BICILLIN CR (Page 4 of 4)

Pneumococcal Infections (except pneumococcal meningitis)

600,000 units in pediatric patients and 1,200,000 units in adults, repeated every 2 or 3 days until the temperature is normal for 48 hours. Other forms of penicillin may be necessary for severe cases.

Method of Administration

Bicillin C-R 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 anterolateral thigh (ventrogluteal). 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.

HOW SUPPLIED

Product: 50090-1815

NDC: 50090-1815-0 2 mL in a SYRINGE

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.
  10. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — 9th ed. CLSI document M07-A9. CLSI, Wayne, PA, 2012.
  11. Clinical and Laboratory Standards Institute, Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement. CLSI document M100-S22 CLSI, Wayne, PA, 2012.
  12. CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests, Approved Standard – 11th ed. CLSI document M02-A11, 2012

Logo

LAB-0635-6.0

June 2016

penicillin G benzathine and penicillin G procaine

Label ImageLabel Image
BICILLIN CR
penicillin g benzathine and penicillin g procaine injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1815(NDC:60793-600)
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 2 mL
PENICILLIN G PROCAINE (PENICILLIN G) PENICILLIN G 600000 [iU] in 2 mL
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SOYBEAN
CARBOXYMETHYLCELLULOSE
POVIDONE, UNSPECIFIED
METHYLPARABEN
PROPYLPARABEN
SODIUM CITRATE, UNSPECIFIED FORM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1815-0 10 SYRINGE in 1 PACKAGE contains a SYRINGE
1 2 mL in 1 SYRINGE This package is contained within the PACKAGE (50090-1815-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050138 05/18/1953
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1815)

Revised: 12/2017 A-S Medication Solutions

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