AMPICILLIN 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:

Civica, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ampicillin for Injection, USP 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, Staphylococcus 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 monocytogenes, 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 o

Product summary:

Ampicillin for Injection, USP for Intramuscular or Intravenous Injection. Ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram, or 2 grams ampicillin per vial. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect the constituted solution from freezing. The container closure 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. Mfd for: Civica, Inc. Lehi, UT 84043 Mfd by: Istituto Biochimico Italiano Made in Italy Revised: June 2020                                    805203

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN- AMPICILLIN INJECTION, POWDER, FOR SOLUTION
CIVICA, INC.
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AMPICILLIN FOR INJECTION, USP
(FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION)
Rx only
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,6ß(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 dry, white to off-white 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 65.8 mg [2.9
mEq] sodium per gram 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, USP, 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 bile in higher concentrations than those
found in serum.
Ampicillin is the least serum-bound of all the penicillins, averag