SPORANOX ORAL SOLUTION

Manufacturer
JANSSEN PHARMACEUTICA N.V.(BELGIUM)

Registraction Number
MAL19993011AZ

Content:

• Active Ingredient: Itraconazole 10 mg/mL
• Inactive Ingredients: Hydroxypropyl-β-cyclodextrin, hydrochloric acid, propylene glycol, purified water, sodium hydroxide, sodium saccharin, sorbitol, cherry flavor, caramel flavor

• Oral and Esophageal Candidosis: For HIV-positive or other immunocompromised patients.
• Prophylaxis of Deep Fungal Infections: In patients with hematological malignancy or undergoing bone marrow transplant who are expected to become neutropenic.
• Treatment of Fluconazole-Resistant Candidosis: For oral and/or esophageal candidosis.

• Dosage:
  • Oral Candidosis: 200 mg (20 mL) per day in two intakes, or alternatively in one intake, for 1 week. If no response after 1 week, continue for another week.
  • Esophageal Candidosis: 100 mg (10 mL) daily for a minimum of 3 weeks. Continue for 2 weeks after resolution of symptoms.
  • Prophylaxis: 5 mg/kg per day administered in two intakes.
• Administration: Take without food (refrain from eating for at least 1 hour after intake). Swish around the oral cavity for approximately 20 seconds and then swallow without rinsing.
• Precautions: Inform your doctor if you have any allergies, liver or kidney problems, or if you are pregnant or planning to become pregnant. Avoid using with certain medications that interact with itraconazole.
• Storage: Store below 30°C, away from moisture and heat.