phentermine prescribing guidelines florida

The medication has been classified as a controlled substance in most countries and is also classified as a schedule IV prescription drug. information highlighted below and resubmit the form. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. Do not crush, break, or chew it. Comprehensive review of current and upcoming anti-obesity drugs. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. This content does not have an English version. 0000003317 00000 n Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. other information we have about you. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. 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. 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. If we combine this information with your protected While these are the most common side effects of the drug, they are not the only consequences associated with the intake of this medication. 99-8; s. 2, ch. 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 is a schedule IV medication (only available by prescription) frequently used for generalized weight loss by acting as an appetite suppressant. Affixed to the original container in which a controlled substance is delivered upon a prescription or authorized refill thereof, as hereinafter provided, there shall be a label bearing the following information: The name and address of the pharmacy from which such controlled substance was dispensed. Therefore, coadministration of Phentermine and these drug products is not recommended. 0000002493 00000 n The Topamax is added to Phentermine in order to intensify its effects and to help patients lose weight faster. 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. In some cases, patients have also found that Phentermine interacts with drugs that contain Tranylcypromine, Henelzine, Isocarboxazid, Diethylpropion, Phendimetrazine, Amphetamine, and Benzphetamine. Rulemaking Authority 458.336 FS. The drug is also available in regular capsules that are taken orally with a glass of water. 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. This content does not have an Arabic version. Place the tablet on the top of your tongue right after removing it from the bottle. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. These are all promoted as weight loss pills that assist obese individuals. Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Since it may lead to such symptoms, it also has the potential to cause severe withdrawal symptoms, especially when a patient goes cold turkey. Won Son J, et al. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. Doses are normally taken before breakfast, or 1 to 2 hours after breakfast. History.s. 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. Current Obesity Reports. Javascript must be enabled for site search. Medically reviewed by Drugs.com. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. hbbd``b` @IHpA\> . 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)]. Skip to Navigation | Skip to Main Content | Skip to Site Map. 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. Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Children 15 years of age and youngerUse is not recommended. Mayo Clinic does not endorse companies or products. Florida has received national attention for the large num- Carefully follow the dosing instructions for the form you are using. potentially hazardous activities such as operating machinery or driving FULL PRESCRIBING INFORMATION in the presence of other risk factors (e.g., controlled hypertension, 333-33-100411 Tasks 35 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. Late evening medication should be avoided because of the possibility of resulting insomnia. Click here for an email preview. 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. Perreault L. Obesity in adults: Drug therapy. 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. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. Section 458.336, F.S. Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of Phentermine with fenfluramine or dexfenfluramine for weight loss. 0000003240 00000 n 893.04 Pharmacist and practitioner.. 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. Concomitant use of alcohol with Phentermine may result in an adverse drug reaction. Statutes, Video Broadcast Even after the period that the drug has been prescribed for, the doctor will often recommend to gradually stop using the Phentermine to avoid the withdrawal symptoms. 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. 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. %%EOF Some of the studies that have linked Phentermine to positive results in humans include: The main active ingredient is known as Phentermine Hydrochloride. Diabetes & Metabolism Journal. Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). l 4 a ( k ( N o L i s t ( z ) . It should melt quickly. . The recommended maximum dosage of Phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). 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. hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. The effective date is January 1, 2020. 0 Accessed Oct. 11, 2022. The most common brand of Phentermine is a product known as Adipex, but officially called Adipex-P. Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. <]>> Later on, between 1940 and 1960, Phentermine was combined with other medications to improve its effectiveness. Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. 0000000828 00000 n Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. 1530 0 obj <> endobj Phentermine is a popular prescription drug that is often used to treat obesity. (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 . 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 journals or printed bills of the respective chambers should be consulted for official purposes. House Bill 831 (2019), Electronic Prescribing, was signed into law by Governor DeSantis. Phentermine is used as part of a short-term plan, along with a low calorie diet, for weight reduction. Last updated on Mar 22, 2023. the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Click here for an email preview. (phentermine hydrochloride) orally disintegrating tablet C IV . In 1968, three years after its release, Aminorex was withdrawn. The prescription of such weight loss enhancers is not generally appropriate for children. 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. This content does not have an English version. If the drug is taken too late in the day, it may also cause insomnia. 79-12; s. 2, ch. 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. To avoid trouble with sleeping, take the last dose of the day about 4 to 6 hours before bedtime, unless your doctor tells you otherwise. To provide you with the most relevant and helpful information, and understand which They inhibit the activity of an entire enzyme family known as monoamine oxidase. This content does not have an Arabic version. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. 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. Phentermine is approved for use for up to 12 weeks. (In combination with a healthy diet and exercise plan). Children 16 years of age and youngerUse is not recommended. 458.336 Drugs to treat obesity; rules establishing guidelines.. 0000002736 00000 n Or it can help you feel full longer. It is obvious that these symptoms can make the entire program useless. 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. Phentermine also is offered combined with topiramate for weight loss (Qsymia). The 2022 Florida Statutes (including 2022 Special Session A and 2023 Special Session B) 458.336 Drugs to treat obesity; rules establishing guidelines.. 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. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). 21 0 obj <> endobj 127: VA Prescription Monitoring Program. Patients who have been on a Phentermine program should not suddenly stop using the drug. While discussing the use of Phentermine with the doctor, a patient is provided a list of lifestyle changes to implement while using this product. Thus, in order to make the most of this drug, patients need make some effort too. - 7 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. