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Intravenous Dilution Guidelines

Micafungin Sodium (Mycamine ®)

The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.    PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Usual Diluents

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.

Stability data:

Drug Stability
Refrigerated
Stability
Room Temp.
Reconstituted
Vial/Powder
Notes P-Insert
Updated
Micafungin   Unopened vials of lyophilized material must be stored at room temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). 

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).
Powder Mycamine is preservative-free. Discard partially used vials. 11 14 14


Mycamine® is indicated for:
1.1 Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses.

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.
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Dosing (Adults):
Do not mix or co-infuse Mycamine with other medications. Mycamine has been shown to precipitate when mixed directly with a number of other commonly used medications.
Mycamine Dosage
Indication

Recommended Reconstituted Dose Once Daily

 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses*  100 mg
Treatment of Esophageal Candidiasis† 150 mg
Prophylaxis of Candida Infections in HSCT Recipients‡ 50 mg
*In patients treated successfully for candidemia and other Candida infections, the mean duration of treatment was 15 days (range 10-47 days).

† In patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10-30 days).

‡ In hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6-51 days).

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.

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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:
Aseptically add 5 mL of 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent) to each 50 mg vial to yield a preparation containing approximately 10 mg micafungin/mL.

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
Mycamine is available in:

* 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)

Storage
Unopened vials of lyophilized material must be stored at room temperature, 25° C (77° F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

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]
Disclaimer
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.  PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.
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