Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. For oral dosage form (disintegrating tablets): Adults and children 17 years of age and olderOne tablet once a day, taken in the morning. health information, we will treat all of that information as protected health 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)]. Section 458.336, F.S. Patients must be instructed on how much Phentermine to take, and when and how to take it [see Dosage and Administration (2)]. Each tablet contains the following inactive ingredients: starch, lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate and blue sugar spheres. Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. Fatigue and depression usually follow the central stimulation. Over 12 weeks, it can be as high as 9-10%. Please consult with your physician before you make any decisions regarding your health. Being extremely irritable and confused, or experienced unusual behavior or thoughts. Advise pregnant women and nursing mothers not to use Phentermine [see Use in Specific Populations (8.1, 8.3)]. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. 0 Low dose + low risk factors . Package insert / product label hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Studies have not been performed with Phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. 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 used as part of a short-term plan, along with a low calorie diet, for weight reduction. Taking Phentermine depends on the brand and preparation of the drug. All rights reserved. startxref If the drug is taken too late in the day, it may also cause insomnia. 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. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F Concomitant use of alcohol with Phentermine may result in an adverse drug reaction. privacy practices. The combined drug is approved for long-term use. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [see ClinicalPharmacology (12.3)]. Statutes, Video Broadcast For a more comprehensive list of drug and nutraceuticals which interact with phentermine hydrochloride, refer to our phentermine drug interactions data. 2009-202. Copyright 2000- 2023 State of Florida. 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. 21 0 obj <> endobj hbbd``b`z$@D`]"@DeX- Bb V ``LA\F*? The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. Cumulative urinary excretion of Phentermine under uncontrolled urinary pH conditions was 62% to 85%. Keep from freezing. Review/update the 90-2; s. 1436, ch. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. The safety and efficacy of combination therapy with Phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. 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. Drug information provided by: Merative, Micromedex. This combination of ingredients was branded as Fen-Phen. It is important to follow these instructions religiously. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place . Long-term efficacy and safety of anti-obesity treatment: Where do we stand? 97-102; s. 301, ch. Unfortunately, patients experienced a variety of side effects, which included severe heart toxicity and hypertension. trailer include protected health information. It has the chemical name of ,,-Dimethylphenethylamine hydrochloride. Registration is accomplished by completing and returning the dispensing physician registration form. You may opt-out of email communications at any time by clicking on 73-331; s. 2, ch. Phentermine should never be taken after 6 pm in the afternoon as it causes insomnia. Not only can losing weight harm an unborn baby during pregnancy, but the drug may also cause adverse effects. 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. History-New 12-4-97, Amended 2-17-98, 8-8-22. 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. Follow your doctor's orders or the directions on the label. In addition to its function as an appetite suppressant, Phentermine drugs also act as energy boosters. Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. This content does not have an Arabic version. In order to use Phentermine, the doctor needs to prescribe the drug for a specific patient. 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. The dosage may be adjusted to the patients need. For oral dosage form (tablets): Adults and children 17 years of age and older. 0000000909 00000 n 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. This website is a resource which lists doctors and clinics who may offer phentermine or appetite suppressants for patients they deem qualified. 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. 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. 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. https://fco.factsandcomparisons.com/. In 1968, three years after its release, Aminorex was withdrawn. It can help weight loss by making you less hungry. Or it can help you feel full longer. = The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. The journals or printed bills of the respective chambers should be consulted for official purposes. Symptoms of extremely high blood pressure, such as uneven heartbeats, chest pain, blurred vision, anxiety and a severe headache. If you are a Mayo Clinic patient, this could Ideally, patients should take it on an empty stomach. Do not keep outdated medicine or medicine no longer needed. The prescription of such weight loss enhancers is not generally appropriate for children. %PDF-1.6 % Some brands use a dissolving tablet that is placed under the tongue, which allows the body to absorb the chemicals in the drug faster. It works as a psychostimulant drug that stimulates the central nervous system to release norepinephrine from the hypothalamus. The amount of medicine that you take depends on the strength of the medicine. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. Also, it may cause certain side effects to become much worse. The doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. If the time is too close to the next dose, it is recommended to skip the dose they have missed. Late evening medication should be avoided because of the possibility of resulting insomnia. It is vital to talk with the doctor before using Phentermine with other products. Pharmacist and practitioner. All rights reserved. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. The Administration's plan is to end the COVID-19 public health emergency on May 11, 2023. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. information highlighted below and resubmit the form. For more FAQs, please see our full archive of Frequently Asked Questions about phentermine and related prescription appetite suppressants. Copyright 2000- 2023 State of Florida. Animal reproduction studies have not been conducted with Phentermine. Required fields are marked *. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. Copyright: Merative US L.P. 1973, 2023. CRIMES. health information, we will treat all of that information as protected health You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. 97-264. Chapter 893 DRUG ABUSE PREVENTION AND CONTROL Entire Chapter. If you miss a dose of this medicine, take it as soon as possible. The FDA has categorized this drug as X for pregnancy, which means it should not be used during pregnancy under any circumstances. But the rate of misuse seems to be low. Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Schedule. Rx only. Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. 