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place . 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. Portions of this document last updated: Feb. 01, 2023. In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with anorectic drugs lost more weight on the average than those treated with placebo and diet. Committee 90-2; s. 1436, ch. 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. Another important fact to consider before taking Phentermine is that it should never be used by women who are pregnant or who are currently breastfeeding. To provide you with the most relevant and helpful information, and understand which 0 Taking Phentermine depends on the brand and preparation of the drug. It is a class IV controlled substance because of its serious side effects and addiction potential. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. ZeS{$d!YS,|C~E;h4DJS?|{x}~ ?`2F. 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. Management of acute Phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Phentermine also is offered combined with topiramate for weight loss (Qsymia). Yes, you need a prescription for phentermine. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Follow your doctor's orders or the directions on the label. Please consult with your physician before you make any decisions regarding your health. hYr ~{L(QdK4^bdsO_d;a BXO--p,!4!,WhfM/@c All rights reserved. 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. However in the presence of topiramate, Phentermine Cmax and AUC increase 13% and 42%, respectively. The doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. Phentermine is a Schedule IV controlled substance. When breastfeeding, the drug may enter the breast milk and travel into the nursing babys body, which may cause harm to them. It should also not be taken within 14 days after taking an MAO inhibitor. Other brands of this drug include Suprenza, Phentercot, Acxion, Elvenir, Terflamex, Panbesy, Duromine, Fentermina, Phentermin, PHentermine and Lomaira. Phentermine is a Schedule 4 drug. But the rate of misuse seems to be low. Ideally, patients should take it on an empty stomach. 97-102; s. 301, ch. %PDF-1.6 % A prescription for a controlled substance listed in Schedule III, Schedule IV, or Schedule V may not be filled or refilled more than five times within a period of 6 months after the date on which the prescription was written unless the prescription is renewed by a practitioner. This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. 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. Schedule. %PDF-1.4 % Advertising revenue supports our not-for-profit mission. 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 By doing this, the metabolism is revved up along with an . 2019; doi:10.1016/j.mayocp.2018.11.020. HB 423 (by Rep. Pigman) was signed into law on April 14, 2016. Selling or giving away Phentermine may harm others and is against the law. All trademarks are the property of their respective owners. Rule 4731-11-04. The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. 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. The PDMP was created in the 2009 session of the Florida legislature to encourage safer prescribing of controlled substances and reduce drug abuse and diversion within the state. 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. RPYcn@b[%XYK'Q %[.()GTkJ WCf.-i>n-oIzE*D40f#Gp'LcddmE8;>u?X"tO 1]M={4,ReC8E8Z Q1Lt$-XpFCrTJ Do not double doses. The risks include, but are not limited to: See also, for example, Adverse Reactions (6) and Use in SpecificPopulations (8). Six years after the approval, a similar drug, called Aminorex, were released in Europe with the same purpose of helping obese individuals. 35 0 obj <>stream Unfortunately, the answer is no in most cases. 97-264. All rights reserved. Or it can help you feel full longer. 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. Why is phentermine a controlled substance? Follow all directions on your prescription label and read all medication guides or instruction sheets. Due to its status as a controlled substance, the sale, distribution, and possession of this drug . These practice guidelines can be found in Rule 64B8-9.012, F.A.C. Numerous side effects have been linked to the use of Phentermine. Metric conversions are as follows: pounds 2.2 = kg; inches x 0.0254 = meters. Tablets containing 37.5 mg Phentermine hydrochloride (equivalent to 30 mg Phentermine base). It is an appetite suppressant with the added ability to help the body produce more energy from fat cells. 0000021285 00000 n These lifestyle changes often include participating in regular exercise and physical activities, as well as eating a well-balanced diet that does not contain large amounts of calories or harmful substances. 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. 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 Instead of simply quitting the program, a patient should rather consult a healthcare provider about quitting. Taking more than the prescribed amount of Phentermine can lead to an overdose, which means if a patient misses a dose, they should never try to make up for it by taking more than the prescribed amount at the next dose. It depends on supplements a patient would like to take. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. 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)]. Over 12 weeks, it can be as high as 9-10%. If the federal government fails to oversee how the money is spent, advocates worry it will be wasted. 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. s. 4, ch. 0000002991 00000 n For oral dosage form (tablets): Adults and children 17 years of age and older. Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. In some cases, the use of this drug in combination with other pills may cause the effects of other drugs to increase. Average users lose 3-5% of their initial body weight as shown in studies. 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 doctor also looks at the patients medical history for any pre-existing medical conditions that the medication should not be taken with. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Moreover, it is strongly recommended to avoid or limit the alcohol intake. Phentermine is most commonly prescribed to patients who experience negative health effects to excessive amounts of body weight. Taking Phentermine depends on the brand and preparation of the drug. Concomitant use of alcohol with phentermine may result in an adverse drug reaction. See Drug Abuse and Dependence (9) and Overdosage (10). 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 the time is too close to the next dose, it is recommended to skip the dose they have missed. Intravenous phentolamine (Regitine, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage. 100 TABLETS What to offer the 99% of patients with severe obesity who do not undergo bariatric surgery? Of course, it is taken orally. 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). Adults and children 17 years of age and older15 to 30 milligrams (mg) once a day, taken at approximately 2 hours after breakfast. Low dose + low risk factors . Phentermine hydrochloride/topiramate. Code R. 64B8-11.001 Advertising weight loss treatment shall be considered false, deceptive, or misleading if it contains representations that: (e) Suggest that weight loss is effortless or magical. Being extremely irritable and confused, or experienced unusual behavior or thoughts. Such prescriptions must contain the date of the oral authorization. Disclaimer: The information on this system is unverified. endstream endobj 1531 0 obj <>/Metadata 26 0 R/Pages 1528 0 R/StructTreeRoot 41 0 R/Type/Catalog>> endobj 1532 0 obj <>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 0/Tabs/S/TrimBox[0.0 0.0 630.0 702.0]/Type/Page>> endobj 1533 0 obj <>stream The Drug Enforcement Administration (DEA) has made 2 changes related to .
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