Micafungin Sodium
Indications
Micafungin Sodium is indicated for:
- Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses: Micafungin 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.
Pharmacology
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.
Dosage
Use in children ≥4 months of age and elderly-
Treatment of invasive candidiasis:
Treatment of invasive candidiasis:
- Body weight >40 kg: 100 mg/day
- Body weight ≤40 kg: 2 mg/kg/day
- Body weight >40 kg: 150 mg/day
- Body weight ≤40 kg: 3 mg/kg/day
- Body weight >40 kg: 50 mg/day
- Body weight ≤40 kg: 1 mg/kg/day.
- Treatment of invasive candidiasis: 4-10 mg/kg/day
- Prophylaxis of Candida infection: 2 mg/kg/day
- No loading dose is required.
Administration
- Aseptically add 5mL of 0.9% Sodium Chloride from supplied 100 ml bottle of 0.9% Sodium Chloride to vial containing Micafungin lyophilized powder.
- Gently dissolve the powder by swirling the vial. Do not vigorously shake the vial. Visually inspect for particulate matter. Do not use material if there is any evidence of precipitation of foreign matter.
- Transfer the freshly prepared solution to the 100 ml vial containing 0.9 % Sodium Chloride solution for further dilution.
- Use as necessary. Do not store the reconstituted solution more than 24 hours.
- Micafungin should be administered by intravenous infusion only. Infuse over one hour. More rapid infusion may result in more frequent histamine mediated reactions.
Interaction
Monitor for Sirolimus, Itraconazole or Nifedipine toxicity and dosage of Sirolimus, Itraconazole or Nifedipine should be reduced, if necessary
Contraindications
This is contraindicated in patients with known hypersensitivity to Micafungin, any component of this preparation.
Side Effects
Most common side effects include Diarrhea, Nausea, Vomiting, Pyrexia, Hypokalemia, Thrombocytopenia and Headache. Histamine-mediated symptoms like Rash, Pruritus, Facial Swelling and Vasodilation
Pregnancy & Lactation
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
Precautions & Warnings
- If anaphylaxis and anaphylactoid reactions occur discontinue Micafungin 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 Micafungin therapy.
- Monitor closely patients who develop abnormalities in liver function test (like Hepatic Dysfunction, Hepatitis, and Hepatic Failure) and evaluate risk/benefit of continuing Micafungin therapy.
- Monitor closely patients with renal dysfunction and acute renal failure
Overdose Effects
Micafungin is highly protein bound, therefore, is not dialyzable. No case of Micafungin 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.
Therapeutic Class
Other Antifungal preparations
Storage Conditions
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.
