AMPICILLIN SODIUM injection, powder, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Mylan Institutional LLC

INN (International Adı):

AMPICILLIN SODIUM

Kompozisyon:

AMPICILLIN 10 g in 100 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 effectiveness of

Ürün özeti:

Each Ampicillin for Injection Pharmacy Bulk Package contains ampicillin sodium equivalent to 10 grams of ampicillin. NDC 67457-404-10 10 grams per Pharmacy Bulk Package – Packaged in individual cartons. Storage Store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

AMPICILLIN SODIUM- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
----------
AMPICILLIN FOR INJECTION, USP
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. 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 white to off-white crystalline
powder. The reconstituted solution is
clear, colorless and free from visible particulates.
Each vial of Ampicillin for Injection, USP Pharmacy Bulk Package
contains ampicillin sodium
equivalent to 10 grams of ampicillin. The sodium content is 65.83 mg
(2.86 mEq) per gram 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).
It has the following molecular structure:
The molecular formula is C H N Na0 S, 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
I6
l8
3
4
excreted largely unchanged in the urine and its excretion c