Instead of simply quitting the program, a patient should rather consult a healthcare provider about quitting. Safety and effectiveness in pediatric patients have not been established. 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. The dosage may be adjusted to the patients need. REGULATION OF PROFESSIONS AND OCCUPATIONS. Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. Tablets containing 37.5 mg Phentermine hydrochloride (equivalent to 30 mg Phentermine base). 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. Of course, it is taken orally. Concomitant use of alcohol with phentermine may result in an adverse drug reaction. 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. Current Obesity Reports. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). Phentermine has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) [see Clinical Pharmacology (12.1)]. The 2022 Florida Statutes (including 2022 Special Session A and 2023 Special Session B) 458.336 Drugs to treat obesity; rules establishing guidelines.. Doses are normally taken before breakfast, or 1 to 2 hours after breakfast. Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. 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. Children 16 years of age and youngerUse is not recommended. Do not keep outdated medicine or medicine no longer needed. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Statutes, Video Broadcast law states . . For more FAQs, please see our full archive of Frequently Asked Questions about phentermine and related prescription appetite suppressants. The effective date is January 1, 2020. 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. Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. 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. Management of acute Phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. HB 423 - ARNP/PA Controlled Substance Prescribing. 73-331; s. 2, ch. %%EOF 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. Such prescriptions must contain the date of the oral authorization. This content does not have an Arabic version. Rule 4731-11-04 | Controlled substances for the treatment of obesity. For example, it can be be used with healthy eating, physical activity and behavior change. 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. You may opt-out of email communications at any time by clicking on 1530 0 obj <> endobj 2020; doi:10.4093/dmj.2020.0258. This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. 0000000828 00000 n hb``````>X,K10wdjdZ(`l Ro4' b2h>$:-9.AKL1}c$vEP;-@c=en`Y %YQh` &^ 0000001039 00000 n 97-102; s. 301, ch. Some brands use a dissolving tablet that is placed under the tongue, which allows the body to absorb the chemicals in the drug faster. It is vital to talk with the doctor before using Phentermine with other products. 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 0000002736 00000 n 0000001488 00000 n 0 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. Or it can help you feel full longer. 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). The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. 0 Do not double doses. 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. hWmo8+jE'"m{F 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. If the federal government fails to oversee how the money is spent, advocates worry it will be wasted. Over 12 weeks, it can be as high as 9-10%. 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. 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. Controlled substances for the treatment of obesity. the unsubscribe link in the e-mail. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Won Son J, et al. 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. Talk with your doctor before starting an exercise program. (3) In any case of dispensing hereunder, the amount or . Phentermine HCl Tablets, USP 37.5 mg Also, it may cause certain side effects to become much worse. 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. Drugs to treat obesity; rules establishing guidelines. Pursuant to Board of Medical Examiners Rule 540-X-4-.05, dispensing physicians are required to register with the Board. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [see ClinicalPharmacology (12.3)]. Javascript must be enabled for site search. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Prescribing Standards: In addition to the laws and rules directly related to the prescription and prescribing, there are other standards which should be followed as well. 2012 Florida Statutes. hX}(I The dosage varies from 15mg to 37.5mg per day. 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. 14 Mid-range score: large amounts of medication in accordance with recommended guidelines.Low dose + high risk factors . The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years. If you miss a dose of this medicine, take it as soon as possible. Advertising revenue supports our not-for-profit mission. Registration is accomplished by completing and returning the dispensing physician registration form. Studies have not been performed with Phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. The initial symptom of PPH is usually dyspnea. Yes, you need a prescription for phentermine. Fatigue and depression usually follow the central stimulation. Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. 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 all directions on your prescription label and read all medication guides or instruction sheets. health information, we will treat all of that information as protected health The following information includes only the average doses of this medicine. (In combination with a healthy diet and exercise plan). If your dose is different, do not change it unless your doctor tells you to do so. 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. This content does not have an English version. 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. 21 15 188 . Tell patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Following the administration of Phentermine, Phentermine reaches peak concentrations (Cmax) after 3 to 4.4 hours. A prescription for a controlled substance listed in Schedule II may not be refilled. Phentermine is not to be used while pregnant or breastfeeding under any circumstances. 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)]. ]c,'303:20/) @d` )2 All trademarks are the property of their respective owners. There is a problem with Schedule. %PDF-1.6 % Metric conversions are as follows: pounds 2.2 = kg; inches x 0.0254 = meters. Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Swallow the tablet whole. Also available as phentermine hydrochloride; dosage expressed in terms of phentermine hydrochloride. History.s. Thus, in order to make the most of this drug, patients need make some effort too. l 4 a ( k ( N o L i s t ( z ) . The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. hYr ~{L(QdK4^bdsO_d;a BXO--p,!4!,WhfM/@c endstream endobj startxref Children 16 years of age and youngerUse is not recommended. 893.04 Pharmacist and practitioner.. For oral dosage form (disintegrating tablets): Adults and children 17 years of age and olderOne tablet once a day, taken in the morning. L^%0:T'xHGi,KGyVfZ5WI6&ZU1/VqM4.ct\i2gTAtQV%[$*/tbn"xS8JU$bljsI2)bs_/FouVGwCqX';z{0REZbSX,bXWPS#Bf|il#o'y`?jv{;!bS F#vPGzD"1~5~F%mW9YlGIQVYOS~kojbdQS!>|@Ph (d) each prescription writtenby a practitioner in this statefor a controlledsubstance listed in schedule ii, schedule iii, or schedule iv must include a writtenand a numerical notation of the quantity of the controlled substance prescribed and a notation of the datein numerical, month/day/year format, or with the abbreviated month writtenout, or the month writtenout in . Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Later on, between 1940 and 1960, Phentermine was combined with other medications to improve its effectiveness. 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. If the time is too close to the next dose, it is recommended to skip the dose they have missed. Ask your healthcare professional how you should dispose of any medicine you do not use. Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. 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. 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. Phentermine is approved for use for up to 12 . It is an appetite suppressant with the added ability to help the body produce more energy from fat cells. Do not crush, break, or chew it. 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. It works as a psychostimulant drug that stimulates the central nervous system to release norepinephrine from the hypothalamus. Late evening medication should be avoided because of the possibility of resulting insomnia. Review/update the What You Should Know Before Taking Phentermine, Frequently Asked Questions About Phentermine, refer to our phentermine drug interactions data, Frequently Asked Questions about phentermine, https://www.drugs.com/ingredient/phentermine.html, http://www.rxlist.com/adipex-p-drug/patient-avoid-while-taking.htm, http://www.everydayhealth.com/drugs/phentermine, https://www.ncbi.nlm.nih.gov/pubmed/27664021, https://www.ncbi.nlm.nih.gov/pubmed/26584649, https://www.ncbi.nlm.nih.gov/pubmed/26446094, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4560177/, https://www.ncbi.nlm.nih.gov/pubmed/25911503, Feeling like they are going to faint, often accompanied by chest pain, Fluttering in the patients chest, as well as pounding heartbeats. @ d include protected health information. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 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. OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946. Lomaira: One tablet three times a day, taken 30 minutes before meals. Accessed Oct. 11, 2022. Different brands manufacture, distribute and sell Phentermine drugs. (phentermine hydrochloride) orally disintegrating tablet C IV . Available for Android and iOS devices. It is not uncommon for patients to experience a change in their sexual interest. Precaution should be taken if a patient has any existing health concerns as the drug may cause further harm to their body. Phentermine is most commonly prescribed to patients who experience negative health effects to excessive amounts of body weight. Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. RPYcn@b[%XYK'Q %[.()GTkJ WCf.-i>n-oIzE*D40f#Gp'LcddmE8;>u?X"tO 1]M={4,ReC8E8Z Q1Lt$-XpFCrTJ