Escitalopram Oxalate Tablets USP 10mg Technical Specification:

Product Name:Escitalopram Oxalate Tablets USP 10mg
Brand Name:EXAPRA
Strength:5mg, 10mg, 20mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antidepressants, Central nervous system
Indication: Escitalopram is used to treat depression and anxiety.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Escitalopram Oxalate Tablets USP 10mg (Exapra)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Escitalopram Oxalate Tablets USP 10mg
    Each film-coated tablet contains:
    Escitalopram Oxalate USP
    Equivalent to Escitalopram…………..10mg
    Excipients……………………………………..q.s.
    Colour: Lake of quinoline yellow

THERAPEUTIC INDICATIONS:

Escitalopram is used to treat depression and anxiety. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Escitalopram belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRI).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning: To be sold by retail on the prescription of a psychiatrist only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Protect from light and moisture.

Dosage: As directed by the psychiatrist.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Escitalopram Oxalate Tablets USP 5mg (Exapra)
B) Escitalopram Oxalate Tablets USP 10mg (Exapra)
C) Escitalopram Oxalate Tablets USP 20mg (Exapra)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Escitalopram Oxalate Tablets USP 5mg
Each film-coated tablet contains:
Escitalopram Oxalate USP
Equivalent to Escitalopram…………….5mg
Excipients……………………………………….q.s.
Colour: Ferric oxide yellow

B) Escitalopram Oxalate Tablets USP 10mg
Each film-coated tablet contains:
Escitalopram Oxalate USP
Equivalent to Escitalopram…………..10mg
Excipients……………………………………..q.s.
Colour: Lake of quinoline yellow


C) Escitalopram Oxalate Tablets USP 20mg
Each film-coated tablet contains:
Escitalopram Oxalate USP
Equivalent to Escitalopram…………20mg
Excipients…………………………………….q.s.
Colour: Fast green FCF

THERAPEUTIC INDICATIONS:

Escitalopram is used to treat depression and anxiety. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Escitalopram belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRI).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a psychiatrist only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the psychiatrist.
Attach dispensing label as per end country.