Phentermine Hcl C-iv
Generic Name: phentermine hcl c-iv
Brand Names:
Phentermine Hcl C-iv
Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α, dimethylphenethylamine hydrochloride. The structural formula is as follows: [Phentermine HCl Molecular Structure] C10H15N•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
Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α, dimethylphenethylamine hydrochloride. The structural formula is as follows: [Phentermine HCl Molecular Structure] C10H15N•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
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/m2, or ≥ 27 kg/m2 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
2.1 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. 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. 2.2 Dosage in Patients With Renal Impairment The recommended maximum dosage of phentermine hydrochloride is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2).
Side Effects
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.
Interactions
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)]. 7.4 Adrenergic Neuron Blocking Drugs Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.
Warnings
5.1 Co-administration with Other Drug Products for Weight Loss Phentermine hydrochloride capsules are 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, co-administration of phentermine and these drug products is not recommended. • 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...
Storage
Phentermine hydrochloride capsules USP, for oral administration, are available as: 15 mg: Grey/yellow powder filled capsules; imprinted “N1” in black ink and supplied as: NDC 11534-157-01 bottles of 100 NDC 11534-157-03 bottles of 1,000 30 mg: Blue/Clear powder filled capsules; imprinted “N16” in black ink and supplied as: NDC 11534-176-01 bottles of 100 NDC 11534-176-03 bottles of 1,000 Store at...
Frequently Asked Questions
What is Phentermine Hcl C-iv used for?▼
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/m2, or ≥ 27 kg/m2 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 Hcl C-iv?▼
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.
What are the important warnings for Phentermine Hcl C-iv?▼
5.1 Co-administration with Other Drug Products for Weight Loss Phentermine hydrochloride capsules are 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, co-administration of phentermine and these drug products is not recommended. • 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...
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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.