0 Animal reproduction studies have not been conducted with Phentermine. %PDF-1.4 % Talk with your doctor before starting an exercise program. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. 21 0 obj <> endobj Take phentermine exactly as prescribed by your doctor. Phentermine is approved for use for up to 12 weeks. Phentermine hydrochloride (phentermine HCL) is the active ingredient in phentermine weight loss pills. 0000002736 00000 n Phentermine is a schedule IV drug that requires a consultation with the doctor and a prescription. These are all promoted as weight loss pills that assist obese individuals. It is not known if Phentermine is excreted in human milk; however, other amphetamines are present in human milk. Disclaimer: The information on this system is unverified. - 7 21 15 information is beneficial, we may combine your email and website usage information with Phentermine has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) [see Clinical Pharmacology (12.1)]. |. . Lomaira: One tablet three times a day, taken 30 minutes before meals. 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 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Over 12 weeks, it can be as high as 9-10%. Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. CIV In order to help patients reduce their risk of developing these diseases when they are obese, doctors usually prescribe Phentermine. Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. 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. 0000001146 00000 n 0000000828 00000 n 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. To provide you with the most relevant and helpful information, and understand which A prescription for a controlled substance listed in Schedule II may not be refilled. The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. 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. After 12 weeks, the patient needs to take a break from the product as it may lead to physical dependence. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). The directions for the use of the controlled substance prescribed in the prescription. hWmo8+jE'"m{F The drug is usually prescribed at the lowest possible dose to new users, which is 15mg per day. Do not crush, break, or chew it. Intravenous phentolamine (Regitine, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage. These rules and statutes . Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. The initials of the pharmacist filling the prescription and the date filled. Studies have not been performed with Phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. Other brands of this drug include Suprenza, Phentercot, Acxion, Elvenir, Terflamex, Panbesy, Duromine, Fentermina, Phentermin, PHentermine and Lomaira. Such prescriptions must contain the date of the oral authorization. We comply with the HONcode standard for trustworthy health information. All rights reserved. Carefully follow the dosing instructions for the form you are using. The risks include, but are not limited to: See also, for example, Adverse Reactions (6) and Use in SpecificPopulations (8). The drug is also available in regular capsules that are taken orally with a glass of water. Advise pregnant women and nursing mothers not to use Phentermine [see Use in Specific Populations (8.1, 8.3)]. 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. 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 Due to its status as a controlled substance, the sale, distribution, and possession of this drug . It can help weight loss by making you less hungry. The use of Topamax and Phentermine is actually an FDA-approved combination. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence). While these are the most common side effects of the drug, they are not the only consequences associated with the intake of this medication. Advertising revenue supports our not-for-profit mission. If your dose is different, do not change it unless your doctor tells you to do so. So some health care providers might order it for longer use. Your email address will not be published. xref 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. Required fields are marked *. Package insert / product label If the prescription is for an animal, the species of animal for which the controlled substance is prescribed. (phentermine hydrochloride) orally disintegrating tablet C IV . It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. Disclaimer: The information on this system is unverified. But the rate of misuse seems to be low. 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 Or it can help you feel full longer. <]>> FULL PRESCRIBING of the risk of hypertensive crisis. 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. The dosage varies from 15mg to 37.5mg per day. See DrugAbuse and Dependence (9.3). Ask your healthcare professional how you should dispose of any medicine you do not use. History-New 12-4-97, Amended 2-17-98, 8-8-22. Drugs to treat obesity; rules establishing guidelines. 35 0 obj <>stream Being extremely irritable and confused, or experienced unusual behavior or thoughts. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. It should also not be taken within 14 days after taking an MAO inhibitor. 0000000596 00000 n Phentermine (Adipex-P, Lomaira) is a prescription medicine used to lessen appetite. Diabetes & Metabolism Journal. 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 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. The 2022 Florida Statutes (including 2022 Special Session A and 2023 Special Session B) 458.336 Drugs to treat obesity; rules establishing guidelines.. hYr ~{L(QdK4^bdsO_d;a BXO--p,!4!,WhfM/@c 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. 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. This website is a resource which lists doctors and clinics who may offer phentermine or appetite suppressants for patients they deem qualified. health information, we will treat all of that information as protected health 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. 458.336 Drugs to treat obesity; rules establishing guidelines.. Pharmacist and practitioner. In some cases, especially when the health concern is not too serious, the doctor may prescribe the drug at lower doses spread throughout the day, instead of advising the patient to take one single dose every day. If we combine this information with your protected https://fco.factsandcomparisons.com/. 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. Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. 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)]. Children 15 years of age and youngerUse is not recommended. It is obvious that these symptoms can make the entire program useless. Adjust dosage according to individual response and tolerance; use the smallest dosage required to produce the desired response. Controlled substances for the treatment of obesity. The doctor may advise the patient to complete the remaining period of the program or help him/her end the program safely. Portions of this document last updated: Feb. 01, 2023. Pursuant to Board of Medical Examiners Rule 540-X-4-.05, dispensing physicians are required to register with the Board. The journals or printed bills of the respective chambers should be consulted for official purposes. 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. The first use of Phentermine as a drug to help treat obesity dates back to 1938. 