VUSION- miconazole nitrate, zinc oxide, white petrolatum ointment

VUSION by

Drug Labeling and Warnings

VUSION by is a Prescription medication manufactured, distributed, or labeled by Mylan Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    1.1 Indication

    Miconazole nitrate, zinc oxide and white petrolatum 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.

    Miconazole nitrate, zinc oxide and white petrolatum ointment 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. Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used as a substitute for frequent diaper changes.

    1.2 Limitations of Use

    The safety and efficacy of miconazole nitrate, zinc oxide and white petrolatum ointment have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).

    The safety and efficacy of miconazole nitrate, zinc oxide and white petrolatum ointment have not been evaluated in incontinent adult patients. Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

  • 2 DOSAGE AND ADMINISTRATION

    Miconazole nitrate, zinc oxide and white petrolatum ointment is not for oral, ophthalmic, or intravaginal use.

    Before applying miconazole nitrate, zinc oxide and white petrolatum ointment, 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 miconazole nitrate, zinc oxide and white petrolatum ointment to the diaper area with each diaper change for 7 days. Do not rub miconazole nitrate, zinc oxide and white petrolatum ointment into the skin as this may cause additional irritation. Thoroughly wash hands after applying miconazole nitrate, zinc oxide and white petrolatum ointment. Continue treatment for the full 7 days, even if there is improvement.

    Do not use miconazole nitrate, zinc oxide and white petrolatum ointment for longer than 7 days. The safety of miconazole nitrate, zinc oxide and white petrolatum ointment when used for longer than 7 days is not known. If symptoms have not improved by day 7, see your health care provider.

  • 3 DOSAGE FORMS AND STRENGTHS

    Miconazole Nitrate, 0.25%, Zinc Oxide, 15% and White Petrolatum, 81.35% Ointment contains 2.5 mg of miconazole nitrate, USP, 150 mg of zinc oxide, USP and 813.5 mg of white petrolatum, USP per gram.

  • 4 CONTRAINDICATIONS

    None

  • 5 WARNINGS AND PRECAUTIONS

     

    5.1 Skin Irritation

    If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.

  • 6 ADVERSE REACTIONS

    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 miconazole nitrate, zinc oxide and white petrolatum ointment 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. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with miconazole nitrate, zinc oxide and white petrolatum ointment were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

    6.2 Post-marketing Experience

    The following adverse reactions have been identified during post approval use of miconazole nitrate, zinc oxide and white petrolatum ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Gastrointestinal Disorders: vomiting

    General Disorders and Administration Site Conditions: burning sensation, condition aggravated, inflammation, pain

    Injury, Poisoning and Procedural Complications: accidental exposure

    Skin and Subcutaneous Tissue Disorders: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation

  • 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 miconazole nitrate, zinc oxide and white petrolatum ointment is unknown.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    There are no available data on miconazole nitrate, zinc oxide and white petrolatum 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 miconazole nitrate, zinc oxide and white petrolatum ointment [see Clinical Pharmacology (12.3)].

    In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

    Data

    Animal Data

    Miconazole nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day.

    8.2 Lactation

    Risk Summary

    There is no available information on the presence of miconazole in human milk, or the effects on the breastfed child, or the effects on milk production following use of miconazole nitrate, zinc oxide and white petrolatum ointment.

    The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for miconazole nitrate, zinc oxide and white petrolatum ointment and any potential adverse effects on the breastfed infant from miconazole nitrate, zinc oxide and white petrolatum ointment or from the underlying maternal condition.

    8.4 Pediatric Use

    Efficacy was not demonstrated in infants less than 4 weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants (less than 1500 g).

    Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent diaper dermatitis.

    The safety of miconazole nitrate, zinc oxide and white petrolatum ointment when used for longer than 7 days is not known. Do not use more than 7 days.

    8.5 Geriatric Use

    Safety and efficacy in a geriatric population have not been evaluated.

