Phendimetrazine Tartrate

INDICATIONS AND 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 follow: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches) Weight 5’0” 5’3” 5’6” 5’9” 6’0” 6’3” (pounds) 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 Phendimetrazine tartrate is indicated for the use as monotherapy only

DOSAGE AND 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, 1⁄2 tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets three times a day.

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.

Interactions Drug Interactions Efficacy of phendimetrazine tartrate with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems. Drug/Laboratory Test Interactions

Drug Interactions Efficacy of phendimetrazine tartrate with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

DESCRIPTION: 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, Magnesium Stearate, Microcrystalline Cellulose 102 and Sodium Starch Glycolate. 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%). C:\Documents and Settings\avyas\Desktop\phend-outsert\SPL\phendimetrazine-image-a.jpg

OVERDOSAGE: Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, 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.

HOW SUPPLIED: Phendimetrazine Tartrate Tablets, USP 35 mg Product: 71335-0074: Blue, round, biconvex tablets debossed “K” above bisect “78” on one side and plain on the other side. NDC: 71335-0074-1 30 TABLET in a BOTTLE NDC: 71335-0074-2 135 TABLET in a BOTTLE NDC: 71335-0074-3 180 TABLET in a BOTTLE NDC: 71335-0074-4 15 TABLET in a BOTTLE NDC: 71335-0074-5 90 TABLET in a BOTTLE NDC: 71335-0074-6 7 TABLET in a BOTTLE NDC: 71335-0074-7 21 TABLET in a BOTTLE NDC: 71335-0074-8 60 TABLET in a BOTTLE NDC: 71335-0074-9 45 TABLET in a BOTTLE NDC: 71335-0074-0 120 TABLET in a BOTTLE Product: 71335-0324: Yellow, round, biconvex tablets debossed “K” above bisect “77” on one side and plain on the other side. NDC: 71335-0324-1 30 TABLET in a BOTTLE NDC: 71335-0324-2 90 TABLET in a BOTTLE NDC: 71335-0324-3 15 TABLET in a BOTTLE NDC: 71335-0324-4 60 TABLET in a BOTTLE NDC: 71335-0324-5 7 TABLET in a BOTTLE NDC: 71335-0324-6 21 TABLET in a BOTTLE NDC: 71335-0324-7 42 TABLET in a BOTTLE NDC: 71335-0324-8 100 TABLET in a BOTTLE NDC: 71335-0324-9 28 TABLET in a BOTTLE NDC: 71335-0324-0 120 TABLET in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504