Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Phendimetrazine Tartrate Tablet 35 mg is a yellow, bisected, round tablet; imprinted “E 76”. NDC 69543-410-10 bottles of 100 tablets NDC 69543-410-11 bottles of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant, container as defined in the USP, with a child-resistant closure (as required). To report SUSPECTED ADVERSE REACTIONS, contact Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by Virtus Pharmaceuticals, LLC Langhorne, PA 19047 Rev. 08/2023 MF4055REV08/23 OE2826; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Phendimetrazine Tartrate Tablets, USP 35 mg, 1000s Label Text NDC 69543-410-11 Phendimetrazine Tartrate Tablets, USP CIII 35 mg Contains FD&C Yellow No. 5 (tartrazine) as a color additive. Rx Only 1000 Tablets VIRTUS ® Pharmaceuticals Phendimetrazine-35mg-1000ct
- HOW SUPPLIED Phendimetrazine Tartrate Tablet 35 mg is a yellow, bisected, round tablet; imprinted “E 76”. NDC 69543-410-10 bottles of 100 tablets NDC 69543-410-11 bottles of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant, container as defined in the USP, with a child-resistant closure (as required). To report SUSPECTED ADVERSE REACTIONS, contact Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by Virtus Pharmaceuticals, LLC Langhorne, PA 19047 Rev. 08/2023 MF4055REV08/23 OE2826
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Phendimetrazine Tartrate Tablets, USP 35 mg, 1000s Label Text NDC 69543-410-11 Phendimetrazine Tartrate Tablets, USP CIII 35 mg Contains FD&C Yellow No. 5 (tartrazine) as a color additive. Rx Only 1000 Tablets VIRTUS ® Pharmaceuticals Phendimetrazine-35mg-1000ct
Overview
Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2 s ,3 s ,)-3,4-dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1). The structural formula is as follows: Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol; insoluble in chloroform, acetone, ether and benzene. Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. Inactive Ingredients: confectioner’s sugar (sucrose and corn starch), lactose monohydrate, povidone, pregelatinized starch, silicon dioxide and stearic acid. The yellow tablets also contain: FD&C yellow No. 5 (see PRECAUTIONS ). chemical-structure.jpg
Indications & Usage
Phendimetrazine tartrate tablets are 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 (see CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below.
Dosage & Administration
Usual Adult Dose: 1 tablet (35 mg) b.i.d. or t.i.d., one hour before meals. Dosage 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.
Warnings & Precautions
WARNINGS Tolerance to the anorectic effect of phendimetrazine develops within a few weeks. When this occurs, its use should be discontinued; the maximum recommended dose should not be exceeded. Use of phendimetrazine tartrate within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis. Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system, phendimetrazine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.
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.
Adverse Reactions
Cardiovascular: Palpitation, tachycardia, elevated blood pressure. Central Nervous System: Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision. Gastrointestinal: Dryness of the mouth, nausea, diarrhea, constipation, stomach pain. Genitourinary: Urinary frequency, dysuria, changes in libido.
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