Itraconazole Capsules Technical Specification:
| Product Name: | Itraconazole Capsules 50mg |
| Brand Name: | Generic |
| Strength: | 50mg, 100mg, 130mg, 200mg |
| Dosage Form: | Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 10s,15s, 40s, 60s, 100s, 120s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet),SmPC (Summary Product Characteristic) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antifungal |
| Indication: | Itraconazole capsule is used to treat fungal infections, such as aspergillosis (fungal infection in the lungs), blastomycosis (Gilchrist’s disease), or histoplasmosis (Darling’s disease). |
| Storage: | Store at dry place, temperature not exceed than 30℃, protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Itraconazole 50mg Capsule
Itraconazole 100mg Capsule
Itraconazole 130mg Capsule
Itraconazole 200mg Capsule
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A)Each hard gelatin capsule contains:
Itraconazole IP …………….50mg
Eq. ………………………………Q.S.
Colour: Approved Colour used in Capsule Shell.
THERAPEUTIC INDICATIONS:
Itraconazole capsule is used to treat fungal infections, such as aspergillosis (fungal infection in the lungs), blastomycosis (Gilchrist’s disease), or histoplasmosis (Darling’s disease).
CAUTION & SCHEDULE:
Keep out of reach of children.
Swallowed whole capsule, do not open, chewed or crushed.
Co- administration of drugs which cause Qtc, prolongation are relatively or absolutely contraindicated with itraconazole.
Itraconazole should not be administered for treatment of onychomycosis in patients with evidence of history of ventricular dysfunction.
SCHEDULE: H DRUG: WARNING: Not sold by retail without prescription of the Specialist Only.
STORAGE & DOSAGE:
Storage: Store at dry place, temperature not exceed than 30℃, protected from light.
Dosage: As directed by Physician.