PENICILLIN G POTASSIUM- penicillin g injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PENICILLIN G POTASSIUM (UNII: VL775ZTH4C) (PENICILLIN G - UNII:Q42T66VG0C)

Available from:

Baxter Healthcare Corporation

INN (International Name):

PENICILLIN G POTASSIUM

Composition:

PENICILLIN G 3000000 [iU] in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Penicillin G Potassium 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 Potassium 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. CLINICAL INDICATION INFECTING ORGANISM Septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis Streptococcus pyogenes (group A β-hemolytic streptococcus), other β-hemolytic streptococci including groups C, H, G, L and M, Streptococcus pneumoniae and Staphylococcus species (non-penicillinase producing strains) Anthrax Bacillus anthrac

Product summary:

Penicillin G Potassium Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL single dose GALAXY containers (PL 2040 Plastic) as follows: 2G3542 NDC 0338-1021-41 1,000,000 units/50 mL (20,000 units/mL) Penicillin G 2G3543 NDC 0338-1023-41 2,000,000 units/50 mL (40,000 units/mL) Penicillin G 2G3544 NDC-0338-1025-41 3,000,000 units/50 mL (60,000 units/mL) Penicillin G Store at or below -20°C/-4°F. [See DIRECTIONS FOR USE OF GALAXY CONTAINER (PL 2040 Plastic).] Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Authorization status:

New Drug Application

Summary of Product characteristics

PENICILLIN G POTASSIUM- PENICILLIN G INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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PENICILLIN G POTASSIUM
INJECTION, USP
IN PL 2040 PLASTIC CONTAINER
FOR INTRAVENOUS USE ONLY
GALAXY CONTAINER (PL 2040 PLASTIC)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Penicillin G Potassium Injection, USP and other antibacterial drugs,
Penicillin G Potassium
Injection, USP should be used only to treat or prevent infections that
are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Penicillin G Potassium, USP is a natural penicillin. It is chemically
designated 4-Thia-1-
azabicyclo[3.2.0]heptane-2-carboxylic
acid,3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino]-,
monopotassium salt, [2_S_-(2α, 5α, 6β)]. It is crystalline. It is
freely soluble in water, in
isotonic sodium chloride solution and in dextrose solutions. The
structural formula is as
shown below.
Penicillin G Potassium Injection, USP (equivalent to 1, 2, or 3
million units of penicillin G) is
a 50 mL premixed, iso-osmotic, sterile, nonpyrogenic, frozen solution
for intravenous
administration. Dextrose, USP has been added to the above dosages to
adjust
osmolality (approximately 2 g, 1.2 g, and 350 mg as dextrose hydrous,
respectively).
Sodium Citrate, USP has been added as a buffer (0.10 g, 0.20 g and
0.30 g as sodium
citrate dihydrate, respectively). The pH has been adjusted with
hydrochloric acid and
may have been adjusted with sodium hydroxide. The pH is 6.5 (5.5 to
8.0). The solution
is contained in a single dose GALAXY container (PL 2040 Plastic) and
is intended for
intravenous use after thawing to room temperature.
This GALAXY container is fabricated from a specially designed
multilayer plastic (PL
2040). Solutions are in contact with the polyethylene layer of this
container and can
leach out certain chemical components of the plastic in very small
amounts within the
expiration period. The suitability of the plastic has been confirmed
in tests in animals
according to the USP biological tests f