While discussing the use of Phentermine with the doctor, a patient is provided a list of lifestyle changes to implement while using this product. However, it caused a chronic condition known as pulmonary hypertension, which led to the death of many patients. 893.04 Pharmacist and practitioner.. Or it can help you feel full longer. In some cases, the side effects were life-threatening and led to the death of a patient. Chapter 893 Section 04 - 2012 Florida Statutes - The Florida Senate 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. Copyright 2000- 2023 State of Florida. This content does not have an English version. 97-102; s. 301, ch. But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. %%EOF It is not uncommon for patients to experience a change in their sexual interest. Yes, you need a prescription for phentermine. CIV The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. This website is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Florida. Phentermine is not to be used while pregnant or breastfeeding under any circumstances. Phentermine Hydrochloride Tablets are indicated as 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 for patients with an initial body mass index 30 kg/m2, or 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. Statutes, Video Broadcast Different brands manufacture, distribute and sell Phentermine drugs. 458.336 Drugs to treat obesity; rules establishing guidelines.. . It is an appetite suppressant with the added ability to help the body produce more energy from fat cells. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. The structural formula is as follows: Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. 104 0 obj <> endobj The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. FULL PRESCRIBING of the risk of hypertensive crisis. 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. Javascript must be enabled for site search. Concomitant use of alcohol with phentermine may result in an adverse drug reaction. Comprehensive review of current and upcoming anti-obesity drugs. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. Your email address will not be published. privacy practices. 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 classified under a certain chemical class known as amphetamine as it has a similar pharmacology value to other drugs classified in the class. startxref 893.049(1)(d), (e),f.s. l 4 a ( k ( N o L i s t ( z ) . Please consult with your physician before you make any decisions regarding your health. Florida has received national attention for the large num- Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Place the tablet on the top of your tongue right after removing it from the bottle. Thus, in order to make the most of this drug, patients need make some effort too. 0000000909 00000 n Unfortunately, the answer is no in most cases. Controlled substances for the treatment of obesity. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. Numerous side effects have been linked to the use of Phentermine. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. In some cases, the use of this drug in combination with other pills may cause the effects of other drugs to increase. Do not crush, break, or chew it. Safety and effectiveness in pediatric patients have not been established. Tak YJ, et al. 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. Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. All rights reserved. 14 These are all promoted as weight loss pills that assist obese individuals. 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. Should a patient realize he/she has missed a dose within a reasonable timeframe after the doses timing, it is acceptable to take it once they remember it. Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. . 0 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. REGULATION OF PROFESSIONS AND OCCUPATIONS. It is obvious that these symptoms can make the entire program useless. 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. This medication has been linked to physical dependence, which means a patient may become addicted to it. 2019; doi:10.1016/j.mayocp.2018.11.020. grants the Board of Medicine the authority to adopt rules to establish the practice guidelines for drugs used to treat obesity. By doing this, the metabolism is revved up along with an . %%EOF Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. This content does not have an Arabic version. Follow your doctor's dosing instructions very carefully. Prescribing Issues | Alabama Board of Medical Examiners & Medical Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. While these are the most common side effects of the drug, they are not the only consequences associated with the intake of this medication. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Phentermine is not recommended for use in pediatric patients 16 years of age. Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. Required fields are marked *. PDF label - Food and Drug Administration Package insert / product label The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. 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). Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. 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 prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Billions of dollars are headed to state and local governments to address the opioid crisis. 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. information is beneficial, we may combine your email and website usage information with However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Average users lose 3-5% of their initial body weight as shown in studies. Children 16 years of age and youngerUse is not recommended. Rule 4731-11-04 - Ohio Administrative Code | Ohio Laws Phentermine also is offered combined with topiramate for weight loss (Qsymia). Rule 4731-11-04 | Controlled substances for the treatment of obesity. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. This is a label given to drugs that can be misused. Click here for an email preview. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). Statutes, Video Broadcast 1530 0 obj <> endobj The following adverse reactions are described, or described in greater detail, in other sections: The following adverse reactions to Phentermine have been identified: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events. Adults and children 17 years of age and older15 to 30 milligrams (mg) once a day, taken at approximately 2 hours after breakfast. Swallow the tablet whole. When breastfeeding, the drug may enter the breast milk and travel into the nursing babys body, which may cause harm to them. Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). HB 423 (by Rep. Pigman) was signed into law on April 14, 2016. 2020; doi:10.4093/dmj.2020.0258. 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 Board of Medicine shall adopt rules to establish practice guidelines for physicians to safely prescribe phentermine, fenfluramine, and other drugs used to treat obesity. It works as a psychostimulant drug that stimulates the central nervous system to release norepinephrine from the hypothalamus. Last updated on Mar 22, 2023. Your email address will not be published. Phentermine hydrochloride USP is a sympathomimetic amine anorectic. The promotion of this brand as a diet pill started in 1990. 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. Over 12 weeks, it can be as high as 9-10%. It is vital to talk with the doctor before using Phentermine with other products. The possible origins of the increased weight loss due to the various drug effects are not established. All rights reserved. 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 Rulemaking Authority 458.336 FS. hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ 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 . After 12 weeks, the patient needs to take a break from the product as it may lead to physical dependence. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Prescribing in Florida - The Health Law Firm information and will only use or disclose that information as set forth in our notice of information highlighted below and resubmit the form. Advertising revenue supports our not-for-profit mission. Patients should be advised to report immediately any deterioration in exercise tolerance. Ideally, patients should take it on an empty stomach. Portions of this document last updated: Feb. 01, 2023. Statutes & Constitution :View Statutes : Online Sunshine Many patients find that if their doctor gradually lowers their dose, for example from 37.5mg per day down to 15mg per day for the last few days, they experience fewer withdrawal symptoms and are able to keep the weight off later. As phentermine is similar to amphetamine, it is a controlled drug (class C5) and has the potential for abuse. This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. law states . - 7 Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. Law Implemented Florida Statutes 458.336. include protected health information. Duromine is not funded by Pharmac, so patients pay $160-$200 per month when they present a standard prescription of 30mg daily - in addition to the GP consultation fee. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. ZeS{$d!YS,|C~E;h4DJS?|{x}~ ?`2F. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Phentermine (Oral Route) Proper Use - Mayo Clinic HVMs8WQl eLg*&{dd $_;lm |NggK6,M]gu\.BNB. The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. Management of acute Phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Search: phentermine guidelines - United States Department of Justice 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)]. All rights reserved. information is beneficial, we may combine your email and website usage information with Registration is accomplished by completing and returning the dispensing physician registration form. @ d The following information includes only the average doses of this medicine. Affixed to the original container in which a controlled substance is delivered upon a prescription or authorized refill thereof, as hereinafter provided, there shall be a label bearing the following information: The name and address of the pharmacy from which such controlled substance was dispensed. 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. CRIMES. 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. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. Opioid settlement billions flow to states, as advocates worry about 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. 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. HB 423 - ARNP/PA Controlled Substance Prescribing. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. 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 . Pharmacists may order the medicinal drug products set forth in each rule subject to the following terms and limitations: . 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 The dose of this medicine will be different for different patients. = Dosage should be individualized to obtain an adequate response with the lowest effective dose. Or it can help you feel full longer. 1591 0 obj <>stream You may opt-out of email communications at any time by clicking on other information we have about you. It is important to follow these instructions religiously. Intravenous phentolamine (Regitine, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage. health information, we will treat all of that information as protected health Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. 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. 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 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. The amount of medicine that you take depends on the strength of the medicine. 0000001039 00000 n Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. 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. Pharmacist and practitioner. Chapter 893 DRUG ABUSE PREVENTION AND CONTROL Entire Chapter. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. Lomaira: One tablet three times a day, taken 30 minutes before meals. 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. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. Rx only. Prescribing Controlled Substances via Telehealth under Florida and hbbd``b` @IHpA\> . Mayo Clinic does not endorse companies or products. The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. Won Son J, et al. Skip to Navigation | Skip to Main Content | Skip to Site Map. 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. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place . 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. 0000000828 00000 n Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. 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. Disclaimer: The information on this system is unverified. See Drug Abuse and Dependence (9) and Overdosage (10). Phentermine for weight loss - Mayo Clinic Unfortunately, patients experienced a variety of side effects, which included severe heart toxicity and hypertension. This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. 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
