| Product Name: | Acitretin Capsule USP |
| Brand Name: | Generic |
| Strength: | 10mg, 17.5mg, 22.5mg, 25mg |
| Dosage Form: | Capsules (Hard gelatin) |
| 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: | Dermatological |
| Indication: | Acitretin is a retinoid, which is a form of vitamin A. Acitretin is used to treat severe psoriasis in adults. Acitretin is not a cure for psoriasis, and you may relapse after you stop taking this medication. Acitretin may also be used for purposes not listed in this medication guide |
| Storage: | Store at 20° to 25°C (68° to 77°F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Acitretin Capsule USP 10mg
- Acitretin Capsule USP 17.5mg
- Acitretin Capsule USP 22.5mg
- Acitretin Capsule USP 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Acitretin Capsule IP 10mg
Each Hard gelatin capsule contains:
Acitretin IP…………………………………….10mg
Excipients………………………………………..q.s. - Acitretin Capsule IP 17.5mg
Each Hard gelatin capsule contains:
Acitretin IP……………………………………17.5mg
Excipients………………………………………..q.s. - Acitretin Capsule IP 22.5mg
Each Hard gelatin capsule contains:
Acitretin IP…………………………………….22.5mg
Excipients………………………………………..q.s. - Acitretin Capsule IP 25mg
Each Hard gelatin capsule contains:
Acitretin IP…………………………………….25mg
Excipients………………………………………..q.s.
THERAPEUTIC INDICATIONS:
Acitretin is a retinoid, which is a form of vitamin A. Acitretin is used to treat severe psoriasis in adults. Acitretin is not a cure for psoriasis, and you may relapse after you stop taking this medication. Acitretin may also be used for purposes not listed in this medication guide
CAUTION & WARNING:
CAUTION: Dispense in well-closed containers.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 Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician.