Phendimetrazine 35 mg

CLINICAL PHARMACOLOGY

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 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.

INDICATIONS AND USAGE Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as (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.

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.

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 be cautioned accordingly.

PRECAUTIONS 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. The phendimetrazine tartrate pink and yellow tablets contain FD&C yellow No. 5 (tartrazine) which may cause reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. 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 who may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Usage in Children Phendimetrazine tartrate is not recommended for use in children under 12 years of age.

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.

DRUG ABUSE AND DEPENDENCE Controlled Substance Phendimetrazine tartrate tablets are defined by the Drug Enforcement Administration as a Schedule III 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.

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 circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Poisoning may result in convulsions, coma death 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.

DOSAGE AND 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 1/2 tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets t.i.d.

HOW SUPPLIED Phendimetrazine Tartrate Tablets 35 mg are available in bottles of 100 and 1000 and are supplied a. pink/white/blue speckled, bisected, capsule-shaped tablet; imprinted "E 75" b. pink, bisected, capsule-shaped tablet; imprinted "E 77" c. yellow, bisected, round tablet; imprinted "E 76" 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sandoz Inc. Princeton, NJ 08540 OS8919 Rev. 12/09 MF4055REV12/09

Phendimetrazine Tartrate Tablets USP, 35 mg x 100 Tablets - Label NDC 0185-4057-01 Phendimetrazine Tartrate Tablets USP CIII 35 mg Yellow Rx only 100 Tablets Sandoz

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