Drug classes: Anorexiants, CNS stimulants. Patients must be instructed on how much Phentermine to take, and when and how to take it [see Dosage and Administration (2)]. Florida. Phentermine HCl Tablets, USP 37.5 mg 97-264. Current Obesity Reports. Mayo Clinic does not endorse companies or products. Ideally, patients should take it on an empty stomach. other information we have about you. 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. It is obvious that these symptoms can make the entire program useless. The medication has been classified as a controlled substance in most countries and is also classified as a schedule IV prescription drug. The structural formula is as follows: Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Chapter 458 Section 336 - 2011 Florida Statutes - The Florida Senate 0000001488 00000 n 97-102; s. 301, ch. Some of these include: As with many other prescription drugs, Phentermine can also interact with certain medications. JC. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. The amount of medicine that you take depends on the strength of the medicine. Phentermine hydrochloride/topiramate. Generic name: Phentermine hydrochloride Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [see ClinicalPharmacology (12.3)]. hX}(I 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)]. There is a problem with The aforementioned statute and rule do not specifically rule out a patient evaluation taking place . The dosage varies from 15mg to 37.5mg per day. 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. |. However, the medication does have a considerable street value. The dosage may be adjusted to the patients need. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). Chapter 893 Section 04 - 2012 Florida Statutes - The Florida Senate Of course, it is taken orally. 21 0 obj <> endobj The possible origins of the increased weight loss due to the various drug effects are not established. Phentermine: Drug Uses, Dosage & Side Effects - Drugs.com 0 The use of Topamax and Phentermine is actually an FDA-approved combination. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Precaution should be taken if a patient has any existing health concerns as the drug may cause further harm to their body. 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 Committee Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. other information we have about you. Or it can help you feel full longer. It is vital to talk with the doctor before using Phentermine with other products. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. 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. Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. Phentermine is not to be used while pregnant or breastfeeding under any circumstances. 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. Your doctor may occasionally change your dose. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. %%EOF It is not known if Phentermine is excreted in human milk; however, other amphetamines are present in human milk. 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. Dosage should be individualized to obtain an adequate response with the lowest effective dose. . It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. (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 . Accessed Oct. 11, 2022. The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. Follow all directions on your prescription label and read all medication guides or instruction sheets. In most cases, the drug is prescribed to users in periods of 12 weeks. The full name and address of the prescribing practitioner and the practitioners federal controlled substance registry number shall be printed thereon. The doctor also looks at the patients medical history for any pre-existing medical conditions that the medication should not be taken with. Taking Phentermine depends on the brand and preparation of the drug. Committee As phentermine is similar to amphetamine, it is a controlled drug (class C5) and has the potential for abuse. Last updated on Mar 22, 2023. In some cases, patients have also found that Phentermine interacts with drugs that contain Tranylcypromine, Henelzine, Isocarboxazid, Diethylpropion, Phendimetrazine, Amphetamine, and Benzphetamine. If we combine this information with your protected This is a label given to drugs that can be misused. Florida has received national attention for the large num- 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 0000000596 00000 n Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. REGULATION OF PROFESSIONS AND OCCUPATIONS. 2019; doi:10.1016/j.mayocp.2018.11.020. This content does not have an English version. Children 16 years of age and youngerUse is not recommended. If we combine this information with your protected startxref After the tablet has melted, swallow or take a sip of water. Talk with your doctor before starting an exercise program. What to offer the 99% of patients with severe obesity who do not undergo bariatric surgery? 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. PDF Reference ID: 3115694 - Food and Drug Administration PDF Prescribing in Florida (Guidance Provided by the Florida Department of But weight management can take time. Do not crush, break, or chew it. See DrugAbuse and Dependence (9.3). 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. Management of acute Phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. It should melt quickly. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. HVMs8WQl eLg*&{dd $_;lm |NggK6,M]gu\.BNB. Statutes & Constitution :View Statutes : Online Sunshine Long-term efficacy and safety of anti-obesity treatment: Where do we stand? Phentermine (as resin complex): Usual dosage is 15 or 30 mg once daily. PDF label - Food and Drug Administration Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Instead of simply quitting the program, a patient should rather consult a healthcare provider about quitting. 