Phentermine
PHENTERMINE — phentermine hydrochloride capsule
Aurolife Pharma, LLC
1 INDICATIONS & 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 greater than or equal to 30 kg/m2 , or greater than or equal to 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.
BODY MASS INDEX (BMI), kg/m2
Height (fe et, 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.
2 DOSAGE & ADMINISTRATION
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 patient’s≤16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.With dry hands, gently remove the Phentermine Hydrochloride Capsule from the bottle. Immediately place the Phentermine Hydrochloride Capsule on top of the tongue where it will dissolve, then swallow with or without water.
2.2 Dosage in Patients with Renal Impairment
The recommended maximum dosage of Phentermine Hydrochloride Capsule is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). Avoid use of Phentermine Hydrochloride Capsule in patients with eGFR less than 15 mL/min/1.73m2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]
3 DOSAGE FORMS & STRENGTHS
Capsules containing 15 mg or 30 mg phentermine hydrochloride (equivalent to 12 mg or 24 mg phentermine base respectively)
15 mg Capsules: white to off-white powder filled in Size ‘3’ gray opaque/yellow opaque capsules, imprinted with “U47” on cap and body in black ink.
30 mg Capsules: white to off-white powder filled in Size ‘3’ yellow opaque/yellow opaque capsules, imprinted with “U48” on cap and body in black ink.
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
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