LOXALATE escitalopram oxalate 5mg tablets bottles

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

escitalopram oxalate, Quantity: 6.39 mg (Equivalent: escitalopram, Qty 5 mg)

Available from:

Alphapharm Pty Ltd

INN (International Name):

escitalopram oxalate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; purified talc; magnesium stearate; croscarmellose sodium; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000

Administration route:

Oral

Units in package:

28 tablets, 30 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: 5.5mm normal convex white film coated tablet debossed "EC" over 5 on one side and "G" on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2008-05-22

Summary of Product characteristics

LOXALATE – PRODUCT INFORMATION
1
LOXALATE
_Escitalopram oxalate tablets _
_ _
1
NAME OF THE MEDICINE
Escitalopram oxalate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Escitalopram oxalate is a fine white to yellow, crystalline material.
Each tablet contains 5 mg, 10 mg or 20 mg of escitalopram (as oxalate)
as the active ingredient.
Each tablet also contains lactose monohydrate. Loxalate also contains
traces of sulfites.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Loxalate 5 mg tablets are convex, white, film-coated tablets, marked
with “EC/5” on one side and “G” on the
other side.
Loxalate 10 mg tablets are convex, white, film-coated tablets, marked
with “EC/10” on one side and “G” on
the other side.
Loxalate 20 mg tablets are convex, white, film-coated tablets, marked
with “EC/20” on one side and “G” on
the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depression.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Escitalopram should be administered as a single oral dose of 10 mg
once daily with or without food. 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.
When stopping SSRI therapy gradual dose reduction should be
considered.
ELDERLY PATIENTS (> 65 YEARS OF AGE)
A longer half-life and a decreased clearance have been demonstrated in
the elderly. 10 mg is the recommended
maximum maintenance dose in the elderly (see
SECTION 5.2 PHARMACOKINETIC PROPERTIES
and
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
CHILDREN AND ADOLESCENTS (< 18 YEA