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
Height (feet, 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 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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