AMPICILLIN- ampicillin sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMPICILLIN SODIUM (UNII: JFN36L5S8K) (AMPICILLIN - UNII:7C782967RD)

Available from:

Eugia US LLC

INN (International Name):

AMPICILLIN SODIUM

Composition:

AMPICILLIN 250 mg

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by Streptococcus pneumoniae, S taphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae , and Group A beta-hemolytic streptococci . Bacterial Meningitis caused by E. coli , Group B Streptococci , and other Gram-negative bacteria (Listeria m onocytogenes , N. meningitidis ). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci , and enterococci . Gram-negative sepsis caused by E. coli , Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis . Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection and other antibacterial drugs, ampicillin for injection 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. Indicated surgical procedures should be performed. A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

Product summary:

Ampicillin for injection, USP for intramuscular or intravenous injection. It is a white to off-white crystalline powder supplied in vials containing ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin per vial. The following packages are available: Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect the constituted solution from freezing. The vial stopper is not made with natural rubber latex. 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. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad – 500032 India Revised: January 2024

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN - AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
EUGIA US LLC
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AMPICILLIN FOR INJECTION, USP
RX ONLY
(FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
ampicillin and other antibacterial drugs, ampicillin should be used
only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Ampicillin for injection, USP the monosodium salt of [2S-[2α, 5α,
6β(S*)]]-6-
[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-
carboxylic acid, is a synthetic penicillin. It is an antibacterial
agent with a broad spectrum
of bactericidal activity against both penicillin-susceptible
Gram-positive organisms and
many common Gram-negative pathogens.
Ampicillin for injection, USP is a white to off-white crystalline
powder. The reconstituted
solution is clear, colorless and free from visible particulates.
Each vial of ampicillin for injection, USP contains ampicillin sodium
equivalent to 250 mg,
500 mg, 1 gram or 2 grams ampicillin. Ampicillin for injection, USP
contains sodium
content as 16.46 mg (0.72 mEq) per 250 mg, 32.91 mg (1.43 mEq) per 500
mg, 65.83
mg (2.86 mEq) per 1 g or 131.66 mg (5.72 mEq) per 2 g of ampicillin.
It has the following molecular structure:
The molecular formula is C
H
N NaO S, and the molecular weight is 371.39. The pH
range of the reconstituted solution is 8 to 10.
CLINICAL PHARMACOLOGY
Ampicillin for injection diffuses readily into most body tissues and
fluids. However,
penetration into the cerebrospinal fluid and brain occurs only when
the meninges are
inflamed. Ampicillin is excreted largely unchanged in the urine and
its excretion can be
delayed by concurrent administration of probenecid. Due to
maturational changes in
renal function, ampicillin half-life decreases as postmenstrual age (a
sum of gestational
age and postnatal age) increases for infants with postnatal age of
less than 28 days. The
active form appears in the