PHENTERMINE HYDROCHLORIDE 37.5 mg Capsule, 1,000-count
Other active recalls for Phentermine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Sympathomimetic Amine Anorectic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Phentermine works by suppressing your appetite, which can help you eat less as part of a calorie-controlled plan. But it is not a magic pill — it's meant to be used alongside a red...
- What exactly is phentermine supposed to do, and will it make me lose weight on its own?
- Most phentermine capsules and tablets are taken once a day — either before breakfast or within a couple of hours of breakfast. You can take them with or without food. The one excep...
- The most common ones people notice are dry mouth, trouble sleeping, feeling jittery or restless, a faster heartbeat, and sometimes constipation or stomach upset. Those are usually...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
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A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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Methyl alcohol, also called methanol, is a simple organic solvent. It helps dissolve and carry active ingredients in liquid medicines, and helps the product mix evenly.
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Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
16 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Phentermine Hydrochloride 37.5 mg 10702-0029-01 | KVK-TECH, | 100 capsules | $0.102 | AA | Availability likely | — |
| Phentermine hydrochloride 37.5 mg 11534-0159-01 | SUNRISE | 100 capsules | $0.102 | AA | Availability likely | — |
| Phentermine 37.5 mg 17224-0890-14 | Calvin | 14 capsules | — | AA | FDA listed | — |
| Phentermine Hydrochloride 37.5 mgthis 42806-0524-10 | Epic | 1000 capsules | — | — | FDA listed | — |
| Phentermine Hydrochloride 37.5 mg 43063-0182-15 | PD-Rx | 15 capsules | — | AA | FDA listed | — |
| Phentermine Hydrochloride 37.5 mg 50090-0653-01 | A-S | 30 capsules | — | AA | FDA listed | — |
| Phentermine hydrochloride 37.5 mg 63629-2386-01 | Bryant | 1000 capsules | — | AA | FDA listed | — |
| Phentermine hydrochloride 37.5 mg 63629-2387-01 | Bryant | 100 capsules | — | AA | FDA listed | — |
| Phentermine hydrochloride 37.5 mg 71335-0646-00 | Bryant | 56 capsules | — | AA | FDA listed | — |
| Phentermine hydrochloride 37.5 mg 71335-2296-01 | Bryant | 100 capsules | — | AA | FDA listed | — |
| Phentermine hydrochloride 37.5 mg 72162-1228-00 | Bryant | 1000 capsules | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 42806-0524-01 | 100 CAPSULE in 1 BOTTLE (42806-524-01) | 2015-04-15 | Active |
| 42806-0524-10 You're viewing this | 1000 CAPSULE in 1 BOTTLE (42806-524-10) | 2015-04-15 | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 42806-0524-10?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Phentermine Hydrochloride Capsules USP, 37.5 mg 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/m 2 , or ≥27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared.
Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 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.
Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) 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/m 2 , or ≥27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia. ( 1 ) The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Dosage should be individualized to obtain an adequate response with the lowest effective dose. ( 2 .1) • Late evening administration should be avoided (risk of insomnia). ( 2 .1) • Phentermine hydrochloride capsules can be taken with or without food. ( 2. 1) • Limit the dosage to 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 ). (2.2)
2.1Exogenous Obesity Generic Section Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one capsule (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast for appetite control. The dosage may be adjusted to the patient’s need.
Phentermine is not recommended for use in pediatric patients ≤ 16 years of age. Late evening medication should be avoided because of the possibility of resulting insomnia.
