138 0 obj <>stream 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. 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. More specifically, this medication is an option for people with a body mass index (BMI): Weight-related conditions that may qualify a lower-BMI patient for phentermine include: type 2 diabetes, high cholesterol (hyperlipidemia), and controlled high blood pressure (hypertension) ( Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. information highlighted below and resubmit the form. Columbus, Ohio 43215 Phone: (614) 466-3934 Web: www.med.ohio.gov State Medical Board of Ohio 30 E . OSMA is actively following this issue and we are hopeful that the medical board will make changes to Ohios rules that will enable physicians to utilize their training and professional judgment, instead of restrictive time limits, when treating some of Ohios most vulnerable patients. Ohio Administrative Code 4731-11-04 and 4731-11-04.1. Perreault L. Obesity in adults: Drug therapy. Your email address will not be published. (2012). 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. 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. W0Qxe {>x??}# cGCSGGC[G(P A@3'i~ (2[n! Phentermine Hydrochloride Tablets, USP 37.5 mg are white oval shaped bisected tablet with blue specs, debossed with 810 on bisected side. To provide you with the most relevant and helpful information, and understand which 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. = Phentermine is approved for use for up to 12 weeks. All rights reserved. Patients should be advised to report immediately any deterioration in exercise tolerance. endstream endobj 108 0 obj <>stream It is important not to perform activities that require a patient to be alert while experiencing mental impairment as an adverse effect. 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)]. It has the chemical name of ,,-Dimethylphenethylamine hydrochloride. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. The most common side effects that patients experience include tremors, headaches, dizziness, dry mouth, diarrhea, constipation, upset stomach, feeling restless and being hyperactive. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Based on Ohio's opioid prescribing guidelines, we developed an opioid prescribing rule that applies to all BWC-certified prescribers. This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. Phentermine Hydrochloride Tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. CTP holders continue to be prohibited from prescribing all other anorexiants including, but not limited to phentermine (Adipex). health information, we will treat all of that information as protected health 2 If you miss a dose of this medicine, take it as soon as possible. A weight loss doctor will be more familiar with the research on phentermine for weight loss and, in many cases, more likely to prescribe it. include protected health information. In most cases, the drug is prescribed to users in periods of 12 weeks. Phentermine is 17.5% plasma protein-bound, while topiramate is 15 - 41% plasma protein-bound when the blood concentration range is 0.5 to 250 g/mL. Selling or giving away Phentermine may harm others and is against the law. Click here for an email preview. If a patient would like to take other supplements, they should consult their doctor first. In some cases, the use of Phentermine has also led to the development of symptoms that are related to erectile dysfunction. Phentermine is not to be used while pregnant or breastfeeding under any circumstances. Press Releases. The Ohio Emergency and Acute Care Facility Opioids and Other Controlled Substances Prescribing Guidelines offer clinical guidance for the acute care environment where there is no established patient-doctor relationship. Tak YJ, et al. Swallow the tablet whole. information highlighted below and resubmit the form. This medication has been linked to physical dependence, which means a patient may become addicted to it. If your primary care physician thinks you are a good candidate for phentermine but does not want to (or cannot) prescribe it, he or she may refer you to a specialist. In some cases, the use of this drug in combination with other pills may cause the effects of other drugs to increase. There is a problem with A physician is the only person who can prescribe phentermine. However, the medication does have a considerable street value. I am looking for information/advice/links to prescribing Phentermine (adipex ) in conjunction with diet and exercise in My private PCP business in the state of Ohio. 4 0 obj Instead, wait until you can go to a local doctor or consider other, over-the-counter weight loss options. Start with your primary care doctor and schedule an appointment to discuss weight. Especially considering Ohios ability to track the prescribing and dispensing of the drug in Ohios drug database, OARRS. Avoid use of Phentermine in patients with eGFR less than 15 mL/min/1.73m2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Acidification of the urine increases Phentermine excretion. \ Detailed Phentermine dosage information Related/similar drugs The dosage may be adjusted to the patients need. These are both major barriers to optimal medical care. 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 board expressed concerns that removing the prescribing restrictions could lead to misuse of weight loss drugs such as phentermine. 1 Specializes in Cardiology, Research, Family Practice. The patient brings in a prescription for the same drug on November 1, 2013. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Learn about the most popular weight loss medications. The usual duration of treatment is 12 weeks or less. 2021; doi:10.1007/s13679-020-00422-w. The recommended maximum dosage of Phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). 2019; doi:10.1016/j.mayocp.2018.11.020. