NIKP Micafungin For Injection Dosage/Direction for Use

Treatment with Micafungin NIKP for Injection should be initiated by a physician experienced in the management of fungal infections.
Posology: Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
The dose regimen of micafungin depends on the body weight of the patient as given in the following tables: Use in adults, adolescents ≥16 years of age and elderly: See Table 3.

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Treatment duration: Invasive candidiasis: The treatment duration of Candida infection should be a minimum of 14 days. The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.
Oesophageal candidiasis: Micafungin should be administered for at least one week after resolution of clinical signs and symptoms.
Prophylaxis of Candida infections: Micafungin should be administered for at least one week after neutrophil recovery.
Use in children ≥4 months of age up to adolescents <16 years of age: See Table 4.

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Use in children (including neonates) <4 months of age: See Table 5.

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Treatment duration: Invasive candidiasis: The treatment duration of Candida infection should be a minimum of 14 days. The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.
Prophylaxis of Candida infections: Micafungin should be administered for at least one week after neutrophil recovery. Experience with Micafungin NIKP for Injection in patients less than 2 years of age is limited.
Hepatic impairment: No dose adjustment is necessary in patients with mild or moderate hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). There are currently insufficient data available for the use of micafungin in patients with severe hepatic impairment and its use is not recommended in these patients (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is necessary in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy in children (including neonates) less than 4 months of age of doses of 4 and 10 mg/kg for the treatment of invasive candidiasis with CNS involvement has not been adequately established. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions.
Method of administration: For intravenous use.
After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour. More rapid infusions may result in more frequent histamine mediated reactions. For reconstitution instructions see Special precautions for disposal and other handling under Cautions for Usage.