2007-156; s. 5, ch. Also, it may cause certain side effects to become much worse. other information we have about you. The 2022 Florida Statutes (including 2022 Special Session A and 2023 Special Session B) 458.336 Drugs to treat obesity; rules establishing guidelines.. 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. Prescribing controlled substances via telehealth - HHS.gov . Phentermine hydrochloride USP is a sympathomimetic amine anorectic. 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 doctor also looks at the patients medical history for any pre-existing medical conditions that the medication should not be taken with. - 7 (phentermine hydrochloride) orally disintegrating tablet C IV . Rulemaking Authority 458.336 FS. Some patients experience an increase in sexual interest, while others notice that they have a lower libido. Disclaimer: The information on this system is unverified. Metric conversions are as follows: pounds 2.2 = kg; inches x 0.0254 = meters. To provide you with the most relevant and helpful information, and understand which 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. 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. health information, we will treat all of that information as protected health 0000000596 00000 n Adults Exogenous Obesity Oral. 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. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. The combined drug is approved for long-term use. The dosage varies from 15mg to 37.5mg per day. Take phentermine exactly as prescribed by your doctor. The doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. Phentermine (Oral Route) Proper Use - Mayo Clinic OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. Phentermine Hydrochloride Tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. ]c,'303:20/) @d` )2 Taking Phentermine depends on the brand and preparation of the drug. Florida HB 423 - ARNP/PA Controlled Substance Prescribing - FANA Drug information provided by: Merative, Micromedex. the unsubscribe link in the e-mail. 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. the unsubscribe link in the e-mail. 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. Place the tablet on the top of your tongue right after removing it from the bottle. "@Hw4`tqCA\+ q [AF]` b L ! The initial symptom of PPH is usually dyspnea. As phentermine is similar to amphetamine, it is a controlled drug (class C5) and has the potential for abuse. A physician will usually start with a physical examination to determine if the patients health is in a state that will not be negatively affected when taking this drug. 0000005652 00000 n Copyright: Merative US L.P. 1973, 2023. law states . 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. It is advised to stay in strict adherence with the instructions and dosage information a doctor prescribes to the patient in order to avoid dangerous side effects. endstream endobj startxref In some cases, the use of this drug in combination with other pills may cause the effects of other drugs to increase. The overdose symptoms include: The side effects of Phentermine can lead to several symptoms that may impair certain functions in the patients body. hbbd``b` @IHpA\> . Low dose + low risk factors . hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ Lomaira: One tablet three times a day, taken 30 minutes before meals. JC. It works as a psychostimulant drug that stimulates the central nervous system to release norepinephrine from the hypothalamus. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [see ClinicalPharmacology (12.3)]. hb```e````a`d`@ f(fcfILLvL~. But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. 1530 0 obj <> endobj Click here for an email preview. Javascript must be enabled for site search. History.s. Last updated on Mar 22, 2023. 458.336, Florida Statutes - Drugs to treat obesity; rules establishing guidelines; Rule 64B8-9.012, Florida Administrative Code - Standards for the Prescription of Obesity . 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. 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. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. If the federal government fails to oversee how the money is spent, advocates worry it will be wasted. 0000002991 00000 n 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. Late evening medication should be avoided because of the possibility of resulting insomnia. This equates to a weight loss of 10-20 pounds for a 200 pound . It is an appetite suppressant with the added ability to help the body produce more energy from fat cells. 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 Yes, you need a prescription for phentermine. Children 16 years of age and youngerUse is not recommended. A prescription for a controlled substance listed in Schedule II may not be refilled. The number of the prescription, as recorded in the prescription files of the pharmacy in which it is filled. If you miss a dose of this medicine, take it as soon as possible. HB 423 (by Rep. Pigman) was signed into law on April 14, 2016. Phentermine is approved for use for up to 12 . Phentermine Monograph for Professionals - Drugs.com Patients who have been on a Phentermine program should not suddenly stop using the drug. The amount of medicine that you take depends on the strength of the medicine. Before starting with consumption of this medication, patients should get informed about potential adverse effects to be able to determine whether a newly-developed symptom is a sign of a health issue or just a side effect associated with Phentermine. You may opt-out of email communications at any time by clicking on Do not crush, break, or chew it. Florida. Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. 