All rights reserved. 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. Phentermine is related chemically and pharmacologically to the amphetamines. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [see ClinicalPharmacology (12.3)]. Phentermine also is offered combined with topiramate for weight loss (Qsymia). FULL PRESCRIBING of the risk of hypertensive crisis. 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 . 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. By doing this, the metabolism is revved up along with an . 2009-202. 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. Medically reviewed by Drugs.com. A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. 97-264. 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. Phentermine: Package Insert - Drugs.com information and will only use or disclose that information as set forth in our notice of Lomaira: One tablet three times a day, taken 30 minutes before meals. But it isn't a good choice for people with heart disease, high blood pressure, an overactive thyroid gland or glaucoma. Why is phentermine a controlled substance? Six years after the approval, a similar drug, called Aminorex, were released in Europe with the same purpose of helping obese individuals. Skip to Navigation | Skip to Main Content | Skip to Site Map. 0000003317 00000 n Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. 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 Ideally, patients should take it on an empty stomach. PDF Prescribing in Florida (Guidance Provided by the Florida Department of This website is a resource which lists doctors and clinics who may offer phentermine or appetite suppressants for patients they deem qualified. 0 Phentermine is not recommended for use in pediatric patients 16 years of age. 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. Florida. Phentermine is a Schedule IV controlled substance. This content does not have an English version. Dosage should be individualized to obtain an adequate response with the lowest effective dose. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Use caution when administering Phentermine to patients with renal impairment. ]^Ng8\!HqX 'nR l# w! {A6.q=0G: S:nR-`\ |%Tx F5z :^EU\)|\eyt0F You may opt-out of email communications at any time by clicking on The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. 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 Doses are normally taken before breakfast, or 1 to 2 hours after breakfast. Section 458.336, F.S. privacy practices. Generic name: Phentermine hydrochloride Duromine is not funded by Pharmac, so patients pay $160-$200 per month when they present a standard prescription of 30mg daily - in addition to the GP consultation fee. . Phentermine. . Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Package insert / product label Follow your doctor's orders or the directions on the label. Of course, it is taken orally. CRIMES. Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast. Another important fact to consider before taking Phentermine is that it should never be used by women who are pregnant or who are currently breastfeeding. Doctors often advise patients that in the case of more serious side effects, they should immediately call for assistance. These are all promoted as weight loss pills that assist obese individuals. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Should a patient realize he/she has missed a dose within a reasonable timeframe after the doses timing, it is acceptable to take it once they remember it. . Your email address will not be published. %PDF-1.4 % information highlighted below and resubmit the form. xb```f``ZAb 1av K3gI{$*i p400t UD J@X$Ybv k=:,fb[ a`x @ ! Some of the studies that have linked Phentermine to positive results in humans include: The main active ingredient is known as Phentermine Hydrochloride. History.s. the prescription is dispensed directly to a member of the United States armed forces serving outside the United States. To provide you with the most relevant and helpful information, and understand which Y$iqzZz\vlt1a;svw&aBS8Z(HGCkr&_Qxt97t,GWceTL^QqX(%8_A2'"%tD'DNz"G*"Tc. Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. Yes, you need a prescription for phentermine. Some brands use a dissolving tablet that is placed under the tongue, which allows the body to absorb the chemicals in the drug faster. Taking Phentermine depends on the brand and preparation of the drug. The dosage may be adjusted to the patients need. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. After the tablet has melted, swallow or take a sip of water. Below is a chart of body mass index (BMI) based on various heights and weights. Florida HB 423 - ARNP/PA Controlled Substance Prescribing - FANA The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled. 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. Losing weight during pregnancy can harm both a mother and her baby. Over 12 weeks, it can be as high as 9-10%. Late evening medication should be avoided because of the possibility of resulting insomnia. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 97-102; s. 301, ch. 73-331; s. 2, ch. 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. In some cases, the side effects were life-threatening and led to the death of a patient. The strength and dosage of Phentermine depend on the brand that is prescribed and the patients specific condition. History.s. hbbd``b` @IHpA\> . When breastfeeding, the drug may enter the breast milk and travel into the nursing babys body, which may cause harm to them. The doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. 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 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. %%EOF Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. 0000001146 00000 n other information we have about you. Disclaimer: The information on this system is unverified. 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. 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. Dosage form: tablet Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. Prescribing Controlled Substances via Telehealth under Florida and The Topamax is added to Phentermine in order to intensify its effects and to help patients lose weight faster. Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Click here for an email preview. If you are a Mayo Clinic patient, this could 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. The number of the prescription, as recorded in the prescription files of the pharmacy in which it is filled. ]c,'303:20/) @d` )2 It should melt quickly. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof. Acidification of the urine increases Phentermine excretion. 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. 458.336, Florida Statutes - Drugs to treat obesity; rules establishing guidelines; Rule 64B8-9.012, Florida Administrative Code - Standards for the Prescription of Obesity . Diabetes & Metabolism Journal. Some of these include: As with many other prescription drugs, Phentermine can also interact with certain medications. Accessed Oct. 11, 2022. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. 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. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). PDF Prescribing Information - Qsymia (Phentermine and Topiramate extended https://www.uptodate.com/contents/search. Law Implemented Florida Statutes 458.336. Unfortunately, patients experienced a variety of side effects, which included severe heart toxicity and hypertension. The following information includes only the average doses of this medicine. 0000002991 00000 n Do not double doses. endstream endobj 108 0 obj <>stream Thus, in order to make the most of this drug, patients need make some effort too. 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. Controlled substances for the treatment of obesity.

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