SUBA Itraconazole is a systemic triazole antifungal with superior bioavailability, developed using advanced SUBA Technology.
SUBA Itraconazole 65 mg capsule is a systemic triazole antifungal with superior bioavailability, developed using advanced SUBA Technology. It selectively inhibits fungal lanosterol 14-α-demethylase (CYP51), blocking ergosterol synthesis and weakening the fungal cell membrane. This results in loss of membrane integrity and effective suppression of fungal growth. Its pH-independent, predictable absorption delivers higher, consistent exposure at a lower dose—ensuring reliable efficacy and better patient outcomes.
Eloza SB Capsule: Each capsule contains Itraconazole BP 65 mg in Superbioavailable (SUBA) form.
Eloza SB is used for the treatment of oropharyngeal candidiasis, vulvovaginal candidiasis, pityriasis versicolor, tinea pedis, tinea cruris, tinea corporis, tinea manuum, onychomycosis, histoplasmosis. It is indicated in the treatment of systemic candidiasis, aspergillosis, and cryptococcosis (including cryptococcal meningitis). It is also used for maintenance therapy in AIDS patients to prevent relapse of underlying fungal infections and in the prevention of fungal infection during prolonged neutropenia.
Itraconazole must be administered with food. Swallow the capsule whole without chewing, crushing or breaking it.
For non-systemic fungal diseases:
|
Indication |
Dose and Duration |
|
Tinea Corporis & Tinea Cruris |
65 mg capsule once daily for 15 days or twice daily for 7 days. |
|
Tinea Pedis & Tinea Manuum |
65 mg capsule daily for 30 days. |
|
Vulvovaginal Candidiasis |
130 mg (2x65 mg capsules) twice daily for 1 day. |
|
Pityriasis Versicolor |
130 mg (2x65 mg capsules) twice daily for 7 days. |
|
Oropharyngeal Candidiasis |
65 mg capsule once daily for 15 days, increase dose to 65 mg twice daily for 15 days. |
|
Onychomycosis (toenails with or without fingernail involvement) |
Either 65 mg capsule twice daily for 3 months or course (pulse) of 130 mg (2x65 mg capsules) twice daily for 7 days; subsequent courses repeated after 21 days interval. Fingernails are two courses; toenails are three courses. |
For systemic fungal diseases:
|
Indication |
Dose and Duration |
|
Aspergillosis |
65 mg capsules twice daily for 2-5 months. Increase dose to 130 mg (2x65 mg capsules) twice daily in case of invasive or disseminated disease. |
|
Candidiasis |
65-130 mg once daily for 3 weeks -7 months. Increase dose to 65 mg twice daily in case of invasive or disseminated disease. |
|
Non- meningeal Cryptococcosis |
65 mg capsule twice daily for 10 weeks. |
|
Cryptococcal Meningitis |
130 mg (2x65 mg capsules) twice daily for 2-6 months. |
|
Histoplasmosis |
130 mg (2x65 mg capsules) once or twice daily for 8 months. |
|
Prophylaxis in neutropenia |
65 mg capsule twice daily until immune recovery. |
|
Maintenance in AIDS |
65 mg capsule twice daily until immune recovery. |
The dose and duration of treatment for systemic antifungal disease should be adjusted depending on the clinical response.
Itraconazole is contraindicated in patients with known hypersensitivity to the drug. Co-administration of certain drugs that are metabolized by human CYP3A4 substrates are contraindicated with Itraconazole. Co-administration with colchicine, fesoterodine and solifenacin are contraindicated in subjects with varying degrees of renal or hepatic impairment.
Physicians should carefully review the risks and benefits of Itraconazole for patients with evidence of Congestive Heart Failure. If clinical signs or symptoms of hepatotoxicity develop that are consistent with liver disease, discontinue treatment and perform testing for liver disease. Concomitant administration of the drugs like Pimozide, Methadone, or Quinidine with oral Itraconazole is contraindicated.
Overdose: Itraconazole is not removed by dialysis. In the event of accidental overdosage, supportive measures should be employed. Activated charcoal may be given if considered appropriate.
Most common side effects of Itraconazole are nausea, rash, vomiting, swelling, headache, diarrhea, fatigue, fever, itching, hypertension, abnormal hepatic function, abdominal pain, dizziness, loss of appetite, decreased libido, somnolence etc.
Itraconazole is mainly metabolized through CYP3A4. Other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of Itraconazole. The drugs like Terfenadine, Astemizole, Cisapride, HMG-CoA reductase inhibitors such as Simvastatin, oral Midazolam or triazolam should not be given concurrently with Itraconazole. Significant interactions are also observed during co-administration of Rifampin, Phenytoin, Phenobarbital, Digoxin, and Calcium channel blockers.
Use in Pregnancy and Lactation: Itraconazole is contraindicated in pregnancy. Breastfeeding while receiving Itraconazole is not recommended.
Use in Children: The efficacy and safety of Itraconazole have not been established in pediatric patients.
Use in Geriatric Patients: Itraconazole should be used with care in elderly patients.
Eloza SB Capsule: Each box contains 30 capsules in alu-alu blister pack.
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