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  • CLASSES

    Topical Antibacterial Agents, Other
    Topical Nasal Anti-infectives

    DEA CLASS

    Rx

    DESCRIPTION

    Unique topical antibiotic produced from Pseudomonas fluorescens; active against gram positive organisms like S. aureus and Strept. pyogenes; used for skin infections like impetigo; also in an intranasal ointment to eradicate nasal colonization of MRSA.

    COMMON BRAND NAMES

    Bactroban, Centany, Centany AT

    HOW SUPPLIED

    Bactroban Nasal Ointment: 2%
    Bactroban/Centany/Centany AT/Mupirocin Topical Ointment: 2%
    Bactroban/Mupirocin/Mupirocin Calcium Topical Cream: 2%

    DOSAGE & INDICATIONS

    For the treatment of impetigo and other skin and skin structure infections due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes.
    For the treatment of impetigo.
    Topical dosage (ointment)
    Adults, Children, and Infants 2 months and older

    Apply a small amount to the affected area(s) 3 times daily. The area(s) may be covered with a sterile gauze dressing. Therapy is usually continued for 1 to 2 weeks. If a response is not evident within 3 to 5 days, the infection should be reevaluated. Studies evaluating use of mupirocin for the treatment of impetigo have found the ointment produces similar cure rates to oral erythromycin.

    For the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area).
    Topical dosage (cream)
    Adults, Children, and Infants 3 months and older

    Apply a small amount to the affected area(s) 3 times daily for 10 days. If a response is not evident within 3 to 5 days, the infection should be reevaluated.

    For methicillin-resistant S. aureus nasal carriage eradication to reduce the risk of infection among high-risk patients during institutional outbreaks.
    Intranasal dosage
    Adults

    Apply approximately half of the ointment from a single-use tube into each nare twice daily for 5 to 10 days.

    Children and Adolescents 12 to 17 years

    Apply approximately half of the ointment from a single-use tube into each nare twice daily for 5 to 10 days.

    Infants† and Children 1 to 11 years†

    Apply into each nare twice daily for 5 to 10 days. Use of the nasal ointment was evaluated in 10 infants with MRSA colonization of the nasal cavity (n = 1), pharynx (n = 8), or both (n = 1). The treatment course was administered as ointment application to both nares 3 times a day for 3 days. MRSA eradication was successful in the nose-limited carrier, 5 of 8 pharynx-limited carriers (63%), and the nose/pharynx carrier. The number of treatments required for MRSA eradication varied from 1 to 7 courses, with 3 infants remaining MRSA positive even after 5 to 7 courses.

    For the treatment of mild methicillin-resistant Staphylococcus aureus (MRSA)-associated infectious neonatal pustulosis†.
    Topical dosage (ointment)
    Neonates and Infants younger than 3 months

    Apply a small amount to the affected area(s) 3 times daily. Clinical practice guidelines support the use of mupirocin for mild cases with localized disease.

    For the treatment of infected eczema† due to susceptible strains of Staphylococcus sp. or Streptococcus sp..
    Topical dosage (ointment)
    Adults, Adolescents, Children, and Infants

    Apply a small amount to the affected area(s) 2 to 3 times daily for 1 to 2 weeks. Topical mupirocin ointment has similar or superior efficacy when compared with systemic antibiotics (i.e., erythromycin, ampicillin, flucloxacillin) for secondary skin infections, including infected eczema.

    For the treatment of folliculitis† due to susceptible strains of Staphylococcus sp. or Streptococcus sp..
    Topical dosage (ointment)
    Adults, Adolescents, and Children

    Apply a small amount to the affected area(s) 3 times daily for 5 to 14 days. Topical mupirocin ointment has similar or superior efficacy when compared with systemic antibiotics (i.e., ampicillin, cloxacillin, erythromycin) for primary skin infections, including folliculitis.

    For the prevention of postoperative nosocomial Staphylococcus aureus infections† (i.e., bacterial infection prophylaxis†).
    Intranasal dosage
    Adults

    Apply a small amount to each nare topically twice daily for up to 5 days pre-operatively. Use in combination with chlorhexidine baths once daily.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    Intranasal, 5 days of twice daily therapy; Topical, maximum dosage information is not available.

