AMPICILLIN- ampicillin sodium injection, powder, for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Xellia Pharmaceuticals USA LLC

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 effect

ملخص المنتج:

Ampicillin for Injection, USP, Pharmacy Bulk Package, contains ampicillin sodium equivalent to 10 grams ampicillin per bottle. Ampicillin for Injection, USP is also available in single use vials supplied as follows: Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect the constituted solution from freezing.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
XELLIA PHARMACEUTICALS USA LLC
----------
AMPICILLIN FOR INJECTION, USP
FOR IV USE ONLY
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 dry, white to off-white powder. The
reconstituted
solution 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.
CLINICAL PHARMACOLOGY
16
18
3
4
Ampicillin for Injection, USP diffuses readily into most body tissues
and fluids. However,
penetration into the cerebrospinal fluid and brain occurs only when
t