MICAFUNGIN injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MICAFUNGIN SODIUM (UNII: IS1UP79R56) (MICAFUNGIN - UNII:R10H71BSWG)

Available from:

Par Pharmaceutical, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Micafungin for Injection is indicated for: - Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)] Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)] - Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older[see Clinical Studies (14.2)] . - Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)] Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)] Limitations of Use - Micafungin for Injection has not been ade

Product summary:

Micafungin for Injection is supplied as a sterile, white lyophilized powder for reconstitution for intravenous infusion, and is available in the following packaging configurations: NDC 42023-229-10: 50 mg single-dose vials supplied in packages of 10 NDC 42023-230-10: 100 mg single-dose vials supplied in packages of 10 The vial stopper is not manufactured with natural rubber latex. Storage Store Micafungin for Injection, for intravenous use at room temperature, 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].  Store the reconstituted product at 25°C (77°F) [see Dosage and Administration (2.3)]. Store the diluted solution at 25°C (77°F) [see Dosage and Administration (2.3)]. Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

MICAFUNGIN- MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MICAFUNGIN FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MICAFUNGIN FOR
INJECTION.
MICAFUNGIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
Micafungin for injection is an echinocandin indicated in adult and
pediatric patients for:
Treatment of Candidemia, Acute Disseminated Candidiasis, _Candida_
Peritonitis and Abscesses in adult
and pediatric patients 4 months of age and older. (1)
Treatment of Esophageal Candidiasis in adult and pediatric patients 4
months of age and older. (1)
Prophylaxis of _Candida_ Infections in adult and pediatric patients 4
months of age and older undergoing
Hematopoietic Stem Cell Transplantation (HSCT). (1)
Limitations of Use
Micafungin for injection has not been adequately studied in patients
with endocarditis, osteomyelitis or
meningoencephalitis due to_ Candida_. (1)
The efficacy of micafungin for injection against infections caused by
fungi other than _Candida_ has not
been established. (1)
DOSAGE AND ADMINISTRATION
RECOMMENDED DOSAGE ADMINISTERED BY INDICATION, WEIGHT AND AGE (2.1,
2.2, 8.4)
ADULT
PEDIATRIC PATIENTS 4 MONTHS AND OLDER
30 KG OR LESS
PEDIATRIC PATIENTS
4 MONTHS AND
OLDER
GREATER THAN
30 KG
TREATMENT OF CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, _CANDIDA
_PERITONITIS AND
ABSCESSES
100 mg daily
2 mg/kg/day
(maximum 100 mg daily)
TREATMENT OF ESOPHAGEAL CANDIDIASIS
150 mg daily
3 mg/kg/day
2.5 mg/kg/day (maximum
150 mg daily)
PROPHYLAXIS OF _CANDIDA_ INFECTIONS IN HSCT RECIPIENTS
50 mg daily
1 mg/kg/day
(maximum 50 mg daily)
Infuse over 1 hour. (2.4)
See full prescribing information for intravenous (IV) preparation and
administration instructions. (2)
DOSAGE FORMS AND STRENGTHS
For injection: 50 mg single-dose vial. (3)
For injection: 100 mg single-dose vial. (3)
CONTRAINDICATIONS
Micafungin for I