Phentermine Hydrochloride
Generic Name: phentermine hydrochloride
Brand Names:
Phentermine Hydrochloride
11 DESCRIPTION Phentermine hydrochloride 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.
Overview
11 DESCRIPTION Phentermine hydrochloride 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.
Uses
1 INDICATIONS AND USAGE Phentermine hydrochloride capsules 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.
Dosage
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/1.73m 2 )- ( 2.2 ) 2.1 Exogenous Obesity Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is 15 mg to 30 mg as prescribed by the physician, at approximately 2 hours after breakfast for appetite control. Administration of one 30 mg capsule daily has been found to be adequate in depression of the appetite for 12 to 14 hours.
Side Effects
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.
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 ) 7.1 Monoamine 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. 7.2 Alcohol Concomitant use of alcohol with phentermine may result in an adverse drug reaction. 7.3 Insulin and Oral Hypoglycemic Medications Requirements may be altered [see WARNINGS AND PRECAUTIONS ( 5.9 )].
Warnings
5 WARNINGS AND PRECAUTIONS Co-administration 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. 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 SPE...
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-5998 NDC: 50090-5998-0 28 CAPSULE in a BOTTLE NDC: 50090-5998-4 30 CAPSULE in a BOTTLE NDC: 50090-5998-5 60 CAPSULE in a BOTTLE
Frequently Asked Questions
What is Phentermine Hydrochloride used for?▼
1 INDICATIONS AND USAGE Phentermine hydrochloride capsules 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.
What are the side effects of Phentermine Hydrochloride?▼
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.
What are the important warnings for Phentermine Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS Co-administration 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. 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 SPE...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.