Escitalopram

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Escitalopram oxalate 25.548mg equivalent to 20 mg escitalopram

Disponible des:

Multichem NZ Limited

Designació comuna internacional (DCI):

Escitalopram oxalate 25.548 mg (= 20 mg escitalopram)

Dosis:

20 mg

formulario farmacéutico:

Film coated tablet

Composición:

Active: Escitalopram oxalate 25.548mg equivalent to 20 mg escitalopram Excipient: Croscarmellose sodium Magnesium stearate Maize starch Mannitol Microcrystalline cellulose Opadry white 04F58804

Unidades en paquete:

Blister pack, PVC/PVdC/Al foil, 28 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Cipla Ltd

indicaciones terapéuticas:

Treatment of major depression.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al foil - 28 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture

Data d'autorització:

2010-04-06

Fitxa tècnica

NEW ZEALAND DATA SHEET
ESCITALOPRAM
Page 1 of 27
1
NAME OF THE MEDICINE
Escitalopram 10 mg film-coated tablets.
Escitalopram 20 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Escitalopram 10 mg:
Each film-coated tablet contains 10 mg escitalopram (as oxalate).
Escitalopram 20 mg:
Each film-coated tablet contains 20 mg escitalopram (as oxalate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Escitalopram 10 mg film-coated tablets:
White, round, biconvex, film coated tablets with E10 debossed on one
side and breakline on the
other side.
Escitalopram 20 mg film-coated tablets:
White, round, biconvex, film coated tablets with E20 debossed on one
side and breakline on the
other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications in adults
Treatment of major depression.
Treatment of social anxiety disorder (social phobia).
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder.
4.2
Dose and method of administration
Escitalopram is administered as a single daily dose and may be taken
with or without food.
Adults
Major Depression
The recommended dose 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
for
antidepressant
response,
although
the
onset
of
therapeutic effect may be seen earlier. The treatment of a single
episode of depression requires
treatment over the acute and the medium term. After the symptoms
resolve during acute
treatment, a period of consolidation of the response is required.
Therefore, treatment of a
depressive episode should be continued for a minimum of 6 months.
NEW ZEALAND DATA SHEET
ESCITALOPRAM
Page 2 of 27
Social anxiety disorder
The recommended dose is 10 mg once daily. Depending on individual
patient response, the
dose may be increased to a maximum of 20 mg daily. Social anxiety
disorder is a disease with a
chronic course and long-term treatment is the