2.2Dosage in Patients With Renal Impairment The recommended maximum dosage of phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m 2 ). Avoid use of phentermine in patients with eGFR less than 15 mL/min/1.73m 2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). • Capsules containing 37.5 mg phentermine hydrochloride. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • 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 • Hyperthyroidism • Glaucoma • Agitated states • History of drug abuse • Pregnancy [see Use in Specific Populations ( 8.1 )] • Nursing [see Use in Specific Populations ( 8.3 )] • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines • History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) ( 4 ) • During or within 14 days following the administration of monoamine oxidase inhibitors ( 4 ) • Hyperthyroidism ( 4 ) • Glaucoma ( 4 ) • Agitated states ( 4 ) • History of drug abuse ( 4 ) • Pregnancy ( 4 , 8.1 ) • Nursing ( 4 , 8.3 ) • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Coadministration with other drugs for weight loss is not recommended (safety and efficacy of combination not established). ( 5.1 ) • Rare cases of primary pulmonary hypertension have been reported. Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema.
( 5.2 ) • Rare cases of serious regurgitant cardiac valvular disease have been reported. ( 5.3 ) • Tolerance to the anorectic effect usually develops within a few weeks. If this occurs, phentermine should be discontinued.
The recommended dose should not be exceeded. ( 5.4 ) • Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. ( 5.5 ) • Risk of abuse and dependence.
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. ( 5.6 ) • Concomitant alcohol use may result in an adverse drug reaction. ( 5.7 ) • Use caution in patients with even mild hypertension (risk of increase in blood pressure).
( 5.8 ) • A reduction in dose of insulin or oral hypoglycemic medication may be required in some patients. ( 5.9 )
5.1Coadministration with Other Drug Products for Weight Loss Phentermine is indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. 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. Therefore, coadministration of phentermine and these drug products is not recommended.
5.2Primary Pulmonary Hypertension 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. 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 initial symptom of PPH is usually dyspnea.
Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. 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.
5.3Valvular Heart Disease Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. 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. The possibility of an association between valvular heart disease and the use of phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.
5.4Development of Tolerance, Discontinuation in Case of Tolerance When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.
5.5Effect on the Ability to Engage in Potentially Hazardous Tasks Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.
5.6 Risk of Abuse and Dependence Phentermine is related chemically and ph…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: • Primary pulmonary hypertension [see Warnings and Precautions ( 5.2 )] • Valvular heart disease [see Warnings and Precautions ( 5.3 )] • Effect on the ability to engage in potentially hazardous tasks [see Warnings and Precautions ( 5.5 )] • Withdrawal effects following prolonged high dosage administration [see Drug Abuse and Dependence ( 9.3 )] The following adverse reactions to phentermine have been identified: Cardiovascular Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.
Central Nervous System Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Allergic Urticaria.
Endocrine Impotence, changes in libido. Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Monoamine oxidase inhibitors: Risk of hypertensive crisis. ( 4 , 7.1 ) • Alcohol: Consider potential interaction ( 7.2 ) • Insulin and oral hypoglycemics: Requirements may be altered. ( 7.3 ) • Adrenergic neuron blocking drugs: Hypotensive effect may be decreased by phentermine. ( 7.4 )
7.1Monoamine Oxidase Inhibitors Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.
7.2Alcohol Concomitant use of alcohol with phentermine may result in an adverse drug reaction.
7.3Insulin and Oral Hypoglycemic Medications Requirements may be altered [see Warnings and Precautions ( 5.9 )].
7.4Adrenergic Neuron Blocking Drugs Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.
Drug Interactions In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. However in the presence of topiramate, phentermine C max and AUC increase 13% and 42 % respectively.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother. ( 4 , 8.3 ) • Pediatric use: Safety and effectiveness not established. ( 8.4 ) • Geriatric use: Due to substantial renal excretion, use with caution. ( 8.5 ) • Renal Impairment: Avoid use in patients with eGFR less than 15 mL/min/m 2 or end-stage renal disease requiring dialysis. (8.6)
8.1Pregnancy Teratogenic Effects Pregnancy Category X Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. 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. Phentermine has pharmacologic activity similar to amphetamine (d- and d l l-amphetamine) [see Clinical Pharmacology ( 12.1 )].
Animal reproduction studies have not been conducted with phentermine. 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.
8.3Nursing Mothers It is not known if phentermine is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.
8.5Geriatric Use 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. 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. 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.
