Benzphetamine Hydrochloride (Page 2 of 3)

Information for Patients

Amphetamines 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.

Drug Interactions

Efficacy of Benzphetamine hydrochloride tablets in combination with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

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.

Amphetamines may decrease the hypotensive effects of antihypertensives. 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

Pregnancy 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

Safety and effectiveness in pediatric patients have not been established. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

Geriatric Use

Clinical studies of Benzphetamine hydrochloride tablets did not include sufficient numbers of subjects aged 65 and over to establish safety and efficacy in this population. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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 and ischemic cardiac events associated with chronic amphetamine use.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no cases of this valvulopathy have been reported when Benzphetamine hydrochloride tablets have been used alone.

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 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 intoxication is psychosis, often clinically indistinguishable from schizophrenia.

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. Cardiovascular 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 convulsions 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 intraperitoneal LD50 in mice is 153 mg/kg.

DOSAGE AND ADMINISTRATION

Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient’s eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

HOW SUPPLIED

Benzphetamine hydrochloride tablets are supplied as follows 50mg (peach,round,imprinted with BP 650, scored)

NDC 12634-118-00 Bottles of 10

NDC 12634-118-01 Bottles of 100

NDC 12634-118-09 Bottles of 35

NDC 12634-118-12 Bottles of 120

NDC 12634-118-18 Bottles of 180

NDC 12634-118-40 Bottles of 40

NDC 12634-118-42 Bottles of 42

NDC 12634-118-45 Bottles of 45

NDC 12634-118-50 Bottles of 50

NDC 12634-118-52 Blister Pack of 12

NDC 12634-118-54 Blister Pack of 14

NDC 12634-118-57 Blister Pack of 20

NDC 12634-118-59 Blister Pack of 30

NDC 12634-118-60 Bottles of 60

NDC 12634-118-61 Blister Pack of 10

NDC 12634-118-63 Blister Pack of 3

NDC 12634-118-66 Blister Pack of 6

NDC 12634-118-67 Blister Pack of 7

NDC 12634-118-69 Blister Pack of 9

NDC 12634-118-71 Bottles of 30

NDC 12634-118-74 Bottles of 24

NDC 12634-118-78 Bottles of 28

NDC 12634-118-79 Bottles of 25

NDC 12634-118-80 Bottles of 20

NDC 12634-118-81 Bottles of 21

NDC 12634-118-82 Bottles of 12

NDC 12634-118-84 Bottles of 14

NDC 12634-118-85 Bottles of 15

NDC 12634-118-90 Bottles of 90

NDC 12634-118-91 Blister Pack of 1

NDC 12634-118-92 Bottles of 2

NDC 12634-118-93 Bottles of 3

NDC 12634-118-94 Bottles of 4

NDC 12634-118-95 Bottles of 5

NDC 12634-118-96 Bottles of 6

NDC 12634-118-97 Bottles of 7

NDC 12634-118-98 Bottles of 8

NDC 12634-118-99 Bottles of 9

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Storage and Handling

Store at 20° to 25°C (68° to 77° F) [see USP controlled room temperature].

Rx only

Manufactured for:

Boca Pharmacal, LLC

Coral Springs, FL 33065

1-800-354-8460

www.bocapharmacal.com

Rev. 08/13

Repackaged & Distributed by:

Apotheca Inc.

Phoenix, AZ 85006

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