  • 11 DESCRIPTION

    Miconazole nitrate, zinc oxide and white petrolatum ointment 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 C18H14Cl4N2OHNO3 and molecular weight of 479.15. The structural formula of miconazole nitrate is as follows:

    Miconazole Nitrate Structural Formula

    The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.

    The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is a purified mixture of semisolid saturated hydrocarbons having the general chemical formula CnH2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.

    Each gram of miconazole nitrate, zinc oxide and white petrolatum ointment contains 2.5 mg of miconazole nitrate, USP, 150 mg of zinc oxide, USP and 813.5 mg of white petrolatum, USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm 1001/B fragrance.

    Miconazole nitrate, zinc oxide and white petrolatum ointment is a smooth, uniform, white ointment.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    The miconazole component of miconazole nitrate, zinc oxide and white petrolatum ointment is an antifungal agent [see Clinical Pharmacology (12.4)]. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.

    12.2 Pharmacodynamics

    The human pharmacodynamics of miconazole nitrate, zinc oxide and white petrolatum ointment is unknown [see Clinical Pharmacology (12.4)for fungal pharmacodynamics].

    12.3 Pharmacokinetics

    The topical absorption of miconazole from miconazole nitrate, zinc oxide and white petrolatum ointment was studied in immunocompetent male and female infants and children (n = 17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from 1 month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for 7 days, the plasma concentrations of miconazole were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other 2 remaining subjects, the plasma concentrations of miconazole were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.

    12.4 Microbiology

    The miconazole nitrate component in this product has been shown to have in vitro activity against Candida albicans, an organism that is associated with diaper dermatitis. The activity of miconazole nitrate against C. albicans is based on the inhibition of the ergosterol biosynthesis in the cell membrane. The accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell. In vitro minimal inhibitory concentration (MIC) test results for C. albicans isolates obtained from treatment failures in Clinical Study 1 [see Clinical Studies (14)] does not appear to indicate that resistance to miconazole nitrate was the reason for treatment failure. The clinical significance of the in vitro activity of miconazole nitrate against C. albicans in the setting of diaper dermatitis is unclear.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    The carcinogenic potential of miconazole nitrate, zinc oxide and white petrolatum ointment in animals has not been evaluated.

    Miconazole nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.

    Miconazole nitrate had no adverse effect on fertility in a study in rats at oral doses of up to 320 mg/kg/day.

  • 14 CLINICAL STUDIES

    Study 1 was a double-blind, multicenter study in which miconazole nitrate, zinc oxide and white petrolatum ointment was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated pseudohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.

    The primary endpoint was “Overall Cure” and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed 1 week following the end of treatment, at Day 14.

    Study results are shown in the following table.

    Overall Cure at Day 14

     

    Miconazole Nitrate, Zinc Oxide and White Petrolatum Ointment
    n = 112

    Zinc Oxide/White Petrolatum
    n = 124

     

    26 (23%)

    12 (10%)

    Two additional studies provided supportive evidence of the clinical efficacy of miconazole nitrate, zinc oxide and white petrolatum ointment in infants and toddlers with diaper dermatitis, some of whom cultured positive for C. albicans. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    16.1 How Supplied

    Miconazole Nitrate, 0.25%, Zinc Oxide, 15% and White Petrolatum, 81.35% Ointment 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: 0378-8222-50
    carton containing one 50 gram tube

    16.2 Storage Conditions

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

    Keep out of reach of children.

