ZOLOFT TABLET 100 mg

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

SERTRALINE

Tersedia dari:

PFIZER PFE PRIVATE LIMITED

Kode ATC:

N06AB06

Dosis:

100 mg

Bentuk farmasi:

TABLET, FILM COATED

Komposisi:

SERTRALINE 100 mg

Rute administrasi :

ORAL

Jenis Resep:

Prescription Only

Diproduksi oleh:

Pfizer Manufacturing Deutschland GmbH

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

1992-11-06

Selebaran informasi

ZOLOFT* 

1. 
NAME OF MEDICINAL PRODUCT 

ZOLOFT* 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Pfizer sertraline is available as film-coated tablets for oral
administration containing 
sertraline hydrochloride equivalent to 50 mg or 100
mg sertraline. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablets. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Sertraline is indicated
for the treatment of symptoms of depression,
including depression 
accompanied by symptoms of anxiety, in patients with
or without a history of mania. 
Following satisfactory response, continuation with
sertraline therapy is effective in 
preventing relapse of the initial episode of depression
or recurrence of further depressive 
episodes. 

Sertraline is also indicated for the treatment
of obsessive compulsive disorder (OCD). 
Following initial response, sertraline
has been associated with sustained efficacy, safety 
and tolerability in up to 2 years of treatment of OCD. 

Sertraline is indicated for the treatment of panic disorder,
with or without agoraphobia. 

Sertraline is indicated for the treatment
of post-traumatic stress disorder (PTSD). 

Sertraline is indicated for the treatment of social
phobia (social anxiety disorder). 

Sertraline is indicated for the treatment
of pre-menstrual dysphoric disorder (PMDD). 

Sertraline is not indicated for use in children and
adolescents under 18 years of age (see 
section 4.4 - SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS FOR USE).

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

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Sertraline should be administered once daily, either in
the morning or evening. Sertraline 
tablets can be administered with or without food. 

INITIAL TREATMENT 

Depression and OCD – Sertraline treatment 

Karakteristik produk

ZOLOFT

1.
NAME OF MEDICINAL PRODUCT
ZOLOFT

2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pfizer sertraline is available as film-coated tablets for oral
administration containing
sertraline hydrochloride equivalent to 50 mg or 100 mg sertraline.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sertraline
is
indicated
for
the
treatment
of
symptoms
of
depression,
including
depression accompanied by symptoms of anxiety, in patients with or
without a history
of mania. Following satisfactory response, continuation with
sertraline therapy is
effective in preventing relapse of the initial episode of depression
or recurrence of
further depressive episodes.
Sertraline is also indicated for the treatment of obsessive compulsive
disorder (OCD).
Following initial response, sertraline has been associated with
sustained efficacy,
safety and tolerability in up to 2 years of treatment of OCD.
Sertraline
is
indicated
for
the
treatment
of
panic
disorder,
with
or
without
agoraphobia.
Sertraline is indicated for the treatment of post-traumatic stress
disorder (PTSD).
Sertraline is indicated for the treatment of social phobia (social
anxiety disorder).
Sertraline is indicated for the treatment of pre-menstrual dysphoric
disorder (PMDD).
Sertraline is not indicated for use in children and adolescents under
18 years of age
(see section
4.4 – SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sertraline should be administered once daily, either in the morning or
evening.
Sertraline tablets can be administered with or without food.
INITIAL TREATMENT
Depression and OCD – Sertraline treatment should be administered at
a dose of
50 mg/day.
Panic Disorder, PTSD and Social Phobia – Therapy should be initiated
at 25 mg/day.
After one week, the dose should be increased to 50 mg once daily. This
dosage
regimen has been shown to reduce the frequency of early-
treatment-emergent side
effects characteristic of panic disorder.
Pre-menstrual Dysphoric Disorde