 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. 0000001039 00000 n Average users lose 3-5% of their initial body weight as shown in studies. hbbd``b`z$@D`]"@DeX- Bb V ``LA\F*? Drug classes: Anorexiants, CNS stimulants. 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. The effective date is January 1, 2020. The drug is also available in regular capsules that are taken orally with a glass of water. 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. . Since it may lead to such symptoms, it also has the potential to cause severe withdrawal symptoms, especially when a patient goes cold turkey. Some brands use a dissolving tablet that is placed under the tongue, which allows the body to absorb the chemicals in the drug faster. Advise pregnant women and nursing mothers not to use Phentermine [see Use in Specific Populations (8.1, 8.3)]. Tak YJ, et al. Adults and children 17 years of age and older15 to 30 milligrams (mg) once a day, taken at approximately 2 hours after breakfast. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 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. 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. 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. In order to help patients reduce their risk of developing these diseases when they are obese, doctors usually prescribe Phentermine. Losing weight during pregnancy can harm both a mother and her baby. 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. Drugs to treat obesity; rules establishing guidelines. 893.04 Pharmacist and practitioner.. It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. The full name and address of the prescribing practitioner and the practitioners federal controlled substance registry number shall be printed thereon.
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