  • 17 PATIENT COUNSELING INFORMATION

    See FDA-Approved Patient Labeling

    Patients using miconazole nitrate, zinc oxide and white petrolatum ointment should be informed about the following information:

    • Miconazole nitrate, zinc oxide and white petrolatum ointment should be used only as directed by the health care provider.
    • Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used as a substitute for frequent diaper changes.
    • Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent diaper dermatitis.
    • Miconazole nitrate, zinc oxide and white petrolatum ointment is for external use only. It is not for oral, ophthalmic, or intravaginal use.
    • Gently cleanse the diaper area with lukewarm water or a very mild soap and pat the area dry with a soft towel before applying miconazole nitrate, zinc oxide and white petrolatum ointment.
    • Gently apply miconazole nitrate, zinc oxide and white petrolatum ointment to the diaper area with the fingertips after each diaper change. Do not rub miconazole nitrate, zinc oxide and white petrolatum ointment into the skin as this may cause additional irritation.
    • Thoroughly wash hands after applying miconazole nitrate, zinc oxide and white petrolatum ointment.
    • Treatment should be continued for 7 days, even if there is improvement. Do not use miconazole nitrate, zinc oxide and white petrolatum ointment for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
    • Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used on children for whom it is not prescribed.
  • PATIENT INFORMATION

    Miconazole Nitrate, Zinc Oxide and White Petrolatum Ointment

    Important Information:Miconazole nitrate, zinc oxide and white petrolatum ointment is for use on the skin only. Do not use miconazole nitrate, zinc oxide and white petrolatum ointment in the eyes, mouth, or vagina. 

    What is miconazole nitrate, zinc oxide and white petrolatum ointment?
    Miconazole nitrate, zinc oxide and white petrolatum ointment is a prescription medicine used on the skin (topical) to treat children 4 weeks of age and older with a normal immune system who have diaper rash (dermatitis) and who also have a yeast infection (candidiasis).

    • Your child’s healthcare provider should do a test to check to make sure that your child also has a yeast infection before starting treatment with miconazole nitrate, zinc oxide and white petrolatum ointment.
    • Miconazole nitrate, zinc oxide and white petrolatum ointment should be used along with gentle cleaning of the diaper area and changing your child’s diaper often. See, “How should I use miconazole nitrate, zinc oxide and white petrolatum ointment?” for detailed instructions on how to use miconazole nitrate, zinc oxide and white petrolatum ointment the right way.
    • Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent diaper rash from developing (preventative treatment). Using miconazole nitrate, zinc oxide and white petrolatum ointment as preventative treatment may cause miconazole nitrate, zinc oxide and white petrolatum ointment to no longer work (resistance).

    It is not known if miconazole nitrate, zinc oxide and white petrolatum ointment is safe and effective for use in incontinent adults.

    It is not known if miconazole nitrate, zinc oxide and white petrolatum ointment is safe and effective for use in children less than 4 weeks of age or very low birth weight (less than 1500 grams).

    Before using miconazole nitrate, zinc oxide and white petrolatum ointment, tell your child’s healthcare provider about all their medical conditions.

    How should I use miconazole nitrate, zinc oxide and white petrolatum ointment?

    • Use miconazole nitrate, zinc oxide and white petrolatum ointment exactly as your child’s healthcare provider tells you to use it.
    • Gently clean the skin on your child’s diaper area with warm (not hot) water and pat the area dry with a soft towel.
    • Using your fingertips, apply a thin layer of miconazole nitrate, zinc oxide and white petrolatum ointment to the affected area at each diaper change for 7 days. Do not rub miconazole nitrate, zinc oxide and white petrolatum ointment into your child’s skin. Rubbing the skin can cause more irritation.
    • Wash your hands after applying miconazole nitrate, zinc oxide and white petrolatum ointment.
    • Miconazole nitrate, zinc oxide and white petrolatum ointment should be used for the full 7 days of treatment. Do not stop treatment before the full 7 days, even if the symptoms improve.
    • Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used for longer than 7 days. Call your child’s healthcare provider if the diaper rash gets worse or does not go away with 7 days of treatment with miconazole nitrate, zinc oxide and white petrolatum ointment.
    • Call your child’s healthcare provider or poison control center right away if miconazole nitrate, zinc oxide and white petrolatum ointment is swallowed or gets in the eyes.

    What should I avoid while using miconazole nitrate, zinc oxide and white petrolatum ointment?

