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.
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