Estopram escitalopram (as oxalate) 10mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

escitalopram oxalate, Quantity: 12.78 mg (Equivalent: escitalopram, Qty 10 mg)

Disponível em:

Micro Labs Pty Ltd

DCI (Denominação Comum Internacional):

escitalopram oxalate

Forma farmacêutica:

Tablet, film coated

Composição:

Excipient Ingredients: purified talc; silicified microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000

Via de administração:

Oral

Unidades em pacote:

28 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Treatment of major depression.,Treatment of social anxiety disorder (social phobia).,Treatment of generalised anxiety disorder.,Treatment of obsessive-compulsive disorder.

Resumo do produto:

Visual Identification: White to off-white, capsule shaped, biconvex, film-coated tablets engraved with 10 on one face and break line on the other face.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Licence status A

Data de autorização:

2017-03-14

Características técnicas

AUSTRALIAN PRODUCT INFORMATION ESTOPRAM (ESCITALOPRAM
OXALATE) TABLETS
1. NAME OF THE MEDICINE
Escitalopram oxalate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ESTOPRAM tablets 10 mg and 20 mg: Film-coated tablets containing 10 mg
and 20 mg
escitalopram (as oxalate)
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
ESTOPRAM 10 mg tablets are white to off-white, capsule shaped,
biconvex, film-coated tablets
engraved with 10 on one face and break line on the other face.
ESTOPRAM 20 mg tablets are white to off-white, capsule shaped,
film-coated, biconvex tablets, engraved with 20 on one face and break
line on the other face.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
ADULTS
Escitalopram is administered as a single oral dose and may be taken
with or without food.
_Major depression _
Usually 2 - 4 weeks are necessary for antidepressant response. 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 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.
_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 therefore warranted to
consolidate response and
prevent relapse.
_Generalised anxiety disorder _
The recommended dose is 10 mg once daily. Depending on individual
patient response,