AMPICILLIN injection, powder, for solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

WG Critical Care, LLC

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.

Produktu pārskats:

Ampicillin for Injection, USP Pharmacy Bulk Package bottle, containing ampicillin sodium equivalent to 10 grams ampicillin per bottle is supplied as follows: NDC 44567-104-01 10 gram Pharmacy Bulk Package Carton of 1 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. Sterile, Nonpyrogenic, Preservative-free. The container closure 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. Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Revised: January 2024

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

AMPICILLIN- AMPICILLIN INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
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AMPICILLIN FOR INJECTION, USP
Rx only
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
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 for 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. Ampicillin
for
Injection, USP is a dry, white to off-white powder. The solution after
reconstitution is
clear, colorless and free from visible particulates. It has the
following structural formula:
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. Ampicillin for
Injection, USP contains 65.8
mg [2.9 mEq] sodium per gram ampicillin. Each Ampicillin for
Injection, USP pharmacy
bulk package bottle contains ampicillin sodium equivalent to 10 grams
of ampicillin. A
pharmacy bulk package is a container of a sterile preparation for
parenteral use that
contains many single doses. The contents of this pharmacy bulk package
are intended
for use by a pharmacy admixture service for addition to suitable
parenteral fluids in the
preparation of admixtures for intravenous infusion (SEE DOSAGE AND
ADMINISTRATION, DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE).
16
18
3
4
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