AMPICILLIN- ampicillin sodium injection, powder, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Medical Purchasing Solutions, LLC

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 resp

Produkt oppsummering:

Ampicillin for Injection, USP for IM or IV Injection. Ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram, or 2 grams ampicillin per vial. Also available as: Store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect the constituted solution from freezing.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
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,
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 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
16
18
3
4
active form appears in the bile in higher concentrations than those
found in serum.
Ampicillin is the least se