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Micafungin Sodium (Mycamine ®)
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|NS or D5W|
Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
| [ 50 mg ] [ 100 ml] [ 1 hour]
[ 150 mg ] [100 ml] [1 hour]
Reconstitute each 50mg or 100 mg vial with 5 ml 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent).
Stability / Miscellaneous
| Stability: 24 hours room temperature.
Label: Protect from light.
Mycamine® is indicated for:
Mycamine has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections.
1.2 Treatment of Patients with Esophageal Candidiasis
1.3 Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation
NOTE: The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.
A loading dose is not required. Typically, 85% of the steady-state concentration is achieved after three daily Mycamine doses.
No dosing adjustments are required based on race, gender, or in patients with severe renal dysfunction or mild-to-moderate hepatic insufficiency. The effect of severe hepatic impairment on micafungin pharmacokinetics has not been studied.
No dose adjustment for Mycamine is required with concomitant use of mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, voriconazole, itraconazole, amphotericin B, ritonavir, or rifampin.
The diluent to be used for reconstitution and dilution is 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent). Alternatively, 5% Dextrose Injection, USP, may be used for reconstitution and dilution of MYCAMINE. Do not mix or co-infuse MYCAMINE with other medications.
Reconstitution: MYCAMINE 50 mg vial:
Dissolution: To minimize excessive foaming, GENTLY dissolve the MYCAMINE powder by swirling the vial. DO NOT VIGOROUSLY SHAKE THE VIAL.Visually inspect the vial for particulate matter. MYCAMINE is preservative-free. Discard partially used vials.
HOW SUPPLIED/STORAGE AND HANDLING
* cartons of 10 individually packaged 50 mg single-use vials, coated with a light protective film and sealed with a blue flip-off cap. (NDC 0469-3250-10).
* cartons of 10 individually packaged 100 mg single-use vials, coated with a light protective film and sealed with a red flip-off cap. (NDC 0469-3211-10)
The reconstituted product may be stored in the original vial for up to 24 hours at room temperature, 25° C (77° F).
The diluted infusion should be protected from light and may be stored for up to 24 hours at room temperature, 25° C (77° F).
Source: [package insert]