Topibac1%

Topibac 1% is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm 2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates ... Read moreTopibac 1% is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm 2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes. Safety in patients younger than 9 months has not been established. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Topibac 1% and other antibacterial drugs, Topibac 1% should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Topical Antibiotic preparations

Topibac 1% is a semisynthetic derivative of the compound pleuromutilin. In vitro activity of Topibac 1% against isolates of Staphylococcus aureus as well as Streptococcus pyogenes has been demonstrated. Topibac 1% 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. Topibac 1% demonstrates no in vitro target-specific cross-resistance with other classes of antibiotics.

Apply a thin layer of Topibac 1% 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.

A thin layer of Topibac should be applied 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.

The effect of concurrent application of Topibac 1% and other topical products to the same area of skin has not been studied.

Contraindicated in patients with hypersensitivity of any ingredient of this preparation.

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

Pregnancy Category B. It is not known whether Topibac 1% 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.

Local Irritation: In the event of sensitization or severe local irritation from Topibac 1%, usage should be discontinued. Not for Systemic or Mucosal Use: Topibac 1% is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Topical Antibiotic preparations

Topibac 1% 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. Topibac 1% is bacteriostatic against Staphylococcus aureus and Streptococcus pyogenes at the Topibac 1% in vitro minimum inhibitory concentration (MIC) for these organisms.

Pregnancy Category B. It is not known whether Topibac 1% is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Topibac 1% is administered to a nursing woman.