Lepax Film-Coated Tablet 10mg

देश: सिंगापुर

भाषा: अंग्रेज़ी

स्रोत: HSA (Health Sciences Authority)

सक्रिय संघटक:

Escitalopram oxalate 12.77mg eqv escitalopram

थमां उपलब्ध:

LUNDBECK SINGAPORE PTE. LTD.

ए.टी.सी कोड:

N06AB10

डोज़:

10mg

फार्मास्यूटिकल फॉर्म:

TABLET, COATED

रचना:

Escitalopram oxalate 12.77mg eqv escitalopram 10mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

Prescription Only

द्वारा बनाया गया:

H. Lundbeck A/S

प्राधिकरण का दर्जा:

ACTIVE

प्राधिकरण की तारीख:

2010-03-31

उत्पाद विशेषताएं

Lepax
®
10 mg
Film-coated tablets Escitalopram (as oxalate)
1. NAME OF MEDICINAL PRODUCT
LEPAX 10 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lepax 10 mg: Each tablet contains 10 mg escitalopram (as 12.77 mg
escitalopram oxalate)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
Lepax 10 mg: Oval, white, scored, film-coated tablet marked with "E”
and “L" on each side of the score on
one side of the tablet.
The 10 mg tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Safety of daily doses above 20 mg has not been demonstrated.
Lepax is administered as a single daily dose and may be taken with or
without food.
Major depressive episodes
Usual dosage is 10 mg once daily. Depending on individual patient
response, the dose may be increased
to a maximum of 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response.
After the symptoms resolve,
treatment for at least 6 months is required for consolidation of the
response.
Panic disorder with or without agoraphobia
An initial dose of 5 mg is recommended for the first week before
increasing the dose to 10 mg daily. The
dose may be further increased, up to a maximum of 20 mg daily,
dependent on individual patient
response.
Maximum effectiveness is reached after about 3 months. The treatment
lasts several months.
Generalised anxiety disorder
Usual dosage is 10 mg once daily. Depending on individual patient
response, the dose may be increased
to a maximum of 20 mg daily.
Treatment for 3 months is recommended to consolidate response.
Long-term treatment of responders for
6 months has been shown to prevent relapse and can be considered on an
individual basis; treatment
benefits should be re-evaluated at regular intervals.
Obsessi