Protriptyline (Protriptyline Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.

DOSAGE AND ADMINISTRATION

Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.

Usual Adult Dosage --Fifteen to 40 mg a day divided into 3 or 4 doses. If necessary, dosage may be increased to 60 mg a day. Dosages above this amount are not recommended. Increases should be made in the morning dose.

Adolescent and Elderly Patients --In general, lower dosages are recommended for these patients. Five mg 3 times a day may be given initially, and increased gradually if necessary. In elderly patients, the cardiovascular system must be monitored closely if the daily dose exceeds 20 mg.

When satisfactory improvement has been reached, dosage should be reduced to the smallest amount that will maintain relief of symptoms.

Minor adverse reactions require reduction in dosage. Major adverse reactions or evidence of hypersensitivity require prompt discontinuation of the drug.

The safety and effectiveness of protriptyline in pediatric patients have not been established.

HOW SUPPLIED

Vivactil® Tablets:

5 mg - Orange, oval, film-coated tablets in bottles of 100.

Debossed OP 701

10 mg - Yellow, oval, film-coated tablets in bottles of 100.

Debossed OP 702

Dispense in a tight container as defined in the USP.

Store at controlled room temperature 15°-30°C (59°-86°F). [see USP].

METABOLISM

Metabolic studies indicate that protriptyline is well absorbed from the gastrointestinal tract and is rapidly sequestered in tissues. Relatively low plasma levels are found after administration, and only a small amount of unchanged drug is excreted in the urine of dogs and rabbits. Preliminary studies indicate that demethylation of the secondary amine moiety occurs to a significant extent, and that metabolic transformation probably takes place in the liver. It penetrates the brain rapidly in mice and rats, and moreover that which is present in the brain is almost all unchanged drug.

Studies on the disposition of radioactive protriptyline in human test subjects showed significant plasma levels within 2 hours, peaking at 8 to 12 hours, then declining gradually.

Urinary excretion studies in the same subjects showed significant amounts of radioactivity in 2 hours. The rate of excretion was slow. Cumulative urinary excretion during 16 days accounted for approximately 50% of the drug. The fecal route of excretion did not seem to be important.

Distributed by Odyssey Pharmaceuticals, Inc.,

East Hanover, New Jersey 07936

Manufactured by PLIVA®, Inc.

East Hanover, NJ 07936

Iss. 1/03