PFIZERPEN- penicillin g potassium powder, for 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:

Roerig

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Penicillin G Potassium 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 Potassium 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. 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 anthracis Actinomycosis (cervico-facial disease and thoracic and abdominal disease) Actinomyces israelii Botulism (adjunctive therapy to antitoxin), gas gangrene, and tetanus (adjunctive therapy to human tetanus immune globulin) Clostridium species Diphtheria (adjunctive therapy to antitoxin and prevention of the carrier state) Corynebacterium diphtheriae Erysipelothrix endocarditis Erysipelothrix rhusiopathiae Fusospirochetosis (severe infections of the oropharynx [Vincent's], lower respiratory tract and genital area) Fusobacterium species and spirochetes Listeria infections including meningitis and endocarditis Listeria monocytogenes Pasteurella infections including bacteremia and meningitis Pasteurella multocida Haverhill fever Streptobacillus moniliformis Rat bite fever Spirillum minus or Streptobacillus moniliformis Disseminated gonococcal infections Neisseria gonorrhoeae (Penicillin-susceptible) Syphilis (congenital and neurosyphilis) Treponema pallidum Meningococcal meningitis and/or septicemia Neisseria meningitidis Gram-negative bacillary infections (bacteremias) Penicillin G is not the drug of choice in the treatment of Gram-negative bacillary infections. Gram-negative bacillary organisms (i.e . Enterobacteriaceae) To reduce the development of drug-resistant bacteria and maintain effectiveness of Penicillin G Potassium and other antibacterial drugs, Penicillin G Potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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. A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

Product summary:

Buffered Pfizerpen® (Penicillin G Potassium for Injection, USP) is available in the following package sizes, buffered with sodium citrate and citric acid to an optimum pH: 10 vials per carton 5,000,000 units each vial NDC 0049-0420-10 (each 1 vial contains 5,000,000 units, NDC 0049-0420-05) 1 vial per carton 20,000,000 units NDC 0049-0430-20 Each million units contains approximately 6.8 milligrams of sodium (0.3 mEq) and 65.6 milligrams of potassium (1.68 mEq). Store the dry powder below 86°F (30°C).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PFIZERPEN- PENICILLIN G POTASSIUM POWDER, FOR SOLUTION
ROERIG
----------
BUFFERED
PFIZERPEN
(PENICILLIN G POTASSIUM FOR INJECTION, USP)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Penicillin G Potassium and other antibacterial drugs, Buffered
Pfizerpen (Penicillin G
Potassium for Injection, USP) should be used only to treat or prevent
infections that are
proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Buffered Pfizerpen (Penicillin G Potassium for Injection, USP) is a
sterile, pyrogen-free
powder for reconstitution. Buffered Pfizerpen for Injection is an
antibacterial agent for
intramuscular, continuous intravenous infusion, intrapleural or other
local infusion, and
intrathecal administration.
Each million units contains approximately 6.8 milligrams of sodium
(0.3 mEq) and 65.6
milligrams of potassium (1.68 mEq). Buffered Pfizerpen (Penicillin G
Potassium for
Injection, USP) is supplied in vials equivalent to 5,000,000 units (5
million units) or
20,000,000 units (20 million units) of penicillin G as the potassium
salt.
Chemically, Pfizerpen is monopotassium
3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-
thia-1-azabicyclo (3.2.0) heptane-2-carboxylate. It has a molecular
weight of 372.48 and
the following chemical structure:
Formula
C
H
KN O S
Penicillin G potassium is a colorless or white crystal, or a white
crystalline powder which
is odorless, or practically so, and moderately hygroscopic. Penicillin
G potassium is very
soluble in water. The pH of the reconstituted product is between
6.0–8.5.
CLINICAL PHARMACOLOGY
Aqueous penicillin G is rapidly absorbed following both intramuscular
and subcutaneous
injection. Initial blood levels following parenteral administration
are high but transient.
Penicillins bind to serum proteins, mainly albumin. Therapeutic levels
of the penicillins are
16
17
2
4
easily achieved under normal circumstances in extracellular fluid and
most other body
tissues. Penicillins are distributed in varying degrees into pleural,
perica