(FEN ter meen)
- Phentermine HCl
- Phentermine Hydrochloride
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral, as hydrochloride:
Adipex-P: 37.5 mg
Generic: 15 mg, 30 mg, 37.5 mg
Tablet, Oral, as hydrochloride:
Adipex-P: 37.5 mg [scored; contains brilliant blue fcf (fd&c blue #1)]
Lomaira: 8 mg [scored; contains brilliant blue fcf (fd&c blue #1), corn starch]
Generic: 37.5 mg
Tablet Dispersible, Oral, as hydrochloride:
Suprenza: 15 mg [DSC] [contains fd&c blue #1 aluminum lake, fd&c yellow #5 aluminum lake]
Suprenza: 30 mg [DSC] [contains fd&c yellow #5 aluminum lake]
Suprenza: 37.5 mg [DSC] [contains fd&c blue #1 aluminum lake]
Brand Names: U.S.
- Suprenza [DSC]
- Central Nervous System Stimulant
Phentermine is a sympathomimetic amine with pharmacologic properties similar to the amphetamines. The mechanism of action in reducing appetite appears to be secondary to CNS effects, including stimulation of the hypothalamus to release norepinephrine.
Well absorbed. Rate and extent of exposure of orally disintegrating tablets (ODT) are equivalent to capsules and tablets administered under fasting conditions. Administration of the ODT after a high-fat/high-calorie breakfast decreased Cmax by ~5% and AUC by ~12%.
Vd: 348 L
Hepatic via p-hydroxylation (aromatic ring) and N-oxidation (alipthatic side chain); primarily metabolized by CYP3A4 (but does not show extensive metabolism).
Primarily urine (62% to 85% as unchanged drug)
Time to Peak
3 to 4.4 hours
Special Populations: Renal Function Impairment
Exposure increases can be expected in patients with renal impairment.
Use: Labeled Indications
Obesity (short-term adjunct): Short-term (few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (eg, diabetes, hyperlipidemia, controlled hypertension).
Hypersensitivity or idiosyncrasy to phentermine, other sympathomimetic amines or any component of the formulation; history of cardiovascular disease (eg, arrhythmias, congestive heart failure, coronary artery disease, stroke, uncontrolled hypertension); hyperthyroidism, glaucoma, agitated states, history of drug abuse; use during or within 14 days following MAO inhibitor therapy; pregnancy, breast-feeding
Note: Dosing is presented in terms of the salt, phentermine hydrochloride (not as phentermine base).
Obesity (short-term adjunct): Oral:
Capsule, tablet (excluding Lomaira): 15 to 37.5 mg daily given in 1 to 2 divided doses. Individualize to achieve adequate response with lowest effective dose.
Tablet (Lomaira only): 8 mg 3 times daily. Individualize to achieve adequate response with lowest effective dose.
Orally disintegrating tablet (ODT): One tablet (15 to 37.5 mg daily) every morning. Individualize to achieve adequate response with lowest effective dose.
Refer to adult dosing.
Obesity (short-term adjunct): Adolescents >16 years: Refer to adult dosing.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Phentermine is excreted in the urine and systemic exposure may be increased in renal impairment; use with caution.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Avoid late evening administration.
Capsules, tablets (excluding Lomaira): Administer before breakfast or 1 to 2 hours after breakfast. Tablets may be divided in half and dose may be given in 2 divided doses.
Tablet (Lomaira only): Administer 30 minutes before meals. Tablets are scored and may be divided in half.
Orally disintegrating tablets (Suprenza): With dry hands, place tablet on the tongue and allow to dissolve, then swallow with or without water. May administer with or without food.
Capsules, tablets (excluding Lomaira): Should be taken before breakfast or 1 to 2 hours after breakfast; avoid taking in the late evening. Most effective when combined with a low-calorie diet and behavior modification counseling.
Tablet (Lomaira only): Should be taken 30 minutes before meals.
Store at 20°C to 25°C (68°F to 77°F).
Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Avoid combination
Alcohol (Ethyl): May enhance the adverse/toxic effect of Phentermine. Monitor therapy
Alkalinizing Agents: May decrease the excretion of Amphetamines. Consider therapy modification
Ammonium Chloride: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Monitor therapy
Analgesics (Opioid): Amphetamines may enhance the analgesic effect of Analgesics (Opioid). Monitor therapy
Antacids: May decrease the excretion of Amphetamines. Monitor therapy
Antihistamines: Amphetamines may diminish the sedative effect of Antihistamines. Monitor therapy
Antihypertensive Agents: Amphetamines may diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy
Antipsychotic Agents: May diminish the stimulatory effect of Amphetamines. Monitor therapy
Ascorbic Acid: May decrease the serum concentration of Amphetamines. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy
Carbonic Anhydrase Inhibitors: May decrease the excretion of Amphetamines. Exceptions: Brinzolamide; Dorzolamide. Monitor therapy
Cocaine: May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Ethosuximide: Amphetamines may diminish the therapeutic effect of Ethosuximide. Amphetamines may decrease the serum concentration of Ethosuximide. Monitor therapy
Gastrointestinal Acidifying Agents: May decrease the serum concentration of Amphetamines. Monitor therapy
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination
Ioflupane I 123: Amphetamines may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification
Lithium: May diminish the stimulatory effect of Amphetamines. Monitor therapy
MAO Inhibitors: May enhance the hypertensive effect of Amphetamines. While linezolid and tedizolid may interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to monographs specific to those agents for details. Exceptions: Linezolid; Tedizolid. Avoid combination
Methenamine: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Monitor therapy
Multivitamins/Fluoride (with ADE): May decrease the serum concentration of Amphetamines. More specifically, the ascorbic acid (vitamin C) in many multivitamins may decrease amphetamine concentrations. Monitor therapy
Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Amphetamines. Monitor therapy
Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Amphetamines. Specifically, vitamin C may impair absorption of amphetamines. Monitor therapy
PHENobarbital: Amphetamines may decrease the serum concentration of PHENobarbital. Monitor therapy
Phenytoin: Amphetamines may decrease the serum concentration of Phenytoin. Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Tricyclic Antidepressants: May enhance the stimulatory effect of Amphetamines. Tricyclic Antidepressants may also potentiate the cardiovascular effects of Amphetamines. Monitor therapy
Urinary Acidifying Agents: May decrease the serum concentration of Amphetamines. Monitor therapy
May interfere with urine detection of amphetamines/methamphetamines (false-positive).
