PHL-DESIPRAMINE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DESIPRAMINE HYDROCHLORIDE

Mevcut itibaren:

PHARMEL INC

ATC kodu:

N06AA01

INN (International Adı):

DESIPRAMINE

Doz:

10MG

Farmasötik formu:

TABLET

Kompozisyon:

DESIPRAMINE HYDROCHLORIDE 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0102137004; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2009-10-26

Ürün özellikleri

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