Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). REGULATION OF PROFESSIONS AND OCCUPATIONS. The drug is also available in regular capsules that are taken orally with a glass of water. Of course, it is taken orally. Copyright 2000- 2023 State of Florida. What to offer the 99% of patients with severe obesity who do not undergo bariatric surgery? Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. 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 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). If the prescriber is not available to verify a prescription, the pharmacist may dispense the controlled substance but may insist that the person to whom the controlled substance is dispensed provide valid photographic identification. 21 0 obj <> endobj Selling or giving away Phentermine may harm others and is against the law. This website is a resource which lists doctors and clinics who may offer phentermine or appetite suppressants for patients they deem qualified. If you miss a dose of this medicine, take it as soon as possible. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. If you are allergic to other stimulants, amphetamines, cold medications or diet pills, you have a higher risk of being allergic to these pills too. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Any controlled substance listed in Schedule III or Schedule IV may be dispensed by a pharmacist upon an oral prescription if, before filling the prescription, the pharmacist reduces it to writing or records the prescription electronically if permitted by federal law. 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. 14 Obesity has been linked to many different diseases, including type 2 diabetes and cardiovascular disease. 0 Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). 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. Patients should be advised to report immediately any deterioration in exercise tolerance. Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Phentermine hydrochloride/topiramate. 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 has two primary functions in the human body, which is the reason why it is always accompanied by these lifestyle changes. 90-2; s. 1436, ch. The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. Javascript must be enabled for site search. 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. Carefully follow the dosing instructions for the form you are using. The dosage may be adjusted to the patients need. 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. Some preparations of the formula, however, have been classified as schedule II drugs. 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 . Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Phentermine also is offered combined with topiramate for weight loss (Qsymia). (In combination with a healthy diet and exercise plan). . 99-8; s. 2, ch. This equates to a weight loss of 10-20 pounds for a 200 pound . 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. Rule 4731-11-04 | Controlled substances for the treatment of obesity. Some brands use a dissolving tablet that is placed under the tongue, which allows the body to absorb the chemicals in the drug faster. If we combine this information with your protected It can help weight loss by making you less hungry. Burguera B, et al. If you are a Mayo Clinic patient, this could Y$iqzZz\vlt1a;svw&aBS8Z(HGCkr&_Qxt97t,GWceTL^QqX(%8_A2'"%tD'DNz"G*"Tc. Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. Average users lose 3-5% of their initial body weight as shown in studies. 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. Dosage form: tablet Publications, Help Searching This content does not have an Arabic version. Phentermine has not been studied in patients with eGFR less than 15 mL/min/1.73m2, including end-stage renal disease requiring dialysis; avoid use in these populations. 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. 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. Ideally, patients should take it on an empty stomach. The combined drug is approved for long-term use. Take this medicine only as directed by your doctor. Phentermine is not recommended for use in pediatric patients 16 years of age. The journals or printed bills of the respective chambers should be consulted for official purposes. 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. 893.04 Pharmacist and practitioner.. Required fields are marked *. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. In some cases, the side effects were life-threatening and led to the death of a patient. 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. Pharmacist and practitioner. A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required. 100 TABLETS Last updated on Mar 22, 2023. It works as a psychostimulant drug that stimulates the central nervous system to release norepinephrine from the hypothalamus. In order to use Phentermine, the doctor needs to prescribe the drug for a specific patient. Phentermine is a Schedule 4 drug. Advise pregnant women and nursing mothers not to use Phentermine [see Use in Specific Populations (8.1, 8.3)]. 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. ZeS{$d!YS,|C~E;h4DJS?|{x}~ ?`2F. 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)]. The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years. |. Taking Phentermine depends on the brand and preparation of the drug. Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Drugs to treat obesity; rules establishing guidelines. 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. 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 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. Swallow the extended-release capsule whole. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. Available for Android and iOS devices. The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. Committee For example, it can be be used with healthy eating, physical activity and behavior change. Skip to Navigation | Skip to Main Content | Skip to Site Map. Moreover, it is strongly recommended to avoid or limit the alcohol intake. See Drug Abuse and Dependence (9) and Overdosage (10). Joint Administrative Procedures Committee (JAPC), Joint Committee on Public Counsel Oversight(JCPO), Joint Legislative Auditing Committee (JLAC), Joint Legislative Budget Commission (JLBC), Joint Select Committee on Collective Bargaining (JSCB), Office of Program Policy Analysis & Government Accountability (OPPAGA), Florida Legislative Committee on Intergovernmental Relations (LCIR), Joint Legislative Committee on Everglades Oversight (JCEO), Joint Legislative Sunset Committee (JCSC), Copyright 1995-2023 The Florida Legislature . 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. Instead of simply quitting the program, a patient should rather consult a healthcare provider about quitting. @ d It is vital to talk with the doctor before using Phentermine with other products. Advertising revenue supports our not-for-profit mission. The initials of the pharmacist filling the prescription and the date filled. 