PENICILLIN G POTASSIUM injection, powder, for solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

WG Critical Care, LLC

INN (שם בינלאומי):

PENICILLIN G POTASSIUM

הרכב:

PENICILLIN G 1000000 [iU]

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Therapy: 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 indicated 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 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 the effectiveness of Penicillin G Potassium for Injection, USP and other antibacterial drugs, Penicillin G Potassium for Injection, USP should be used only to treat 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.

leaflet_short:

Penicillin G Potassium for Injection, USP is supplied in dry powder form in vials containing 1,000,000 units (1 million units), 5,000,000 units (5 million units) or 20,000,000 units (20 million units) of crystalline penicillin G as the potassium salt, buffered with sodium citrate to an optimum pH. Each million units contains approximately 6.9 milligrams of sodium (0.3 mEq) and 65.8 milligrams of potassium (1.68 mEq). NDC 44567-310-10 1,000,000 units (1 million units) vial (carton of 10) NDC 44567-311-10 5,000,000 units (5 million units) vial (carton of 10) NDC 44567-312-01 20,000,000 units (20 million units) vial (single carton) NDC 44567-312-10 20,000,000 units (20 million units) vial (carton of 10) Store the dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled RoomTemperature]. Sterile constituted solution may be kept in refrigerator 2° to 8°C (36° to 46°F) for 7 days without significant loss of potency. Clinitest is a registered trademark of Miles, Inc. Clinistix is a registered trademark of Bayer Corporation. Tes-Tape is a registered trademark of Eli Lilly Company. Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Rev: 08/2022 Made it Italy

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PENICILLIN G POTASSIUM- PENICILLIN G POTASSIUM INJECTION, POWDER, FOR
SOLUTION
WG CRITICAL CARE, LLC
----------
PENICILLIN G POTASSIUM FOR INJECTION, USP
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Penicillin G Potassium for Injection, USP and other antibacterial
drugs, 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
Penicillin G Potassium for Injection, USP is a natural penicillin.
Penicillin G Potassium for
Injection, USP is a sterile, pyrogen-free powder for reconstitution.
Penicillin G Potassium
for Injection, USP is an antibacterial agent for intramuscular,
continuous intravenous
drip, intrapleural or other local infusion, and intrathecal
administration. Chemically,
Penicillin G Potassium for Injection, USP is monopotassium (2S,5R,6R)
-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 structural formula:
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. Penicillin G
potassium is buffered with sodium citrate to an optimum pH.
Penicillin G Potassium for Injection, USP is supplied in vials
equivalent to 1,000,000 units
(1 million units), 5,000,000 units (5 million units), for
intramuscular and intravenous use
or 20,000,000 units (20 million units), for intravenous use only, of
penicillin G as the
potassium salt. Each million units contains approximately 6.9
milligrams of sodium (0.3
mEq) and 65.8 milligrams of potassium (1.68 mEq).
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