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:

Fresenius Kabi USA, LLC

INN (International Name):

AMPICILLIN SODIUM

Sammensetning:

AMPICILLIN 250 mg

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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. Ampicillin for Injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Respiratory Tract Infections caused by S. pneumoniae , Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae , and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by

Produkt oppsummering:

Ampicillin for Injection, USP for IM or IV Injection. Ampicillin sodium equivalent to 250, 500 mg, 1 or 2 grams of ampicillin per vial. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex. Manufactured for: Lake Zurich, IL 60047 Made in Italy 45931G Revised: July 2015

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
AMPICILLIN
Rx only
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 bacteria.
DESCRIPTION:
Ampicillin for Injection, USP, the monosodium salt of
D(-)-6-(2-amino-2-phenylacetamido)-3,3-
dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate is a
sterile synthetic penicillin for
intramuscular or intravenous use. 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.
It has the following structural formula:
C
H
N
NAO
S M.W. 371.39
Ampicillin for Injection contains approximately 2.9 milliequivalents
of sodium per 1 gram of drug.
CLINICAL PHARMACOLOGY:
Ampicillin 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. 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, averaging
about 20% compared to
approximately 60% to 90% for other penicillins. Ampicillin is well
tolerated by most patients and has
been given in doses of 2 grams daily for many weeks without adverse
reactions.
MICROBIOLOGY
While _in vitro _studies have demonstrated the susceptibility of most
strains of the following organisms,
clinical efficacy for infections other than those included in the
INDICATIONS AND USAGE section
has not been demonstrated.
INDICATIONS AND USAGE:
16
18
3
4
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ampicillin