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:

General Injectables and Vaccines, 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 of ampicil

Product summary:

Ampicillin for Injection, USP for IM or IV Injection. Each vial of ampicillin for injection contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram, or 2 grams ampicillin.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN- AMPICILLIN INJECTION, POWDER, FOR SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
----------
AMPICILLIN FOR INJECTION, USP (FOR INTRAMUSCULAR AND 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,
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
sterile powder and forms a
clear colorless solution upon reconstitution with sterile water for
injection, USP or
Bacteriostatic water for injection, USP.
Each vial of ampicillin for injection, USP contains ampicillin sodium
equivalent to 250 mg,
500 mg, 1 gram or 2 grams ampicillin. The sodium content is 16.46 mg
(0.71 mEq) per
250 mg, 32.91 mg (1.43 mEq) per 500 mg, 65.83 mg (2.86 mEq) per 1 g,
131.66 mg
(5.72 mEq) per 2 g of ampicillin.
It has the following molecular structure:
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 bile in higher concentrations than those
found in serum.
Ampicillin is the lea