Itraconazole Sustained Release Tablet 400mg Technical Specification:
| Product Name: | Itraconazole Sustained Release Tablet 400mg |
| Brand Name: | Generic |
| Strength: | 400mg |
| Dosage Form: | SR Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 4s, 7s, 10s, 40s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antifungal, Antibiotic |
| Indication: | To treat Fungal Infection |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Itraconazole Sustained Release Tablet 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Itraconazole Sustained Release Tablet 400mg
Each Film Coated Sustained Release Tablet Contains:
Itraconazole IP……….400mg
Excipients……….………Q.S.
THERAPEUTIC INDICATIONS:
This medication is used in the treatment of Aspergillosis, Cryptococcosis, Candidiasis, Mycosis and Sporotrichosis.
CAUTION & SCHEDULE:
CAUTION:
Tablet should be swallowed whole and not to be chewed or crushed.
Keep medicine out of reach of children.
Terfenadine or Astemizole should not be taken simultaneously when the patient is on this medication.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.
STORAGE & DOSAGE:
Storage: Must be stored in a cool, dry & dark place below 30°C.
Protect from direct sunlight, heat & moisture.
Dosage: As directed by the Physician.
For optimal absorption, Itraconazole should be taken immediately after full meal.