AMPICILLIN- ampicillin sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ampi

Product summary:

Ampicillin for Injection, USP, Pharmacy Bulk Package, contains ampicillin sodium equivalent to 10 grams ampicillin per bottle. NDC 0409-3725-01 10 gram Pharmacy Bulk Package – Packaged in 10s 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. Revised: August 2020 46275235 Manufactured by Sandoz GmbH for Hospira, Inc., Lake Forest, IL 60045, USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
HOSPIRA, INC
----------
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 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 for intravenous use. The pharmacy bulk package
contains sterile ampicillin sodium
equivalent to 10 grams ampicillin. 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 solution after
reconstitution is clear, colorless and free from visible particulates.
Each Pharmacy Bulk Package bottle contains ampicillin sodium
equivalent to 10 grams of ampicillin.
The sodium content is 65.8 mg (2.9 mEq) per one gram 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).
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.
16
18
3
4
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
infl