Micafungin Sodium

Micagin is indicated for:

Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses: Micagin has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections.

Treatment of Patients with Esophageal Candidiasis.

Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation.

Micafungin is a sterile, lyophilized product for intravenous (IV) infusion that contains Micafungin Sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin inhibits the synthesis of 1,3-β-D-glucan, an integral component of the fungal cell wall, which is not present in mammalian cell.

Use in children ≥4 months of age and elderly- Treatment of invasive candidiasis:

Body weight >40 kg: 100 mg/day

Body weight ≤40 kg: 2 mg/kg/day

Treatment of oesophageal candidiasis(only for patients ≥ 16 years of age):

• Body weight >40 kg: 150 mg/day
• Body weight ≤40 kg: 3 mg/kg/day
• Prophylaxis of Candida infection:
• Body weight >40 kg: 50 mg/day

Body weight ≤40 kg: 1 mg/kg/day.

• Use in children (including neonates) <4 months of age:
• Treatment of invasive candidiasis: 4-10 mg/kg/day
• Prophylaxis of Candida infection: 2 mg/kg/day

No loading dose is required.

Monitor for Sirolimus, Itraconazole or Nifedipine toxicity and dosage of Sirolimus, Itraconazole or Nifedipine should be reduced, if necessary

This is contraindicated in patients with known hypersensitivity to Micafungin, any component of this preparation.

Most common side effects include Diarrhea, Nausea, Vomiting, Pyrexia, Hypokalemia, Thrombocytopenia and Headache. Histamine-mediated symptoms like Rash, Pruritus, Facial Swelling and Vasodilation

There is no adequate and well-controlled studies of Micafungin in pregnant women. Micafungin should be used in pregnancy only if potential benefit justifies the potential risk to the fetus. It is not known whether Micafungin is excreted in human milk. Caution should be exercised when Micafungin Sodium is administered to a nursing mother

If anaphylaxis and anaphylactoid reactions occur discontinue Micagin and administer appropriate treatment.

Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported. Monitor closely those patients and evaluate risk/benefit of continuing Micagin therapy.

Monitor closely patients who develop abnormalities in liver function test (like Hepatic Dysfunction, Hepatitis, and Hepatic Failure) and evaluate risk/benefit of continuing Micagin therapy.

Monitor closely patients with renal dysfunction and acute renal failure

Micagin is highly protein bound, therefore, is not dialyzable. No case of Micagin over dosage has been reported. Repeated daily doses up to 8mg/kg (maximum total dose of 896 mg) in adult patients have been administered in clinical trials with no reported dose-limiting toxicity.

Before Reconstitution: Do not store above 30°C. Keep away from light and out of the reach of children. After Reconstitution: Do not store the reconstituted solution above 30°C. The diluted infusion should mbe protected from light and may be stored for up to 24 hours at room temperature.