    • Avoid using scented soaps, shampoos or lotions in the diaper area during treatment with miconazole nitrate, zinc oxide and white petrolatum ointment.

    What are the possible side effects of miconazole nitrate, zinc oxide and white petrolatum ointment?

    Miconazole nitrate, zinc oxide and white petrolatum ointment may cause serious side effects, including:

    • Skin irritation. Stop using miconazole nitrate, zinc oxide and white petrolatum ointment and call your child’s healthcare provider if your child’s diaper rash gets worse or if your child develops skin irritation at the application site during treatment with miconazole nitrate, zinc oxide and white petrolatum ointment.

    These are not all the possible side effects of miconazole nitrate, zinc oxide and white petrolatum ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store miconazole nitrate, zinc oxide and white petrolatum ointment?

    • Store miconazole nitrate, zinc oxide and white petrolatum ointment at room temperature between 68°F to 77°F (20°C to 25°C).
    • Keep miconazole nitrate, zinc oxide and white petrolatum ointment and all medicines out of the reach of children.

    General information about the safe and effective use of miconazole nitrate, zinc oxide and white petrolatum ointment.
    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use miconazole nitrate, zinc oxide and white petrolatum ointment for a condition for which it was not prescribed. Do not give miconazole nitrate, zinc oxide and white petrolatum ointment to other people, even if they have the same symptoms your child has. It may harm them. You can ask your child’s healthcare provider or pharmacist for information about miconazole nitrate, zinc oxide and white petrolatum ointment that is written for healthcare professionals.

    What are the ingredients in miconazole nitrate, zinc oxide and white petrolatum ointment?
    Active Ingredients: miconazole nitrate, zinc oxide, and white petrolatum
    Inactive Ingredients: trihydroxystearin, butylated hydroxytoluene (BHT), and Chemoderm 1001/B fragrance

    Manufactured for: Mylan Pharmaceuticals Inc.,Morgantown, WV 26505 U.S.A.

    This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

    Manufactured for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Manufactured by:
    Confab Laboratories, Inc.
    Saint-Hubert (QC) Canada J3Y 3X3

    Revised: 8/2018
    301923-02
    CON:MZPOING:R2

  • PRINCIPAL DISPLAY PANEL – 0.25%, 15% and 81.35%

    NDC: 0378-8222-50

    Miconazole
    Nitrate,
    0.25%
    Zinc Oxide,
    15%
    and White
    Petrolatum,
    81.35% Ointment

    For Topical Use Only

    Usual Dosage: See package insert.

    Caution: Not for oral, ophthalmic, or
    intravaginal use. Keep out of reach of
    children. If seal is damaged or
    punctured, do not use, and return
    product to place of purchase.

    Description: Each gram contains 2.5 mg
    miconazole nitrate USP, 150 mg zinc
    oxide USP, and 813.5 mg white
    petrolatum USP containing butylated
    hydroxytoluene, trihyforxystearin, and
    Chemoderm 1001/B fragrance.

    Store at 20º to 25ºC (68º to 77ºF).
    [See USP Controlled Room
    Temperature.]

    See flap for lot number and expiration date.

    For additional information, call Mylan at
    1-877-446-3679 (1-877-4-INFO-RX).

    Serious side effects associated with the
    use of this product may be reported to
    this number.

    Manufactured for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Made in Canada

    CON:8222:50:1C:R1     301922-01

    Mylan.com

    Miconazole Nitrate 0.25%, Zinc Oxide 15%, and White Petrolatum 81.35% Carton Label
  • INGREDIENTS AND APPEARANCE
    VUSION 
    miconazole nitrate, zinc oxide, white petrolatum ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0378-8222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2.5 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE150 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM813.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0378-8222-501 in 1 CARTON11/06/2018
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02102611/06/2018
    Labeler - Mylan Pharmaceuticals Inc. (059295980)

    • Trademark Results [VUSION]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VUSION
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