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. Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. 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. 127: VA Prescription Monitoring Program. Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. The doctor also looks at the patients medical history for any pre-existing medical conditions that the medication should not be taken with. Thus, in order to make the most of this drug, patients need make some effort too. information is beneficial, we may combine your email and website usage information with 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). The promotion of this brand as a diet pill started in 1990. . The dosage varies from 15mg to 37.5mg per day. Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. This equates to a weight loss of 10-20 pounds for a 200 pound . Mayo Clinic does not endorse companies or products. Diabetes & Metabolism Journal. The full name and address of the prescribing practitioner and the practitioners federal controlled substance registry number shall be printed thereon. While these are the most common side effects of the drug, they are not the only consequences associated with the intake of this medication. It is obvious that these symptoms can make the entire program useless. information highlighted below and resubmit the form. It is often prescribed to be taken in the morning, before or after breakfast. 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. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. 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. Facts & Comparisons eAnswers. 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 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 drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. endstream endobj startxref 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. 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 By doing this, the metabolism is revved up along with an . 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. 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. 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 a schedule IV drug that requires a consultation with the doctor and a prescription. endstream endobj startxref Drugs of this class used in obesity are commonly known as anorectics or anorexigenics. It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved. "@Hw4`tqCA\+ q [AF]` b L ! Accessed Oct. 11, 2022. Do not double doses. Patients should be advised to report immediately any deterioration in exercise tolerance. In order to help patients reduce their risk of developing these diseases when they are obese, doctors usually prescribe Phentermine. This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. Drugs to treat obesity; rules establishing guidelines. Phentermine is a Schedule IV controlled substance. 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. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). 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. 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. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day. 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. 0000001039 00000 n Javascript must be enabled for site search. The recommended maximum dosage of Phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). Place the tablet on the top of your tongue right after removing it from the bottle. @ d Dosage form: tablet 0000002493 00000 n Some of these include: As with many other prescription drugs, Phentermine can also interact with certain medications. Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. Mid-range score: large amounts of medication in accordance with recommended guidelines.Low dose + high risk factors . 138 0 obj <>stream 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. Florida. The 2022 Florida Statutes (including 2022 Special Session A and 2023 Special Session B) 458.336 Drugs to treat obesity; rules establishing guidelines.. (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 . (3) In any case of dispensing hereunder, the amount or . For oral dosage form (extended-release capsules): Adults and children 16 years of age and olderOne capsule once a day, taken before breakfast or 10 to 14 hours before sleeping. 0000003317 00000 n HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. As mentioned above, new mothers should avoid using this medication when breastfeeding. Like other weight-loss medicines ordered by providers, phentermine is meant to be only part of a weight-loss plan. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of Phentermine hydrochloride (equivalent to 30 mg of Phentermine base). They inhibit the activity of an entire enzyme family known as monoamine oxidase. 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. Committee 35 0 obj <>stream Phentermine HCl Tablets, USP 37.5 mg 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. 100 TABLETS 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. Phentermine is approved for use for up to 12 . Of course, it is taken orally. Advertising revenue supports our not-for-profit mission. This content does not have an English version. 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. Javascript must be enabled for site search. A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom prescribed. Medically reviewed by Drugs.com. Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. 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. ZeS{$d!YS,|C~E;h4DJS?|{x}~ ?`2F. 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. 21 15 Patients who have been on a Phentermine program should not suddenly stop using the drug. Each brand has its own way of manufacturing the drug and, in some cases, combines it with other chemicals to make it more effective or to add additional features to its use. There are reports of patients who have increased the dosage of these drugs to many times than recommended. See Drug Abuse and Dependence (9) and Overdosage (10). Some patients experience an increase in sexual interest, while others notice that they have a lower libido. Taking Phentermine depends on the brand and preparation of the drug. JC. For example, it can be be used with healthy eating, physical activity and behavior change. Perreault L. Obesity in adults: Drug therapy. Moreover, it is strongly recommended to avoid or limit the alcohol intake. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Law Implemented Florida Statutes 458.336. Amphetamines and other stimulant drugs have been extensively abused and 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. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. CIV Management of acute Phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. 0000000828 00000 n hWmo8+jE'"m{F REGULATION OF PROFESSIONS AND OCCUPATIONS. Losing weight during pregnancy can harm both a mother and her baby. The additional boost in energy will also increase the physical activity levels, thereby providing an additional method for them to lose weight and gain overall health benefits. Publications, Help Searching This medication has been linked to physical dependence, which means a patient may become addicted to it. Your email address will not be published. The possible origins of the increased weight loss due to the various drug effects are not established. Use caution when administering Phentermine to patients with renal impairment. 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
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