Penicillin G Sodium

Indications

INDICATIONS AND USAGE Therapy Penicillin G Sodium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Sodium for Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Penicillin G Sodium for injection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows: Adult Patients Clinical Indication Dosage Serious infections due to susceptible strains of streptococci (including S. pneumoniae ) and staphylococci-septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis 5 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours Anthrax Minimum of 8 million units/day in divided doses every 6 hours. Higher doses may be required depending on susceptibility of organism.

Contraindications

CONTRAINDICATIONS A history of hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

Warnings and precautions

WARNINGS SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (anaphylactic) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS.

Pregnancy

Pregnancy Teratogenic Effects Reproduction studies performed in the mouse, rat, and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to penicillin G. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus.

Storage and supply

STORAGE Store dry powder at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Sterile constituted solution may be kept in refrigerator (2° to 8°C) for 3 days without significant loss of potency. Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540 46270951 May 2020

Source: Penicillin G Sodium (Penicillin G Sodium) — US FDA prescribing information, 2020-05-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.