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:

Sandoz Inc

INN (International Name):

AMPICILLIN SODIUM

Sammensetning:

AMPICILLIN 250 mg

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ampicillin for injection 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 effectiveness of a

Produkt oppsummering:

Ampicillin for injection, USP for intramuscular or intravenous injection. Ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram, or 2 grams ampicillin per vial. NDC 0781-9242-95 250 mg vial packaged in 10s NDC 0781-9250-95 500 mg vial packaged in 10s NDC 0781-9261-95 1 gram vial packaged in 10s NDC 0781-9273-95 2 gram vial packaged in 10s Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect the constituted solution from freezing. 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. PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540 Revised: August 2020 46275232

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
SANDOZ INC
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AMPICILLIN FOR INJECTION, USP
RX ONLY
(FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION)
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 cream-tinged, 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
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 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 form appears in the bile in higher
concentrations than those found in
serum. Ampicillin is the least serum-bound of all the penicilli