Sx Pre - Op Prep Pouch - Mupirocin Ointment

Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of

• For Topical Use Only.
• Apply a small amount of Mupirocin Ointment USP, 2%, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days.
• Cover the treated area with gauze dressing if desired.
• Re-evaluate patients not showing a clinical response within 3 to 5 days.
• Mupirocin Ointment USP, 2% is not for intranasal, ophthalmic, or other mucosal use [
  
  
  see Warnings and Precautions (5.2, 5.6)
  ].
  
• Do not apply Mupirocin Ointment USP, 2% concurrently with any other lotions, creams, or ointments [
  
  
  see Clinical Pharmacology (12.3)
  ].
  

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base supplied in 15-gram and 22-gram tubes.

There are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [

The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Mupirocin administered subcutaneously to rats in a pre- and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area. The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose.

• Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin, including Mupirocin Ointment USP, 2%. (
  
  
  5.1 Severe Allergic Reactions

  Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of mupirocin, including Mupirocin Ointment USP, 2% [

  see Adverse Reactions (6.2)

  ].
  )
  
• Eye Irritation: Avoid contact with eyes. (
  
  
  5.2 Eye Irritation

  Avoid contact with the eyes. In case of accidental contact, rinse well with water.
  )
  
• Local Irritation: Discontinue in the event of sensitization or severe local irritation. (
  
  
  5.3 Local Irritation

  In the event of a sensitization or severe local irritation from Mupirocin Ointment USP, 2%, usage should be discontinued, and appropriate alternative therapy for the infection instituted.
  )
  
• Clostridium difficile
  -Associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. (
  
  
  5.4

  Clostridium difficile

  -Associated Diarrhea

  Clostridium difficile

  -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of

  C. difficile

  .

  C. difficile

  produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of

  C. difficile

  cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use.

  Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

  If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against

  C. difficile

  may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of

  C. difficile

  , and surgical evaluation should be instituted as clinically indicated.
  )
  
• Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. (
  
  
  5.5 Potential for Microbial Overgrowth

  As with other antibacterial products, prolonged use of Mupirocin Ointment USP, 2% may result in overgrowth of nonsusceptible microorganisms, including fungi [

  see Dosage and Administration (2)

  ].
  )
  
• Risk Associated with Mucosal Use: Mupirocin Ointment USP, 2% is not formulated for use on mucosal surfaces. A separate formulation, *BACTROBAN nasal ointment, is available for intranasal use. (
  
  
  5.6 Risk Associated with Mucosal Use

  Mupirocin Ointment USP, 2% is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A separate formulation, *BACTROBAN^®(mupirocin calcium) nasal ointment, is available for intranasal use.
  )
  
• Risk of Polyethylene Glycol Absorption: Mupirocin Ointment USP, 2% should not be used where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. (
  
  
  5.7 Risk of Polyethylene Glycol Absorption

  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, Mupirocin Ointment USP, 2% 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.
  )
  
• Risk Associated with Use at Intravenous Sites: Mupirocin Ointment USP, 2% should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance. (
  
  
  5.8 Risk Associated with Use at Intravenous Sites

  Mupirocin Ointment USP, 2% should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance.
  )