VUSION- miconazole nitrate, zinc oxide, white petrolatum ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. The safety and efficacy of VUSION have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term). The safety and efficacy of VUSION have not been evaluated in incontinent adult

Product summary:

VUSION (miconazole nitrate, zinc oxide and white petrolatum) contains 2.5 mg of miconazole nitrate USP, 150 mg of zinc oxide USP and 813.5 mg of white petrolatum USP per gram. The smooth, uniform, white ointment supplied in an aluminum tube is available as follows: NDC 0378-9730-50 carton containing one 50 gram tube Store at 20 ° to 25 °C (68 ° to 77 °F). [See USP Controlled Room Temperature.] Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

VUSION- MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM OINTMENT
MYLAN PHARMACEUTICALS 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
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2018
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 AND PRECAUTIONS
5.1 Skin Irritation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
®
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. (1.1)
VUSION Ointment should not be used as a substitute for frequent diaper
changes. (1.1)
VUSION Ointment should not be used to prevent the occurrence of diaper
dermatitis, since preventative use may
result in the development of drug resistance. (1.2)
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 u