l 4 a ( k ( N o L i s t ( z ) . RPYcn@b[%XYK'Q %[.()GTkJ WCf.-i>n-oIzE*D40f#Gp'LcddmE8;>u?X"tO 1]M={4,ReC8E8Z Q1Lt$-XpFCrTJ Rule 4731-11-04. In 1968, three years after its release, Aminorex was withdrawn. Last updated on Mar 22, 2023. When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. Primary Pulmonary Hypertension (PPH) a rare, frequently fatal disease of the lungs has been reported to occur in patients receiving a combination of Phentermine with fenfluramine or dexfenfluramine. One of the most important things to consider is the fact that the drug should never be accompanied by an MAO inhibitor. Precaution should be taken if a patient has any existing health concerns as the drug may cause further harm to their body. L^%0:T'xHGi,KGyVfZ5WI6&ZU1/VqM4.ct\i2gTAtQV%[$*/tbn"xS8JU$bljsI2)bs_/FouVGwCqX';z{0REZbSX,bXWPS#Bf|il#o'y`?jv{;!bS F#vPGzD"1~5~F%mW9YlGIQVYOS~kojbdQS!>|@Ph 0000000909 00000 n HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . If a patient would like to take other supplements, they should consult their doctor first. All rights reserved. The initial symptom of PPH is usually dyspnea. 104 0 obj <> endobj Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. 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. 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. Acidification of the urine increases Phentermine excretion. This content does not have an Arabic version. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. 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. 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. HB 423 - ARNP/PA Controlled Substance Prescribing. Diabetes & Metabolism Journal. information highlighted below and resubmit the form. REGULATION OF PROFESSIONS AND OCCUPATIONS. https://fco.factsandcomparisons.com/. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. SE, which stands for Electronic Florida Online Reporting of Controlled Sub-stances Evaluation program. Also available as phentermine hydrochloride; dosage expressed in terms of phentermine hydrochloride. Portions of this document last updated: Feb. 01, 2023. Follow your doctor's dosing instructions very carefully. Being extremely irritable and confused, or experienced unusual behavior or thoughts. Ideally, patients should take it on an empty stomach. Committee 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. 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. 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. Lomaira: One tablet three times a day, taken 30 minutes before meals. 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. Copyright 2000- 2023 State of Florida. If a prescription includes a numerical notation of the quantity of the controlled substance or date, but does not include the quantity or date written out in textual format, the pharmacist may dispense the controlled substance without verification by the prescriber of the quantity or date if the pharmacy previously dispensed another prescription for the person to whom the prescription was written. hbbd``b` @IHpA\> . 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. Fatigue and depression usually follow the central stimulation. 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. 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. Some of the studies that have linked Phentermine to positive results in humans include: The main active ingredient is known as Phentermine Hydrochloride. It is often prescribed to be taken in the morning, before or after breakfast. Phentermine is not recommended for use in pediatric patients 16 years of age. Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Obesity has been linked to many different diseases, including type 2 diabetes and cardiovascular disease. information is beneficial, we may combine your email and website usage information with Phentermine is related chemically and pharmacologically to the amphetamines. . 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)]. Or it can help you feel full longer. 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. For example, it can be be used with healthy eating, physical activity and behavior change. IBM Micromedex. 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. Phentermine (as resin complex): Usual dosage is 15 or 30 mg once daily. 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. Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. However, it caused a chronic condition known as pulmonary hypertension, which led to the death of many patients. Disclaimer: The information on this system is unverified. health information, we will treat all of that information as protected health It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. Phentermine is not to be used while pregnant or breastfeeding under any circumstances. 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. Drug classes: Anorexiants, CNS stimulants. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Intravenous phentolamine (Regitine, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage. . Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. Concomitant use of alcohol with Phentermine may result in an adverse drug reaction. Current Obesity Reports. A pharmacist may not dispense a controlled substance listed in Schedule II, Schedule III, or Schedule IV to any patient or patients agent without first determining, in the exercise of her or his professional judgment, that the order is valid. Phentermine is a schedule IV medication (only available by prescription) frequently used for generalized weight loss by acting as an appetite suppressant. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). Different brands manufacture, distribute and sell Phentermine drugs. xref Follow all directions on your prescription label and read all medication guides or instruction sheets. 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. While discussing the use of Phentermine with the doctor, a patient is provided a list of lifestyle changes to implement while using this product. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. It can help weight loss by making you less hungry. Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. In addition to its function as an appetite suppressant, Phentermine drugs also act as energy boosters. 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. Numerous side effects have been linked to the use of Phentermine. History.s. Like other weight-loss medicines ordered by providers, phentermine is meant to be only part of a weight-loss plan. Dosage form: tablet Patients should be advised to report immediately any deterioration in exercise tolerance. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F (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 . The aforementioned statute and rule do not specifically rule out a patient evaluation taking place . If you are a Mayo Clinic patient, this could 100 TABLETS Perreault L. Obesity in adults: Drug therapy. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. This content does not have an English version. Rulemaking Authority 458.336 FS. 75-18; s. 12, ch. the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. The strength and dosage of Phentermine depend on the brand that is prescribed and the patients specific condition. This brand is manufacturedby Teva Pharmaceuticals (formerly GATE Pharmaceuticals). Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. Phentermine Hydrochloride Tablets are indicated as 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 for patients with an initial body mass index 30 kg/m2, or 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). When breastfeeding, the drug may enter the breast milk and travel into the nursing babys body, which may cause harm to them. But the rate of misuse seems to be low. 0000001039 00000 n HB 423 (by Rep. Pigman) was signed into law on April 14, 2016. Of course, it is taken orally. A prescription for a controlled substance listed in Schedule II may not be refilled. Accessed Oct. 11, 2022. Over 12 weeks, it can be as high as 9-10%. 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 Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). ZeS{$d!YS,|C~E;h4DJS?|{x}~ ?`2F. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. Adults Exogenous Obesity Oral. 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. Law Implemented Florida Statutes 458.336. Phentermine is a Schedule IV controlled substance. Phentermine. 97-264. Mayo Clinic does not endorse companies or products. 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. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 2021; doi:10.1007/s13679-020-00422-w. They inhibit the activity of an entire enzyme family known as monoamine oxidase. Mayo Clinic offers appointments in Arizona, Florida and Minnesota and at Mayo Clinic Health System locations. Advise pregnant women and nursing mothers not to use Phentermine [see Use in Specific Populations (8.1, 8.3)]. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. Mayo Clinic does not endorse companies or products. 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. There are reports of patients who have increased the dosage of these drugs to many times than recommended. Swallow the tablet whole. 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. The combined drug is approved for long-term use. 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)]. The number of the prescription, as recorded in the prescription files of the pharmacy in which it is filled. Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. 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 . Not only can losing weight harm an unborn baby during pregnancy, but the drug may also cause adverse effects. Of course, it is taken orally. Advertising revenue supports our not-for-profit mission. 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. 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. Carefully follow the dosing instructions for the form you are using. other information we have about you. (phentermine hydrochloride) orally disintegrating tablet C IV . information submitted for this request. Moreover, it is strongly recommended to avoid or limit the alcohol intake. Place the tablet on the top of your tongue right after removing it from the bottle. The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years. information submitted for this request. There is a problem with 188 . But weight management can take time. Patients must be informed about the risks of use of Phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. Even patients who are overweight and pregnant at the same time are not allowed to use this product. Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. Doses are normally taken before breakfast, or 1 to 2 hours after breakfast. Children 16 years of age and youngerUse is not recommended. the unsubscribe link in the e-mail. information is beneficial, we may combine your email and website usage information with The use of Topamax and Phentermine is actually an FDA-approved combination. They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. Later on, between 1940 and 1960, Phentermine was combined with other medications to improve its effectiveness. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [see ClinicalPharmacology (12.3)]. The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. This website is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Phentermine is approved for use for up to 12 weeks. This equates to a weight loss of 10-20 pounds for a 200 pound . Drug information provided by: Merative, Micromedex. law states . 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. %PDF-1.6 % hb```e````a`d`@ f(fcfILLvL~. The 2022 Florida Statutes (including 2022 Special Session A and 2023 Special Session B) 458.336 Drugs to treat obesity; rules establishing guidelines.. Metric conversions are as follows: pounds 2.2 = kg; inches x 0.0254 = meters. . Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. 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. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Phentermine hydrochloride USP is a sympathomimetic amine anorectic. trailer Instead of simply quitting the program, a patient should rather consult a healthcare provider about quitting. Common side effects of phentermine include: Phentermine is one of the most prescribed weight-loss medicines. 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. Phentermine hydrochloride/topiramate. Drugs to treat obesity; rules establishing guidelines. 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. This website is a resource which lists doctors and clinics who may offer phentermine or appetite suppressants for patients they deem qualified. 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. ]c,'303:20/) @d` )2 Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. 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). 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 So some health care providers might order it for longer use. A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets.

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