DailyMed Label: PHENDIMETRAZINE TARTRATE

DailyMed Label: Phendimetrazine Tartrate

2010

DailyMed Prescription

Phendimetrazine Tartrate

phendimetrazine tartrate

Physicians Total Care, Inc.

NDC: 54868-0252

NDC: 54868-0252

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: C 12 H 17 NO•C 4 H 6 O 6                                             M.W. 341.36 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. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and FD&C Blue #1 Lake or FD&C Yellow #6 and D&C Yellow #10 as coloring. image of chemical structure

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.

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.

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.

Caution is to be exercised in prescribing phendimetrazine tartrate for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine and the concomitant dietary regimen. Phendimetrazine 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. 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. Pediatric Patients Phendimetrazine tartrate is not recommended for use in pediatric patients under 12 years of age.

Each single-scored, yellow, round tablet contains 35 mg phendimetrazine tartrate. Tablets are supplied: in bottles of 21 (NDC 54868-0252-5), in bottles of 30 (NDC 54868-0252-0), in bottles of 90 (NDC 54868-0252-4), in bottles of 100 (NDC 54868-0252-3). Storage: Store at controlled room temperature 15º-30ºC (59º-86ºF). Dispense in tight containers with child-resistant closures. Manufactured by: MIKART, INC. Atlanta, GA 30318 Rev. 05/96                            Code 698Z00 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Phendimetrazine tartrate is a phenylalkylamine sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics”. It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions or metabolic effects, may be involved, for example. Adult obese subjects instructed in dietary management and treated with “anorectic” drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short term clinical trials. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an anorectic drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration, thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

Phendimetrazine tartrate Tablets 35 mg image of package label