| Product Name: | Ketoconazole Tablets USP |
| Brand Name: | Generic |
| Strength: | 200mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antifungal |
| Indication: | Ketoconazole is an antifungal medicine. It’s used to treat skin infections caused by a fungus (yeast). It can also prevent them coming back. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ketoconazole Tablets USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ketoconazole Tablets USP 200mg
Each uncoated tablet contains:
Ketoconazole USP………………..200mg
Excipients…………………………….q.s.
Colour: Ferric Oxide Yellow
THERAPEUTIC INDICATIONS:
Ketoconazole is used to treat skin infections such as athlete’s foot, jock itch, ringworm, and certain kinds of dandruff. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Ketoconazole is an azole antifungal that works by preventing the growth of fungus.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Ketoconazole has been associated with hepatic toxicity including some fatalities. Patient receiving this drug should be informed of the risk and should be closely monitored.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Dermatologist/Gynaecologist.