Suprenza

SUPRENZA- phentermine hydrochloride tablet, orally disintegrating
Akrimax Pharmaceuticals, LLC

1 INDICATIONS AND USAGE

Suprenza 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 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.

Height (feet, inches)

BODY MASS INDEX (BMI), kg/m2
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 Suprenza, [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. Suprenza is 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 Suprenza (phentermine hydrochloride ODT) tablet from the bottle. Immediately place the Suprenza tablet on top of the tongue where it will dissolve, then swallow with or without water.

3 DOSAGE FORMS AND STRENGTHS

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 ODT is a yellow with blue spots round tablet embossed with AX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 on one side. The 37.5 mg ODT is a white with blue spots round tablet embossed with AX8 on one 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

Suprenza is indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination th erapy with Suprenza and any other drug products for weight loss includin g 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 Suprenza and these drug products is not recommended.

5.2 Primary Pulmonary Hypertension

Primary Pulmonary Hypertension (PPH) – a rare, frequently fatal disease of the lungs – has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of Suprenza alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for the possible presence of pulmonary hypertension.

Page 1 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.