amitriptyline hydrochloride 10 mg
INDICATIONS AND USAGE For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
unichem pharmaceuticals (usa), inc.
ROUND BROWN U 421
U 421 ROUND BROWN
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HOW SUPPLIED
AMITRIPTYLINE HYDROCHLORIDE tablets, USP for oral administration are available as: 10 mg: pink colored, round shaped, film-coated tablets, debossed with "60" on one side and "U" on the other side, and supplied as: NDC 29300-419-01 bottles of 100 NDC 29300-419-05 bottles of 500 NDC 29300-419-10 bottles of 1000 25 mg: yellow colored, round shaped, film-coated tablets, debossed with "420" on one side and "U" on the other side, and supplied as: NDC 29300-420-01 bottles of 100 NDC 29300-420-05 bottles of 500 NDC 29300-420-10 bottles of 1000 50 mg: brown colored, round shaped, film-coated tablets, debossed with "421" on one side and "U" on the other side, and supplied as: NDC 29300-421-01 bottles of 100 NDC 29300-421-05 bottles of 500 NDC 29300-421-10 bottles of 1000 75 mg: yellow colored, round shaped, film-coated tablets, debossed with "422" on one side and "U" on the other side, and supplied as: NDC 29300-422-01 bottles of 100 NDC 29300-422-05 bottles of 500 100 mg: orange colored, round shaped, film-coated tablets, debossed with "423" on one side and "U" on the other side, and supplied as: NDC 29300-423-01 bottles of 100 NDC 29300-423-05 bottles of 500 150 mg: green colored, capsule shaped, film-coated tablets, debossed with "424" on one side and "U" on the other side, and supplied as: NDC 29300-424-01 bottles of 100 NDC 29300-424-05 bottles of 500 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN. METABOLISM Studies in man following oral administration of 14 C-labeled drug indicated that amitriptyline is rapidly absorbed and metabolized. Radioactivity of the plasma was practically negligible, although significant amounts of radioactivity appeared in the urine by 4 to 6 hours and one-half to one-third of the drug was excreted within 24 hours. Amitriptyline is metabolized by N-demethylation and bridge hydroxylation in man, rabbit, and rat. Virtually the entire dose is excreted as glucuronide or sulfate conjugate of metabolites, with little unchanged drug appearing in the urine. Other metabolic pathways may be involved.
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