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 . 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 privacy practices. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. Each tablet contains the following inactive ingredients: starch, lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate and blue sugar spheres. You may opt-out of email communications at any time by clicking on Concomitant use of alcohol with phentermine may result in an adverse drug reaction. There is a problem with 0000005652 00000 n Or it can help you feel full longer. The dosage varies from 15mg to 37.5mg per day. 2020; doi:10.4093/dmj.2020.0258. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. 0000000016 00000 n HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Diabetes & Metabolism Journal. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). After the tablet has melted, swallow or take a sip of water. If the drug is taken too late in the day, it may also cause insomnia. Thus, in order to make the most of this drug, patients need make some effort too. 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. 0000002493 00000 n information is beneficial, we may combine your email and website usage information with information highlighted below and resubmit the form. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. Low dose + low risk factors . These practice guidelines can be found in Rule 64B8-9.012, F.A.C. However, it caused a chronic condition known as pulmonary hypertension, which led to the death of many patients. The dosage varies from 15mg to 37.5mg per day. Follow your doctor's orders or the directions on the label. 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 Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Such prescriptions must contain the date of the oral authorization. There is a problem with hWmo8+jE'"m{F A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. 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). 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. Rx only. It depends on supplements a patient would like to take. 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. 35 0 obj <>stream Phentermine has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) [see Clinical Pharmacology (12.1)]. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. 79-12; s. 2, ch. %%EOF This brand is manufacturedby Teva Pharmaceuticals (formerly GATE Pharmaceuticals). endstream endobj startxref 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. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Phentermine doctors network. Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. hbbd``b` @IHpA\> . Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. https://www.uptodate.com/contents/search. While these are the most common side effects of the drug, they are not the only consequences associated with the intake of this medication. Also, it may cause certain side effects to become much worse. Phentermine also is offered combined with topiramate for weight loss (Qsymia). Medically reviewed by Drugs.com. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Dosage should be individualized to obtain an adequate response with the lowest effective dose. In most cases, the drug is prescribed to users in periods of 12 weeks. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Some of these include: As with many other prescription drugs, Phentermine can also interact with certain medications. Following the administration of Phentermine, Phentermine reaches peak concentrations (Cmax) after 3 to 4.4 hours. 127: VA Prescription Monitoring Program. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. They help the body produce a larger amount of energy from fat cells, which further reduces body fat percentage. This content does not have an Arabic version. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F 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. Phentermine is used as part of a short-term plan, along with a low calorie diet, for weight reduction. The directions for the use of the controlled substance prescribed in the prescription. 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 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). Mayo Clinic College of Medicine and Science, Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Graduate Medical Education, Mayo Clinic School of Continuous Professional Development, Mayo Clinic on Incontinence - Mayo Clinic Press, NEW Mayo Clinic on High Blood Pressure - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press, Financial Assistance Documents Minnesota, Biliopancreatic diversion with duodenal switch (BPD/DS), Endoscopic Sleeve Gastroplasty (Gastric Sleeve), Biliopancreatic diversion with duodenal switch. If the federal government fails to oversee how the money is spent, advocates worry it will be wasted. = xb```f``ZAb 1av K3gI{$*i p400t UD J@X$Ybv k=:,fb[ a`x @ ! 458.336 Drugs to treat obesity; rules establishing guidelines.. 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. 2009-202. Patients who have been on a Phentermine program should not suddenly stop using the drug. It is not uncommon for patients to experience a change in their sexual interest. House Bill 831 (2019), Electronic Prescribing, was signed into law by Governor DeSantis. The first use of Phentermine as a drug to help treat obesity dates back to 1938. It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. Mid-range score: large amounts of medication in accordance with recommended guidelines.Low dose + high risk factors . Billions of dollars are headed to state and local governments to address the opioid crisis. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. The doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. 1530 0 obj <> endobj Review/update the Disclaimer: The information on this system is unverified. Take the disintegrating tablet with or without food. 188, ch. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). 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. 0 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. Copyright: Merative US L.P. 1973, 2023. Common side effects of phentermine include: Phentermine is one of the most prescribed weight-loss medicines. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed. 0000021285 00000 n Comprehensive review of current and upcoming anti-obesity drugs. 0000000909 00000 n All rights reserved. Do not crush, break, or chew it. 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. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not crush, break, or chew it. include protected health information. 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. Yes, you need a prescription for phentermine. 0000000828 00000 n 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. If the time is too close to the next dose, it is recommended to skip the dose they have missed. Make sure your hands are dry before touching the tablet. 188 . Since it may lead to such symptoms, it also has the potential to cause severe withdrawal symptoms, especially when a patient goes cold turkey.
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