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. . This content does not have an Arabic version. Rulemaking Authority 458.336 FS. Committee Please consult with your physician before you make any decisions regarding your health. endstream endobj 108 0 obj <>stream 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). Swallow the extended-release capsule whole. While this drug may sound like a wonder pill, patients should ensure they know are familiar with the precautions, interactions, side effects and other important details before they start taking it. Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. This combination of ingredients was branded as Fen-Phen. Dosage form: tablet This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. Take the disintegrating tablet with or without food. Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. All trademarks are the property of their respective owners. Use caution when administering Phentermine to patients with renal impairment. The amount of medicine that you take depends on the strength of the medicine. 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, under the following conditions: Oral prescriptions must be promptly reduced to writing by the pharmacist or recorded electronically if permitted by federal law. A pharmacist may, upon verification by the prescriber, document any information required by this paragraph. Use caution in prescribing Phentermine for patients with even mild hypertension (risk of increase in blood pressure). To provide you with the most relevant and helpful information, and understand which Requirements may be altered [see Warnings and Precautions (5.9)]. (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 also is offered combined with topiramate for weight loss (Qsymia). If you miss a dose of this medicine, take it as soon as possible. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Rule 4731-11-04 | Controlled substances for the treatment of obesity. Drugs to treat obesity; rules establishing guidelines. 893.04 Pharmacist and practitioner.. . A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. Y$iqzZz\vlt1a;svw&aBS8Z(HGCkr&_Qxt97t,GWceTL^QqX(%8_A2'"%tD'DNz"G*"Tc. 0 0000001488 00000 n Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Medically reviewed by Drugs.com. 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. For oral dosage form (tablets): Adults and children 17 years of age and older. However, the medication does have a considerable street value. Fatigue and depression usually follow the central stimulation. 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. In most cases, the drug is prescribed to users in periods of 12 weeks. 75-18; s. 12, ch. %PDF-1.6 % The doctor also looks at the patients medical history for any pre-existing medical conditions that the medication should not be taken with. 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. For oral dosage form (disintegrating tablets): Adults and children 17 years of age and olderOne tablet once a day, taken in the morning. It isnt prescribed on request, but rather when a healthcare provider notices it may be beneficial for a specific patient to lose weight in order to improve their overall health or to decrease the risk of certain health concerns. While the drug is considered to be relatively safe for individuals who are older than 16, the recommended age is 18. The effective date is January 1, 2020. Won Son J, et al. 73-331; s. 2, ch. Thus, in order to make the most of this drug, patients need make some effort too. 0000001920 00000 n Accessed Oct. 11, 2022. The safety and efficacy of combination therapy with Phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. hbbd``b` @IHpA\> . hX}(I Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Some preparations of the formula, however, have been classified as schedule II drugs. Phentermine is related chemically and pharmacologically to the amphetamines. Phentermine hydrochloride/topiramate. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . The initial symptom of PPH is usually dyspnea. In some cases, the use of this drug in combination with other pills may cause the effects of other drugs to increase. include protected health information. @ d Patients should be advised to report immediately any deterioration in exercise tolerance. 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. This content does not have an English version. The drug is mainly an appetite suppressant, thus making a patient feel fuller after (and between) meals and making the patient more likely to consume foods that have lower amounts of calories. If you are a Mayo Clinic patient, this could (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 . (In combination with a healthy diet and exercise plan). 121 0 obj <>/Filter/FlateDecode/ID[<5D80FCFEE48BF540827EEA7155FB4128>]/Index[104 35]/Info 103 0 R/Length 85/Prev 180155/Root 105 0 R/Size 139/Type/XRef/W[1 2 1]>>stream Children 16 years of age and youngerUse is not recommended. While discussing the use of Phentermine with the doctor, a patient is provided a list of lifestyle changes to implement while using this product. 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. As much as 33% of the U.S. adult population are considered to be obese. Of course, it is taken orally. Publications, Help Searching Phentermine hydrochloride USP is a sympathomimetic amine anorectic. 2009-202. 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. privacy practices. include protected health information. hb```e````a`d`@ f(fcfILLvL~. 0000005652 00000 n information is beneficial, we may combine your email and website usage information with Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Publications, Help Searching 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. Unfortunately, the answer is no in most cases. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. 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. The amount of weight loss associated with the use of an anorectic drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. Last updated on Mar 22, 2023. ZeS{$d!YS,|C~E;h4DJS?|{x}~ ?`2F. When breastfeeding, the drug may enter the breast milk and travel into the nursing babys body, which may cause harm to them. 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. information and will only use or disclose that information as set forth in our notice of Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. information submitted for this request. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10). It is vital to talk with the doctor before using Phentermine with other products. 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. Swallow the tablet whole. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. %%EOF Today, Phentermine can still be obtained through the doctors prescription in the majority of countries around the world. 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 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. Since it may lead to such symptoms, it also has the potential to cause severe withdrawal symptoms, especially when a patient goes cold turkey. Lomaira: One tablet three times a day, taken 30 minutes before meals. Precaution should be taken if a patient has any existing health concerns as the drug may cause further harm to their body. Children 16 years of age and youngerUse is not recommended. As mentioned above, new mothers should avoid using this medication when breastfeeding.