Medieos Lifesciences LLP

Itraconazole Capsules and Tablets are broad-spectrum azole antifungal agents widely used in India for the treatment and prevention of systemic, superficial, and invasive fungal infections. These include dermatophytoses, onychomycosis, candidiasis, aspergillosis, blastomycosis, and histoplasmosis.
10. WARNINGS AND PRECAUTIONS

• Monitor liver function tests for prolonged therapy

• Adjust dose in hepatic impairment

• Use caution in patients with heart failure

• Avoid concomitant use with CYP3A4 inhibitors/inducers without monitoring

• Use cautiously in pregnancy and lactation

11. CONTRAINDICATIONS

• Hypersensitivity to itraconazole or excipients

• Severe hepatic impairment

• Co-administration with drugs causing QT prolongation

• Empiric use in critically ill patients without confirmed fungal infection

12. DRUG INTERACTIONS

• CYP3A4 inhibitors (ketoconazole, erythromycin) → increase itraconazole levels

• CYP3A4 inducers (rifampicin, phenytoin) → decrease efficacy

• Statins → increased myopathy risk

• Warfarin → monitor INR

• Herbal supplements (St. John’s Wort, grapefruit juice) → reduced efficacy

13. USE IN SPECIAL POPULATIONS Pregnancy

• Category C (use only if benefits outweigh risk)

Breastfeeding

• Avoid or monitor infant exposure

Pediatric

• Weight-based dosing under specialist supervision

Elderly

• Adjust dose for hepatic or renal impairment

14. STORAGE AND HANDLING

• Store at 25°C or below

• Protect from moisture, heat, and light

• Keep in original packaging

• Keep out of reach of children

• Do not use past expiry date

FREQUENTLY ASKED QUESTIONS (FAQ) Q1. What are Itraconazole Capsules and Tablets used for?

Treat systemic, superficial, and invasive fungal infections in hospitals and clinics.

Q2. How does itraconazole work?

By inhibiting fungal ergosterol synthesis, disrupting cell membrane integrity.

Q3. Can itraconazole treat nail infections?

Yes, with long-term therapy, particularly for onychomycosis.

Q4. How long before improvement is seen?

Skin infections: 1–4 weeks; nail or systemic infections: several months.

Q5. Are there side effects?

Common: nausea, diarrhea, headache; rare: hepatotoxicity, QT prolongation.

Q6. Can it be used in pregnancy?

Only under specialist supervision if benefits outweigh risks.

Q7. Can children take itraconazole?

Yes, with weight-based dosing under supervision.

Q8. Should itraconazole be taken with food?

Capsules: with meals; tablets: with or without meals.

Q9. Can itraconazole interact with other medications?

Yes, especially CYP3A4 inhibitors/inducers, statins, and warfarin.

Q10. Is long-term therapy safe?

Yes, with regular liver function monitoring.

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