Pirnuo

PIRNUO 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 isolates of

• •For Topical Use Only.
• •Apply a small amount of PIRNUO cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 10 days.
• •Cover the treated area with gauze dressing if desired.
• •Re-evaluate patients not showing a clinical response within 3 to 5 days.
• •PIRNUO cream is not for intranasal, ophthalmic, or other mucosal use
  [see Warnings and Precautions (

  5.2 Eye Irritation

  Avoid contact with the eyes. In case of accidental contact, rinse well with water.

  ,

  5.6 Risk Associated with Mucosal Use

  PIRNUO cream is not formulated for use on mucosal surfaces. A separate formulation, BACTROBAN(mupirocin) nasal ointment, is available for intranasal use.

  )]
  .
• •Do not apply PIRNUO cream concurrently with any other lotions, creams, or ointments
  [see Clinical Pharmacology (

  12.3 Pharmacokinetics

  Absorption

  Systemic absorption of mupirocin through intact human skin is minimal. The systemic absorption of mupirocin was studied following application of mupirocin cream 3 times daily for 5 days to various skin lesions greater than 10 cm in length or 100 cm²in 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, in urine. Data from this trial indicated more frequent occurrence of percutaneous absorption in children (90% of subjects) compared with adults (44% of subjects); however, the observed urinary concentrations in children (0.07 to 1.3 mcg per mL [1 pediatric subject had no detectable level]) are within the observed range (0.08 to 10.03 mcg per 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.

  The effect of the concurrent application of mupirocin cream with other topical products has not been studied

  [see Dosage and Administration ]

  .

  Elimination

  In a trial conducted in 7 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.

  Metabolism:

  Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, demonstrates no antibacterial activity.

  Excretion:

  Monic acid is predominantly eliminated by renal excretion.

  )].

PIRNUO^TM Cream (Mupirocin Cream USP, 2%) is a white cream that contains 20 mg (2% w/w) of mupirocin per gram (equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium, USP) in an oil- and water-based emulsion, supplied in 42.5 gram pumps.

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

The estimated background risk of major birth defects and miscarriage 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 cream. (
  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 cream

  [see Adverse Reactions ].
  )
• •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 PIRNUO cream, 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 PIRNUO cream may result in overgrowth of nonsusceptible microorganisms, including fungi

  [see Dosage and Administration ]

  .
  )
• •Risk Associated with Mucosal Use: PIRNUO cream 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

  PIRNUO cream is not formulated for use on mucosal surfaces. A separate formulation, BACTROBAN(mupirocin) nasal ointment, is available for intranasal use.
  )