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 Prestium Pharma, Inc., Delcor Asset Corporation, GlaxoSmithKline Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    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. A positive fungal culture for Candida albicansis 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.

    1.2 Limitations of Use

     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 patients. VUSION 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

    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.

    Apply VUSION to the affected area at each diaper change for 7 days. Continue treatment for the full 7 days, even if there is improvement. The safety of VUSION when used for longer than 7 days is not known. Do not use VUSION for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.

    Gently apply a thin layer of VUSION to the diaper area with the fingertips. Do not rub VUSION into the skin as this may cause additional irritation. Thoroughly wash hands after applying VUSION.

  • 3 DOSAGE FORMS AND STRENGTHS

    White ointment containing 0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum.

  • 4 CONTRAINDICATIONS

    None

  • 5 WARNINGS AND PRECAUTIONS

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

    The safety and efficacy of VUSION have not been evaluated in incontinent adult patients. VUSION 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.

  • 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 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. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with VUSION 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 VUSION.

    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

    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.

  • 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.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Pregnancy Category C

    There are no adequate and well-controlled studies of VUSION in pregnant women. Therefore, VUSION should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    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, which are 28 and 45 times the maximum possible topical exposure of caregivers, respectively, assuming 100% absorption.

    8.3 Nursing Mothers

    Safety and efficacy of VUSION have not been established in nursing mothers. It is not known if the active components of VUSION may be present in milk.

    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.

    VUSION should not be used to prevent diaper dermatitis.

    The safety of VUSION 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

    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 C18H14Cl4N2OHNO3 and molecular weight of 479.15. The structural formula of miconazole nitrate is as follows:

    Structural formula of miconazole nitrate

    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 VUSION 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.1

    VUSION is a smooth, uniform, white ointment.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    The miconazole component of VUSION 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 Vusion is unknown [see Clinical Pharmacology (12.4) for fungal pharmacodynamics].

    12.3 Pharmacokinetics

    The topical absorption of miconazole from VUSION 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 VUSION 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, which is 89 times the maximum possible topical exposure of caregivers, assuming 100% absorption.

  • 14 CLINICAL STUDIES

    Study 1 was a double-blind, multicenter study in which VUSION 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 psuedohyphae 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

     

    VUSION
    n=112

    Zinc Oxide/White Petrolatum
    n=124

     

    26 (23%)

    12 (10%)

    Two additional studies provided supportive evidence of the clinical efficacy of VUSION 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

    VUSION is a smooth, uniform, white ointment supplied in an aluminum tube, as follows:

    50g (NDC: 40076-002-50)

    16.2 Storage Conditions

    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.

  • 17 PATIENT COUNSELING INFORMATION

    See FDA-Approved Patient Labeling

    Patients using VUSION should be informed about the following information:

    • VUSION is to be used only for diaper dermatitis that is complicated by documented candidiasis (i.e. documented by microscopic testing).
    • VUSION should not be used as a substitute for frequent diaper changes.
    • VUSION should not be used to prevent diaper dermatitis.
    • VUSION should not be used long term.
    • VUSION should be used only as directed by the health care provider.
    • VUSION 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 VUSION.
    • Gently apply VUSION to the diaper area with the fingertips after each diaper change. Do not rub VUSION into the skin as this may cause additional irritation.
    • Thoroughly wash hands after applying VUSION.
    • Treatment should be continued for 7 days, even if there is improvement. Do not use VUSION for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
    • VUSION should not be used on children for whom it is not prescribed.

    Manufactured for:
    Prestium Pharma, Inc.
    Newtown, PA 18940

    Manufactured by:
    GlaxoSmithKline
    Mississauga, ON, Canada
    Made in Canada

    © 2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.

    Revised Oct 2013            VSN:3PI

  • PATIENT PACKAGE INSERT

    FDA-Approved Patient Labeling
    VUSION® (Vu-sion) Ointment
    (0.25% miconazole nitrate, 15% zinc oxide and 81.35% white petrolatum)

    IMPORTANT: For Skin Use Only. Do not use in the mouth, eyes, or vagina. 
    Read the Patient Information that comes with VUSION before you use it on your child. This leaflet does not take the place of talking to your health care provider about your child’s medical condition or treatment. If you have any questions or if you are not sure about any of the information on VUSION, ask your health care provider, or pharmacist.

    What is VUSION?
    VUSION is a prescription skin medicine used to treat diaper rash that also has a yeast infection in children who are at least 4 weeks old and who have a normal immune system. VUSION contains medicines that will help treat the yeast infection and the diaper rash, but you must also change your child’s diapers very often so that your child is not wearing a wet or soiled diaper.  Even if you use VUSION, diaper rash will not go away if you do not keep your child’s diaper area clean and dry. You should use water or a very mild cleanser to clean your child’s diaper area. VUSION is not to be used to prevent diaper rash or to be used for more than 7 days.

    Your health care provider will need to do a special test to tell if your child’s diaper rash also has a yeast infection. Do not use VUSION on your child’s diaper rash unless your health care provider tells you that there is also a yeast infection.

    Who should not use VUSION?
    VUSION is not for treatment of all cases of diaper rash. VUSION is only for diaper rash that also has a yeast infection. Most cases of diaper rash do not need the yeast medicine that is in VUSION because most cases of diaper rash do not also have a yeast infection.

    Do not use VUSION on any other children or other family member.

    Do not use VUSION on your child’s diaper rash if they are allergic to anything in it.  See the end of this leaflet for a list of ingredients in VUSION.

