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:

Henry Schein, Inc.

Administreringsrute:

INTRAMUSCULAR

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 respond to intravenous therapy. The addition of an aminoglycoside may enhance the ef

Produkt oppsummering:

Ampicillin for Injection, USP is a white to off-white crystalline powder supplied in vials containing ampicillin sodium equivalent to 250 mg, 500 mg, 1 g or 2 g of ampicillin. The following packages are available: Store the dry powder at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. The vial stopper is not made with natural rubber latex. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect the constituted solution from freezing. The vial stopper is not made with natural rubber latex. 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. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad – 500032 India Revised: December 2022

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
HENRY SCHEIN, INC.
----------
AMPICILLIN FOR INJECTION, USP
RX ONLY
(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 white to off-white crystalline
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 sodium
content as 16.46 mg (0.72 mEq) per 250 mg, 32.91 mg (1.43 mEq) per 500
mg, 65.83
mg (2.86 mEq) per 1 g or 131.66 mg (5.72 mEq) per 2 g of ampicillin.
It has the following molecular structure:
The molecular formula is C16H18n3Na04S, 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
active