Phentermine Hydrochloride

PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride tablet, orally disintegrating
Zydus Pharmaceuticals (USA) Inc.

1 INDICATIONS AND USAGE

Phentermine hydrochloride orally disintegrating tablets 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(feet , inches)
Header$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 hydrochloride, [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

Exogenous Obesity

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food. Phentermine hydrochloride orally disintegrating tablets are not recommended for use in pediatric patients less than or equal to 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 orally disintegrating tablet from the bottle. Immediately place the phentermine hydrochloride orally disintegrating tablet on top of the tongue where it will dissolve, then swallow with or without water.

3 DOSAGE FORMS AND STRENGTHS

Phentermine hydrochloride orally disintegrating tablets (ODT) containing 15 mg, 30 mg, or 37.5 mg phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg phentermine base, respectively). The tablets are not scored.

  • The 15 mg orally disintegrating tablet (ODT) is a white to off-white, round, beveled, biconvex, uncoated tablets, debossed with ’703′ on one side and plain on other side.
  • The 30 mg orally disintegrating tablet (ODT) is a white to off-white, oval, beveled, biconvex, uncoated tablets, debossed with ’704′ on one side and plain on other side.
  • The 37.5 mg orally disintegrating tablet (ODT) is a white to off-white, round, beveled, biconvex, uncoated tablets, debossed with ’670′ on one side and plain on other side.

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

5 WARNINGS AND PRECAUTIONS

5.1 Coadministration with Other Drug Products for Weight Loss

Phentermine hydrochloride orally disintegrating tablets 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 hydrochloride orally disintegrating tablets 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, coadministration of phentermine hydrochloride orally disintegrating tablets and these drug products is not recommended.

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