FDA approved Bicillin C-R (penicillin G benzathine and procaine) for Streptococcal and Pneumococcal InfectionsFDA approved new antibiotic Bicillin C-R for certain infections.

Penicillin G is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). It is active against susceptible gram-positive bacteria.

Bicillin C-R is indicated in adults and pediatric patients for moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci (Groups A, C, G, H, L, and M; Group D including enterococci are resistant). It is also indicated for moderately severe pneumonia and otitis media due to susceptible Streptococcus pneumoniae. The drug should not be used for venereal diseases including syphilis, gonorrhea, yaws, bejel, and pinta.

For streptococcal infections: Adults and pediatric patients over 60 lbs: 2,400,000 units; 30 to 60 lbs: 900,000 to 1,200,000 units; under 30 lbs: 600,000 units. Usually given as a single session using multiple IM sites. An alternative schedule is half the dose on day 1 and half on day 3. For pneumococcal infections: 600,000 units in pediatric patients and 1,200,000 units in adults, repeated every 2 to 3 days until afebrile for 48 hours. Administer by deep IM injection only, in the upper outer quadrant of the buttock or ventrogluteal site. In neonates, infants, and small children, the midlateral thigh may be preferred. Do not inject intravenously or into an artery or nerve.

Trial data not available in label.

Boxed warning: Not for intravenous use. Inadvertent IV administration has been associated with cardiorespiratory arrest and death. Serious and occasionally fatal anaphylactic reactions have been reported, more likely in patients with a history of penicillin hypersensitivity or sensitivity to multiple allergens. Severe cutaneous adverse reactions (SCAR) including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported. If an allergic reaction occurs, discontinue Bicillin C-R and institute appropriate therapy. Contraindicated in patients with a history of hypersensitivity to penicillins, cephalosporins, or other allergens.

Bicillin C-R is a combination of short-acting and long-acting penicillin G formulations, providing both immediate and sustained serum levels. It is indicated for moderately severe infections where penicillin G-susceptible organisms are confirmed or strongly suspected. It should not be used for severe infections requiring high sustained serum levels, such as bacteremia, meningitis, or endocarditis, where penicillin G sodium or potassium is preferred. Use only for approved indications to reduce development of drug-resistant bacteria.