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. 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. 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. Review/update the Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly. Phentermine. Phentermine HCl Tablets, USP 37.5 mg 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. Mid-range score: large amounts of medication in accordance with recommended guidelines.Low dose + high risk factors . endstream endobj startxref Rulemaking Authority 458.336 FS. https://www.uptodate.com/contents/search. Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. To provide you with the most relevant and helpful information, and understand which 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. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. Generic name: Phentermine hydrochloride Precaution should be taken if a patient has any existing health concerns as the drug may cause further harm to their body. 0000000828 00000 n 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, under the following conditions: Oral prescriptions must be promptly reduced to writing by the pharmacist or recorded electronically if permitted by federal law. 0 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Your email address will not be published. Disclaimer: The information on this system is unverified. The dose of this medicine will be different for different patients. 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. HB 423 (by Rep. Pigman) was signed into law on April 14, 2016. Taking Phentermine depends on the brand and preparation of the drug. During the COVID-19 public health emergency (PHE), authorized providers can prescribe controlled substances via telehealth, without the need for an in-person medical evaluation. 0000003317 00000 n Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID-19, plus expertise on managing health. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. The directions for the use of the controlled substance prescribed in the prescription. Lomaira: One tablet three times a day, taken 30 minutes before meals. 0000000016 00000 n Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. Since Phentermine is a drug that contains chemical compounds, it is important to know about all of the risks that are involved with its use and precautions a person should be aware of before the consumption. This documentation contains information regarding prescribing in Florida and is an effort to highlight Florida laws and rules related to prescribing in one doc ument. Concomitant use of alcohol with Phentermine may result in an adverse drug reaction. Make sure your hands are dry before touching the tablet. 0000000909 00000 n There is a problem with 893.04 Pharmacist and practitioner.. (In combination with a healthy diet and exercise plan). Diabetes & Metabolism Journal. 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. The initial symptom of PPH is usually dyspnea. Phentermine hydrochloride/topiramate. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. 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. 0000002493 00000 n Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Patients must be instructed on how much Phentermine to take, and when and how to take it [see Dosage and Administration (2)]. (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 . endstream endobj 108 0 obj <>stream BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Pharmacists may order the medicinal drug products set forth in each rule subject to the following terms and limitations: . Of course, it is taken orally. Keep from freezing. A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required. Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . Or it can help you feel full longer. 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. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. https://fco.factsandcomparisons.com/. 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. information is beneficial, we may combine your email and website usage information with Low dose + low risk factors . Numerous side effects have been linked to the use of Phentermine. Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. Comprehensive review of current and upcoming anti-obesity drugs. For example, it can be be used with healthy eating, physical activity and behavior change. CIV Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. s. 4, ch. Pharmacist and practitioner. 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. Phentermine also is offered combined with topiramate for weight loss (Qsymia). They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. 97-102; s. 301, ch. 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. ZeS{$d!YS,|C~E;h4DJS?|{x}~ ?`2F. 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. After the tablet has melted, swallow or take a sip of water. "@Hw4`tqCA\+ q [AF]` b L ! By doing this, the metabolism is revved up along with an . Drug classes: Anorexiants, CNS stimulants. Following the administration of Phentermine, Phentermine reaches peak concentrations (Cmax) after 3 to 4.4 hours. JC. 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. Common side effects of phentermine include: Phentermine is one of the most prescribed weight-loss medicines. The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. All rights reserved. Phentermine is one of the most effective prescription weight loss medications, with FDA approval since 1959. Review/update the Copyright 2000- 2023 State of Florida. 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 . The PDMP was created in the 2009 session of the Florida legislature to encourage safer prescribing of controlled substances and reduce drug abuse and diversion within the state. Take this medicine only as directed by your doctor. 75-18; s. 12, ch. Patients must be informed that Phentermine hydrochloride is a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity, and that coadministration of Phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5.1)]. OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. 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. 0000003240 00000 n The 2022 Florida Statutes (including 2022 Special Session A and 2023 Special Session B) 458.336 Drugs to treat obesity; rules establishing guidelines.. 458.336 Drugs to treat obesity; rules establishing guidelines.. While these are the most common side effects of the drug, they are not the only consequences associated with the intake of this medication. 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 Medically reviewed by Drugs.com. Dosage should be individualized to obtain an adequate response with the lowest effective dose. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. 2007-156; s. 5, ch. - 7 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. 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. After 12 weeks, the patient needs to take a break from the product as it may lead to physical dependence. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Some patients experience an increase in sexual interest, while others notice that they have a lower libido. the unsubscribe link in the e-mail. Why is phentermine a controlled substance? Phentermine (as resin complex): Usual dosage is 15 or 30 mg once daily. Copyright 2000- 2023 State of Florida. Thus, in order to make the most of this drug, patients need make some effort too. hX}(I See DrugAbuse and Dependence (9.3). 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. |. LZ(6&JQKU5@5_M.~#p = yLgzP"Z90* v~1iu0pV (s:J&Q,. } }& 8}q>u@y)dO|fRmknw huA0@6-%&k-1qI6fSt4#>=sHMk>8fztq9_ nw:>NxHfib Lx.c QEWg\@y@ ~[*+-Dze~Ej+%.E`|IdW#o~#` MM Pursuant to Board of Medical Examiners Rule 540-X-4-.05, dispensing physicians are required to register with the Board. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. Take phentermine exactly as prescribed by your doctor. You may opt-out of email communications at any time by clicking on 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. The promotion of this brand as a diet pill started in 1990. 0000021285 00000 n Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. hbbd``b` @IHpA\> . If you are a Mayo Clinic patient, this could This does not only include prescription drugs but also: Common drugs that are known to interact with Phentermine include Dopamine, Venlafaxine, Linezolid, Ephedrine, Isoproterenol, Epinephrine, Norepinephrine and a Phenylephrine injection. CRIMES. For oral dosage form (disintegrating tablets): Adults and children 17 years of age and olderOne tablet once a day, taken in the morning. See Drug Abuse and Dependence (9) and Overdosage (10). The journals or printed bills of the respective chambers should be consulted for official purposes. Patients should be advised to report immediately any deterioration in exercise tolerance. Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. 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 name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. Carefully follow the dosing instructions for the form you are using. Statutes, Video Broadcast This equates to a weight loss of 10-20 pounds for a 200 pound . Javascript must be enabled for site search. Since it may lead to such symptoms, it also has the potential to cause severe withdrawal symptoms, especially when a patient goes cold turkey. These are all promoted as weight loss pills that assist obese individuals. 0 Phentermine is a Schedule 4 drug. Some of these include: As with many other prescription drugs, Phentermine can also interact with certain medications. Children 16 years of age and youngerUse is not recommended. 1530 0 obj <> endobj 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. 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)]. It also isn't for people who are pregnant, may become pregnant or are breastfeeding. It is often prescribed to be taken in the morning, before or after breakfast. information and will only use or disclose that information as set forth in our notice of Taking Phentermine depends on the brand and preparation of the drug. 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. Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. https://www.micromedexsolutions.com. Below is a chart of body mass index (BMI) based on various heights and weights. It is important to follow these instructions religiously. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. A pharmacist may not knowingly fill a prescription that has been forged for a controlled substance listed in Schedule II, Schedule III, or Schedule IV. 73-331; s. 2, ch. 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. The MAO inhibitors (Monoamine Oxidase Inhibitors) are used to treat depression, especially a specific type called atypical depression. This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. Phentermine is approved for use for up to 12 . Phentermine Hydrochloride Tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. 1558 0 obj <>/Filter/FlateDecode/ID[<7182559B062CF74D9CEE71C953F61692>]/Index[1530 62]/Info 1529 0 R/Length 121/Prev 89015/Root 1531 0 R/Size 1592/Type/XRef/W[1 2 1]>>stream 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). 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. Package insert / product label 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 Phentermine is related chemically and pharmacologically to the amphetamines. Symptoms of extremely high blood pressure, such as uneven heartbeats, chest pain, blurred vision, anxiety and a severe headache. All trademarks are the property of their respective owners. The written prescription must be dated and signed by the prescribing practitioner on the day when issued. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. 100 TABLETS Selling or giving away Phentermine may harm others and is against the law. 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 Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). 0000002991 00000 n 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. Follow your doctor's orders or the directions on the label. law states . Some preparations of the formula, however, have been classified as schedule II drugs. = 0000000596 00000 n the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Use caution when administering Phentermine to patients with renal impairment. The recommended maximum dosage of Phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). 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. Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. Click here for an email preview. Mayo Clinic does not endorse companies or products. Do not keep outdated medicine or medicine no longer needed. The Drug Enforcement Administration (DEA) has made 2 changes related to . Law Implemented Florida Statutes 458.336. 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. These rules and statutes . 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. Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. Such prescriptions must contain the date of the oral authorization. endstream endobj startxref information is beneficial, we may combine your email and website usage information with NDC 42806-810-01 Like other weight-loss medicines ordered by providers, phentermine is meant to be only part of a weight-loss plan. 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. Unfortunately, the answer is no in most cases. The amount of medicine that you take depends on the strength of the medicine. Burguera B, et al. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. Obesity has been linked to many different diseases, including type 2 diabetes and cardiovascular disease. Schedule. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. Children 16 years of age and youngerUse is not recommended. Committee Accessed Oct. 11, 2022. 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. Swallow the tablet whole. The name of the prescribing practitioner. 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. In addition to its function as an appetite suppressant, Phentermine drugs also act as energy boosters. 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. Accessed Oct. 11, 2022. House Bill 831 (2019), Electronic Prescribing, was signed into law by Governor DeSantis. 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. Skip to Navigation | Skip to Main Content | Skip to Site Map. 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. Such controlled substances may be sold only upon an order form, when such an order form is required for sale by the drug abuse laws of the United States or this state, or regulations pursuant thereto. hbbd``b`z$@D`]"@DeX- Bb V ``LA\F*? The effective date is January 1, 2020. information and will only use or disclose that information as set forth in our notice of 14 This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ideally, patients should take it on an empty stomach. 127: VA Prescription Monitoring Program. Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID-19, plus expertise on managing health. (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 . It can help weight loss by making you less hungry. Follow your doctor's dosing instructions very carefully. 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. But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. In order to use Phentermine, the doctor needs to prescribe the drug for a specific patient. The first use of Phentermine as a drug to help treat obesity dates back to 1938. 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. IBM Micromedex. Dosage form: tablet As mentioned above, new mothers should avoid using this medication when breastfeeding. 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. 21 0 obj <> endobj 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.
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