Drugs Details

Drugs Info of Bactroban
Drugs Details
  • Drugs Type  : FDA
  • Date : 24th Mar 2015 10:14 pm
  • Brand Name : Bactroban
  • Generic Name : mupirocin topical (Pronunciation: myoo PEER oh sin),Mupirocin Calcium Cream,(mupirocin calcium) Cream 2%
Descriptions

BACTROBAN CREAM (mupirocin calcium cream), 2% contains the dihydrate crystalline calcium hemi-salt of the antibiotic mupirocin. Chemically, it is (olE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-p-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate.

The molecular formula of mupirocin calcium is (C26H43O9)2Ca•2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is:

 

BACTROBAN (mupirocin calcium)  structural formula illustration

 

BACTROBAN CREAM is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% mupirocin free acid) in an oil and water-based emulsion. The inactive ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum.

 

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 Cream »

What are the precautions when taking mupirocin calcium cream (Bactroban Cream)?

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 Cream »

 

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

Indications

BACTROBAN CREAM (mupirocin calcium cream) is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S. aureus and S. pyogenes.

Dosage Administration

A small amount of BACTROBAN CREAM (mupirocin calcium cream) should be applied to the affected area three times daily for 10 days. The area treated may be covered with gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

How Supplied

BACTROBAN CREAM (mupirocin calcium cream) is supplied in 15-gram and 30-gram tubes.

NDC 0029-1527-22 (15-gram tube)
NDC 0029-1527-25 (30-gram tube)

Store at or below 25°C (77°F). Do not freeze.

Manufactured by DPT Laboratories San Antonio, TX 78215. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. September 2004

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

Side Effects

In 2 randomized, double-blind, double-dummy trials, 339 patients were treated with topical BACTROBAN CREAM (mupirocin calcium cream) plus oral placebo. Adverse events thought to be possibly or probably drug-related occurred in 28 (8.3%) patients. The incidence of those events that were reported in at least 1% of patients enrolled in these trials were: Headache (1.7%), rash, and nausea (1.1% each).

Other adverse events thought to be possibly or probably drug-related which occurred in less than 1% of patients were: Abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary woundinfection, and ulcerative stomatitis.

In a supportive study in the treatment of secondarily infected eczema, 82 patients were treated with BACTROBAN CREAM (mupirocin calcium cream) . The incidence of adverse events thought to be possibly or probably drug-related was as follows: Nausea (4.9%), headache, and burning at application site (3.6% each), pruritus (2.4%) and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.

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

Learn More »

Interactions

The effect of the concurrent application of topical mupirocin calcium cream and other topical products has not been studied.

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

Warnings

Avoid contact with the eyes.

In the event of a sensitization or severe local irritation from BACTROBAN CREAM (mupirocin calcium cream) , usage should be discontinued, and appropriate alternative therapy for the infection instituted.

Precautions

General

As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. (See DOSAGE AND ADMINISTRATION.) BACTROBAN CREAM (mupirocin calcium cream) is not formulated for use on mucosal surfaces.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocincalcium 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 mutagenicity: 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.

Fertility studies were performed in rats with mupirocin administered subcutaneously at doses up to 49 times a human topical dose of 1 gram/day (approximately 20 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of impaired fertility from mupirocin sodium.

Pregnancy

Teratogenic EffectsPregnancy Category B. Teratology studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 78 and 154 times, respectively, a human topical dose of 1 gram/day (approximately 20 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 reproduction 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 CREAM (mupirocin calcium cream) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of BACTROBAN CREAM (mupirocin calcium cream) have been established in the age groups 3 months to 16 years. Use of BACTROBAN CREAM (mupirocin calcium cream) in these age groups is supported by evidence from adequate and well-controlled studies of BACTROBAN CREAM in adults with additional data from 93 pediatric patients studied as part of the pivotal trials in adults. (See Clinical Studies.)

Geriatric Use

In 2 well-controlled studies, 30 patients older than 65 years were treated with BACTROBAN CREAM (mupirocin calcium cream) . No overall difference in the efficacy or safety of BACTROBAN CREAM was observed in this patient population when compared to that observed in younger patients.

