Drugs Details

Drugs Info of Bactroban Ointment
Drugs Details
  • Drugs Type  : FDA
  • Date : 26th Dec 2014 10:28 pm
  • Brand Name : Bactroban Ointment
  • Generic Name : mupirocin topical (Pronunciation: myoo PEER oh sin)
Descriptions

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:

 

Bactroban Ointment (mupirocin ointment) structural formula illustration

What are the possible side effects of mupirocin topical (Bactroban)?

Serious side effects are not expected to occur with mupirocin topical therapy. Stop using mupirocin topical and see your doctor if you experience unusual blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Bactroban Ointment »

What are the precautions when taking mupirocin (Bactroban Ointment)?

Before using mupirocin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as polyethylene glycol found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (if you are using a brand of mupirocin that contains polyethylene glycol).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Bactroban Ointment »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Bactroban Ointment (mupirocin ointment), 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes.

Dosage Administration

A small amount of Bactroban Ointment (mupirocin) should be applied to the affected area three 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.

How Supplied

Bactroban Ointment (mupirocin ointment), 2% is supplied in 22 gram tubes.

NDC 0029-1525-44 (22 gram tube)

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

DATE OF ISSUANCE NOV. 2001. GlaxoSmithKline., Research Triangle Park, NC 27709. FDA rev date: 11/9/2001

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following local adverse reactions have been reported in connection with the use of Bactroban Ointment (mupirocin) : burning, stinging, or pain in 1.5% of patients; itching in 1% of patients; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients. Systemic reactions to Bactroban Ointment (mupirocin) have occurred rarely.

Read the Bactroban Ointment (mupirocin) Side Effects Center for a complete guide to possible side effects

Interactions

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

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Bactroban Ointment is not for ophthalmic use.

Precautions

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Bactroban Ointment (mupirocin ointment) 2%, treatment should be discontinued and appropriate alternative therapy for the infection instituted.

As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

Bactroban Ointment is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A paraffin-based formulation - Bactroban Nasal® (mupirocin calcium ointment) - is available for intranasal use.

Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, Bactroban Ointment (mupirocin) should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.

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/m²basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin.

Pregnancy

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.

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 (mupirocin) is administered to a nursing woman.

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

This monograph has been modified to include the generic and brand name in many instances.

OverDose

NO INFORMATION PROVIDED.

ContrainDications

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Application of 14C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption ( < 1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application.

Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a study conducted in seven healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency.

Microbiology: Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). It is also active against certain gram-negative bacteria. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this unique mode of action, mupirocin demonstrates no in vitro cross-resistance with other classes of antimicrobial agents.

Resistance occurs rarely. However, when mupirocin resistance does occur, it appears to result from the production of a modified isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC > 1024 mcg/mL) has been reported in some strains of S. aureus and coagulase-negative staphylococci.

Mupirocin is bactericidal at concentrations achieved by topical administration. However, the minimum bactericidal concentration (MBC) against relevant pathogens is generally eight-fold to thirty-fold higher than the minimum inhibitory concentration (MIC). In addition, mupirocin is highly protein bound ( > 97%), and the effect of wound secretions on the MICs of mupirocin has not been determined.

Mupirocin has been shown to be active against most strains of Staphylococcus aureus and Streptococcus pyogenes, both in vitro and in clinical studies. (See INDICATIONS AND USAGE.) The following in vitro data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN. Mupirocin is active against most strains of Staphylococcus epidermidis and Staphylococcus saprophyticus.

Clinical Studies

The efficacy of topical Bactroban Ointment (mupirocin) in impetigo was tested in two studies. In the first, patients with impetigo were randomized to receive either Bactroban Ointment (mupirocin) or vehicle placebo t.i.d. for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric patients included) were 71% for Bactroban Ointment (mupirocin) (n=49) and 35% for vehicle placebo (n=51). Pathogen eradication rates in the evaluable populations were 94% for Bactroban Ointment (mupirocin) and 62% for vehicle placebo. There were no side effects reported in the group receiving Bactroban Ointment (mupirocin) .

In the second study, patients with impetigo were randomized to receive either Bactroban Ointment (mupirocin) t.i.d. or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded study) 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 patients included) were 93% for Bactroban Ointment (mupirocin) (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable patient populations were 100% for both test groups. There were no side effects reported in the Bactroban Ointment (mupirocin) group.

Pediatrics

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

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes. The medication should be stopped and your healthcare practitioner contacted if irritation, severe itching, or rash occurs.

If impetigo has not improved in 3 to 5 days, contact your healthcare practitioner.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

MUPIROCIN OINTMENT - TOPICAL

 

(mue-PIR-oh-sin)

 

COMMON BRAND NAME(S): Bactroban

 

USES: Mupirocin is used to treat certain skin infections (e.g., impetigo). It is an antibiotic that works by stopping the growth of certain bacteria.

