LUVOX

Country: Indonesia

Language: Indonesian

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

Active ingredient:

FLUVOXAMINE MALEATE

Available from:

ABBOTT INDONESIA - Indonesia

INN (International Name):

FLUVOXAMINE MALEATE

Dosage:

100 MG

Pharmaceutical form:

TABLET SALUT SELAPUT

Units in package:

DUS, 2 BLISTER @ 15 TABLET SALUT SELAPUT

Manufactured by:

MYLAN LABORATORIES SAS, MAILLARD - France

Authorization date:

2016-11-28

Summary of Product characteristics

Page 1 of 12 LUVOX RDCCDS00052 V9.0 – V13.0
LUVOX
®
FLUVOXAMINE MALEATE
NAME OF THE MEDICINAL PRODUCT
Luvox
®
, film-coated tablets, 50 mg
Luvox
®
, film-coated tablets, 100 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: fluvoxamine maleate
Each tablet contains 50 mg or 100 mg of fluvoxamine maleate.
For a full list of excipients, see Section List of Excipients.
PHARMACEUTICAL FORM
Film-coated tablets 50mg
Round, biconvex, scored, white to off-white film coated tablets for
oral administration.
The tablets can be divided into equal halves.
Film-coated tablets 100mg
Oval, biconvex, scored, white to off-white film coated tablets for
oral administration.
The tablets can be divided into equal halves.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
-
Treatment of depressive illness and symptoms of depressive disorder.
-
Treatment of Obsessive Compulsive Disorder (OCD)
POSOLOGY AND METHOD OF ADMINISTRATION
Depressive illness and symptoms of depressive disorder
The recommended starting dose is 50 or 100 mg, given as single dose in
the evening. It is recommended to
increase the dose gradually until an effective dose is reached. The
usual effective dose is 100 mg per day
and should be adjusted on individual patient response. Doses of up to
300 mg per day have been given.
Dosages above 150 mg should be given in divided doses.
In agreement with the consensus statement of the WHO, antidepressant
medication should be continued for
at least 6 months after recovery from a depressive episode. Luvox
®
at a fixed single daily dose of 100 mg
is the recommended dose for the prevention of recurrence of
depression.
Obsessive Compulsive Disorder (OCD)
_Adults _
The recommended starting dose is 50 mg per day for 3 - 4 days. The
effective dosage usually lies between
100 mg and 300 mg per day. The dosage should be increased gradually
until the effective dosage is
achieved, with a maximum of 300 mg per day.
Doses up to 150 mg can be given as a single dose, preferably in the
evening. It is advisable that a total daily
dose