2019; doi:10.1016/j.mayocp.2018.11.020. W0Qxe {>x??}#
cGCSGGC[G(P A@3'i~ (2[n! The possible origins of the increased weight loss due to the various drug effects are not established. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place . Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. A pharmacist may not dispense a controlled substance listed in Schedule II, Schedule III, or Schedule IV to any patient or patients agent without first determining, in the exercise of her or his professional judgment, that the order is valid. The Drug Enforcement Administration (DEA) has made 2 changes related to . 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. Instead of simply quitting the program, a patient should rather consult a healthcare provider about quitting. The dosage varies from 15mg to 37.5mg per day. Publications, Help Searching
Statutes, Video Broadcast
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. information is beneficial, we may combine your email and website usage information with 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. %PDF-1.6
%
Use of Phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. If the time is too close to the next dose, it is recommended to skip the dose they have missed. See DrugAbuse and Dependence (9.3). This search engine indexes the Drug Enforcement Administration Diversion Control Program Web Site (www.deadiversion.usdoj.gov) only. 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. Mayo Clinic does not endorse companies or products. -
7
Pharmacist and practitioner. 0000001039 00000 n
75-18; s. 12, ch. 0
other information we have about you. The full name and address of the prescribing practitioner and the practitioners federal controlled substance registry number shall be printed thereon. Phentermine has been linked to many complications; knowing these details will help patients minimize their risk of experiencing such unwanted scenarios. Y$iqzZz\vlt1a;svw&aBS8Z(HGCkr&_Qxt97t,GWceTL^QqX(%8_A2'"%tD'DNz"G*"Tc. Lomaira: One tablet three times a day, taken 30 minutes before meals. The FDA in the United States first approved the use of Amphetamine as a drug that can be used to suppress a patients appetite in 1959. Rule 4731-11-04. Or it can help you feel full longer. 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. |. 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. Mayo Clinic offers appointments in Arizona, Florida and Minnesota and at Mayo Clinic Health System locations. 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 . 0
health information, we will treat all of that information as protected health 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
The dosage varies from 15mg to 37.5mg per day. Accessed Oct. 11, 2022. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. Follow all directions on your prescription label and read all medication guides or instruction sheets. Phentermine is related chemically and pharmacologically to the amphetamines. 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. 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. 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. Chapter 893 DRUG ABUSE PREVENTION AND CONTROL Entire Chapter. The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. Systemic exposure of Phentermine may increase up to 91%, 45%, and 22% in patients with severe, moderate, and mild renal impairment, respectively [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)]. HB 423 - ARNP/PA Controlled Substance Prescribing. Ask your healthcare professional how you should dispose of any medicine you do not use. Last updated on Mar 22, 2023. Patients who have been on a Phentermine program should not suddenly stop using the drug. Swallow the tablet whole. 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 . 104 0 obj
<>
endobj
FULL PRESCRIBING of the risk of hypertensive crisis. Schedule. However, the medication does have a considerable street value. In most cases, the drug is prescribed to users in periods of 12 weeks. If the federal government fails to oversee how the money is spent, advocates worry it will be wasted. The initial symptom of PPH is usually dyspnea. Make sure your hands are dry before touching the tablet. Drugs to treat obesity; rules establishing guidelines. History.s. . Other initial symptoms may include angina pectoris, syncope or lower extremity edema. A prescription for a controlled substance listed in Schedule III, Schedule IV, or Schedule V may not be filled or refilled more than five times within a period of 6 months after the date on which the prescription was written unless the prescription is renewed by a practitioner. 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 prescription of such weight loss enhancers is not generally appropriate for children. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. If the prescription is for an animal, the species of animal for which the controlled substance is prescribed. Phentermine is approved for use for up to 12 weeks. Registration is accomplished by completing and returning the dispensing physician registration form. hbbd``b` @IHpA\> . Later on, between 1940 and 1960, Phentermine was combined with other medications to improve its effectiveness. Phentermine is a popular prescription drug that is often used to treat obesity. Click here for an email preview. All rights reserved. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. Safety and effectiveness in pediatric patients have not been established. 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. The name of the prescribing practitioner. 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. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [see ClinicalPharmacology (12.3)]. The doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. s. 4, ch. Rx only. Phentermine is approved for use for up to 12 .
Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). 0
Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F 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. Some of the studies that have linked Phentermine to positive results in humans include: The main active ingredient is known as Phentermine Hydrochloride. Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. After 12 weeks, the patient needs to take a break from the product as it may lead to physical dependence. 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
Portions of this document last updated: Feb. 01, 2023. Different brands manufacture, distribute and sell Phentermine drugs. The MAO inhibitors (Monoamine Oxidase Inhibitors) are used to treat depression, especially a specific type called atypical depression. (3) In any case of dispensing hereunder, the amount or . Some preparations of the formula, however, have been classified as schedule II drugs. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. It should also not be taken within 14 days after taking an MAO inhibitor. This bill allows ARNPs and PAs to prescribe controlled substances under existing supervision and protocol requirements, and subject to a formulary to be developed by a committee under the Board of Nursing. Phentermine is a Schedule 4 drug. Statutes, Video Broadcast
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. Required fields are marked *. endstream
endobj
108 0 obj
<>stream
If you are a Mayo Clinic patient, this could Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. 0000001146 00000 n
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. 1591 0 obj
<>stream
0000001488 00000 n
This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. There is a problem with All rights reserved. Ideally, patients should take it on an empty stomach. 188, ch. 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. It is obvious that these symptoms can make the entire program useless. The Administration's plan is to end the COVID-19 public health emergency on May 11, 2023. 2007-156; s. 5, ch. Patients must be informed about the risks of use of Phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. Phentermine is for people with obesity or overweight who haven't been able to lose enough weight with diet and exercise alone to improve their health. CRIMES. So some health care providers might order it for longer use. This includes prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems. IBM Micromedex. Therefore, coadministration of Phentermine and these drug products is not recommended. Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. 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. If the drug is taken too late in the day, it may also cause insomnia. If you are a Mayo Clinic patient, this could 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. A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required. 127: VA Prescription Monitoring Program. In some cases, patients have also found that Phentermine interacts with drugs that contain Tranylcypromine, Henelzine, Isocarboxazid, Diethylpropion, Phendimetrazine, Amphetamine, and Benzphetamine. Take phentermine exactly as prescribed by your doctor. 2009-202. Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. Taking too much Phentermine can be harmful to the patients body. One should bear in mind that Phentermine is not only a drug to help reduce the baseline body weight of patients, but it also reduces a patients risk of developing certain health diseases. 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. 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. information and will only use or disclose that information as set forth in our notice of Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. The dosage may be adjusted to the patients need. This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. 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. ]c,'303:20/) @d` )2
458.336, Florida Statutes - Drugs to treat obesity; rules establishing guidelines; Rule 64B8-9.012, Florida Administrative Code - Standards for the Prescription of Obesity . The initials of the pharmacist filling the prescription and the date filled. 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. A pharmacist may not dispense more than a 30-day supply of a controlled substance listed in Schedule III upon an oral prescription issued in this state. It should melt quickly. The combined drug is approved for long-term use. Section 458.336, F.S. House Bill 831 (2019), Electronic Prescribing, was signed into law by Governor DeSantis. 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. Some brands use a dissolving tablet that is placed under the tongue, which allows the body to absorb the chemicals in the drug faster. Requirements may be altered [see Warnings and Precautions (5.9)]. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Pharmacists may order the medicinal drug products set forth in each rule subject to the following terms and limitations: . the unsubscribe link in the e-mail. hWmo8+jE'"m{F 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. Follow your doctor's dosing instructions very carefully. 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. 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. It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. Metric conversions are as follows: pounds 2.2 = kg; inches x 0.0254 = meters. This content does not have an English version. 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. 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. Phentermine Hydrochloride Tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. In some cases, the use of Phentermine has also led to the development of symptoms that are related to erectile dysfunction. 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. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). endstream
endobj
startxref
2021; doi:10.1007/s13679-020-00422-w. The effective date is January 1, 2020. Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. After the tablet has melted, swallow or take a sip of water. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). SE, which stands for Electronic Florida Online Reporting of Controlled Sub-stances Evaluation program. 99-8; s. 2, ch. Rulemaking Authority 458.336 FS. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 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). Mid-range score: large amounts of medication in accordance with recommended guidelines.Low dose + high risk factors . When mental impairment is present while taking Phentermine, a patient is also advised not to drive to avoid the risk of being involved in an accident. Being extremely irritable and confused, or experienced unusual behavior or thoughts. 0000021285 00000 n
Selling or giving away Phentermine may harm others and is against the law. In 1968, three years after its release, Aminorex was withdrawn. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. 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. 2012 Florida Statutes. information is beneficial, we may combine your email and website usage information with Follow your doctor's orders or the directions on the label. "@Hw4`tqCA\+ q [AF]` b L ! If we combine this information with your protected Studies have not been performed with Phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. Committee
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). (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 . Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Symptoms of extremely high blood pressure, such as uneven heartbeats, chest pain, blurred vision, anxiety and a severe headache. health information, we will treat all of that information as protected health It is an appetite suppressant with the added ability to help the body produce more energy from fat cells. This is a label given to drugs that can be misused. It is often prescribed to be taken in the morning, before or after breakfast. 35 0 obj
<>stream
But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. Also available as phentermine hydrochloride; dosage expressed in terms of phentermine hydrochloride. 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. Since it may lead to such symptoms, it also has the potential to cause severe withdrawal symptoms, especially when a patient goes cold turkey. 1530 0 obj
<>
endobj
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). Drug information provided by: Merative, Micromedex. Comprehensive review of current and upcoming anti-obesity drugs. The drug is usually prescribed at the lowest possible dose to new users, which is 15mg per day. 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. 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. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. 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. Review/update the Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. Perreault L. Obesity in adults: Drug therapy. A prescription for a controlled substance listed in Schedule II may not be refilled. 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
%PDF-1.6
%
Doctors used it to help patients who experience certain health issues caused by obesity to lose weight and improve the symptoms they are experiencing. The journals or printed bills of the respective chambers should be consulted for official purposes. To provide you with the most relevant and helpful information, and understand which 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Do not crush, break, or chew it. Florida. Concomitant use of alcohol with Phentermine may result in an adverse drug reaction. hX}(I Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. The goal of the drug is to help patients lose weight and increase energy since the withdrawal symptoms of include fatigue and weight gain through an increase in appetite, the product is rendered a waste of the patients time and money. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. 0000003240 00000 n
hbbd``b`z$@D`]"@DeX- Bb V ``LA\F*? 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. These practice guidelines can be found in Rule 64B8-9.012, F.A.C. 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. 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. For more FAQs, please see our full archive of Frequently Asked Questions about phentermine and related prescription appetite suppressants. Moreover, it is strongly recommended to avoid or limit the alcohol intake. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine).