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HOW AND WHERE TO BUY PHENDIMETRAZINE TARTRATE (BONTRIL) 35 MG, 105 MG CAPSULES OR TABLETS ONLINE:

BONTRIL PDM (PHENDIMETRAZINE TARTRATE) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Phendimetrazine Tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1).

Phendimetrazine Tartrate is a white, odorless cyrstalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene.

In addition, the following inactive ingredients in Bontril PDM (Phendimetrazine) tablets are present: confectioner's sugar, compressible sugar, FD&C Blue #1, D&C Yellow #10, FD&C Yellow #6, isopropyl alcohol, magnesium stearate, lactose anhydrous, povidone, microcrystalline cellulose, sodium starch glycolate, purified water.


CLINICAL PHARMACOLOGY

Bontril PDM clinical pharmacology


INDICATIONS AND USAGE

Bontril PDM (Phendimetrazine Tartrate) is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class should be measured against possible risk factors inherent in their use such as those described below.


CONTRAINDICATIONS

Known hypersensitivity or idiosyncratic reactions to sympathomimetics.

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, and glaucoma.

Highly nervous or agitated patients.

Patients with a history of drug abuse.

Patients taking other CNS stimulants, including monoamine oxidase inhibitors.


WARNINGS AND PRECAUTIONS

Bontril PDM warnings and precautions


ADVERSE REACTIONS

Bontril PDM adverse reactions


OVERDOSAGE

Acute overdosage with Phendimetrazine (Bontril PDM) may manifest itself by the following signs and symptoms: confusion, unusual restlessness, belligerence, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include hypertension, arrhythmias, or hypotension and circulatory collapse. Gastrointestinal symptoms include vomiting, nausea, diarrhea, and abdominal cramps.

Poisoning may result in convulsions, coma, and death.

The management of overdosage is largely symptomatic. It includes sedation with a barbiturate. If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered.

Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.


DOSAGE AND ADMINISTRATION

Usual Adult Dosage: 1 tablet (35 mg) b.i.d. or t.i.d., one hour before meals.

Dosage of Phendimetrazine (Bontril PDM) tablets should be individualized to obtain an adequate response with the lowest effective dosage. In some cases, 1/2 tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets t.i.d.


HOW SUPPLIED

Three-layered green, white and yellow tablet with "B35" on the scored side and the letter "V" on the other. Bontril PDM tablets containing 35 mg of phendimetrazine tartrate are available in bottles of 100 and 1000.

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).

Manufactured and distributed by Valeant, Mallinckrodt pharmaceutical companies and their divisions.

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