PT. Dexa Medica, Indonesia

DEXA

Itraconazole

100 mg

36 months

Hard Capsules

Box of 3 blisters x 4 hard capsules

VN-22669-20

31/12/2020

Systemic antifungal drug, triazole derivative

Itraconazole capsules are indicated for the treatment of the following diseases:
• Gynecology:
- Vaginal - vulvar Candida infection.
• Skin/mucosal/ophthalmic:
- Fungal skin infections;
- Tinea versicolor;
- Candida infection in the mouth;
- Fungal keratitis.
• Onychomycosis caused by Dermatophyte and/or yeast.
• Systemic fungal:
- Systemic fungal infections caused by Aspergillus and Candida;
- Cryptococcus infections (including Cryptococcus meningitis): in immunocompromised patients with Cryptococcal infection and all patients with central nervous system Cryptococcus infection, use itraconazole only when initial therapy is inappropriate or proven ineffective;
- Histoplasma fungal infection;
- Blastomyces fungal infection;
- Sporothrix fungal infection;
- Paracoccidioides fungal infection;
- Other rare systemic or tropical fungal infections.

Take itraconazole capsules immediately after a full meal to achieve maximum absorption.
Capsules must be swallowed whole.
Gynecology:
For the treatment of vulvovaginal candidiasis, the medication can be used in two ways:
- 200 mg twice daily for 1 day, or 200 mg once daily for 3 days.
Dermatological/Mucosal/Ophthalmological Infections:
- For dermatophytosis, itraconazole can be used at 200 mg once daily or 100 mg once daily for 7 or 15 days.
- For highly keratinized areas such as the soles of the feet or palms, the treatment dosage may be 200 mg twice daily or 100 mg once daily, for 7 to 30 days.
- For tinea versicolor, use 200 mg once daily for 7 days.
- For oral candidiasis, the dose is 100 mg once daily for 15 days.
In some immunocompromised patients (such as those with neutropenia, AIDS, or organ transplant recipients), the oral bioavailability of itraconazole capsules may be reduced. Therefore, the dose should be doubled.
- In cases of fungal keratitis, the treatment dose is 200 mg once daily for 21 days. Treatment duration should be adjusted based on clinical response.
Onychomycosis (nail infections caused by dermatophytes and/or yeasts):
There are two treatment options: pulse therapy or continuous therapy.
1. Pulse Therapy:
One treatment cycle consists of two capsules (200 mg), taken twice daily for 1 week.
Two cycles are used for fingernail infections.Three cycles are used for toenail infections. There is a 3-week drug-free interval between cycles. Clinical response becomes evident as the nail grows back after therapy ends.
Toenail onychomycosis (with or without fingernail involvement):
Week 1: Cycle 1
Weeks 2–4: No medication
Week 5: Cycle 2
Weeks 6–8: No medication
Week 9: Cycle 3
Fingernail onychomycosis only:
Week 1: Cycle 1
Weeks 2–4: No medication
Week 5: Cycle 2
2. Continuous Therapy:
Use 200 mg once daily for 3 months for toenail onychomycosis, with or without fingernail involvement.
Itraconazole is eliminated more slowly from skin and nails than from plasma.
Optimal clinical and mycological response is typically achieved 2 to 4 weeks after completing treatment for skin infections, and 6 to 9 months after completing nail treatment.
Systemic Mycoses:
- Aspergillosis: 200 mg once daily for 2 to 5 months. In invasive or disseminated cases, the dose can be increased to 200 mg twice daily.
- Candidiasis: Recommended dose is 100 to 200 mg once daily for 3 weeks to 7 months. In disseminated or invasive cases, dose may be increased to 200 mg twice daily.
- Non-meningeal cryptococcosis: 200 mg once daily for 2 months to 1 year.
- Cryptococcal meningitis: Requires a higher dose of 200 mg twice daily for 2 months to 1 year. For maintenance therapy, refer to Warnings and Precautions.
- Histoplasmosis: 200 mg once or twice daily for about 8 months.
- Blastomycosis: Dosage ranges from 100 mg once daily to 200 mg twice daily for 6 months.
- Sporotrichosis of skin and lymphatic system: 100 mg once daily for 3 months.
- Paracoccidioides brasiliensis infection: 100 mg once daily for 6 months. However, there are no data on the efficacy of itraconazole capsules at this dose for treating Paracoccidioides brasiliensis in AIDS patients.
-Dematiaceous fungal infections: 100 to 200 mg once daily for 6 months.
Treatment duration should be adjusted based on clinical response.