SEROQUEL

País: Indonèsia

Idioma: indonesi

Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

ingredients actius:

QUETIAPINE FUMARATE

Disponible des:

ASTRAZENECA INDONESIA - Indonesia

Designació comuna internacional (DCI):

QUETIAPINE FUMARATE

Dosis:

28.72 Mg

formulario farmacéutico:

TABLET SALUT SELAPUT

Unidades en paquete:

DUS, 6 BLISTER @ 10 TABLET SALUT SELAPUT

Fabricat per:

ASTRAZENECA PHARMACEUTICAL CO. LTD - China

Data d'autorització:

2019-09-13

Fitxa tècnica

1
SEROQUEL

_quetiapine fumarate_
FILM-COATED TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEROQUEL 25
mg contains 25
mg quetiapine (as quetiapine fumarate).
SEROQUEL 100
mg contains 100
mg quetiapine (as quetiapine fumarate).
SEROQUEL 200
mg contains 200
mg quetiapine (as quetiapine fumarate).
SEROQUEL 300
mg contains 300
mg quetiapine (as quetiapine fumarate).
For excipients, see _List of expicients_.
PHARMACEUTICAL FORM
Film-coated tablet.
SEROQUEL 25
mg tablets are peach coloured, round biconvex and engraved with
SEROQUEL 25 on one side.
SEROQUEL 100
mg tablets are yellow, round biconvex and engraved with SEROQUEL 100
on one side.
SEROQUEL 200
mg tablets are white, round biconvex and engraved with SEROQUEL 200
on one side.
SEROQUEL 300
mg tablets are white, capsule-shaped and engraved with SEROQUEL on
one side and 300 on the other side.
THERAPEUTIC INDICATIONS_ _
Treatment of schizophrenia
Treatment of manic episodes associated with bipolar disorder
Treatment of depressive episodes associated with bipolar disorder
POSOLOGY AND METHOD OF ADMINISTRATION
Different dosing schedules exist for each indication. It must
therefore be ensured that
patients receive clear information on the appropriate dosage for their
condition. SEROQUEL
can be administered with or without food.
ADULTS
_FOR THE TREATMENT OF SCHIZOPHRENIA_
SEROQUEL should be administered twice daily. The total daily dose for
the first 4 days of
therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg
(Day 4).
From Day 4 onwards, the dose should be titrated to the usual effective
dose range of 300 to
450
mg/day. Depending on the clinical response and tolerability of the
individual patient, the
dose may be adjusted within the range 150 to 750
mg/day._ _
_ _
_FOR THE TREATMENT OF MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER
_
SEROQUEL should be administered twice daily. As monotherapy or as
adjunct therapy to
mood stabilizers, the total daily dose for the first four days of
therapy is 100 mg (Day 1), 200
DISETUJUI OLEH BPOM : 3/12/2021