Source: FDA, National Drug Code (US) Revision Year: 2021
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin L-A and other antibacterial drugs, Bicillin L-A should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response.
The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine:
Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci.
Venereal infections—Syphilis, yaws, bejel, and pinta.
Medical Conditions in which Penicillin G Benzathine Therapy is indicated as Prophylaxis:
Rheumatic fever and/or chorea—Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.
Streptococcal (Group A) Upper Respiratory Infections (for example, pharyngitis):
Adults: a single injection of 1,200,000 units
Older pediatric patients: a single injection of 900,000 units
Infants and pediatric patients under 60 lbs.: 300,000 to 600,000 units.
Syphilis:
Primary, secondary, and latent: 2,400,000 units (1 dose).
Late (tertiary and neurosyphilis): 2,400,000 units at 7-day intervals for three doses.
Congenital:
Under 2 years of age: 50,000 units/kg/body weight
Ages 2 to 12 years: adjust dosage based on adult dosage schedule.
Yaws, Bejel, and Pinta: 1,200,000 units (1 injection).
Prophylaxis: for rheumatic fever and glomerulonephritis.
Following an acute attack, penicillin G benzathine (parenteral) may be given in doses of 1,200,000 units once a month or 600,000 units every 2 weeks.
BICILLIN L-A IS INTENDED FOR INTRAMUSCULAR INJECTION ONLY. DO NOT INJECT INTO OR NEAR AN ARTERY OR NERVE, OR INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. (SEE WARNINGS SECTION.)
Administer by DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock (dorsogluteal) or the ventrogluteal site. In neonates, infants and small children, the midlateral aspect of the thigh may be preferable. When doses are repeated, vary the injection site.
Because of the high concentration of suspended material in this product, the needle may be blocked if the injection is not made at a slow, steady rate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Penicillin in overdosage has the potential to cause neuromuscular hyperirritability or convulsive seizures.
Store in a refrigerator, 2° to 8°C (36° to 46°F).
Keep from freezing.
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