Inosert-50 (Sertraline Tablets 50 mg)

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

SERTRALINE HYDROCHLORIDE

Dostopno od:

Neshdwara Services

INN (mednarodno ime):

SERTRALINE HYDROCHLORIDE

Enote v paketu:

28tablet Tablets

Izdeluje:

IPCA LABORATORIES LIMITED

Lastnosti izdelka

MALAYSIA
In-house
P:\Art Work Data\Open Artworks\Inosert\Malaysia
SIZE: 4 0 X 120 MM
0
Ph Code: 5050 STD
_For the use only of a Registered Medical Practitioner or a Hospital
or_
_a Laboratory_
Inosert
Sertraline Tablets
DESCRIPTION
Sertraline is a selective serotonin reuptake inhibitor (SSRI) for oral
administration. Sertraline hydrochloride has the following chemical
name: (1S-cis) – 4 - (3,4 - dichlorophenyl) - 1,2,3,4 – tetrahydro
–N-
methyl-1-naphthalenamine hydrochloride. The empirical formula is
C H NCl HCl with molecular weight of 342.7 (free base 306.2).
17
17
2
COMPOSITION
INOSERT-50
Each film-coated tablet contains:
Sertraline Hydrochloride
equivalent to Sertraline 50 mg
INOSERT-100
Each film-coated tablet contains:
Sertraline Hydrochloride
equivalent to Sertraline 100mg
PRODUCT DESCRIPTION
INOSERT-50: White to off white, caplet shaped,
biconvex, film coated
tablets.
INOSERT-100:
White to off
white,
caplet
shaped,
biconvex,
film
coated tablets.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Sertraline inhibits the CNS neuronal
uptake of
serotonin (5HT).
Sertraline also blocks the uptake of serotonin into human platelets.
Sertraline is a potent and selective inhibitor of neuronal
serotonin
reuptake and has only very weak effects on norepinephrine and
dopamine neuronal
reuptake.
Sertraline's inhibition of
serotonin
reuptake enhances serotonergic transmission,
which results in
subsequent inhibition of adrenergic activity in the locus ceruleus.
Sertraline has no affinity for muscarinic, serotonergic, dopaminergic
adrenergic, histaminergic, GABA or benzodiazepine receptors. It is
devoid of
stimulant,
sedative or
anticholinergic activity or
cardiotoxicity in animals.
PHARMACOKINETICS
Sertraline appears to be slowly but well absorbed from the GI tract
following oral
administration with peak plasma concentrations
occurring about 4.5 to 8.4 hours
after ingestion. Area under the
plasma concentration time curve (AUC)
was slightly increased
when drug was administered with food but the C
was 25% greater,
max
while the