Suprenza

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.

BODY MASS INDEX (BMI), kg/m²

The limited usefulness of agents of this class, including Suprenza, [see CLINICAL PHARMACOLOGY] should be measured against possible risk factors inherent in their use such as those described below.

• Akrimax Pharmaceuticals, LLC

Serious side effects have been reported with Suprenza including the following:

• Primary pulmonary hypertension. This is a condition when there is high blood pressure in the arteries to your lungs. Your doctor may stop treatment with Suprenza if you develop this complication. Symptoms include
  • shortness of breath during routine activity, such as climbing two flights of stairs
  • tiredness
  • chest pain
  • a racing heartbeat
  • pain on the upper right side of the abdomen
  • decreased appetite
• Development of Tolerance. Suprenza is a controlled substance. There is a potential for developing tolerance. Tolerance to the anorectic effect usually develops within a few weeks. When tolerance to the Suprenza develops, the recommended dose should not be exceeded in an attempt to increase the effect. Instead Suprenza should be discontinued.

• Effect on the Ability to Engage in Potentially Hazardous Tasks.  Suprenza may impair the ability of the patient to drive or operate heavy machinery. Do not drive or operate heavy machinery until you know how Suprenza affects you.

• Risk of Abuse and Dependence. Suprenza should not be stopped all of a sudden especially if Suprenza dose is high. This can lead to serious problems.

• Valvular heart disease.

• Use in Patients with Hypertension. Patients with even mild hypertension (high blood pressure) are at risk of an increase in blood pressure if taking Suprenza.

• Risk of Allergic Reactions due to Tartrazine. Suprenza 15 mg and 30 mg ODT contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

You should not take Suprenza if you have:

• are allergic to Suprenza or to any of its ingredients
• heart disease
• lung disease
• hyperthyroidism
• glaucoma
• a history of drug abuse or dependence
• agitated state
• depression being treated with certain antidepressant medications called MAOI inhibitors

Suprenza should not be used during pregnancy or while breastfeeding.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of phentermine can be fatal.

• If you have an allergy to phentermine or any other part of Suprenza (phentermine orally disintegrating tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have ever had any of these health problems: Heart disease like heart failure or a heartbeat that is not normal, drug abuse, high blood pressure, or stroke.
• If you have any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
• If you have kidney disease or are on dialysis.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Fluoxetine, fluvoxamine, paroxetine, or sertraline.
• If you are taking or will be taking another drug like this one.
• If you are taking any other drug (prescription or OTC, natural product) for weight loss.
• If you are pregnant or may be pregnant. Do not take Suprenza if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Suprenza.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Suprenza early in the day to prevent sleep problems.
• Take with or without food.
• Be sure your hands are dry before you touch this medicine.
• Place on your tongue and let it melt. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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.

9.1       Controlled Substance

Phentermine is a Schedule IV controlled substance.

9.2       Abuse

Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program.

9.3       Dependence

Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Patients must be informed that Suprenza is 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, and that coadministration of phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5)].

Patients must be instructed on how much Suprenza to take, and when and how to take it [see Dosage and Administration (2)].

Advise pregnant women and nursing mothers not to use Suprenza (see Use in Specific Populations (8.1, 8.3)].

Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:

• Development of primary pulmonary hypertension [see Warnings and Precautions (5.2)]
  
• Development of serious valvular heart disease [see Warnings and Precautions (5.3)]
  
• Effects on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)]
  
• The risk of an increase in blood pressure [see Warnings and Precautions (5.8) and Adverse Reactions (6)]
  
• The risk of interactions [see Contraindications (4), Warnings and Precautions (5) and Drug Interactions (7)]

See also, for example, Adverse Reactions (6) and Use in Specific Populations (8).

The patients must also be informed about

• the potential for developing tolerance and actions if they suspect development of tolerance [see Warnings and Precautions (5.4)] and
  
• the risk of dependence and the potential consequences of abuse [see Warnings and Precautions (5.6), Drug Abuse and Dependence (9), and Overdosage (10)].

Tell patients to keep Suprenza in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away Suprenza may harm others and is against the law.

Manufactured for
Akrimax Pharmaceuticals, LLC
Cranford, NJ 07016

by: Alpex Pharma SA
Lugano, Switzerland

Marketed and Distributed by:
Akrimax Pharmaceuticals, LLC
Cranford, NJ 07016

372F006

Principal Display Panel – 15 mg Bottle Label
NDC 24090-720-85
SuprenzaTM 
(Phentermine Hydrochloride)
Orally Disintegrating Tablets
15 mg
Rx Only
30 Tablets CIV

Principal Display Panel – 30 mg Bottle Label
NDC 24090-721-85
SuprenzaTM 
(Phentermine Hydrochloride)
Orally Disintegrating Tablets
30 mg
Rx Only
30 Tablets CIV

Principal Display Panel – 37.5 mg Bottle Label
NDC 24090-722-85
SuprenzaTM
(Phentermine Hydrochloride)
Orally Disintegrating Tablets
37.5 mg
Rx Only
30 Tablets CIV