Active ingredient: Miconazole

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Miconazole uses


1 INDICATIONS AND USAGE

1.1 Indication

miconazole 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.

miconazole 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 should not be used as a substitute for frequent diaper changes. miconazole 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 miconazole 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 have not been evaluated in incontinent adult patients. miconazole 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.

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2 DOSAGE AND ADMINISTRATION

miconazole is not for oral, ophthalmic, or intravaginal use.

Before applying miconazole, 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 miconazole 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 miconazole when used for longer than 7 days is not known. Do not use miconazole for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.

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

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

None

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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 miconazole have not been evaluated in incontinent adult patients. miconazole 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

To report SUSPECTED ADVERSE REACTIONS, contact Prestium Pharma, Inc. at 1-866-897-5002 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 miconazole group, 58 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 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.

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.

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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 is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of miconazole in pregnant women. Therefore, miconazole 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 miconazole have not been established in nursing mothers. It is not known if the active components of miconazole 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.

miconazole should not be used to prevent diaper dermatitis.

The safety of miconazole 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.

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11 DESCRIPTION

miconazole 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 miconazole 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

miconazole is a smooth, uniform, white ointment.

Structural formula of miconazole nitrate

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The miconazole component of miconazole is an antifungal agent. 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 is unknown.

12.3 Pharmacokinetics

The topical absorption of miconazole from miconazole was studied in immunocompetent male and female infants and children 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 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 miconazole 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
miconazole

n=112

Zinc Oxide/White Petrolatum

n=124

26 (23%) 12 (10%)

Two additional studies provided supportive evidence of the clinical efficacy of miconazole 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 is a smooth, uniform, white ointment supplied in an aluminum tube, as follows:

50g

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 miconazole should be informed about the following information:


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

miconazole® (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 miconazole 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 miconazole, ask your health care provider, or pharmacist.

What is miconazole?

miconazole 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. miconazole 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 miconazole, 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. miconazole 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 miconazole on your child’s diaper rash unless your health care provider tells you that there is also a yeast infection.

Who should not use miconazole?

miconazole is not for treatment of all cases of diaper rash. miconazole 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 miconazole because most cases of diaper rash do not also have a yeast infection.

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

Do not use miconazole 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 miconazole.

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 miconazole on my child?

miconazole is applied to the skin on your child’s diaper area at each diaper change for 7 days.

Apply miconazole 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 miconazole. miconazole should not be used for more than 7 days.

To apply miconazole:


miconazole is for skin use only.

Call your child’s health care provider or poison control center right away if any miconazole is swallowed. Call your child’s health care provider if miconazole gets in the eye.

Keep out of reach of children.

What other steps will help diaper rash go away?


What are the possible side effects of miconazole?

miconazole 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 miconazole?


General information about miconazole

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

Do not use miconazole for a condition for which it was not prescribed. Do not give miconazole 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 miconazole. 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 miconazole 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 miconazole?

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

miconazole®

(miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP)

Ointment

50 grams

Rx only

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

Miconazole available forms, composition, doses:

Price
Antifungal 2% cream0.1 USD
CVS Pharmacy miconazole 7 cream0.18 USD
Cream; Topical; Miconazole Nitrate 2%
Cream; Topical; Vaginal; Miconazole Nitrate 2%
Cream; Vaginal; Miconazole Nitrate 2%
Cream; Vaginal; Miconazole Nitrate 4%
Lotrimin af 2% liquid spray0.04 USD
Micatin 2% aerosol spray0.05 USD
Miconazole 3 3 200 mg Suppository Box51.2 USD
Miconazole 7 cream0.15 USD
Miconazole Nitrate 2% Cream 28 gm Tube12.99 USD
Miconazole nitrate 2% cream0.19 USD
Miconazole nitrate powder3.55 USD
Miconazole powder4.59 USD
Monistat 1 6.5% ointment3.6 USD
Monistat 1 combination pack16.81 USD
Monistat 7 combination pack15.96 USD
Monistat-Derm 2% Cream 15 gm Tube32.0 USD
Monistat-Derm 2% Cream 28.35 gm Tube41.99 USD
Monistat-derm 2% cream1.11 USD
Suppositories; Rectal; Vaginal; Miconazole Nitrate 100 mg
Suppositories; Rectal; Vaginal; Miconazole Nitrate 200 mg
Vusion 0.25-15-81.35% Ointment 50 gm Tube284.34 USD
Vusion ointment3.17 USD

Indications and Usages:

ATC codes:


ICD-10 codes:


Miconazole destination | category:


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Drugs with same active ingredients (Pharmaceutical companies):


References

  1. Dailymed."RASH RELIEF ANTIFUNGAL (MICONAZOLE) LIQUID [TOUCHLESS CARE CONCEPTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."MICONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "miconazole". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Miconazole?

Depending on the reaction of the Miconazole after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Miconazole not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Miconazole addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Miconazole, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Miconazole consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Miconazole is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Expensive1
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Miconazole drug as prescribed by the doctor?

Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Miconazole is mentioned below.
Visitors%
Once in a day1
100.0%

One visitor reported doses

What is the dose of Miconazole drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 11-50mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
11-50mg1
100.0%

Two visitors reported time for results

What is the time duration Miconazole drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 1 day to notice the result from using Miconazole drug. The time needed to show improvement in health condition after using the medicine Miconazole need not be same for all the users. It varies based on other factors.
Visitors%
1 day1
50.0%
3 days1
50.0%

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

Visitor reviews


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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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