They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. 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. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. 188, ch. Burguera B, et al. Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. The medication has been classified as a controlled substance in most countries and is also classified as a schedule IV prescription drug. https://fco.factsandcomparisons.com/. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. 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. NDC 42806-810-01 (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 . It has the chemical name of ,,-Dimethylphenethylamine hydrochloride. Skip to Navigation | Skip to Main Content | Skip to Site Map. (phentermine hydrochloride) orally disintegrating tablet C IV . 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. History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension), During or within 14 days following the administration of monoamine oxidase inhibitors, Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, Effect on the ability to engage in potentially hazardous tasks [see, Withdrawal effects following prolonged high dosage administration [see, Development of primary pulmonary hypertension [see, Development of serious valvular heart disease [see, Effects on the ability to engage in potentially hazardous tasks [see, The risk of an increase in blood pressure [see, the potential for developing tolerance and actions if they suspect development of tolerance [see, the risk of dependence and the potential consequences of abuse [see. The dose of this medicine will be different for different patients. What to offer the 99% of patients with severe obesity who do not undergo bariatric surgery? Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Patients are advised to report any symptoms or diseases they may have before the doctor prescribes the drug this may include high blood pressure and kidney problems, as well as any type of diabetes and thyroid disorders. Phentermine HCl Tablets, USP 37.5 mg Mayo Clinic Proceedings. The first use of Phentermine as a drug to help treat obesity dates back to 1938. Rule 4731-11-04 | Controlled substances for the treatment of obesity. RPYcn@b[%XYK'Q %[.()GTkJ WCf.-i>n-oIzE*D40f#Gp'LcddmE8;>u?X"tO 1]M={4,ReC8E8Z Q1Lt$-XpFCrTJ The combined drug is approved for long-term use. Obesity has been linked to many different diseases, including type 2 diabetes and cardiovascular disease. Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. Click here for an email preview. Following the administration of Phentermine, Phentermine reaches peak concentrations (Cmax) after 3 to 4.4 hours. Copyright 2000- 2023 State of Florida. 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. Talk with your doctor before starting an exercise program. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. 21 0 obj <> endobj 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. 893.04 Pharmacist and practitioner.. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. See DrugAbuse and Dependence (9.3). Average users lose 3-5% of their initial body weight as shown in studies. Florida Board of Medicine Where can I find the laws and rules However in the presence of topiramate, Phentermine Cmax and AUC increase 13% and 42%, respectively. PDF label - Food and Drug Administration 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. 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. hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ 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. endstream endobj startxref It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. HB 423 (by Rep. Pigman) was signed into law on April 14, 2016. the unsubscribe link in the e-mail. 0000000909 00000 n trailer 0000002493 00000 n Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. 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. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Schedule. Acidification of the urine increases Phentermine excretion. The drug has two primary functions in the human body, which is the reason why it is always accompanied by these lifestyle changes. The drug is also available in regular capsules that are taken orally with a glass of water. %PDF-1.6 % Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. Mayo Clinic does not endorse companies or products. Requirements may be altered [see Warnings and Precautions (5.9)]. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Use of Phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. Phentermine is not recommended for use in pediatric patients 16 years of age. Prescribing Standards: In addition to the laws and rules directly related to the prescription and prescribing, there are other standards which should be followed as well. 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. 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 Phentermine has been linked to many complications; knowing these details will help patients minimize their risk of experiencing such unwanted scenarios. 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. Disclaimer: The information on this system is unverified. For a more comprehensive list of drug and nutraceuticals which interact with phentermine hydrochloride, refer to our phentermine drug interactions data. Perreault L. Obesity in adults: Drug therapy. information highlighted below and resubmit the form. Swallow the extended-release capsule whole. Six years after the approval, a similar drug, called Aminorex, were released in Europe with the same purpose of helping obese individuals. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. 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. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. Keep from freezing. Click here for an email preview. Advertising revenue supports our not-for-profit mission. 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. While discussing the use of Phentermine with the doctor, a patient is provided a list of lifestyle changes to implement while using this product. Patients who have been on a Phentermine program should not suddenly stop using the drug. hbbd``b`z$@D`]"@DeX- Bb V ``LA\F*? The drug is classified under a certain chemical class known as amphetamine as it has a similar pharmacology value to other drugs classified in the class. 0000001039 00000 n 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. Mayo Clinic offers appointments in Arizona, Florida and Minnesota and at Mayo Clinic Health System locations. Also available as phentermine hydrochloride; dosage expressed in terms of phentermine hydrochloride. But the rate of misuse seems to be low. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Taking Phentermine depends on the brand and preparation of the drug. 893.049(1)(d), (e),f.s. Carefully follow the dosing instructions for the form you are using. https://www.uptodate.com/contents/search. Today, Phentermine can still be obtained through the doctors prescription in the majority of countries around the world. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. If we combine this information with your protected Like other weight-loss medicines ordered by providers, phentermine is meant to be only part of a weight-loss plan. PDF Reference ID: 3115694 - Food and Drug Administration Rule 4731-11-04. 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. Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Lomaira: One tablet three times a day, taken 30 minutes before meals. Prescribing in Florida - The Health Law Firm 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. Chapter 458 Section 336 - 2011 Florida Statutes - The Florida Senate xref Phentermine doctors network. 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. Package insert / product label This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. Phentermine is not to be used while pregnant or breastfeeding under any circumstances. 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.
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