Itraconazole Capsules BP 100mg Technical Specification:
| Product Name: | Itraconazole Capsules BP 100mg |
| Brand Name: | Generic |
| Strength: | 50mg, 65mg, 100mg, 130mg, 200mg, 400mg |
| Dosage Form: | Hard Gelatin Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 4s, 6s, 10s, 40s, 60s, 100s |
| 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 |
| 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 100mg
Each Hard Gelatin Capsule Contains:
Itraconazole ……………………………………………….100mg
(As Immediate Release Pellets Form)
Excipients……………………………………………Q.S.
Approved colours used in empty capsule shells & pellets
INDICATIONS:
It is used for the treatment of nosocomial pneumonia, community-acquired pneumonia, acute bacterial rhinosinusitis, acute bacterial exacerbation of chronic bronchitis, acute bacterial prostatitis, acute pyelonephritis, urinary tract infection, skin or skin structure infections, prophylaxis and treatment of plaque due to Yersinia pestis and to reduce the incidence of disease progression of inhalational anthrax.
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.