Itraconazole Capsules 100mg Technical Specification:

Product Name:Itraconazole Capsules 100mg
Brand Name:Preventfung
Strength:100mg, 200mg, 400mg
Dosage Form:Capsules (Hard gelatin)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
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 below 30 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Itraconazole Capsules 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Itraconazole Capsules 100mg
    Each hard gelatin Capsule contains:
    Itraconazole BP …………………100mg
    (As Pallets)
    Excipients ………………………. q.s.
    Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Itraconazole is an antifungal medication used to treat a number of fungal infections. This includes aspergillosis, blastomycosis, coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis. It may be given by mouth or intravenously.

CAUTION & SCHEDULE:

CAUTION:  Terfenadine or Astemizole should not be taken simultaneously when the patient is on this medication.

Keep medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH

FOR OPTIMAL ABSORPTION, ITRACONAZOLE CAPSULES SHOULD BE TAKEN IMMEDIATELY AFTER A FULL MEAL.

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A registered medical practitioner.

Read enclosed leaflet before use.

STORAGE & DOSAGE:

Storage: Store below 30 °C.

Protect from Light and moisture.

Dosage: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Itraconazole Capsules 100mg
B. Itraconazole Capsules 200mg
C. Itraconazole Capsules 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Itraconazole Capsules 100mg
Each hard gelatin Capsule contains:
Itraconazole BP …………………100mg
(As Pallets)
Excipients ………………………. q.s.
Approved colours used in capsule shells.


B. Itraconazole Capsules 200mg
Each hard gelatin Capsule contains:
Itraconazole BP ………………….200mg
(As Pallets)
Excipients ………………………. q.s.
Approved colours used in capsule shells.

C. Itraconazole Capsules 400mg
Each hard gelatin Capsule contains:
Itraconazole BP………………….400mg
(As Pallets)
Excipients …………………………… q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Itraconazole is an antifungal medication used to treat a number of fungal infections. This includes aspergillosis, blastomycosis, coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis. It may be given by mouth or intravenously.

CAUTION & SCHEDULE:

CAUTION: Terfenadine or Astemizole should not be taken simultaneously when the patient is on this medication.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
FOR OPTIMAL ABSORPTION, ITRACONAZOLE CAPSULES SHOULD BE TAKEN IMMEDIATELY AFTER A FULL MEAL.
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
Read enclosed leaflet before use.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light and moisture.
Dosage: As directed by the Physician.