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Phendimetrazine (Phendimetrazine Tartrate) - Warnings and Precautions

 
 



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 therefore be cautioned accordingly.

PRECAUTIONS

General

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 and C yellow No. 5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD and C yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.


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.


Pediatric use

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

Page last updated: 2011-04-21

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