Drug: Bontril PDM

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:
C12H17NO•C4H6O6..........................M.W. 341.36 Phendimetrazine tartrate is a white, odorless crystaline 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 are present: Compressible Sugar, Confectioner's Sugar, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Isopropyl Alcohol, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Purified Water, Sodium Starch Glycolate.

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Cardiovascular: Palpitation, 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. Drug Abuse And Dependence Controlled Substance: Bontril® PDM (phendimetrazine tartrate) is a Schedule lll controlled substance. Dependence: Phendimetrazine tartrate is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of phendimetrazine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. 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 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. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. Read the Bontril PDM (phendimetrazine tartrate tablets) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

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.

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Efficacy of phendimetrazine tartrate with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems. Read the Bontril PDM Drug Interactions Center for a complete guide to possible interactions Learn More »

Source: http://www.rxlist.com

Bontril® PDM (phendimetrazine tartrate) is indicatedin 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/m2 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 bythe patient's height,inmeters (m), squared. Metric conversions are as follows: pounds รท 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2
Height (feet, inches) Weight (pounds) 5'0” 5'3” 5'6” 5'9” 6'0” 6'3” 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 use as monotherapy only.

Source: http://www.rxlist.com

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. Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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.

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Three-layered green, white and yellow tablet with “B 35” 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 (NDC 0187-0497-01) and 1000 (NDC 0187-0497-02). Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). DEA Order Form Required. Distributed by: Valeant Pharmaceuticals North America. One Enterprise, Aliso Viejo, CA 92656 USA. Manufactured by: Mallinckrodt, Inc. Hobart, NY 13788. Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Caution is to be exercised in prescribing phendimetrazine for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine tartrate and the concomitant dietary regimen. Phendimetrazine tartrate may decrease the hypotensive effect of guanethidine. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Phendimetrazine Tartrate have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregancy: Pregnancy Category C Animal reproduction studies have not been conducted with phendimetrazine tartrate. It is also not known whether phendimetrazine tartrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Usage in Pregnancy Safe use in pregnancy has not been established. Until more information is available, phendimetrazine tartrate should not be taken by women who are or may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, phendimetrazine tartrate should not be taken by women who are nursing unless, in the opinion of the physician, the potential benefits outweigh the possible hazards. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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