Dosing & Uses
Dosage Forms & Strengths
ointment
- 1% (5, 10, 15g tubes)
Impetigo
Indicated for impetigo caused by MSSA or Streptococcus pyogenes
Apply thin layer to affected area (up to 100 cm²) BID x5 days
Dosage Forms & Strengths
ointment
- 1% (5, 10, 15g tubes)
Impetigo
Indicated for impetigo caused by MSSA or Streptococcus pyogenes
<9 months: Safety and efficacy not established
≥9 months: Apply thin layer to affected area (up to 2% BSA) BID x5 days
Adverse Effects
1-10%
Application site irritation (2%)
Warnings
Contraindications
None
Cautions
Not for oral, intranasal, ophthalmic or intravaginal use; efficacy and safety for mucosal surfaces not established
Discontinue if sensitization or severe local irritation develops
Epistaxis reported with use on nasal mucosa
Not evaluated on mucosal surfaces
Pregnancy & Lactation
Pregnancy
There are no available data on use in pregnant women to inform any drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes; drug is negligibly absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure
Animal data
- Animal reproduction studies were not conducted with drug; however, in animal studies where drug was administered by oral gavage or intravenous infusion to pregnant rats and rabbits, respectively, during organogenesis, maternal toxicity was seen at doses ≥150 mg/kg/day and 7.2 mg/kg/day (8-fold the maximum achievable human exposure based on AUC) for oral and intravenous routes, respectively
Lactation
There are no data available on presence of drug in human milk, its effects on breastfed infant or on milk production; however, breastfeeding is not expected to result in exposure of child to drug due to negligible systemic absorption in humans following topical administration of drug
Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Pleuromutilin antibacterial; binds to 50S ribosomal subunit and inhibits bacterial protein synthesis, bateriostatic at MIC; bactericidal at 1000x MIC
Pharmacokinetics
Absorption: Low
Protein Bound: 94%
Metabolism: in vitro by liver CYP3A4
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
