Mupirocin

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Mupirocin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
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  • Content

Overview

Mupirocin is a anti-bacterial, anti-infective agent that is FDA approved for the treatment of impetigo. There is a Black Box Warning for this drug as shown here. Common adverse reactions include application site pain, sensation of burning of skin, stinging of skin.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Impetigo
  • BACTROBAN Ointment is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes.
  • Dosing Information
  • A small amount of BACTROBAN Ointment should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

Secondary infection - Skin lesion

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Mupirocin in adult patients.

Non–Guideline-Supported Use

Complication of catheter - Infectious disease, Exit site; Prophylaxis
  • Dosing Information
  • Dosage
Superficial bacterial infection of skin

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mupirocin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Impetigo
  • Dosing Information
  • Dosage
Secondary infection - Skin lesion

There is limited information regarding FDA-Labeled Use of Mupirocin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Mupirocin in pediatric patients.

Non–Guideline-Supported Use

Superficial bacterial infection of skin
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mupirocin in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
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  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

The following local adverse reactions have been reported in connection with the use of BACTROBAN Ointment: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of subjects.

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of BACTROBAN.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Mupirocin in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • The effect of the concurrent application of BACTROBAN Ointment and other drug products has not been studied.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B Teratogenic Effects:Pregnancy Category B

  • Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mupirocin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mupirocin during labor and delivery.

Nursing Mothers

  • It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BACTROBAN Ointment is administered to a nursing woman.

Pediatric Use

  • The safety and effectiveness of BACTROBAN Ointment have been established in the age range of 2 months to 16 years. Use of BACTROBAN Ointment in these age groups is supported by evidence from adequate and well-controlled trials of BACTROBAN Ointment in impetigo in pediatric subjects studied as a part of the pivotal clinical trials (see CLINICAL STUDIES).

Geriatic Use

There is no FDA guidance on the use of Mupirocin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Mupirocin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Mupirocin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Mupirocin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Mupirocin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Mupirocin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Mupirocin in patients who are immunocompromised.

Administration and Monitoring

Administration

  • A small amount of BACTROBAN Ointment should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

Monitoring

There is limited information regarding Monitoring of Mupirocin in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Mupirocin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Mupirocin in the drug label.

Pharmacology

Mechanism of Action

Structure

Each gram of BACTROBAN Ointment (mupirocin ointment, 2%) contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C26H44O9, and the molecular weight is 500.63. The chemical structure is:

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Mupirocin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Mupirocin in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted.

Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

Reproduction studies were performed in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin.

Clinical Studies

The efficacy of topical BACTROBAN Ointment in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either BACTROBAN Ointment or vehicle placebo 3 times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for BACTROBAN Ointment (n = 49) and 35% for vehicle placebo (n = 51). Pathogen eradication rates in the evaluable populations were 94% for BACTROBAN Ointment and 62% for vehicle placebo. There were no side effects reported in the group receiving BACTROBAN Ointment.

In the second trial, subjects with impetigo were randomized to receive either BACTROBAN Ointment 3 times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects included) were 93% for BACTROBAN Ointment (n = 29) and 78.5% for erythromycin (n = 28). Pathogen eradication rates in the evaluable populations were 100% for both test groups. There were no side effects reported in the group receiving BACTROBAN Ointment.

Pediatrics

There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for BACTROBAN Ointment (n = 42) and 36% for vehicle placebo (n = 49). In the second trial described above, all subjects were pediatric except 2 adults in the group receiving BACTROBAN Ointment. The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for BACTROBAN Ointment (n = 27) was 96%, and for erythromycin it was unchanged (78.5%).

How Supplied

BACTROBAN Ointment is supplied in 22-gram tubes.

NDC 0029-1525-44 (22-gram tube)

Storage

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Information for Patients

  • Use this medication only as directed by the healthcare provider. It is for external use only. Avoid contact with the eyes. If BACTROBAN Ointment gets in or near the eyes, rinse thoroughly with water. The medication should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs.
  • If impetigo has not improved in 3 to 5 days, contact the healthcare provider.

Precautions with Alcohol

  • Alcohol-Mupirocin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Bactroban Centany Centany AT

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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