Država: Kanada
Jezik: engleski
Izvor: Health Canada
DOXEPIN (DOXEPIN HYDROCHLORIDE)
AA PHARMA INC
N06AA12
DOXEPIN
25MG
CAPSULE
DOXEPIN (DOXEPIN HYDROCHLORIDE) 25MG
ORAL
100/500
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0107703001; AHFS:
APPROVED
2018-01-09
PRODUCT MONOGRAPH PR DOXEPIN DOXEPIN HYDROCHLORIDE CAPSULES 10 MG, 25 MG, 50 MG, 75 MG, 100 MG AND 150 MG DOXEPIN HOUSE STANDARD ANTIDEPRESSANT AND ANXIOLYTIC AA PHARMA INC. DATE OF PREPARATION: 1165 CREDITSTONE ROAD, UNIT #1 DECEMBER 29, 2017 VAUGHAN, ONTARIO L4K 4N7 _Control No.: 211196_ _ _ 1 ACTION DOXEPIN is a psychotropic agent with antidepressant and anxiolytic properties. It also has sedative and anticholinergic effects, and, in the higher dosage range, it produces peripheral adrenergic blocking effects. Studies of electroencephalograms in humans have shown decreases in amplitude, and amplitude variability, also, the delta, theta and 24-35 CPS activities increased. COMPARATIVE BIOAVAILABILITY STUDIES A standard 2-way crossover comparative bioavailability study, conducted under fasting conditions, was performed on healthy male volunteers. The results obtained from 37 volunteers who completed the study are summarized in the following tables. The rate and extent of absorption of doxepin were measured and compared following a single oral dose ( 1 x 150 mg capsule) of APO-DOXEPIN (doxepin hydrochloride) 150 mg (Apotex Inc.) and Sinequan (desmethyldoxepin) 150 mg capsule (Pfizer Inc.). Doxepin (_1 x 150_mg) From Measured Data Geometric Mean Arithmetic Mean (CV%) Parameter Test* Reference † Ratio of Geometric Means (%) 90% Confidence Interval (%) AUC T (ng•h/mL) 380 485 (62) 392 495 (66) 97 87 - 107 AUC I (ng•h/mL) 441 539 (59) 450 564 (69) 98 90 - 107 C max (ng/mL) 39.3 46.7 (53) 43.4 53.9 (71) 91 80 - 104 T max § (h) 2.32 (0.92) 2.19 (0.99) T ½ § (h) 12.6 (6.6) 11.9 (6.1) *Apo-Doxepin (doxepin) 150 mg capsules (Apotex Inc.). † Sinequan (desmethyl doxepin) 150 mg capsules (Pfizer Inc.) were purchased in Canada. § Expressed as the arithmetic mean (CV%) only. INDICATIONS The antidepressant and anxiolytic properties of -DOXEPIN (doxepin hydrochloride) have been found to be of value in the drug treatment of: 1. Psychoneurotic patients with anxiety and/or depressive reactions; 2 Anxiety neurosis asso Pročitajte cijeli dokument