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Mupirocin


General


Pronunciation

(myoo PEER oh sin)


Brand Names: U.S.

  • Bactroban
  • Bactroban Nasal
  • Centany
  • Centany AT

Indications


Use: Labeled Indications

Topical infection:

Intranasal: Eradication of nasal colonization with methicillin-resistant S. aureus (MRSA) in adult and pediatric patients ≥12 years of age and health care workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of MRSA infection during institutional outbreaks of infections with this microorganism

Limitations of use: Insufficient data for use as part of an intervention program to prevent autoinfection of high-risk patients from their own S. aureus nasal colonization or for general prophylaxis of any infection in any patient population.

Topical cream: Treatment of secondary 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

Topical ointment: Treatment of impetigo due to S. aureus and S. pyogenes


Contraindications


Hypersensitivity to mupirocin or any component of the formulation


Dosing and Administration


Dosing: Adult

Impetigo: Topical: Ointment: Apply to affected area 3 times daily; re-evaluate after 3 to 5 days if no clinical response

Secondary skin infections: Topical: Cream: Apply to affected area 3 times daily for 10 days; re-evaluate after 3 to 5 days if no clinical response

Elimination of MRSA colonization: Intranasal: Approximately one-half of the ointment from the single-use tube should be applied into one nostril and the other half into the other nostril twice daily (morning and evening) for 5 days

Surgical prophylaxis in methicillin-resistant S. aureus (MRSA) carriers (off-label use): Intranasal: Approximately one-half of the ointment from the single-use tube should be applied into one nostril and the other half into the other nostril twice daily for 5 days (Bode, 2010; Lee, 2013)


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Eradication of nasal MRSA: Intranasal: Children ≥12 years and Adolescents: Refer to adult dosing.

Impetigo: Topical: Ointment: Infants ≥2 months, Children, and Adolescents: Refer to adult dosing.

Secondary skin infections: Topical: Cream: Infants ≥3 months, Children, and Adolescents: Refer to adult dosing.


Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer 's labeling (has not been studied).


Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer 's labeling.


Administration

Intranasal ointment: After application into nostrils, press sides of nose together and gently massage to spread ointment throughout the insides of the nostrils for ~1 minute; in single-use tubes (may decrease contamination risk); discard tube after use. Not for use in eyes. In case of accidental contact in or near eyes, rinse well with water. Do not apply concurrently with any other intranasal products. Wash hands before and after application.

Topical cream, ointment: For external use only; not for use in eyes or on mucous membranes (components may be absorbed systemically and cause drying and irritation). Apply small amount to affected area using gauze pad or cotton swab; area may be covered with a gauze dressing if desired. In case of accidental contact in or near eyes, rinse well with water. Wash hands before and after application.


Storage

Intranasal: Store between 20 � �C and 25 � �C (68 � �F and 77 � �F); excursions are permitted between 15 � �C and 30 � �C (59 � �F and 86 � �F). Do not refrigerate.

Topical cream: Store at or below 25 � �C (77 � �F). Do not freeze.

Topical ointment: Store between 20 � �C and 25 � �C (68 � �F and 77 � �F).


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as calcium [strength expressed as base]:

Bactroban: 2% (15 g, 30 g)

Generic: 2% (15 g, 30 g)

Kit, External:

Centany AT: 2% [contains propylene glycol monostearate]

Ointment, External:

Bactroban: 2% (22 g [DSC])

Centany: 2% (30 g) [contains propylene glycol monostearate]

Generic: 2% (22 g)

Ointment, Nasal, as calcium [strength expressed as base]:

Bactroban Nasal: 2% (1 g)


Drug Interactions

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification


Adverse Reactions


1% to 10%:

Central nervous system: Headache (2% to 9%), localized burning (<4%), stinging sensation (<2%)

Dermatologic: Pruritus ( ≤2%), skin rash ( ≤1%)

Gastrointestinal: Nausea (1% to 5%), dysgeusia (3%)

Local: Local pain (<2%)

Respiratory: Rhinitis (6%), respiratory congestion (5%), pharyngitis (4%), cough (2%)

<1% (Limited to important or life-threatening): Aphthous stomatitis, blepharitis, cellulitis, Clostridium difficile associated diarrhea, dermatitis, epistaxis, hypersensitivity reaction, increased wound secretion, xeroderma


Warnings/Precautions


Concerns related to adverse effects:

- Hypersensitivity: May be associated with systemic allergic reactions, including anaphylaxis, urticarial, angioedema, and generalized rash. If a systemic reaction occurs, discontinue use.

- Irritation: If sensitization or local irritation occurs, discontinue use.

- Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

- Renal impairment: Topical ointment and intranasal: Use with caution in patients with renal impairment (has not been studied).

Concurrent drug therapy issues:

- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

- Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol ( ≥99 mg/kg/day) have been associated with a potentially fatal toxicity (gasping syndrome") in neonates; the "gasping syndrome " � consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer 's labeling.

- Polyethylene glycol: Potentially toxic amounts of polyethylene glycol contained in some topical products may be absorbed percutaneously in patients with extensive burns or open wounds. Do not use polyethylene glycol-based ointments in conditions where absorption of large quantities of polyethylene glycol is possible, especially in the presence of moderate or severe renal impairment.

Other warnings/precautions:

- Appropriate use: For external use only. Avoid contact with eyes; in case of accidental contact in or near eyes, rinse well with water.

- Intranasal: May cause severe burning and tearing in eyes (resolves within days to weeks after discontinuation). Available in single-use tubes to decrease risk of contamination.

- Topical cream and ointment: Not for ophthalmic or nasal use or use on mucosal surfaces. May cover treated areas with gauze dressing.

- Limitations of use:

- Nasal ointment: There are insufficient data to establish that product is safe and effective as part of an intervention program to prevent autoinfection of high-risk patients from their own nasal colonization with S. aureus; should not be used for general prophylaxis of any infection in any patient population; >90% of patients had eradication of nasal colonization within 2 to 4 days after therapy was completed; ~30% recolonization within 4 weeks of therapy was reported in one study.

- Topical ointment: Should not be used with intravenous (IV) cannulae or at central IV sites because of the potential to promote fungal infections and antimicrobial resistance.


Pregnancy Risk Factor

B


Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.


Actions


Pharmacology

Binds to bacterial isoleucyl transfer-RNA synthetase resulting in the inhibition of protein synthesis


Absorption

Topical ointment and cream: Penetrates outer layers of skin; systemic absorption minimal through intact skin

Intranasal: Adults: ~3%; Neonates and premature infants: Absorption may be significant


Metabolism

Rapidly metabolized to monic acid (inactive)


Excretion

Urine (as monic acid [inactive])


Half-Life Elimination

17 to 36 minutes


Protein Binding

>97%


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience burning, stinging, headache, rhinorrhea, pharyngitis, cough, rhinitis, or change in taste. Have patient report immediately to prescriber signs of signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools), application site irritation, or severe itching (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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