Country: Կանադա
language: անգլերեն
source: Health Canada
DOXEPIN (DOXEPIN HYDROCHLORIDE)
TEVA CANADA LIMITED
N06AA12
DOXEPIN
75MG
CAPSULE
DOXEPIN (DOXEPIN HYDROCHLORIDE) 75MG
ORAL
100/500
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0107703003; AHFS:
CANCELLED POST MARKET
2019-08-08
PRODUCT MONOGRAPH PR NOVO-DOXEPIN Doxepin hydrochloride Capsule USP 25 mg, 50 mg, 75 mg, 100 mg and 150 mg Capsules ANTIDEPRESSANT AND ANXIOLYTIC AGENT Teva Canada Limited Date of Preparation: 30 Novopharm Court March 7, 2014 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Control # 172120 ACTION NOVO-DOXEPIN (doxepin HCl) 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. A comparative, two-way, single-dose bioavailability study was performed on NOVO- DOXEPIN and SINEQUAN ® 150mg Capsules. The pharmacokinetic data calculated for the NOVO-DOXEPIN and SINEQUAN ® Capsule formulations are tabulated below: Pharmacokinetic Indices for Trans-Doxepin: Geometric Mean Arithmetic Mean (C.V.) NOVO-DOXEPIN (1 x 150 mg) SINEQUAN ® (1 x 150 mg) Percentage of SINEQUAN ® AUC T (ng·h/mL) 454.9 522.8 (52) 518.0 598.8 (56) 88 AUC I (ng·h/mL) 544.6 622.0 (57) 614.0 691.2 (51) 89 C max (ng/mL) 38.86 44.93 (50) 42.95 50.02 (55) 90 T max * (h) 2.79 (1.63) 2.10 (1.00) - T 1/2 * (h) 22.58 (30.70) 23.06 (22.60) - Pharmacokinetic Indices for Trans-N-Desmethyldoxepin: Geometric Mean Arithmetic Mean (C.V.) NOVO-DOXEPIN (1 x 150 mg) SINEQUAN ® (1 x 150 mg) Percentage of SINEQUAN ® AUC T (ng·h/mL) 156.0 294.8 (154) 165.7 278.9 (142) 94 AUC I (ng·h/mL) 217.0 374.1 (147) 225.9 (349.2 (137) 96 C max (ng/mL) 8.25 9.50 (53) 8.41 9.64 (52) 98 T max * (h) 5.72 (6.74) 4.72 (4.31) - T 1/2 * (h) 20.20 (12.17) 20.24 (10.48) - * For the T max and T 1/2 parameters these are the arithmetic means (standard deviation). Pharmacokinetic Indices for Cis-Doxepin: Geometric Mean Arithmetic Mean (C.V.) NOVO-DOXEPIN (1 x 150 mg) SINEQUAN ® (1 x 150 mg) Percentage of SINEQUAN ® AUC T (ng·h/mL) 51.42 62.42 (68) 54.05 64.22 (62) 95 AUC I (n read_full_document