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:

Hospira, Inc.

INN (Kansainvälinen yleisnimi):

AMPICILLIN SODIUM

Koostumus:

AMPICILLIN 250 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
HOSPIRA, INC.
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AMPICILLIN FOR INJECTION, USP
FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION
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. 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.
It has the following structural formula:
The molecular formula is C
H N NaO S, and the molecular weight is 371.39. Ampicillin for
Injection, USP contains 65.8 mg (2.86 mEq) of sodium per gram of drug.
Each Ampicillin for Injection vial contains ampicillin sodium
equivalent to 250 mg, 500 mg, 1 gram or 2
grams of ampicillin. The 250 mg, 500 mg and 1 gram strength is for
Intramuscular or Intravenous use.
The 2 gram strength is for Intravenous use.
Ampicillin for Injection, USP is white to off-white crystalline
powder. The solution after constitution is
clear pale yellow to yellow. pH of the aqueous solution is between 8.0
and 10.0.
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 in the urine and its excretion can be
delayed by concurrent administration of
probenecid. The active form appears in the bile in higher
concentrations than those found in serum.
Ampicillin is the least serum-bound of all the penicillins, averaging
about 20% compared to
approximately 60 to 90% for other penicillins. Ampicillin for
I