Frequency not defined.
Cardiovascular: Hypertension, ischemia, palpitations, tachycardia
Central nervous system: Dizziness, dysphoria, euphoria, headache, insomnia, overstimulation, psychosis, restlessness
Endocrine & metabolic: Change in libido
Gastrointestinal: Constipation, diarrhea, gastrointestinal distress, unpleasant taste, xerostomia
Neuromuscular & skeletal: Tremor
<1% (Limited to important or life-threatening): Acquired valvular heart disease (regurgitant), primary pulmonary hypertension
Concerns related to adverse effects:
• CNS effects: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).
• Heart failure: In a scientific statement from the American Heart Association, phentermine has been determined to be an agent that may cause direct myocardial toxicity (magnitude: major) (AHA [Page 2016]).
• Primary pulmonary hypertension (PPH): A rare, frequently fatal disease of the lungs, PPH has been reported to occur in patients receiving a combination of phentermine and fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; rare cases of PPH have been reported in patients taking phentermine alone. Discontinue in patients experiencing new-onset dyspnea, chest pain, syncope, or lower extremity edema.
• Valvular heart disease: Serious regurgitant cardiac valvular disease (primarily affecting the mitral, aortic, and/or tricuspid valves) has been reported to occur in patients receiving a combination of phentermine and fenfluramine or dexfenfluramine. The possibility of an association between valvular heart disease and the use of phentermine alone cannot be ruled out; rare cases of valvular heart disease have been reported in patients taking phentermine alone.
• Cardiovascular disease: Avoid stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that could increase the risk of sudden death that these conditions alone carry.
• Diabetes: Use with caution in patients with diabetes mellitus; antidiabetic agent requirements (eg, insulin or oral hypoglycemic agents) may be decreased with anorexigens and concomitant dietary restrictions.
• Hypertension: Use with caution in patients with mild hypertension and other cardiovascular conditions that might be exacerbated by increases in blood pressure or heart rate.
• Renal impairment: Use caution in patients with renal impairment (use has not been studied); however, an increase in exposure is expected in renal impairment.
• Seizure disorders: Avoid or use with caution in patients with history of seizures (Apovian 2015).
• Tourette syndrome: Use with caution in patients with Tourette syndrome; stimulants may unmask tics.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Elderly: Use caution in this age group due to the risk for causing dependence, hypertension, angina, and myocardial infarction.
Dosage form specific issues:
• Tartrazine (FDC yellow #5): Some products may contain tartrazine which may cause allergic reactions in patients with sensitivity (caution in patients with asthma or aspirin hypersensitivity).
• Abuse potential: Phentermine is pharmacologically related to the amphetamines, which have a high abuse potential; prolonged use may lead to dependency. Prescriptions should be written for the smallest quantity consistent with good patient care to minimize possibility of overdose.
• Appropriate use: Phentermine is not approved for long-term use. Clinicians should carefully examine the potentially benefits against potential risks associated with use of medications in this class. Consult weight loss guidelines for current pharmacotherapy recommendations. Therapy should be used in conjunction with a comprehensive weight management program.
• Tolerance: Tolerance to the anorectic effect usually develops within a few weeks; discontinue use when tolerance develops, do not exceed recommended dosage in an attempt to overcome tolerance.
Weight, waist circumference; blood pressure
Pregnancy Risk Factor
Use is contraindicated during pregnancy (lack of potential benefit and possible fetal harm). The risks of using appetite suppressing drugs in pregnant women are not known (NHLBI 1998) and limited information is available about the use of phentermine in pregnancy (Jones 2002; McElhatton 2006). Weight loss therapy is generally not recommended for pregnant women. Obese and overweight women should be encouraged to participate in weight reduction programs prior to attempting pregnancy; weight gain during pregnancy should be determined by their prepregnancy BMI and current guidelines (ACOG 2013; ADA 2009).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience anxiety, constipation, diarrhea, dry mouth, insomnia, bad taste, decreased libido, sexual dysfunction, or agitation. Have patient report immediately to prescriber behavioral changes, angina, tachycardia, arrhythmia, mood changes, tremors, shortness of breath, swelling of arms or legs, severe dizziness, passing out, or severe headache (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about phentermine
- Phentermine (AHFS Monograph)
- Phentermine Hydrochloride (AHFS Monograph)
- Phentermine (FDA)
- Phentermine Capsules (FDA)
- Phentermine Extended Release (FDA)