    Geriatric

    Intranasal, 5 days of twice daily therapy; Topical, maximum dosage information is not available.

    Adolescents

    Intranasal, 5 days of twice daily therapy; Topical, maximum dosage information is not available.

    Children

    12 years: Intranasal, 5 days of twice daily therapy; Topical, maximum dosage information is not available.
    1 to 11 years: Maximum dosage information is not available for topical ointment or cream. Safety and efficacy not established for intranasal ointment; however, intranasal ointment has been used off-label.

    Infants

    3 months and older: Maximum dosage information is not available for topical ointment or cream. Safety and efficacy not established for intranasal ointment; however, intranasal ointment has been used off-label.
    2 months: Maximum dosage information is not available for topical ointment. Safety and efficacy not established for topical cream or intranasal ointment; however, intranasal ointment has been used off label.
    younger than 2 months: Safety and efficacy not established; however, topical and intranasal ointment have been used off-label.
     

    Neonates

    Safety and efficacy not established; however, topical ointment has been used off-label.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment needed.

    Renal Impairment

    No dosage adjustment needed.

    ADMINISTRATION

     
    NOTE: Prolonged use of mupirocin is not recommended because of possible overgrowth of resistant organisms, including fungi. This overgrowth may cause superinfection.

    Topical Administration
    Cream/Ointment/Lotion Formulations

    Apply to affected area. Treated area may be covered with sterile gauze dressing if desired.
    Do not apply topical ointment to the eye or in the nose.

    Other Administration Route(s)

    Nasal Administration
    Apply nasal ointment inside the nose.
    Do not apply ointment to the eye.
    After application, close the nostrils by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.
    Discard each tube after use.
    Do not use concurrently with any other intranasal product.

    STORAGE

    Bactroban:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Centany:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Centany AT :
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Prolonged use of mupirocin is not recommended because of possible overgrowth of resistant organisms including fungi. This overgrowth can cause superinfection.

    Burns, renal impairment

    Normal undamaged epithelial surfaces inhibit the absorption of polyethylene glycol, the vehicle for mupirocin skin ointment. Damaged epithelial surfaces allow absorption of polyethylene glycol. Mupirocin skin ointment should not be used on burns (especially extensive burns), open wounds, or other damaged skin. Increased absorption of polyethylene glycol should be avoided, especially if there is evidence of moderate to severe renal impairment.

    Children, infants, neonates

    The intranasal form of mupirocin is not for use in neonates, infants, or children < 12 years old. Safe use and pharmacokinetic properties have not been studied in these groups. The safety and efficacy of mupirocin topical cream have not been established in pediatric patients less than 3 months and the safety and efficacy of the topical ointment have not been established in pediatric patients less than 2 months of age.

    Ocular exposure, ophthalmic administration

    Mupirocin is not for ophthalmic administration. Avoid ocular exposure of mupirocin as ocular contact produces severe burning and tearing.

    Pregnancy

    There are insufficient human data to establish a drug-associated risk with mupirocin use during pregnancy. Systemic absorption of mupirocin through intact skin is minimal after topical administration of mupirocin. No developmental toxicity was observed in rats or rabbits given mupirocin subcutaneously at doses 11 and 22 times the human topical dose based on calculations of dose divided by the entire body surface area.

    Breast-feeding

    It is not known whether mupirocin is present in human breast milk, has effects on the breast-fed child, or has effects on milk production. However, breast-feeding is not expected to result in exposure of the child to mupirocin due to the minimal systemic absorption of mupirocin after topical administration. Consider the benefits of breast-feeding along with the mother's clinical need for mupirocin and any potential adverse effects on the breast-fed child from mupirocin or the underlying maternal condition. To minimize oral exposure of the drug to the breast-feeding child, thoroughly wash a breast and/or nipple being treated with mupirocin prior to breast-feeding.