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. 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. Of course, it is taken orally. include protected health information. Phentermine also is offered combined with topiramate for weight loss (Qsymia). 2021; doi:10.1007/s13679-020-00422-w. the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. 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. 127: VA Prescription Monitoring Program. All trademarks are the property of their respective owners. Advise pregnant women and nursing mothers not to use Phentermine [see Use in Specific Populations (8.1, 8.3)]. PDF label - Food and Drug Administration Billions of dollars are headed to state and local governments to address the opioid crisis. 0 Mayo Clinic does not endorse companies or products. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. For more FAQs, please see our full archive of Frequently Asked Questions about phentermine and related prescription appetite suppressants. 2020; doi:10.4093/dmj.2020.0258. Y$iqzZz\vlt1a;svw&aBS8Z(HGCkr&_Qxt97t,GWceTL^QqX(%8_A2'"%tD'DNz"G*"Tc. It can help weight loss by making you less hungry. Average users lose 3-5% of their initial body weight as shown in studies. information and will only use or disclose that information as set forth in our notice of The risks include, but are not limited to: See also, for example, Adverse Reactions (6) and Use in SpecificPopulations (8). You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Search: phentermine guidelines - United States Department of Justice Phentermine should never be taken after 6 pm in the afternoon as it causes insomnia. 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 BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Florida Board of Medicine Where can I find the laws and rules The dosage varies from 15mg to 37.5mg per day. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. 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 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. 97-102; s. 301, ch. This search engine indexes the Drug Enforcement Administration Diversion Control Program Web Site (www.deadiversion.usdoj.gov) only. They inhibit the activity of an entire enzyme family known as monoamine oxidase. The written prescription must be dated and signed by the prescribing practitioner on the day when issued. The recommended maximum dosage of Phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). Tak YJ, et al. 2009-202. Your email address will not be published. The effective date is January 1, 2020. After 12 weeks, the patient needs to take a break from the product as it may lead to physical dependence. Copyright 2000- 2023 State of Florida. 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. 97-264. l 4 a ( k ( N o L i s t ( z ) . 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. (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 . As mentioned above, new mothers should avoid using this medication when breastfeeding. %%EOF 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. If your dose is different, do not change it unless your doctor tells you to do so. A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom prescribed. To avoid trouble with sleeping, take the last dose of the day about 4 to 6 hours before bedtime, unless your doctor tells you otherwise. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Selling or giving away Phentermine may harm others and is against the law. 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. 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. Therefore, coadministration of Phentermine and these drug products is not recommended. 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 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. Rule 4731-11-04 - Ohio Administrative Code | Ohio Laws It is important to follow these instructions religiously. information highlighted below and resubmit the form. Numerous side effects have been linked to the use of Phentermine. Each written prescription prescribed by a practitioner in this state for a controlled substance listed in Schedule II, Schedule III, or Schedule IV must include both a written and a numerical notation of the quantity of the controlled substance prescribed on the face of the prescription and a notation of the date, with the abbreviated month written out on the face of the prescription. If the time is too close to the next dose, it is recommended to skip the dose they have missed. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Ideally, patients should take it on an empty stomach. Taking too much Phentermine can be harmful to the patients body. The strength and dosage of Phentermine depend on the brand that is prescribed and the patients specific condition. 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. 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. Section 458.336, F.S. Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. Symptoms of extremely high blood pressure, such as uneven heartbeats, chest pain, blurred vision, anxiety and a severe headache. 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. REGULATION OF PROFESSIONS AND OCCUPATIONS. 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. When breastfeeding, the drug may enter the breast milk and travel into the nursing babys body, which may cause harm to them. It is obvious that these symptoms can make the entire program useless. 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. Swallow the extended-release capsule whole. Chapter 458 Section 336 - 2011 Florida Statutes - The Florida Senate Such prescriptions must contain the date of the oral authorization. privacy practices.

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