BENZPHETAMINE HYDROCHLORIDE
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benzphetamine hydrochloride tablet
PD-Rx Pharmaceuticals, Inc.
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DESCRIPTION
Benzphetamine hyrochloride tablets 50 mg contain the anorectic agent benzphetamine hydrochloride.Benzephet-
amine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name
for benaphetamine hydrochloride is
d-N,a-Dimethyl-N-(phenylmethyl)-benzeneethanamine hydrochloride and its
moleculas weight is 275.82.
The structural formula (dextro form) is represented as follows below:
Each Benzphetamine hydrochloride tablets 50 mg, for oral administration, contains 50 mg of benzphetamine hydrochloride.
Inactive ingredients: Calcium Stearate, Polyethylene Glycol, FD and C Yellow No. 6, Lactose Anhydrous, Sorbitol.
CLINICAL PHARMACOLOGY
Benzphetamine hydrochloride is a sympathomimetic amine with
pharmacologic 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.
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 the 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 to be
clinically limited.
PHARMACOKINETICS
Pharmacokinetic data in humans are not available.
INDICATION AND USAGE
Benzphetamine Hydrochloride 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 weighed against possible
risks inherent in their use such as those described below.
CONTRAINDICATIONS
Benzphetamine Hydrochloride Tablets are contraindicated in
patients with advanced arteriosclerosis, symptomatic cardiovascular disease,
moderate to severe hypertension, hyperthyroidism, known hypersensitivity or
idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not
be given to patients who are in an agitated state or who have a history of drug
abuse.
Hypertensive crises have resulted when sympathomimetic amines have been used
concomitantly or within 14 days following use of monoamine oxidase inhibitors.
Benzphetamine Hydrochloride Tablets should not be used concomitantly with other
CNS stimulants.
Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to
a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic
in mammals at high multiples of the human dose. Benzphetamine Hydrochloride
Tablets are contraindicated in women who are or may become pregnant. If this
drug is used during pregnancy, or if the patient becomes pregnant while taking
this drug, the patient should be apprised of the potential hazard to the fetus.
WARNINGS
When tolerance to the anorectic effect develops, the recommended dose should not
be exceeded in an attempt to increase the effect; rather, the drug should be
discontinued
PRECAUTIONS
General
Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions.
Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime.
Caution is to be exercised in prescribing amphetamines for patients with mild hypertension. The least amount feasible
should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Information For Patients
Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or
driving a vehicle; the patient should therefore be cautioned accordingly.
Drug Interactions
Hypertensive crises have resulted when sympathamimetic amines have been used concomitantly or within 14 days following use of
monoamine oxidase inhibitors. Benzphetamine hydrochloride tablets should not be used concomitantly with other CNS stimulants.
Amphetamines may enhance the effects of tricyclic antidepressants.
Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying
agents decrease blood levels and increase excretion of amphetamines.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed.
Pregnancy
Pregnant Category X
(see CONTRAINDICATIONS section).
Nursing Mothers
Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
Pediatric Use
Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.
ADVERSE REACTIONS
The following have been associated with the use of benzphetamine hydrochloride:
Cardiovascular:
Palpitation, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
CNS:
Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at
recommended doses; depression following withdrawal of the drug.
Gastrointestinal:
Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances.
Allergic:
Urticaria and other allergic reactions involving the skin.
Endocrine:
Changes in libido.
DRUG ABUSE AND DEPENDENCE
Benzphetamine is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and has been assigned to Schedule III
Benzphetamine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and
related stimulant drugs have been extensively abused, and the possibility of abuse of benzphetamine Hydrochloride Tablets
should be kept in mind when evaluating the desirabilityof 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 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 intoxication is psychosis, often clinically indistinguishable from schizophirenia.
OVERDOSAGE
Manifestations of Overdosage:
Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness and panic states.
Fatigue and depression usually follow the central stimulation. Cardiovasculas effects include arrhythmias,
hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting,
diarrhea, and abdominal cramps. Hyperpyrexia and rhabdomyolysis have been reported and can lead to a number
of associated complications. Fatal poisoning is usually preceded by convulsion and coma.
Treatment of Overdosage:(see WARNINGS)
Information concerning the effects of overdosage with benzphetamine hydrochloride tablets is extremely limited. The following
is based on experience with other anorexiants.
Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension
is marked, the use of a nitrite or rapidly acting alpha receptor blocking agent should be considered.
Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard.
Acidification of the urine increases amphetamine excretion. The oral LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitioneal LD50 in mice is 153 mg/kg.
DOSAGE & ADMINISTRATION
Benzphetamine Hydrochloride Tablets are supplied as follows:
50 mg (peach, round, imprinted with BP 650, scored)
12634-118-56 Bottle of 56
12634-118-44 Bottle of 84
STORAGE AND HANDLING
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP
Controlled Room Temperature].
Dispense in a tight, light-resistant container
as defined in the USP.
A Schedule CS-III controlled drug substance.
PACKAGE LABEL,PRINCIPAL DISPLAY PANEL
56 Tablets NDC 12634-118-56
Benzphetamine Tablets USP
CIII
50mg
Rx Only
Each Tablet Contains:
Benzphetamine Hydrochloride 50mg
Usual Adult Dosage:
1/2 to 1 tablet one to three times daily. See insert for
full prescribing information.
Keep This and all Medication Out of Reach of
Children.
Dispense in a tight, light-resistant container
as defined
in the USP, using a child-resistant closure.
Manufactured by Tidor Pharma for
Boca Pharmacal, Inc.
Coral Springs, FL 33065
NDC 64376-650-01
Repackaged and Distributed by
Apotheca, Inc.
Phoenix, AZ 85006
PD-Rx Bottle Labels
BENZPHETAMINE HYDROCHLORIDE
benaphetamine tablet |
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Revised: 03/2010 PD-Rx Pharmaceuticals, Inc.