AMPICILLIN 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:

WG Critical Care, LLC

INN (International Name):

AMPICILLIN SODIUM

Sammensetning:

AMPICILLIN 250 mg

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 S. pneumoniae, Staphylococcus aureus (penicillinase and non-penicillinase 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 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. Indicated surgical procedures should be performed. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP 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. A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

Produkt oppsummering:

Ampicillin for Injection, USP equivalent to 250 mg, 500 mg, 1 or 2 grams ampicillin as the sodium salt per vial is supplied as follows: NDC 44567-100-10 250 mg vial (Package of 10) NDC 44567-101-10 500 mg vial (Package of 10) NDC 44567-102-10 1 gram vial (Package of 10) NDC 44567-103-10 2 gram vial (Package of 10) Ampicillin for Injection, USP dry powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions. 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 Revised: January 2024

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMPICILLIN- AMPICILLIN INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
----------
AMPICILLIN FOR INJECTION, USP
Rx only
FOR INTRAMUSCULAR OR INTRAVENOUS USE
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Ampicillin and other antibacterial drugs, Ampicillin for Injection,
USP should be used only
to treat infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Ampicillin for Injection, USP the monosodium salt of [2S-[2a, 5a,
6b(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. It has the following chemical 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 8.0 to 10.0. Ampicillin for
Injection, USP contains
65.8 mg [2.9 mEq] sodium per gram ampicillin.
Ampicillin for Injection, USP is supplied in vials equivalent to 125
mg, 250 mg, 500 mg, 1
gram or 2 grams of ampicillin. It is to be administered by intravenous
or intramuscular
routes.
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
16
18
3
4
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
fou