retapamulin (Rx)

Brand and Other Names:Altabax
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Dosing & Uses

AdultPediatric

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

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Adverse Effects

1-10%

Application site irritation (2%)

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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

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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.

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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

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Formulary

FormularyPatient Discounts

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.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.