8.6Renal Impairment Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment. [see Clinical Pharmacology ( 12.3 )]. Use caution when administering phentermine to patients with renal impairment. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m 2 ), limit the dosage of phentermine to 15 mg daily [see Dosage and Administration (2.2)].
Phentermine has not been studied in patients with eGFR less than 15 mL/min/1.73m 2 , including end-stage renal disease requiring dialysis; avoid use in these populations.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects Pregnancy Category X Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. 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. Phentermine has pharmacologic activity similar to amphetamine (d- and d l l-amphetamine) [see Clinical Pharmacology ( 12.1 )].
Animal reproduction studies have not been conducted with phentermine. 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.
🧓 Geriatric Use ▾
8.5Geriatric Use 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. 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. 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.
🆘 Overdosage ▾
10 OVERDOSAGE The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
10.1Acute Overdosage Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include tachycardia, arrhythmia, hypertension or hypotension, and circulatory collapse.
Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning and usually terminates in convulsions and coma. Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate.
Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine ® , CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.
10.2Chronic Intoxication Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See Drug Abuse and Dependence ( 9.3 ).
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and d l l-amphetamine). Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.
12.2Pharmacodynamics Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.
12.3Pharmacokinetics Following the administration of phentermine, phentermine reaches peak concentrations (C max ) after 3 to 4.4 hours. Drug Interactions In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. However in the presence of topiramate, phentermine C max and AUC increase 13% and 42 % respectively.
Specific Populations Renal Impairment Cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions was 62%-85%. 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)].
🧬 Mechanism of Action ▾
12.1Mechanism of Action Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and d l l-amphetamine). Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Available as capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Phentermine Hydrochloride Capsules, USP 37.5 mg are #3 bright blue opaque cap, white opaque body, imprinted " Є 524 " in black ink on cap and body, filled with white powder. They are supplied in bottles of 100 (NDC 42806-524-01); and 1000 (NDC 42806-524-10).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
📋 Description ▾
11 DESCRIPTION Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows: C 10 H 15 N•HCl M.W.
185.7 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. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). In addition, each capsule contains the following inactive ingredients: lactose monohydrate, magnesium stearate and talc.
The capsule shell is composed of D&C Red No. 33, FD&C Blue No.1, titanium dioxide and gelatin. The imprinting ink contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, D&C Yellow No.
10 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. structural-formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Patients must be informed that phentermine hydrochloride is 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, and that coadministration of phentermine with other drugs for weight loss is not recommended [see Indications and Usage ( 1 ) and Warnings and Precautions ( 5.1 ). Patients must be instructed on how much phentermine to take, and when and how to take it [see Dosage and Administration ( 2 )].
Advise pregnant women and nursing mothers not to use phentermine [see Use in Specific Populations ( 8.1 , 8.3 )]. 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 risks include, but are not limited to: • Development of primary pulmonary hypertension [see Warnings and Precautions ( 5.2 )] • Development of serious valvular heart disease [see Warnings and Precautions ( 5.3 )] • Effects on the ability to engage in potentially hazardous tasks [see Warnings and Precautions ( 5.5 )] • The risk of an increase in blood pressure [see Warnings and Precautions ( 5.8 ) and Adverse Reactions ( 6 )] • The risk of interactions [see Contraindications ( 4 ), Warnings and Precautions ( 5.7 , 5.9 ) and Drug Interactions ( 7 )] See also, for example, Adverse Reactions ( 6 ) and Use In Specific Populations ( 8 ).
The patients must also be informed about • the potential for developing tolerance and actions if they suspect development of tolerance [see Warnings and Precautions ( 5.4 )] and • the risk of dependence and the potential consequences of abuse [see Warnings and Precautions ( 5.6 ), Drug Abuse and Dependence ( 9 ), and Overdosage ( 10 )]. Tell patients to keep phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away phentermine may harm others and is against the law.
Manufactured and Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Rev.04-2017-00 MF524REV04/17 OE1525