Indications

Retapamulin ointment is indicated for the topical treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes in patients aged 9 months or older. It is also indicated to treat infected small lacerations, abrasions or sutured wounds.

Therapeutic Class

Topical Antibiotic preparations

Pharmacology

Retapamulin is a semisynthetic derivative of the compound pleuromutilin. In vitro activity of Retapamulin against isolates of Staphylococcus aureus as well as Streptococcus pyogenes has been demonstrated. Retapamulin selectively inhibits bacterial protein synthesis by interacting at a site on the 50S subunit of the bacterial ribosome through an interaction that is different from that of other antibiotics.This binding site involves ribosomal protein L3 and is in the region of the ribosomal P-site and peptidyl transferase center. By virtue of binding to this site, pleuromutilins inhibit peptidyl transfer, block P-site interactions and prevent the normal formation of active 50S ribosomal subunits. Retapamulin demonstrates no in vitro target-specific cross-resistance with other classes of antibiotics.

Dosage & Administration

Apply a thin layer of Retapamulin to the affected area (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) twice daily for 5 days.

The treated area may be covered with a sterile bandage or gauze dressing if desired.

Interaction

The effect of concurrent application of Retapamulin and other topical products to the same area of skin has not been studied.

Contraindications

Hypersensitivity.

Side Effects

Side effects: Headache, pyrexia, pruritus, eczema, diarrhoea. Application site irritation, pain, erythema, contact dermatitis.

Adverse effects: Application site irritation (<2% of patients may experience).

Pregnancy & Lactation

Pregnancy Category B. It is not known whether Retapamulin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Precautions & Warnings

In the event of sensitization or severe local irritation, usage should be discontinued. Not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use.

Storage Conditions

Store in a cool (below 25° C)and dry place protected from light. Keep out of the reach of children.