Miconazole Nitrate, Zinc Oxide, White Petrolatum
Generic Name: miconazole nitrate, zinc oxide, white petrolatum
Brand Names:
Vusion
11 DESCRIPTION VUSION contains the synthetic antifungal agent, miconazole nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP. The chemical name of miconazole nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C 18 H 14 Cl 4 N 2 O•HNO 3 and molecular weight of 479.15. The structural formula of miconazole nitrate is as follows: The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.
Overview
11 DESCRIPTION VUSION contains the synthetic antifungal agent, miconazole nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP. The chemical name of miconazole nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C 18 H 14 Cl 4 N 2 O•HNO 3 and molecular weight of 479.15. The structural formula of miconazole nitrate is as follows: The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.
Uses
1 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. ( 1.1 ) • 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 ) 1.1 Indication 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.
Dosage
2 DOSAGE AND ADMINISTRATION VUSION is not for oral, ophthalmic, or intravaginal use. Before applying VUSION, gently cleanse the skin with lukewarm water and pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area. Gently apply a thin layer of VUSION to the diaper area with each diaper change for 7 days. Do not rub VUSION into the skin as this may cause additional irritation. Thoroughly wash hands after applying VUSION. Continue treatment for the full 7 days, even if there is improvement. Do not use VUSION for longer than 7 days. The safety of VUSION when used for longer than 7 days is not known. If symptoms have not improved by day 7, see your health care provider. • VUSION Ointment is for topical use only.
Side Effects
6 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the VUSION group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events.
Interactions
7 DRUG INTERACTIONS Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a miconazole intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and VUSION is unknown.
Warnings
5 WARNINGS AND PRECAUTIONS • If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. ( 5.1 ) 5.1 Skin Irritation If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. 4 CONTRAINDICATIONS None • None
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on VUSION Ointment use in pregnant women to inform a drug‑associated risk for adverse developmental outcomes. In animal reproduction studies, prolonged gestation, increased number of resorptions, and decreased numbers of live young were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of VUSION [see Clinical Pharmacology (12.3) ].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 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.
Frequently Asked Questions
What is Miconazole Nitrate, Zinc Oxide, White Petrolatum used for?▼
1 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. ( 1.1 ) • 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 ) 1.1 Indication 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.
What are the side effects of Miconazole Nitrate, Zinc Oxide, White Petrolatum?▼
6 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the VUSION group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events.
Can I take Miconazole Nitrate, Zinc Oxide, White Petrolatum during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on VUSION Ointment use in pregnant women to inform a drug‑associated risk for adverse developmental outcomes. In animal reproduction studies, prolonged gestation, increased number of resorptions, and decreased numbers of live young were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of VUSION [see Clinical Pharmacology (12.3) ].
What are the important warnings for Miconazole Nitrate, Zinc Oxide, White Petrolatum?▼
5 WARNINGS AND PRECAUTIONS • If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. ( 5.1 ) 5.1 Skin Irritation If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. 4 CONTRAINDICATIONS None • None
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.