 

HOW TO USE: Use this medication only on the skin. Clean and dry the affected area first. Then apply a small amount of ointment to the area 3 times a day, or as directed by your doctor. You may cover the treated area with a bandage.

Use this medication regularly in order to get the most benefit from it. Continue to use it for the full amount of time prescribed. Stopping the medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Avoid using this medication around your eyes, nose, mouth, or on large areas of damaged or broken skin unless otherwise directed by your doctor.

Inform your doctor if your condition does not improve in 3-5 days.

Consumer Overview Side Effect

SIDE EFFECTS: This medication may cause burning, stinging, itching or pain at first as your body adjusts to it. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if a rash or severe itching occurs.

Use of this medication for prolonged or repeated periods may result in a new infection (e.g., fungal infection). Contact your doctor if you notice signs of a new infection.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Bactroban Ointment (mupirocin) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using mupirocin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as polyethylene glycol found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (if you are using a brand of mupirocin that contains polyethylene glycol).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: chloramphenicol.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medicine may be harmful if swallowed.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C). Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Bactroban

Generic Name: mupirocin topical (Pronunciation: myoo PEER oh sin)

  • What is mupirocin topical (Bactroban Ointment)?
  • What are the possible side effects of mupirocin topical (Bactroban Ointment)?
  • What is the most important information I should know about mupirocin topical (Bactroban Ointment)?
  • Who should not use mupirocin topical (Bactroban Ointment)?
  • How should I use mupirocin topical (Bactroban Ointment)?
  • What happens if I miss a dose (Bactroban Ointment)?
  • What happens if I overdose (Bactroban Ointment)?
  • What should I avoid while using mupirocin topical (Bactroban Ointment)?
  • What other drugs will affect mupirocin topical (Bactroban Ointment)?
  • Where can I get more information?

What is mupirocin topical (Bactroban Ointment)?

Mupirocin is an antibiotic. Mupirocin topical prevents bacteria from growing on your skin.

Mupirocin topical is used to treat infections of the skin such as impetigo.

Mupirocin topical may also be used for purposes other than those listed in this medication guide.

Bactroban Ointment

What are the possible side effects of mupirocin topical (Bactroban Ointment)?

Serious side effects are not expected to occur with mupirocin topical therapy. Stop using mupirocin topical and see your doctor if you experience unusual blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Bactroban Ointment (mupirocin) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about mupirocin topical (Bactroban Ointment)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Avoid your eyes, nose, mouth, and lips when applying mupirocin topical. If medication gets in any of these areas, wash with water.

Watch for signs of improvement in 3 to 5 days. If your condition gets worse or does not improve, see your doctor.

Side Effects Centers
  • Bactroban Ointment
  • Bactroban Cream

Patient Detailed How Take

Who should not use mupirocin topical (Bactroban Ointment)?

Do not use mupirocin topical if you have ever had an allergic reaction to it.

You may not be able to use mupirocin topical if you have a very large open wound. This medication contains polyethylene glycol, which may cause damage to your kidneys if too much drug is absorbed through your skin.

Mupirocin topical is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not use mupirocin topical without first talking to your doctor if you are pregnant.

Mupirocin topical passes into breast milk and may affect a nursing infant. Do not use mupirocin topical without first talking to your doctor if you are breast-feeding a baby.

How should I use mupirocin topical (Bactroban Ointment)?

Use mupirocin topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply a small amount of the ointment as directed.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

You should notice improvement in 3 to 5 days. If the infection gets worse or does not improve, consult your doctor.

Do not use bandages that do not allow air circulation over the affected area unless otherwise directed by your doctor. A light, cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth or in large, open wounds.

Store mupirocin topical at room temperature away from moisture and heat.

Side Effects Centers
  • Bactroban Ointment
  • Bactroban Cream

Patient Detailed Avoid Taking

What happens if I miss a dose (Bactroban Ointment)?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only the regular amount of mupirocin topical. Do not use a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose (Bactroban Ointment)?

An overdose of mupirocin topical is rare. Consult a doctor if you suspect an overdose. No symptoms of an overdose are known.

If mupirocin topical gets in your eyes or mouth, rinse with water.

If mupirocin topical is ingested, consult a poison control center.

What should I avoid while using mupirocin topical (Bactroban Ointment)?

Avoid using other topical preparations on the same area at the same time unless directed to do so by your doctor.

What other drugs will affect mupirocin topical (Bactroban Ointment)?

Other topical medications may change the way that your skin absorbs mupirocin topical. Avoid using other products on the same area at the same time unless directed to do so by your doctor.

Where can I get more information?

Your pharmacist has additional information about mupirocin topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.06. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Bactroban Ointment
  • Bactroban Cream

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI