Страна: Канада
Язык: английский
Источник: Health Canada
DESIPRAMINE HYDROCHLORIDE
PHARMEL INC
N06AA01
DESIPRAMINE
10MG
TABLET
DESIPRAMINE HYDROCHLORIDE 10MG
ORAL
100
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0102137004; AHFS:
CANCELLED POST MARKET
2009-10-26
PRODUCT MONOGRAPH PR PHL-DESIPRAMINE (Desipramine Hydrochloride Tablets, USP) 10 mg, 25 mg, 50 mg, 75 mg and 100 mg ANTIDEPRESSANT PHARMEL INC. DATE OF PREPARATION: 8699 8th AVENUE December 6, 2004 MONTREAL, QUEBEC DATE OF REVISION : H1Z 2X4 CONTROL #: 095607 2 PRODUCT MONOGRAPH PR PHL-DESIPRAMINE (Desipramine Hydrochloride Tablets, USP) 10 mg, 25 mg, 50 mg, 75 mg and 100 mg THERAPEUTIC CLASSIFICATION Antidepressant ACTION/CLINICAL PHARMACOLOGY Desipramine Hydrochloride is a trycyclic antidepressant with actions and uses similar to those of the other tricyclic compounds. It is the principal active metabolite of imipramine and as such, shares many of imipramine's pharmacological effects. Untoward effects are similar to those produced by imipramine, but its anticholinergic and sedative actions have been found to be less pronounced. Desipramine Hydrochloride has been found to cause ECG changes such as prolongation of the P-R interval and a decreased magnitude with an increased width of the T wave. These ECG changes were seen most frequently in elderly patients as is postural hypotension. Desipramine Hydrochloride has been known to lower the convulsive threshold. Desipramine HCl has been shown to increase the percentage of Stage 4 sleep (deep sleep) and decrease the percentage of REM sleep. A partial recovery of REM sleep has been seen after 3 to 5 weeks of drug administration. In spite of this recovery, it has been observed that a REM rebound occurred following rapid drug withdrawal, which was experienced as an increase in dreaming. 3 However, the significance of these effects on the sleep cycle has not yet been clarified. As an early manifestation of the effects of Desipramine Hydrchloride, an increase in psychomotor activity has been observed; however a significant antidepressant effect should not be expected before the end of the second week. Paths of metabolism of Desipramine Hydrochloride include hydroxylation, N-oxidation, and conjugation with glucuronic acid. Desipramine Hydrochloride is easily absorbed follo Прочитать полный документ