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Since it may lead to such symptoms, it also has the potential to cause severe withdrawal symptoms, especially when a patient goes cold turkey. This content does not have an English version. At January's meeting, the board discussed the rules and elected to investigate what other states are doing to regulate weight loss medication. Six years after the approval, a similar drug, called Aminorex, were released in Europe with the same purpose of helping obese individuals. In some cases, the side effects were life-threatening and led to the death of a patient. 4 Like other weight-loss medicines ordered by providers, phentermine is meant to be only part of a weight-loss plan. Existing health conditions that may act as a problem include diabetes, thyroid disorders, hypertension and kidney disease. Mayo Clinic Proceedings. The use of Topamax and Phentermine is actually an FDA-approved combination. https://med.ohio.gov/LinkClick.aspx?fileticket=Q2JmI7o-3HI%3d&portalid=0. Therefore, coadministration of Phentermine and these drug products is not recommended. 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. Before taking phentermine, tell your doctor and pharmacist if you are allergic to phentermine, any other medications, or any of the ingredients in phentermine tablets. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Advertising revenue supports our not-for-profit mission. ). However, weight loss clinics are not the perfect solution. By using the site you agree to our Privacy, Cookies, and Terms of Service Policies. Below is a chart of body mass index (BMI) based on various heights and weights. Phentermine is not recommended for use in pediatric patients 16 years of age. Swallow the extended-release capsule whole. Yes, you need a prescription for phentermine. Learn about the benefits and advantages of Phen Caps! 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)]. Special Populations Geriatric Patients Select dosage with caution, starting at lower end of dosage range. If your dose is different, do not change it unless your doctor tells you to do so. 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. As much as 33% of the U.S. adult population are considered to be obese. Make sure your hands are dry before touching the tablet. CIV But regarding phentermine monotherapy, phentermine hydrochloride (HCl) is a sympathomimetic Drug Enforcement Agency (DEA) scheduled IV drug approved as an anti-obesity medication and marketed in the US since 1959 (See Table 1).The reported weight reduction efficacy of phentermine [10] derived from . Taking Phentermine depends on the brand and preparation of the drug. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. Trends in Prescribing and Dispensing Patterns . Phentermine HCl Tablets, USP 37.5 mg Of course, it is taken orally. Many patients find that if their doctor gradually lowers their dose, for example from 37.5mg per day down to 15mg per day for the last few days, they experience fewer withdrawal symptoms and are able to keep the weight off later. Missed Dose . Some of the most common withdrawal symptoms include weight gain, fatigue, insomnia and a bad mood. 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. Our mission is to Empower, Unite, and Advance every nurse, student, and educator. Below we explain how to get phentermine, including why you need a prescription, who can take this medication, and how to get your doctor to prescribe phentermine. As a result, they may be more open to the idea of prescribing phentermine. x\8zS wU^TM;J`Kc=@y\} Blf\3K|xL?D$aesY"_(ceD!s!@P,?K&Bd8cKS~zq=7'kiw\dqL:A ?O0O@+}y"z[?Os/Kht;[SN4h9c31{8Eh7dPc\BFE(e&9;!PUqK\aD 7) &\1!j-_Y7jD,Sp)AWc/igg?v{5\%a'd9"D0=gRGEZgpbMQJD *k*;1'w24w, d r d?&8xeEj`\2C6xrhq2@-{P5CbBL(/0m8&8Ltnvf};y852q*+I%l=+rwGUv*:!80|>tb?U?L,zG8%K`n]+:,LCE")Xz\^):{~{=vu=Qg`A\6qT=WCZ TcR%mi,OV_RtK1e&:By~i~!nu 1558 0 obj <>/Filter/FlateDecode/ID[<7182559B062CF74D9CEE71C953F61692>]/Index[1530 62]/Info 1529 0 R/Length 121/Prev 89015/Root 1531 0 R/Size 1592/Type/XRef/W[1 2 1]>>stream Phentermine hydrochloride: Usual dosage is 8 mg 3 times daily (given 30 minutes before meals) or 15-37.5 mg once daily (in the morning). In fact, one study conducted at the Duke University School of Medicine found that apart from the Phentermines ability to effectively reduce body weight, it can also help improve a patients health-related quality of life. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. One of the most important things to consider is the fact that the drug should never be accompanied by an MAO inhibitor. information submitted for this request. hYr ~{L(QdK4^bdsO_d;a BXO--p,!4!,WhfM/@c This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Alternatively, 18.75 mg twice daily. 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. Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. 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. It can help weight loss by making you less hungry. Late evening medication should be avoided because of the possibility of resulting insomnia. Phentermine also has many potential drug interactions (e.g., with MAOIs), so the prescribing doctor and pharmacist know about ALL other medications and supplements taken within the last two weeks. Phentermine is approved for short-term weight loss therapy. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. OSMA has historically had concerns with the limitations that these rules place on physicians who treat patients with obesity. If the time is too close to the next dose, it is recommended to skip the dose they have missed. Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. N;d0)zQ|,]8EtXy(En"GX omjU3Y3>kfkYHYi]-zhm{= o`i$G1BK%?9Z+(dm`mKt,?;6K@Q 7}}*Tw>7BkKsJ;E|Viexb T-3j%5QB%wI5'$5oB :h*C"Q7yjTzLO%6QS/u>HX 4DGz*A!1*p"7$-joX2YF8ht@\l[&LS$FU=udM&y.l_ other information we have about you. 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. %PDF-1.3 information and will only use or disclose that information as set forth in our notice of 5 Obesity has been linked to many different diseases, including type 2 diabetes and cardiovascular disease. The first use of Phentermine as a drug to help treat obesity dates back to 1938. Take 1 tablet or capsule once a day before breakfast or 1-2 hours after breakfast. Mayo Clinic offers appointments in Arizona, Florida and Minnesota and at Mayo Clinic Health System locations. