Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Phendimetrazine Tartrate Tablets, USP 35 mg are available as White, round, biconvex tablets debossed “K” above bisect “45” on one side and plain on the other side. Bottles of 30 NDC 10702-045-03 Bottles of 100 NDC 10702-045-01 Bottles of 1000 NDC 10702-045-10 Yellow, round, biconvex tablets debossed “K” above bisect “77” on one side and plain on the other side. Bottles of 30 NDC 10702-077-03 Bottles of 100 NDC 10702-077-01 Bottles of 1000 NDC 10702-077-10 Blue, round, biconvex tablets debossed “K” above bisect “78” on one side and plain on the other side. Bottles of 30 NDC 10702-078-03 Bottles of 100 NDC 10702-078-01 Bottles of 1000 NDC 10702-078-10; Principal Display Panel 30s Label NDC 10702-045-03 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 30 Tablets KVK-TECH 100s Label NDC 10702-045-01 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 100 Tablets KVK-TECH 1000s Label NDC 10702-045-10 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 1000 Tablets KVK-TECH 045-30s-label 045-100s-label 045-1000s-label; Principal Display Panel 30s Label NDC 10702-077-03 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 30 Tablets KVK-TECH 100s Label NDC 10702-077-01 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 100 Tablets KVK-TECH 1000s Label NDC 10702-077-10 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 1000 Tablets KVK-TECH 077-30s-label 077-100s-label 077-1000s-label; Principal Display Panel 30s Label NDC 10702-078-03 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 30 Tablets KVK-TECH 100s Label NDC 10702-078-01 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 100 Tablets KVK-TECH 1000s Label NDC 10702-078-10 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 1000 Tablets KVK-TECH 078-30s-label 078-100s-label 078-1000s-label
- HOW SUPPLIED: Phendimetrazine Tartrate Tablets, USP 35 mg are available as White, round, biconvex tablets debossed “K” above bisect “45” on one side and plain on the other side. Bottles of 30 NDC 10702-045-03 Bottles of 100 NDC 10702-045-01 Bottles of 1000 NDC 10702-045-10 Yellow, round, biconvex tablets debossed “K” above bisect “77” on one side and plain on the other side. Bottles of 30 NDC 10702-077-03 Bottles of 100 NDC 10702-077-01 Bottles of 1000 NDC 10702-077-10 Blue, round, biconvex tablets debossed “K” above bisect “78” on one side and plain on the other side. Bottles of 30 NDC 10702-078-03 Bottles of 100 NDC 10702-078-01 Bottles of 1000 NDC 10702-078-10
- Principal Display Panel 30s Label NDC 10702-045-03 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 30 Tablets KVK-TECH 100s Label NDC 10702-045-01 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 100 Tablets KVK-TECH 1000s Label NDC 10702-045-10 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 1000 Tablets KVK-TECH 045-30s-label 045-100s-label 045-1000s-label
- Principal Display Panel 30s Label NDC 10702-077-03 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 30 Tablets KVK-TECH 100s Label NDC 10702-077-01 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 100 Tablets KVK-TECH 1000s Label NDC 10702-077-10 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 1000 Tablets KVK-TECH 077-30s-label 077-100s-label 077-1000s-label
- Principal Display Panel 30s Label NDC 10702-078-03 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 30 Tablets KVK-TECH 100s Label NDC 10702-078-01 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 100 Tablets KVK-TECH 1000s Label NDC 10702-078-10 Phendimetrazine Tartrate Tablets, USP 35 mg CIII Rx Only 1000 Tablets KVK-TECH 078-30s-label 078-100s-label 078-1000s-label
Overview
Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)- tartrate (1:1). The structural formula is: 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 white tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, the following inactive ingredients are present: Colloidal Silicon Dioxide, Lactose Monohydrate, Microcrystalline Cellulose 102, Sodium Starch Glycolate and Stearic Acid. The yellow tablet also contains FD&C Yellow # 5 Aluminum Lake (15-17%). The blue tablet also contains FD&C Blue # 1 Aluminum Lake (11-13%). chemical structure
Indications & Usage
: 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 in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. 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. Phendimetrazine tartrate is indicated for use as monotherapy only. bmi index
Dosage & Administration
: Usual Adult Dosage: 1 tablet (35 mg) twice a day or three times a day one hour before meals. Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases, ½ tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets three times a day.
Warnings & Precautions
WARNINGS: Phendimetrazine tartrate should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations and herbal products. In a case-control epidemiological study, the use of anorectic agents, including phendimetrazine tartrate, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, phendimetrazine tartrate should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. However, no cases of this valvulopathy have been reported when phendimetrazine tartrate has been used alone. The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of phendimetrazine treatment. Phendimetrazine tartrate is not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. To limit unwarranted exposure and risks, treatment with phendimetrazine tartrate should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient). 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 tartrate 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. Phendimetrazine tartrate is not recommended for patients who used any anorectic agents within the prior year.
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: Palpitations, tachycardia, elevated blood pressure, ischemic events. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no case of this valvulopathy has been reported when phendimetrazine tartrate has been used alone. 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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