Escitalopram Oxalate Tablets USP 5mg Technical Specification:
| Product Name: | Escitalopram Oxalate Tablets USP 5mg |
| 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 5mg (Exapra)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Escitalopram Oxalate Tablets USP 5mg
Each film-coated tablet contains:
Escitalopram Oxalate USP
Equivalent to Escitalopram…………..5mg
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)
B) Escitalopram Oxalate Tablets USP 10mg (Exapra)
C) Escitalopram Oxalate Tablets USP 20mg (Exapra)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Pantoprazole Sodium Delayed Release Tablets USP 20mg
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 20mg
Excipients……………………………………….q.s.
Color: Ferric oxide yellow
B) Pantoprazole Sodium Delayed Release Tablets USP 40mg
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 40mg
Excipients……………………………………….q.s.
Color: Brilliant blue FCF
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 20mg
Excipients……………………………………….q.s.
Color: Ferric oxide yellow
B) Pantoprazole Sodium Delayed Release Tablets USP 40mg
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 40mg
Excipients……………………………………….q.s.
Color: Brilliant blue 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.
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.
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the psychiatrist.
Attach dispensing label as per end country.
