MYLAN-SERTRALINE CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Διαθέσιμο από:

MYLAN PHARMACEUTICALS ULC

Φαρμακολογική κατηγορία (ATC):

N06AB06

INN (Διεθνής Όνομα):

SERTRALINE

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0123417001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2018-03-09

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
PR
MYLAN-SERTRALINE
(sertraline hydrochloride)
25 mg, 50 mg, and 100 mg Capsules
ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT
MYLAN PHARMACEUTICALS ULC
85 Advance Rd.
Toronto, ON
M8Z 2S6
Date of Revision: August 29, 2018
Control number: 218939
2
NAME OF DRUG
PR
MYLAN-SERTRALINE
(sertraline hydrochloride)
25 mg, 50 mg and 100 mg Capsules
THERAPEUTIC CLASSIFICATION
Antidepressant – Antipanic – Antiobsessional Agent
ACTION
The mechanism of action of sertraline is presumed to be linked to its
ability to inhibit the
neuronal reuptake of serotonin. It has only very weak effects on
norepinephrine and
dopamine neuronal reuptake. At clinical doses, sertraline blocks the
uptake of serotonin
into human platelets.
Like most clinically effective antidepressants, sertraline
downregulates brain
norepinephrine and serotonin receptors in animals. In receptor binding
studies, sertraline
has no significant affinity for adrenergic (_alpha_
_1_
_, alpha_
_2_
_, & beta_), cholinergic, GABA,
dopaminergic, histaminergic, serotonergic (5-HT1A, 5-HT1B, 5-HT2) or
benzodiazepine
binding sites.
In placebo-controlled studies in normal volunteers, sertraline
hydrochloride did not cause
sedation and did not interfere with psychomotor performance.
PHARMACOKINETICS: Following multiple oral once-daily doses of 200 mg,
the mean peak
plasma concentration (C
max
) of sertraline is 0.19 µg/mL occurring between 6 to 8 hours
post-dose. The area under the plasma concentration time curve is 2.8
mg hr/l. For
desmethylsertraline, C
max
is 0.14 µg/mL, the half-life 65 hours and the area under the
curve 2.3 mg hr/l. Following single or multiple oral once-daily doses
of 50 to 400
mg/day the average terminal elimination half-life is approximately 26
hours. Linear dose
proportionality has been demonstrated over the clinical dose range of
50 to 200 mg/day.
Food appears to increase the bioavailability by about 40%: it is
recommended that
MYLAN-SERTRALINE be administered with meals.
Sertraline is extensively metabolized to N-desmethy