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW The Essential Diabetes Book - Mayo Clinic Press, NEW Ending the Opioid Crisis - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Numerous side effects have been linked to the use of Phentermine. Why is phentermine a controlled substance? There are reports of patients who have increased the dosage of these drugs to many times than recommended. 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. He or she may prescribe the medication him/herself if you are an appropriate candidate, or he/she may choose to refer you to a specialist for further evaluation and follow-up. Yes, phentermine is a federally controlled substance because it may be abused or lead to Phentermine is related chemically and pharmacologically to the amphetamines. 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). The drug is always accompanied by increased physical activity and a diet that includes a lower amount of calories. The medical board would like to work with the pharmacy board to make OARRS reports more available and helpful to physicians. Phentermine is not a miracle drug taken daily and the body simply starts losing weight all by itself. Unfortunately, the answer is no in most cases. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Taking too much Phentermine can be harmful to the patients body. The FDA has categorized this drug as X for pregnancy, which means it should not be used during pregnancy under any circumstances. It should also not be taken within 14 days after taking an MAO inhibitor. 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). Members of Losing Weight with Phentermine Support Group on Facebook. Clinics specializing in weight loss often employ bariatric specialists who have additional training in obesity management. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Some preparations of the formula, however, have been classified as schedule II drugs. This combination of ingredients was branded as Fen-Phen. Click here for an email preview. Ideally, patients should take it on an empty stomach. It is impossible for them to complete the necessary physical evaluation (and follow-up) that is required to ensure that phentermine will not cause you undue harm. 1530 0 obj <> endobj Along with Ohio's telehealth law in Sub. If not, additional education or an additional certification may be needed. Follow your doctor's orders or the directions on the label. These are two schedule- IV medications, phentermine/topiramate (Qsymia), and locaserin (Belviq), as well as non-controlled naltrexone hydrochloride/ buproprion hydrochloride (Contrave). However, if it is almost time for your next dose, skip the missed dose and go back to your . Rule 4731-11-04 | Controlled substances: Utilization of short term anorexiants for weight reduction. Ohio has some of the strictest rules in the country andthe current rules place time limitations on prescriptions that, many times, force physicians to stop a medication that is showing positive weight loss results. Cumulative urinary excretion of Phentermine under uncontrolled urinary pH conditions was 62% to 85%. 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. The patient could have had the prescription for the month of October filled at another pharmacy. Although phentermine is the agent-of-choice among physicians specializing in obesity treatment, the use of this drug for obesity treatment by other physicians has long been curtailed because misapprehensions regarding phentermine safety. The drug is usually prescribed at the lowest possible dose to new users, which is 15mg per day. A doctor is the only person who can determine if phentermine is right for you. The medication has been classified as a controlled substance in most countries and is also classified as a schedule IV prescription drug. Phentermine. Phentermine hydrochloride USP is a sympathomimetic amine anorectic. It is a class IV controlled substance because of its serious side effects and addiction potential. Phen Caps is recommended by over 30,000 people like you who want to lose weight fast and effectively without the drawbacks of prescription medications. Phentermine is approved for use for up to 12 . Requirements may be altered [see Warnings and Precautions (5.9)]. Patients who have been on a Phentermine program should not suddenly stop using the drug. Should the collaborating physician have restrictions on his/her ability to prescribe controlled substances including controlled substance weight loss medications, the CTP holder would be limited by the same restrictions.The administrative rules, Advanced Practice Registered Nurse Certification and Practice, contained in Chapter 4723-8, of Ohio Administrative Code (OAC), require all APRNs to utilize and incorporate into the nurses practice knowledge of Chapter 4731.,ORC, and rules adopted under that chapter by the State Medical Board that govern the practice of the nurses collaborating physician. Some patients experience an increase in sexual interest, while others notice that they have a lower libido. The dosage varies from 15mg to 37.5mg per day. Drug classes: Anorexiants, CNS stimulants. 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 Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. Weight Loss Prescribing Rules Ohio Administrative Code 4731-11-04 and 4731-11-04.1 The medical board is currently reviewing its long-standing rules regarding prescribing controlled substances for the treatment of obesity. 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. Phentermine should never be taken after 6 pm in the afternoon as it causes insomnia. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. This was often referred to as Rainbow Pills as all four drugs were often provided to a patient at the same time. 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. NDC 42806-810-01 Your doctor may prescribe both of these drugs separately, or choose to prescribe Qsymia, which is another medication that combines Phentermine and Topamax. Phentermine, an amphetamine congener, is the most widely used anti-obesity drug in the U.S. Tablets are packaged in bottles of 100 (NDC 42806-810-01); and 1000 (NDC 42806-810-10).