AMPICILLIN sodium injection powder for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

APP Pharmaceuticals, LLC

INN (Kansainvälinen yleisnimi):

AMPICILLIN SODIUM

Koostumus:

AMPICILLIN 10 g

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
APP PHARMACEUTICALS, LLC
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AMPICILLIN
FOR INJECTION, USP PHARMACY BULK PACKAGE-
NOT FOR DIRECT INFUSION
Rx only
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 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.
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 structural formula:
C
H N NAO S M.W. 371.39
The pH range of the reconstituted solution is 8 to 10. Ampicillin for
Injection, USP contains 65.83 mg
(2.86 milliequivalents) of sodium per 1 gram of drug. Ampicillin for
Injection, USP is white to off-
white crystalline powder. The solution after constitution is clear and
colorless. Each Ampicillin for
Injection Pharmacy Bulk Package bottle contains ampicillin sodium
equivalent to 10 grams of ampicillin.
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 meninge