Itraconazole Capsules BP 400mg Technical Specification:
| Product Name: | Itraconazole Capsules BP 400mg |
| Brand Name: | Generic |
| Strength: | 50mg, 65mg, 100mg, 130mg, 200mg, 400mg |
| Dosage Form: | Hard Gelatin Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 4s, 7s, 10s, 40s, 70s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antifungal |
| Indication: | To treat variety of yeast and fungal infections |
| Storage: | Store between 15° to 30°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Itraconazole Capsules BP 50mg
Itraconazole Capsules BP 65mg
Itraconazole Capsules BP 100mg
Itraconazole Capsules BP 130mg
Itraconazole Capsules BP 200mg
Itraconazole Capsules BP 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Itraconazole Capsules BP 400mg
Each Hard Gelatin Capsule Contains:
Itraconazole BP……………….400mg
Excipients…………………………Q.S.
Approved colours used in empty capsule shells.
INDICATIONS:
Itraconazole capsule is used to treat yeast and fungal infections, such as aspergillosis (fungal infection in the lungs), blastomycosis (Gilchrist’s disease), histoplasmosis (Darling’s disease), Coccidioidomycosis and paracoccidioidomycosis.
CAUTION & SCHEDULE:
CAUTION:
Keep medicine out of reach of children.
Do not open, chew or crush the capsule. Capsule should be swallowed whole with water.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.
STORAGE & DOSAGE:
STORAGE: Store between 15° to 30°C. Protect from direct light and moisture.
DOSAGE: As directed by the Physician.
For optimal absorption, Itraconazole capsules should be taken immediately after a full meal.