0000002991 00000 n endstream endobj startxref You may opt-out of email communications at any time by clicking on By doing this, the metabolism is revved up along with an . Children 16 years of age and youngerUse is not recommended. It can help weight loss by making you less hungry. There are reports of patients who have increased the dosage of these drugs to many times than recommended. Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. All rights reserved. 2012 Florida Statutes. Concomitant use of alcohol with Phentermine may result in an adverse drug reaction. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. 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. How to Get a Prescription for Phentermine - Phentermine.com xref HB 423 - ARNP/PA Controlled Substance Prescribing. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. The promotion of this brand as a diet pill started in 1990. This website is a resource which lists doctors and clinics who may offer phentermine or appetite suppressants for patients they deem qualified. 2020; doi:10.4093/dmj.2020.0258. PDF Volume 25, Number 8 September 2011 Drugs & Therapy 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. 1530 0 obj <> endobj But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. Why is phentermine a controlled substance? While discussing the use of Phentermine with the doctor, a patient is provided a list of lifestyle changes to implement while using this product. When breastfeeding, the drug may enter the breast milk and travel into the nursing babys body, which may cause harm to them. Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. All rights reserved. Prescribing Controlled Substances via Telehealth under Florida and "@Hw4`tqCA\+ q [AF]` b L ! History.s. 0000002736 00000 n In 1968, three years after its release, Aminorex was withdrawn. It has the chemical name of ,,-Dimethylphenethylamine hydrochloride. The most common brand of Phentermine is a product known as Adipex, but officially called Adipex-P. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. 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 written prescription must be dated and signed by the prescribing practitioner on the day when issued. Take phentermine exactly as prescribed by your doctor. . Mayo Clinic Proceedings. 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. Taking Phentermine depends on the brand and preparation of the drug. This search engine indexes the Drug Enforcement Administration Diversion Control Program Web Site (www.deadiversion.usdoj.gov) only. 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. 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. Symptoms of extremely high blood pressure, such as uneven heartbeats, chest pain, blurred vision, anxiety and a severe headache. 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). 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. include protected health information. This brand is manufacturedby Teva Pharmaceuticals (formerly GATE Pharmaceuticals). 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. Take this medicine only as directed by your doctor. Package insert / product label Y$iqzZz\vlt1a;svw&aBS8Z(HGCkr&_Qxt97t,GWceTL^QqX(%8_A2'"%tD'DNz"G*"Tc. 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. Acidification of the urine increases Phentermine excretion. A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required. The combined drug is approved for long-term use. 893.049(1)(d), (e),f.s. Common side effects of phentermine include: Phentermine is one of the most prescribed weight-loss medicines. Place the tablet on the top of your tongue right after removing it from the bottle. 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. If the time is too close to the next dose, it is recommended to skip the dose they have missed. Comprehensive review of current and upcoming anti-obesity drugs. It is important to follow these instructions religiously. Drug information provided by: Merative, Micromedex. PDF Prescribing Information - Qsymia (Phentermine and Topiramate extended Copyright: Merative US L.P. 1973, 2023. Unfortunately, patients experienced a variety of side effects, which included severe heart toxicity and hypertension. Dosage form: tablet Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. 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. Phentermine also is offered combined with topiramate for weight loss (Qsymia). To provide you with the most relevant and helpful information, and understand which Safety and effectiveness in pediatric patients have not been established. After 12 weeks, the patient needs to take a break from the product as it may lead to physical dependence. Phentermine is a popular prescription drug that is often used to treat obesity. It is a class IV controlled substance because of its serious side effects and addiction potential. Publications, Help Searching PDF Prescription Drug Time and Dosage Limit Laws - CDC These practice guidelines can be found in Rule 64B8-9.012, F.A.C. 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 (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 . (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 . 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. See Drug Abuse and Dependence (9) and Overdosage (10). A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. 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 has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) [see Clinical Pharmacology (12.1)]. Moreover, it is strongly recommended to avoid or limit the alcohol intake. 35 0 obj <>stream Studies have not been performed with Phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. 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. Copyright 2000- 2023 State of Florida. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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
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