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

OverDose

Intravenous infusions of 252 mg, as well as single oral doses of 500 mg of mupirocin, have been well tolerated in healthy adult subjects. There is no information regarding overdose of BACTROBAN CREAM (mupirocin calcium cream) .

ContrainDications

BACTROBAN CREAM (mupirocin calcium cream) is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

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

Clinical Pharamacology

Systemic absorption of mupirocin through intact human skin is minimal. The systemic absorption of mupirocin was studied following application of BACTROBAN CREAM three times daily for 5 days to various skin lesions (greater than 10 cm in length or 100 cm in area) in 16 adults (aged 29 to 60 years) and 10 children (aged 3 to 12 years). Some systemic absorption was observed as evidenced by the detection of the metabolite, monic acid, inurine. Data from this study indicated more frequent occurrence ofpercutaneous absorption in children (90% of patients) compared to adults (44% of patients); however, the observed urinary concentrations in children (0.07 - 1.3 mcg/mL [1 pediatric patient had no detectable level]) are within the observed range (0.08 - 10.03 mcg/mL [9 adults had no detectable level]) in the adult population. In general, the degree of percutaneous absorption following multiple dosing appears to be minimal in adults and children. Any mupirocin reaching the systemic circulation is rapidly metabolized, predominantly to inactive monic acid, which is eliminated by renal excretion.

Microbiology

Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluoresceins. It is active against a wide range ofgram-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 Staphylococcus aureus and coagulase-negative staphylococci.

Mupirocin is bactericidal at concentrations achieved by topical application. The minimum bactericidal concentration (MBC) against relevant pathogens is generally 8-fold to 30-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 S. aureus andStreptococcus pyogenes, both in vitro and in clinical studies. (SeeINDICATIONS 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 CREAM (mupirocin calcium cream) for the treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, and abrasions not more than 10 cm in length or 100 cm2 in total area) was compared to that of oral cephalexin in 2 randomized, double-blind, double-dummy clinical trials. Clinical efficacy rates at follow-up in the per protocol populations (adults and pediatric patients included) were 96.1% for BACTROBAN CREAM (mupirocin calcium cream) (n = 231) and 93.1% for oral cephalexin (n = 219). Pathogen eradication rates at follow-up in the per protocol populations were 100% for both BACTROBAN CREAM (mupirocin calcium cream) and oral cephalexin.

Pediatrics: There were 93 pediatric patients aged 2 weeks to 16 years enrolled per protocol in the secondarily infected skin lesion studies, although only 3 were less than 2 years of age in the population treated with BACTROBAN CREAM (mupirocin calcium cream) . Patients were randomized to either 10 days of topical BACTROBAN CREAM three times daily or 10 days of oral cephalexin (250 mg four times daily for patients > 40 kg or 25 mg/kg/day oral suspension in 4 divided doses for patients ≤ 40 kg). Clinical efficacy at follow-up (7 to 12 days post-therapy) in the per protocol populations was 97.7% (43/44) for BACTROBAN CREAM (mupirocin calcium cream) and 93.9% (46/49) for cephalexin. Only 1 adverse event (headache) was thought to be possibly or probably related to drug therapy with BACTROBAN CREAM (mupirocin calcium cream) in the intent-to-treat pediatric population of 70 children (1.4%).

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 treated area may be covered by gauze dressing if desired.
  • Report to your healthcare provider any signs of local adverse reactions. The medication should be stopped and your healthcare provider contacted if irritation, severe itching, or rash occurs.
  • If no improvement is seen in 3 to 5 days, contact your healthcare provider.

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

What is mupirocin topical (Bactroban Cream)?

 

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 Cream

 

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

 

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 Cream (mupirocin calcium cream) Side Effects Centerfor a complete guide to possible side effects

Learn More »
 

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

 

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 Cream)?

 

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 Cream)?

 

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 Cream)?

 

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 Cream)?

 

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 Cream)?

 

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 Cream)?

 

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.

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  • Bactroban Ointment
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