BICILLIN L-A (Page 3 of 3)

OVERDOSAGE

Penicillin in overdosage has the potential to cause neuromuscular hyperirritability or convulsive seizures.

DOSAGE AND ADMINISTRATION

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.

METHOD OF ADMINISTRATION

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. Administration in the anterolateral thigh is not recommended due to the adverse effects observed (see WARNINGS section), and vascularity of this region. 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.

HOW SUPPLIED

Product: 50090-1016

NDC: 50090-1016-0 2 mL in a SYRINGE / 10 in a PACKAGE

NDC: 50090-1016-1 2 mL in a SYRINGE / 1 in a PACKAGE

Product: 50090-1666

NDC: 50090-1666-0 1 mL in a SYRINGE / 10 in a PACKAGE

REFERENCES

  1. SHAW, E.: Transverse myelitis from injection of penicillin. Am. J. Dis. Child., 111: 548, 1966.
  2. KNOWLES, J.: Accidental intra-arterial injection of penicillin. Am. J. Dis. Child., 111: 552, 1966.
  3. DARBY, C. et al: Ischemia following an intragluteal injection of benzathine-procaine penicillin G mixture in a one-year-old boy. Clin. Pediatrics, 12: 485, 1973.
  4. BROWN, L. & NELSON, A.: Postinfectious intravascular thrombosis with gangrene. Arch. Surg., 94: 652, 1967.
  5. BORENSTINE, J.: Transverse myelitis and penicillin (Correspondence). Am. J. Dis. Child., 112: 166, 1966.
  6. ATKINSON, J.: Transverse myelopathy secondary to penicillin injection. J. Pediatrics, 75: 867, 1969.
  7. TALBERT, J. et al: Gangrene of the foot following intramuscular injection in the lateral thigh: A case report with recommendations for prevention. J. Pediatrics, 70: 110, 1967.
  8. FISHER, T.: Medicolegal affairs. Canad. Med. Assoc. J., 112: 395, 1975.
  9. SCHANZER, H. et al: Accidental intra-arterial injection of penicillin G. JAMA, 242: 1289, 1979.

Logo

LAB-0588-17.0
Revised: 05/2021

penicillin G benzathine

Label ImageLabel Image

penicillin G benzathine

Label ImageLabel Image
BICILLIN L-A
penicillin g benzathine injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1016(NDC:60793-701)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN G BENZATHINE (PENICILLIN G) PENICILLIN G 1200000 [iU] in 2 mL
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SOYBEAN
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
POVIDONE, UNSPECIFIED
METHYLPARABEN
PROPYLPARABEN
SODIUM CITRATE, UNSPECIFIED FORM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1016-0 10 SYRINGE in 1 PACKAGE contains a SYRINGE
1 2 mL in 1 SYRINGE This package is contained within the PACKAGE (50090-1016-0)
2 NDC:50090-1016-1 1 SYRINGE in 1 PACKAGE contains a SYRINGE
2 2 mL in 1 SYRINGE This package is contained within the PACKAGE (50090-1016-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050141 06/27/1952
BICILLIN L-A
penicillin g benzathine injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1666(NDC:60793-700)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN G BENZATHINE (PENICILLIN G) PENICILLIN G 600000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SOYBEAN
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
POVIDONE, UNSPECIFIED
METHYLPARABEN
PROPYLPARABEN
SODIUM CITRATE, UNSPECIFIED FORM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1666-0 10 SYRINGE in 1 PACKAGE contains a SYRINGE
1 1 mL in 1 SYRINGE This package is contained within the PACKAGE (50090-1666-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050141 06/27/1952
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1016), RELABEL (50090-1666)

Revised: 06/2021 A-S Medication Solutions

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