    C. difficile-associated diarrhea, diarrhea, pseudomembranous colitis

    Consider pseudomembranous colitis in patients presenting with diarrhea after antibacterial use. Careful medical history is necessary as pseudomembranous colitis has been reported to occur over 2 months after the administration of antibacterial agents. Almost all antibacterial agents, including mupirocin, have been associated with pseudomembranous colitis or C. difficile-associated diarrhea (CDAD) which may range in severity from mild to life-threatening. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

    ADVERSE REACTIONS

    Severe

    angioedema / Rapid / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known

    Moderate

    erythema / Early / 0-1.0
    contact dermatitis / Delayed / 0-1.0
    blepharitis / Early / 0-1.0
    stomatitis / Delayed / 0-1.0
    pseudomembranous colitis / Delayed / Incidence not known
    superinfection / Delayed / Incidence not known

    Mild

    rash / Early / 1.0-10.0
    headache / Early / 1.7-9.0
    rhinitis / Early / 6.0-6.0
    nausea / Early / 0-4.9
    pharyngitis / Delayed / 4.0-4.0
    skin irritation / Early / 0-3.6
    dysgeusia / Early / 3.0-3.0
    nasal irritation / Early / 2.0-2.0
    cough / Delayed / 2.0-2.0
    xerosis / Delayed / 0-1.0
    diarrhea / Early / 0-1.0
    xerostomia / Early / 0-1.0
    epistaxis / Delayed / 0-1.0
    otalgia / Early / 0-1.0
    pruritus / Rapid / Incidence not known
    urticaria / Rapid / Incidence not known
    abdominal pain / Early / Incidence not known
    dizziness / Early / Incidence not known
    infection / Delayed / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Mupirocin products.

    PREGNANCY AND LACTATION

    Pregnancy

    There are insufficient human data to establish a drug-associated risk with mupirocin use during pregnancy. Systemic absorption of mupirocin through intact skin is minimal after topical administration of mupirocin. No developmental toxicity was observed in rats or rabbits given mupirocin subcutaneously at doses 11 and 22 times the human topical dose based on calculations of dose divided by the entire body surface area.

    It is not known whether mupirocin is present in human breast milk, has effects on the breast-fed child, or has effects on milk production. However, breast-feeding is not expected to result in exposure of the child to mupirocin due to the minimal systemic absorption of mupirocin after topical administration. Consider the benefits of breast-feeding along with the mother's clinical need for mupirocin and any potential adverse effects on the breast-fed child from mupirocin or the underlying maternal condition. To minimize oral exposure of the drug to the breast-feeding child, thoroughly wash a breast and/or nipple being treated with mupirocin prior to breast-feeding.

    MECHANISM OF ACTION

    Mupirocin is bacteriostatic at low concentrations and bactericidal at high concentrations. Bacterial protein and RNA synthesis are inhibited when mupirocin reversibly binds to bacterial isoleucyl-tRNA synthetase. This enzyme normally promotes the conversion of isoleucine and tRNA to isoleucyl-tRNA. The epoxide side chain of mupirocin is similar to isoleucine and competes with it for binding sites on the synthetase enzyme. The cellular concentration of isoleucyl-tRNA becomes depleted, subsequently inhibiting bacterial protein and RNA synthesis. Unlike many other antibiotics, mupirocin has little effect on bacterial DNA synthesis and cell wall peptidoglycan formation.

    PHARMACOKINETICS

    Mupirocin is administered topically to the skin or the nares. Once in systemic circulation, it is rapidly metabolized to inactive monic acid and is excreted via the kidneys. The elimination half-life is 20—40 minutes for mupirocin and 30—80 minutes for monic acid.

    Topical Route

    Percutaneous absorption through intact skin is minimal in both pediatric and adult patients. Following topical administration, > 97% of the drug is bound to protein. Polyethylene glycol (PEG), the vehicle used for the ointment, can be absorbed from open or damaged skin and may cause renal failure.

    Other Route(s)

    Intranasal Route
    In adults, systemic absorption of intranasally applied mupirocin ointment is minimal. One study suggested 3.3% (range: 1.2—5.1%) of an applied dose may be absorbed from the nasal mucosa of adults. Pharmacokinetic studies have not been conducted in pediatric patients < 12 years of age.