Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. In addition to its function as an appetite suppressant, Phentermine drugs also act as energy boosters. 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. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F 35 0 obj <>stream A pharmacist may not dispense more than a 30-day supply of a controlled substance listed in Schedule III upon an oral prescription issued in this state. While discussing the use of Phentermine with the doctor, a patient is provided a list of lifestyle changes to implement while using this product. 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. Cumulative urinary excretion of Phentermine under uncontrolled urinary pH conditions was 62% to 85%. If your dose is different, do not change it unless your doctor tells you to do so. Phentermine Hydrochloride Tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. 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. The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. It is obvious that these symptoms can make the entire program useless. 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. 893.049(1)(d), (e),f.s. The FDA in the United States first approved the use of Amphetamine as a drug that can be used to suppress a patients appetite in 1959. So some health care providers might order it for longer use. The medication has been classified as a controlled substance in most countries and is also classified as a schedule IV prescription drug. This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. Why is phentermine a controlled substance? 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. Requirements may be altered [see Warnings and Precautions (5.9)]. Prescribing Information - Qsymia (Phentermine and Topiramate extended . the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Taking Phentermine depends on the brand and preparation of the drug. Some patients need to take the drug an hour before they eat breakfast, while others are advised to take it approximately one to two hours after breakfast. A prescription for a controlled substance listed in Schedule II may not be refilled. Doses are normally taken before breakfast, or 1 to 2 hours after breakfast. The Administration's plan is to end the COVID-19 public health emergency on May 11, 2023. information highlighted below and resubmit the form. The number of the prescription, as recorded in the prescription files of the pharmacy in which it is filled. 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. The possible origins of the increased weight loss due to the various drug effects are not established. 0000000909 00000 n 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. Due to its status as a controlled substance, the sale, distribution, and possession of this drug . Y$iqzZz\vlt1a;svw&aBS8Z(HGCkr&_Qxt97t,GWceTL^QqX(%8_A2'"%tD'DNz"G*"Tc. Your doctor may occasionally change your dose. Click here for an email preview. History-New 12-4-97, Amended 2-17-98, 8-8-22. Phentermine is a Schedule 4 drug. Both the law and the rule for treating obesity outline practice guidelines for the safe use of phentermine, fenfluramine, and ot her drugs used to . Your email address will not be published. Phentermine is approved for use for up to 12 . the unsubscribe link in the e-mail. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. health information, we will treat all of that information as protected health The FDA has categorized this drug as X for pregnancy, which means it should not be used during pregnancy under any circumstances. %%EOF Average users lose 3-5% of their initial body weight as shown in studies. It helps patients lose weight by suppressing their appetite and boosting their energy levels, thus leading to a more active lifestyle and greater calorie burn. The written prescription must be dated and signed by the prescribing practitioner on the day when issued. Some of these include: As with many other prescription drugs, Phentermine can also interact with certain medications. Lomaira: One tablet three times a day, taken 30 minutes before meals. Other brands of this drug include Suprenza, Phentercot, Acxion, Elvenir, Terflamex, Panbesy, Duromine, Fentermina, Phentermin, PHentermine and Lomaira. If the doctor finds that the patient is a good candidate for Phentermine, they may prescribe a certain dose and provide specific details on dosage and lifestyle choices that should accompany the use of this medicine. Pursuant to Board of Medical Examiners Rule 540-X-4-.05, dispensing physicians are required to register with the Board. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom prescribed. 75-18; s. 12, ch. |. Avoid use of Phentermine in patients with eGFR less than 15 mL/min/1.73m2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 0000001039 00000 n 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 drug has two primary functions in the human body, which is the reason why it is always accompanied by these lifestyle changes. Today, Phentermine can still be obtained through the doctors prescription in the majority of countries around the world. 100 TABLETS information and will only use or disclose that information as set forth in our notice of 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. Burguera B, et al. The first use of Phentermine as a drug to help treat obesity dates back to 1938. However, the medication does have a considerable street value. It is not uncommon for patients to experience a change in their sexual interest. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). 458.336, Florida Statutes - Drugs to treat obesity; rules establishing guidelines; Rule 64B8-9.012, Florida Administrative Code - Standards for the Prescription of Obesity . However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. 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. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Advertising revenue supports our not-for-profit mission. Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. HVMs8WQl eLg*&{dd $_;lm |NggK6,M]gu\.BNB. However, it caused a chronic condition known as pulmonary hypertension, which led to the death of many patients. 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. 