    Do not use on infants less than 4 weeks of age.

    Do not use in infants or children who do not have a normal immune system.

    How should I use VUSION on my child?
    VUSION is applied to the skin on your child’s diaper area at each diaper change for 7 days.

    Apply VUSION for the full 7 days even if the diaper rash starts to go away. Call your child’s health care provider if the diaper rash gets worse or does not go away with 7 days of treatment with VUSION. VUSION should not be used for more than 7 days.

    To apply VUSION:

    • Gently, clean the skin on your child’s diaper area with warm (not hot) water. You may also use a very mild soap. Pat the area dry with a soft towel.
    • Use your fingertips and gently apply a thin layer of VUSION to your child’s diaper area at each diaper change. Do not rub VUSION into your child’s skin. Rubbing the skin can cause more irritation.
    • Wash your hands after applying VUSION on your child.

    VUSION is for skin use only.
    Call your child’s health care provider or poison control center right away if any VUSION is swallowed. Call your child’s health care provider if VUSION gets in the eye.

    Keep out of reach of children.

    What other steps will help diaper rash go away?

    • Check your child’s diaper often. Change the diaper at the first sign of wetness.
    • Clean your child’s diaper area after each diaper change. Gently wipe the diaper area from the front to back using warm (not hot )water. You may also use a mild soap. Rinse the diaper area well. Pat dry with a soft towel.
    • Keep the diaper area open to air when possible.
    • Even if you use VUSION, diaper rash will not go away if you do not keep your child’s diaper area clean and dry.

    What are the possible side effects of VUSION?
    VUSION may cause irritation. You should call your child’s health care provider if irritation appears or if the diaper rash gets worse.

    How should I store VUSION?

    • Keep VUSION out of the reach of children to avoid the risk of accidental ingestion.
    • Store VUSION at room temperature between 68°F to 77°F (20°C to 25°C).

    General information about VUSION
    Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

    Do not use VUSION for a condition for which it was not prescribed. Do not give VUSION to other children or family members, even if they have the same symptoms your child has. It may harm them.

    This leaflet summarizes the most important information about VUSION. If you would like more information, talk to your child’s health care provider. You can ask your child’s health care provider or pharmacist for information about VUSION that is written for healthcare professionals.

    Side effects may be reported to Prestium Pharma, Inc. at 1-866-897-5002 or the FDA at 1-800-FDA-1088.

    What are the ingredients in VUSION?
    Active Ingredients:  miconazole nitrate, zinc oxide, and white petrolatum
    Inactive Ingredients:  trihydroxystearin, butylated hydroxyltoluene (BHT), and Chemoderm® 1001/B fragrance
    This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.
    The Patient Information leaflet was last revised: October 2013

    Manufactured for:
    Prestium Pharma, Inc.
    Newtown, PA 18940

    Manufactured by:
    GlaxoSmithKline
    Mississauga, ON, Canada
    Made in Canada

    © 2013 Delcor Asset Corporation, an affiliate of
    Prestium Pharma, Inc.

    Revised Oct 2013
    VSN:3PIL

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel
    NDC: 40076-002-50
    Vusion®
    (miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP)
    Ointment
    50 grams
    Rx only

    Principal Display Panel NDC: <a href=/NDC/40076-002-50>40076-002-50</a> Vusion® (miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP) Ointment 50 grams Rx only
  • INGREDIENTS AND APPEARANCE
    VUSION 
    miconazole nitrate, zinc oxide, white petrolatum ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 40076-002
    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: 40076-002-501 in 1 CARTON05/14/200701/31/2021
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02102605/14/200701/31/2021
    Labeler - Prestium Pharma, Inc. (078304674)
    Registrant - Delcor Asset Corporation (965099505)
    Establishment
    NameAddressID/FEIBusiness Operations
    GlaxoSmithKline Inc205556368MANUFACTURE(40076-002)

  • Trademark Results [VUSION]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VUSION
    VUSION
    87897764 not registered Live/Pending
    SES-IMAGOTAG
    2018-04-27
    VUSION
    VUSION
    87843141 not registered Live/Pending
    SES-IMAGOTAG
    2018-03-21
    VUSION
    VUSION
    87057729 not registered Dead/Abandoned
    ILONA, INC.
    2016-06-02
    VUSION
    VUSION
    86545634 not registered Dead/Abandoned
    Gold Crest LLC
    2015-02-25
    VUSION
    VUSION
    85455107 4170836 Dead/Cancelled
    NYX2 TRADING INC.
    2011-10-25
    VUSION
    VUSION
    79191121 not registered Dead/Abandoned
    Armada Nutrition Pty Ltd
    2016-05-24
    VUSION
    VUSION
    78949177 3337408 Live/Registered
    Ortho Development Corporation
    2006-08-10
    VUSION
    VUSION
    78629993 3218835 Live/Registered
    STIEFEL LABORATORIES, INC.
    2005-05-13
    VUSION
    VUSION
    78552544 not registered Dead/Abandoned
    GEOFF FARR and FORREST HALLER
    2005-01-24
    VUSION
    VUSION
    77747151 3929242 Dead/Cancelled
    Clarendon Foundation, Inc.
    2009-05-28
    VUSION
    VUSION
    77464530 not registered Dead/Abandoned
    STIEFEL LABORATORIES, INC.
    2008-05-02
    VUSION
    VUSION
    77159890 3450514 Dead/Cancelled
    Staples The Office Superstore, LLC
    2007-04-18

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