Vusion

Name: Vusion

Vusion Dosage

Take miconazole exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dosing schedule for miconazole is the application of one 50 mg buccal tablet to the upper gum region once daily for 14 consecutive days.

 

Miconazole and zinc oxide topical side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • severe discomfort, redness, or other irritation of treated skin areas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How is this medicine (Vusion) best taken?

Use Vusion as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Use as you have been told, even if your signs get better.
  • Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
  • Wash your hands before and after use.
  • Clean affected part before use. Make sure to dry well.
  • Put a thin layer on the affected part.
  • Do not rub into skin.

What do I do if I miss a dose?

  • Put on a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not put on 2 doses or extra doses.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Vusion, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Vusion. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Vusion (miconazole and zinc oxide).

Review Date: October 4, 2017

Adverse Reactions

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.

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.

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.

Vusion 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 C18H14Cl4N2O•HNO3 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.

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.

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

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

Vusion 
miconazole nitrate, zinc oxide, white petrolatum ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:40076-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 2.5 mg  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 150 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM 813.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE  
TRIHYDROXYSTEARIN  
Packaging
# Item Code Package Description
1 NDC:40076-002-50 1 TUBE in 1 CARTON
1 50 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021026 05/14/2007
Labeler - Prestium Pharma, Inc. (078304674)
Registrant - Delcor Asset Corporation (965099505)
Establishment
Name Address ID/FEI Operations
GlaxoSmithKline Inc 205556368 MANUFACTURE(40076-002)
Revised: 10/2013   Prestium Pharma, Inc.

Important information

Vusion Ointment is used to treat diaper rash with yeast infection (candidiasis). This medicine should not be used to prevent diaper rash.This medicine should not be used to prevent diaper rash.

Call your doctor at once if your child has severe discomfort or redness of treated skin areas.

Vusion will not be effective without frequent diaper changes

What happens if I miss a dose?

Since Vusion ointment is used with each diaper change, you are not likely to miss a dose.

Vusion side effects

Get emergency medical help if you have signs of an allergic reaction to Vusion ointment: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • severe discomfort, redness, or other irritation of treated skin areas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Skin irritation.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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