A total of 24 patients developed heart valve disease while taking this drug, which led the FDA to withdraw the product from the market in 1997. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. Low dose + low risk factors . Also, it may cause certain side effects to become much worse. REGULATION OF PROFESSIONS AND OCCUPATIONS. In order to determine the effectiveness of certain pharmaceuticals, supplements and other substances, clinical trials and scientific research are often conducted among a group of volunteers. hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . This content does not have an Arabic version. One of the most important things to consider is the fact that the drug should never be accompanied by an MAO inhibitor. For oral dosage form (disintegrating tablets): Adults and children 17 years of age and olderOne tablet once a day, taken in the morning. It is vital to talk with the doctor before using Phentermine with other products. Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. Phentermine also is offered combined with topiramate for weight loss (Qsymia). %PDF-1.6 % Phentermine also is offered combined with topiramate for weight loss (Qsymia). This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. 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. They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. Today, Phentermine can still be obtained through the doctors prescription in the majority of countries around the world. 2007-156; s. 5, ch. Safety and effectiveness in pediatric patients have not been established. https://fco.factsandcomparisons.com/. Ideally, patients should take it on an empty stomach. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). This brand is manufacturedby Teva Pharmaceuticals (formerly GATE Pharmaceuticals). The combined drug is approved for long-term use. This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. The number of the prescription, as recorded in the prescription files of the pharmacy in which it is filled. A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required. 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. Phentermine has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) [see Clinical Pharmacology (12.1)]. Or it can help you feel full longer. Patients should be advised to report immediately any deterioration in exercise tolerance. Each tablet contains the following inactive ingredients: starch, lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate and blue sugar spheres. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. (phentermine hydrochloride) orally disintegrating tablet C IV . OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 21 15 @ d other information we have about you. See Drug Abuse and Dependence (9) and Overdosage (10). Phentermine is a schedule IV medication (only available by prescription) frequently used for generalized weight loss by acting as an appetite suppressant. 0000000596 00000 n If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom prescribed. Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. The written prescription must be dated and signed by the prescribing practitioner on the day when issued. Use caution when administering Phentermine to patients with renal impairment. However, the medication does have a considerable street value. 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. (1) 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 . If you are a Mayo Clinic patient, this could Facts & Comparisons eAnswers. Mayo Clinic offers appointments in Arizona, Florida and Minnesota and at Mayo Clinic Health System locations. 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 Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. 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 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. 0000001488 00000 n Law Implemented Florida Statutes 458.336. Concomitant use of alcohol with Phentermine may result in an adverse drug reaction. information highlighted below and resubmit the form. s. 4, ch. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Some brands use a dissolving tablet that is placed under the tongue, which allows the body to absorb the chemicals in the drug faster. Adults and children 17 years of age and older15 to 30 milligrams (mg) once a day, taken at approximately 2 hours after breakfast. All rights reserved. Some preparations of the formula, however, have been classified as schedule II drugs. Different brands manufacture, distribute and sell Phentermine drugs. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. The following information includes only the average doses of this medicine. %%EOF It can help weight loss by making you less hungry. 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. As mentioned above, new mothers should avoid using this medication when breastfeeding. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). https://www.micromedexsolutions.com. 79-12; s. 2, ch. 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. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Rx only. Not only can losing weight harm an unborn baby during pregnancy, but the drug may also cause adverse effects. The Topamax is added to Phentermine in order to intensify its effects and to help patients lose weight faster. 14 HVMs8WQl eLg*&{dd $_;lm |NggK6,M]gu\.BNB. 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). . l 4 a ( k ( N o L i s t ( z ) . 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 The full name and address of the prescribing practitioner and the practitioners federal controlled substance registry number shall be printed thereon. 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. Selling or giving away Phentermine may harm others and is against the law. Phentermine hydrochloride USP is a sympathomimetic amine anorectic. The medication has been classified as a controlled substance in most countries and is also classified as a schedule IV prescription drug. Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). Phentermine hydrochloride/topiramate. 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. Take phentermine exactly as prescribed by your doctor. Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. The use of Topamax and Phentermine is actually an FDA-approved combination. The possible origins of the increased weight loss due to the various drug effects are not established. 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. Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. This equates to a weight loss of 10-20 pounds for a 200 pound . health information, we will treat all of that information as protected health 104 0 obj <> endobj For example, it can be be used with healthy eating, physical activity and behavior change. Being extremely irritable and confused, or experienced unusual behavior or thoughts. 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. Use of Phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. 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.