VUSION- miconazole nitrate, zinc oxide, white petrolatum ointment

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

Dostępny od:

Prestium Pharma, Inc.

INN (International Nazwa):

MICONAZOLE NITRATE

Skład:

MICONAZOLE NITRATE 2.5 mg in 1 g

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

VUSION Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment. VUSION should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. VUSION should not be used as a substitute for frequent diaper changes. VUSION should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.  The safety and efficacy of VUSION have not been demonstrated in immunocompromised pa

Podsumowanie produktu:

VUSION is a smooth, uniform, white ointment supplied in an aluminum tube, as follows: 50g (NDC 40076-002-50) Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

VUSION- MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM OINTMENT
PRESTIUM PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VUSION OINTMENT SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR VUSION OINTMENT.
VUSION (MICONAZOLE NITRATE, ZINC OXIDE, AND WHITE PETROLATUM)
OINTMENT, FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
VUSION Ointment is indicated for adjunctive treatment of diaper
dermatitis when complicated by documented
candidiasis (microscopic evidence of pseudohyphae and /or budding
yeast) in immunocompetent pediatric patients 4
weeks and older. (1)
VUSION Ointment should not be used as a substitute for frequent diaper
changes. (1)
VUSION Ointment should not be used to prevent the occurrence of diaper
dermatitis, since preventative use may
result in the development of drug resistance. (1)
DOSAGE AND ADMINISTRATION
VUSION Ointment is for topical use only. VUSION Ointment is not for
oral, ophthalmic, or intravaginal use. (2)
VUSION Ointment should be applied as a thin layer to the affected area
at each diaper change for 7 days. (2)
VUSION Ointment should be used as part of a treatment regimen that
includes gentle cleansing of the diaper area and
frequent diaper changes. (2)
DOSAGE FORMS AND STRENGTHS
Ointment with 0.25% miconazole nitrate, 15% zinc oxide, and 81.35%
white petrolatum. (3)
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
If irritation occurs or if the disease worsens, discontinue use of the
medication, and contact the health care provider. (5)
ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PRESTIUM PHARMA, INC.
AT 1-866-897-5002 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Indication
1.2 Limitations of Use
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS