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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
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 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.
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.
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
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
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
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 allergic type reactions
(including bronchial asthma) in certain susceptible individuals.
Although the overall incidence of FD&C yellow 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.
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
Phendimetrazine tartrate tablets are defined by the Drug Enforcement Administration as a Schedule III controlled substance.
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.
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 over dosage 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.
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 cases 1/2 tablet (17.5 mg) per dose
may be adequate. Dosage should not exceed 2 tablets t.i.d.
Phendimetrazine Tartrate Tablets 35 mg are available in bottles of 100 and 1000 and are supplied as:
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"
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.
Princeton, NJ 08540
Phendimetrazine Tartrate Tablets USP, 35 mg x 100 Tablets - Label
Phendimetrazine Tartrate Tablets USP CIII
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