104 0 obj <> endobj 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. |. 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. Statutes, Video Broadcast This search engine indexes the Drug Enforcement Administration Diversion Control Program Web Site (www.deadiversion.usdoj.gov) only. See Drug Abuse and Dependence (9) and Overdosage (10). 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. Comprehensive review of current and upcoming anti-obesity drugs. Today, Phentermine can still be obtained through the doctors prescription in the majority of countries around the world. 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. 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. It can help weight loss by making you less hungry. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. Click here for an email preview. Even patients who are overweight and pregnant at the same time are not allowed to use this product. 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. This medication has been linked to physical dependence, which means a patient may become addicted to it. Copyright: Merative US L.P. 1973, 2023. Do not crush, break, or chew it. OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. Six years after the approval, a similar drug, called Aminorex, were released in Europe with the same purpose of helping obese individuals. %%EOF 0000000828 00000 n 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. Initial U.S. Approval: 1959 -----INDICATIONS AND USAGE----- Suprenza is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of . Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. Rule 4731-11-04 | Controlled substances for the treatment of obesity. When breastfeeding, the drug may enter the breast milk and travel into the nursing babys body, which may cause harm to them. However, the medication does have a considerable street value. Y$iqzZz\vlt1a;svw&aBS8Z(HGCkr&_Qxt97t,GWceTL^QqX(%8_A2'"%tD'DNz"G*"Tc. Phentermine is a Schedule IV controlled substance. 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 medication has been classified as a controlled substance in most countries and is also classified as a schedule IV prescription drug. 188 . It is often prescribed to be taken in the morning, before or after breakfast. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Pharmacist and practitioner. Section 458.336, F.S. startxref 188, ch. Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Mayo Clinic Proceedings. 2009-202. 0000021285 00000 n xref The full name and address of the prescribing practitioner and the practitioners federal controlled substance registry number shall be printed thereon. Ask your healthcare professional how you should dispose of any medicine you do not use. All rights reserved. 79-12; s. 2, ch. The promotion of this brand as a diet pill started in 1990. In some cases, patients have also found that Phentermine interacts with drugs that contain Tranylcypromine, Henelzine, Isocarboxazid, Diethylpropion, Phendimetrazine, Amphetamine, and Benzphetamine. Phentermine is approved for use for up to 12 . (phentermine hydrochloride) orally disintegrating tablet C IV . Due to its status as a controlled substance, the sale, distribution, and possession of this drug . Package insert / product label xb```f``ZAb 1av K3gI{$*i p400t UD J@X$Ybv k=:,fb[ a`x @ ! Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. 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. Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. It is not uncommon for patients to experience a change in their sexual interest. 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)]. To provide you with the most relevant and helpful information, and understand which Phentermine has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) [see Clinical Pharmacology (12.1)]. 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. Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. 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 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. Disclaimer: The information on this system is unverified. %%EOF 0000000016 00000 n 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. information and will only use or disclose that information as set forth in our notice of Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Do not crush, break, or chew it. Mayo Clinic does not endorse companies or products. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Pharmacists may order the medicinal drug products set forth in each rule subject to the following terms and limitations: . The pharmacist may dispense the controlled substance, in the exercise of her or his professional judgment, when the pharmacist or pharmacists agent has obtained satisfactory patient information from the patient or the patients agent. Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. Later on, between 1940 and 1960, Phentermine was combined with other medications to improve its effectiveness. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (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 . Accessed Oct. 11, 2022. 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. All rights reserved. Instead of simply quitting the program, a patient should rather consult a healthcare provider about quitting. 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. The following adverse reactions are described, or described in greater detail, in other sections: The following adverse reactions to Phentermine have been identified: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events. 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. SECTION 04. Mid-range score: large amounts of medication in accordance with recommended guidelines.Low dose + high risk factors . Schedule. W0Qxe {>x??