| Product Name: | Escitalopram Tablets USP |
| 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 Tablets USP 5mg
- Escitalopram Tablets USP 10mg
- Escitalopram Tablets USP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Escitalopram Tablets USP 5mg
Each film-coated tablet contains:
Escitalopram Oxalate USP
Equivalent to Escitalopram…………….5mg
Excipients……………………………………….q.s.
Colour: Ferric oxide yellow. - Escitalopram Tablets USP 10mg
Each film-coated tablet contains:
Escitalopram Oxalate USP
Equivalent to Escitalopram…………..10mg
Excipients……………………………………..q.s.
Colour: Lake of quinoline yellow - Escitalopram 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 the enclosed leaflet before use.
Keep the 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 a tight container. Protect from light and moisture.
Dosage: As directed by the psychiatrist.
