Retapamulin 1% Topical

Indications

Retapamulin 1% Topical is used for: Impetigo, Bacterial skin infections

Adult Dose

Topical/Cutaneous Impetigo; Bacterial skin infections due to meticillin-susceptible, Staphylococcus aureus and Streptococcus pyogenes Adult: As 1% ointment: Apply onto affected area bid for 5 days. Re-evaluate if there is no response after 3 days of treatment. Total treatment area: <100 cm2 total body surface area.

Child Dose

Topical/Cutaneous Impetigo; Bacterial skin infections due to meticillin-susceptible, Staphylococcus aureus and Streptococcus pyogenes Child: As 1% ointment: >9 mth: Apply onto affected area bid for 5 days. Total treatment area: <2% of total body surface area.

Renal Dose

Administration

Contra Indications

Hypersensitivity.

Precautions

Discontinue use if skin irritation occurs. Prolonged use may result in fungal or bacterial superinfection. Re-evaluate if there is no response within 3 days. Children <9 mth. Pregnancy, lactation. Lactation: use caution

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

Interactions

Concurrent application w/ other topical products to the same skin area is not recommended.

Adverse Effects

Side effects of Retapamulin 1% Topical : 1-10% Application site irritation (2%) Headache, pyrexia, pruritus, eczema, diarrhoea.

Mechanism of Action

Retapamulin is a pleuromutilin antibacterial isolated from the fungus Clitopilus passeckerianus. It is a bacteriostatic agent that works by inhibiting biosynthesis of bacterial protein by binding at protein L3 on the ribosomal 50S subunit. It also inhibits peptidyl transfer and blocks P-site interactions at this site, thus preventing the formation of active 50S ribosomal subunits.