AMPICILLIN AND SULBACTAM injection powder for solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Hospira, Inc

INN (nemzetközi neve):

AMPICILLIN SODIUM

Összetétel:

AMPICILLIN 100 mg in 1 mL

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

AMPICILLIN AND SULBACTAM- AMPICILLIN AND SULBACTAM INJECTION, POWDER,
FOR SOLUTION
HOSPIRA, INC
----------
AMPICILLIN AND SULBACTAM 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 SULBACTAM FOR INJECTION AND OTHER ANTIBACTERIAL DRUGS,
AMPICILLIN AND SULBACTAM FOR INJECTION SHOULD BE USED ONLY TO TREAT
INFECTIONS THAT ARE PROVEN OR
STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
DESCRIPTION
Ampicillin and Sulbactam for Injection, USP is a sterile injectable
antibacterial combination consisting
of the semisynthetic antibacterial ampicillin sodium and the
beta-lactamase inhibitor sulbactam sodium
for parenteral administration. THE INTENT OF THIS PHARMACY BULK
PACKAGE IS FOR
PREPARATION OF SOLUTIONS FOR IV INFUSION ONLY.
Ampicillin sodium is derived from the penicillin nucleus,
6-aminopenicillanic acid. Chemically, it is
monosodium (2S, 5R,
6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of
371.39. Its chemical formula is
C
H N NaO S.
The structural formula is:
Sulbactam sodium is a derivative of the basic penicillin nucleus.
Chemically, sulbactam sodium is
sodium penicillinate sulfone; sodium (2S,
5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-
carboxylate 4,4-dioxide. Its chemical formula is C H NNaO S with a
molecular weight of 255.22.
The structural formula is:
Ampicillin and Sulbactam for Injection, USP parenteral combination, is
available as a white to yellowish
dry powder for reconstitution. Ampicillin and Sulbactam for Injection,
USP dry powder is freely
soluble in aqueous diluents to yield pale yellow to yellow solutions
containing ampicillin sodium and
sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg
sulbactam per mL. The pH of the
solutions is between 8 and 10.
16
18
3
4
8
10
5
Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL)
are essentially colorless to pale