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. l 4 a ( k ( N o L i s t ( z ) . 1591 0 obj <>stream It is often prescribed to be taken in the morning, before or after breakfast. 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 Some brands use a dissolving tablet that is placed under the tongue, which allows the body to absorb the chemicals in the drug faster. Ask your healthcare professional how you should dispose of any medicine you do not use. %%EOF Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years. https://www.uptodate.com/contents/search. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. 127: VA Prescription Monitoring Program. Selling or giving away Phentermine may harm others and is against the law. Statutes, Video Broadcast 0000002736 00000 n The date on which the prescription for such controlled substance was filled. 104 0 obj <> endobj 0000005652 00000 n 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. Different brands manufacture, distribute and sell Phentermine drugs. 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. 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. 0000003240 00000 n Patients should be advised to report immediately any deterioration in exercise tolerance. information and will only use or disclose that information as set forth in our notice of This is a label given to drugs that can be misused. Since it may lead to such symptoms, it also has the potential to cause severe withdrawal symptoms, especially when a patient goes cold turkey. They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. Phentermine also is offered combined with topiramate for weight loss (Qsymia). (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 . In some cases, the use of Phentermine has also led to the development of symptoms that are related to erectile dysfunction. Yes, you need a prescription for phentermine. HB 423 - ARNP/PA Controlled Substance Prescribing. You may opt-out of email communications at any time by clicking on Required fields are marked *. In order to help patients reduce their risk of developing these diseases when they are obese, doctors usually prescribe Phentermine. 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 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. But weight management can take time. The prescription of such weight loss enhancers is not generally appropriate for children. If you are a Mayo Clinic patient, this could Billions of dollars are headed to state and local governments to address the opioid crisis. 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. Unfortunately, the answer is no in most cases. Accessed Oct. 11, 2022. But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. It is an appetite suppressant with the added ability to help the body produce more energy from fat cells. Apart from not combining Phentermine with the MAO inhibitors, a patient should also first ensure they are not allergic to Phentermine before they take it. Over 12 weeks, it can be as high as 9-10%. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Each tablet contains the following inactive ingredients: starch, lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate and blue sugar spheres. All rights reserved. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). This combination of ingredients was branded as Fen-Phen. 0000021285 00000 n It can help weight loss by making you less hungry. 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. These practice guidelines can be found in Rule 64B8-9.012, F.A.C. information submitted for this request. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Won Son J, et al. 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 Diabetes & Metabolism Journal. If we combine this information with your protected 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. 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. Mid-range score: large amounts of medication in accordance with recommended guidelines.Low dose + high risk factors . 138 0 obj <>stream 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)]. The usual adult dose is one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. For example, it can be be used with healthy eating, physical activity and behavior change. When mental impairment is present while taking Phentermine, a patient is also advised not to drive to avoid the risk of being involved in an accident. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place . Children 15 years of age and youngerUse is not recommended. Acidification of the urine increases Phentermine excretion. Facts & Comparisons eAnswers. Adults Exogenous Obesity Oral. 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. 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. SE, which stands for Electronic Florida Online Reporting of Controlled Sub-stances Evaluation program. . Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. Package insert / product label 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. Drug classes: Anorexiants, CNS stimulants. 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 HCl Tablets, USP 37.5 mg After 12 weeks, the patient needs to take a break from the product as it may lead to physical dependence. Place the tablet on the top of your tongue right after removing it from the bottle. hbbd``b` @IHpA\> . Publications, Help Searching Take phentermine exactly as prescribed by your doctor. https://www.micromedexsolutions.com. 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. 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. 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. 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. (A) A prescriber may utilize a schedule III or IV controlled substance for the treatment of obesity only if it has an F.D.A approved indication for this purpose and then only in accordance with all of the . 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. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. A prescription for a controlled substance listed in Schedule II may be dispensed only upon a written prescription of a practitioner, except that in an emergency situation, as defined by regulation of the Department of Health, such controlled substance may be dispensed upon oral prescription but is limited to a 72-hour supply.
