Phentermine Hydrochloride 15 mg/1
phentermine hydrochloride · CAPSULE · Bryant Ranch Prepack
Phentermine Hydrochloride is a capsule containing phentermine hydrochloride at 15 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Phentermine Hydrochloride
- Generic Name
- phentermine hydrochloride
- NDC Code (Product)
63629-2383- Manufacturer
- Bryant Ranch Prepack
- Strength
- 15 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA205019
- Marketing Start
- 01/24/2017
Recall History
KVK-Tech, Inc.
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
KVK Tech, Inc.
cGMP deviations
PD-Rx Pharmaceuticals, Inc.
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Phentermine hydrochloride is 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 × 0.0254 = meters. BODY MASS INDEX (BMI), kg/m 2 The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [ 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 ex…
Dosage & 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 tablets 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) 2.1 Exogenous Obesity Dosage should be individualized to obtain an adequate response with the lowest effective dose. 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. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day. Phentermine hydrochloride 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 are 15 mg daily for patients with severe renal impai…
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 )
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 ) 7.1 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.
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 Sun Pharmaceutical Industries…
Frequently Asked Questions
What is Phentermine Hydrochloride used for?
Phentermine Hydrochloride contains phentermine hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is Phentermine Hydrochloride a controlled substance?
Yes, Phentermine Hydrochloride is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Phentermine Hydrochloride?
The generic name for Phentermine Hydrochloride is phentermine hydrochloride. There are 4 other brand versions of phentermine hydrochloride.
What is the NDC code for Phentermine Hydrochloride 15 mg/1?
The NDC (National Drug Code) for Phentermine Hydrochloride 15 mg/1 is 63629-2383, listed by Bryant Ranch Prepack.
Other Phentermine Hydrochloride Dosages
- Phentermine Hydrochloride30 mg/172162-1231
- Phentermine Hydrochloride30 mg/184053-676
- Phentermine Hydrochloride30 mg/111534-176
- Phentermine Hydrochloride30 mg/143063-654
- Phentermine Hydrochloride30 mg/155289-624
- Phentermine Hydrochloride30 mg/163629-1108
- Phentermine Hydrochloride37.5 mg/171335-0161
- Phentermine Hydrochloride37.5 mg/110702-025
Other Phentermine Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)