Itraconazole Capsules USP 100mg Technical Specification:
| Product Name: | Itraconazole Capsules USP |
| Brand Name: | Generic |
| Strength: | 100mg |
| Dosage Form: | Hard Gelatin Capsules |
| Route of Administration: | Via Oral Route |
| Packing: | 30s, 300s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Antifungal, Antibiotic |
| Indication: | To treat Fungal Infection |
| Storage: | Store between 15°C to 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Itraconazole Capsules USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Itraconazole Capsules USP 100mg
Each Hard Gelatin Capsule Contains:
Itraconazole USP……….100mg
(As Itraconazole Pellets)
THERAPEUTIC INDICATIONS:
This medication is used in the treatment of Aspergillosis, Cryptococcosis, Candidiasis, Mycosis and Sporotrichosis.
CAUTION & WARNING:
Keep medicine out of reach of children.
To be sold by retail on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
Storage: Store at controlled Room Temperature 15°C to 25°C (59°F to 77°F).
Dosage: See accompanying product literature.