Ipca-Escitalopram Tablets

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Escitalopram oxalate 6.37mg equivalent to Escitalopram 5 mg

Disponible depuis:

Ipca Pharma (NZ) Pty Limited

DCI (Dénomination commune internationale):

Escitalopram oxalate 6.37 mg (equivalent to Escitalopram 5 mg)

Dosage:

5 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Escitalopram oxalate 6.37mg equivalent to Escitalopram 5 mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Macrogol 400 Magnesium stearate Microcrystalline cellulose Purified talc   Purified water Titanium dioxide

Type d'ordonnance:

Prescription

Fabriqué par:

Neuland Laboratories Limited

indications thérapeutiques:

In adults: Treatment of major depression. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, PVDC/PVC/Aluminium - 14 tablets - 48 months from date of manufacture stored at or below 30°C. Keep in a dry place - Blister pack, PVDC/PVC/Aluminium - 28 tablets - 48 months from date of manufacture stored at or below 30°C. Keep in a dry place - Blister pack, PVDC/PVC/Aluminium - 56 tablets - 48 months from date of manufacture stored at or below 30°C. Keep in a dry place - Blister pack, PVDC/PVC/Aluminium - 98 tablets - 48 months from date of manufacture stored at or below 30°C. Keep in a dry place

Date de l'autorisation:

2015-08-03

Résumé des caractéristiques du produit

NEW ZEALAND DATA SHEET
IPCA-ESCITALOPRAM
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 1
1.
IPCA-ESCITALOPRAM
(5MG, 10MG&20MG FILM COATED TABLETS)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Escitalopram5mg, 10mg or 20mg (as oxalate)
Chemical Structure:
Chemistry
Escitalopram is the active enantiomer (s-enantiomer) of citalopram.
Escitalopram oxalate (CAS
no.219861-08-2)
is
chemically
described
as
S(+)-1-(3-dimethyl-aminopropyl)-1-(4-fluorophenyl)-
1,3dihydroisobenzofuran-5-carbonitrile
hydrogen
oxalate.
Its
empirical
formula
is
C
20
H
21
FN
2
O,
C
2
H
2
O
4
and molecular weight is 414.42.
Escitalopram
oxalate
is
a
fine
white
to
yellow,
crystalline
material
and
sparingly
soluble
in
water,slightly soluble in acetone, soluble in ethanol and freely
soluble in methanol. No polymorphic
formshave been detected.
EXCIPIENT(S) OF KNOWN EFFECT
Ipca-Escitalopram does not contain lactose and gluten.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
IPCA-ESCITALOPRAM 5mg tablets are white to off-white, circular,
biconvex film coated tablets with
‘C5’ embossed on one side and plain on other side.
IPCA-ESCITALOPRAM 10mg tablets are white to off-white, oval, biconvex
film coated tablets with ‘C4’
embossed on one side and a notch break-line on other side.
IPCA-ESCITALOPRAM 20mg tablets are white to off-white, oval, biconvex
film coated tablets with ‘C3’
embossed on one side and a notch break-line on other side
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.
IPCA-ESCITALOPRAM
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 2
4.2 DOSE AND METHOD OF ADMINISTRATION
Escitalopram is administered as a single daily dose and may be taken
with or without food.
DOSE
ADULTS
MAJOR DEPRESSION
The recommended dose is 10mg once daily. Depending on