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].
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