}# cGCSGGC[G(P A@3'i~ (2[n! History.s. Adults and children 17 years of age and older. 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. Also, it may cause certain side effects to become much worse. Make sure your hands are dry before touching the tablet. include protected health information. Yes, you need a prescription for phentermine. This combination of ingredients was branded as Fen-Phen. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). Phentermine hydrochloride USP is a sympathomimetic amine anorectic. After 12 weeks, the patient needs to take a break from the product as it may lead to physical dependence. Diabetes & Metabolism Journal. Other brands of this drug include Suprenza, Phentercot, Acxion, Elvenir, Terflamex, Panbesy, Duromine, Fentermina, Phentermin, PHentermine and Lomaira. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. It is a class IV controlled substance because of its serious side effects and addiction potential. Rule 4731-11-04. Publications, Help Searching It has the chemical name of ,,-Dimethylphenethylamine hydrochloride. 0000002736 00000 n Phentermine also is offered combined with topiramate for weight loss (Qsymia). health information, we will treat all of that information as protected health Copyright 2000- 2023 State of Florida. Required fields are marked *. The use of Topamax and Phentermine is actually an FDA-approved combination. Tak YJ, et al. The first use of Phentermine as a drug to help treat obesity dates back to 1938. This content does not have an Arabic version. While these are the most common side effects of the drug, they are not the only consequences associated with the intake of this medication. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. law states . The combined drug is approved for long-term use. 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. grants the Board of Medicine the authority to adopt rules to establish the practice guidelines for drugs used to treat obesity. 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. It is not known if Phentermine is excreted in human milk; however, other amphetamines are present in human milk. Portions of this document last updated: Feb. 01, 2023. 0 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. 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. Of course, it is taken orally. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. Long-term efficacy and safety of anti-obesity treatment: Where do we stand? BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. Tablets containing 37.5 mg Phentermine hydrochloride (equivalent to 30 mg Phentermine base). The drug is usually prescribed at the lowest possible dose to new users, which is 15mg per day. The effective date is January 1, 2020. As much as 33% of the U.S. adult population are considered to be obese. Some of these include: As with many other prescription drugs, Phentermine can also interact with certain medications. %PDF-1.6 % - 7 https://fco.factsandcomparisons.com/. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). It works as a psychostimulant drug that stimulates the central nervous system to release norepinephrine from the hypothalamus. If the prescription is for an animal, the species of animal for which the controlled substance is prescribed. The written prescription must be dated and signed by the prescribing practitioner on the day when issued. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. 0000000596 00000 n 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. 2012 Florida Statutes. 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. 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 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. But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. JC. Take the disintegrating tablet with or without food. 14 There is a problem with 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. Different brands manufacture, distribute and sell Phentermine drugs. 99-8; s. 2, ch. What You Should Know Before Taking Phentermine, Frequently Asked Questions About Phentermine, refer to our phentermine drug interactions data, Frequently Asked Questions about phentermine, https://www.drugs.com/ingredient/phentermine.html, http://www.rxlist.com/adipex-p-drug/patient-avoid-while-taking.htm, http://www.everydayhealth.com/drugs/phentermine, https://www.ncbi.nlm.nih.gov/pubmed/27664021, https://www.ncbi.nlm.nih.gov/pubmed/26584649, https://www.ncbi.nlm.nih.gov/pubmed/26446094, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4560177/, https://www.ncbi.nlm.nih.gov/pubmed/25911503, Feeling like they are going to faint, often accompanied by chest pain, Fluttering in the patients chest, as well as pounding heartbeats. This is a label given to drugs that can be misused. Moreover, it is strongly recommended to avoid or limit the alcohol intake. 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. 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. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Phentermine is for people with obesity or overweight who haven't been able to lose enough weight with diet and exercise alone to improve their health. Phentermine is related chemically and pharmacologically to the amphetamines. Children 15 years of age and youngerUse is not recommended. The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. health information, we will treat all of that information as protected health 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. 0000003240 00000 n Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. 127: VA Prescription Monitoring Program. . Phentermine is approved for use for up to 12 weeks.
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