Phentermine Resin ER
PHENTERMINE RESIN ER- phentermine capsule, extended release
Lannett Company, Inc.
1 INDICATIONS AND USAGE
Phentermine resin extended-release 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.
BODY MASS INDEX (BMI), kg/m2 | ||||||
Weight | 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 AND ADMINISTRATION
2.1 Exogenous Obesity
One capsule daily, before breakfast or 10-14 hours before retiring. For individuals exhibiting greater drug responsiveness, phentermine resin extended-release capsules, 15 mg, will usually suffice. Phentermine resin extended-release capsules, 30 mg, are recommended for less responsive patients. Phentermine resin extended-release capsules are not recommended for use in pediatric patients under 16 years of age.
Phentermine resin extended-release capsules should be swallowed whole.
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 is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). Avoid use of phentermine 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 AND STRENGTHS
Phentermine Resin Extended-Release Capsules are available in two strengths:
15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body.
30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body.
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