AMPICILLIN sodium injection powder for solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Cardinal Health

INN:

AMPICILLIN SODIUM

composition:

AMPICILLIN 250 mg

prescription_type:

PRESCRIPTION DRUG

authorization_status:

Abbreviated New Drug Application

SPC

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
CARDINAL HEALTH
----------
AMPICILLIN
_FOR INJECTION, USP_
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.
The following bacteria have been shown in _in vitro_ studies to be
susceptible to ampicillin:
GRAM-POSITIVE ORGANISM