AMPICILLIN SODIUM AND SULBACTAM SODIUM injection powder for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

AGILA SPECIALTIES PRIVATE LIMITED

INN (International Name):

AMPICILLIN SODIUM

Sammensætning:

AMPICILLIN 10 g in 15 g

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

AMPICILLIN SODIUM AND SULBACTAM SODIUM- AMPICILLIN SODIUM AND
SULBACTAM
SODIUM INJECTION, POWDER, FOR SOLUTION
AGILA SPECIALTIES PRIVATE LIMITED
----------
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 OR PREVENT INFECTIONS THAT ARE PROVEN OR
STRONGLY SUSPECTED TO BE
CAUSED BY BACTERIA.
DESCRIPTION
Ampicillin and Sulbactam for Injection, USP is an injectable
antibacterial combination consisting of the
semisynthetic antibiotic ampicillin sodium and the beta-lactamase
inhibitor sulbactam sodium for
intravenous administration and intramuscular administration.
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, ampicillin
sodium/sulbactam sodium parenteral
combination, is available as a white to off-white dry powder for
reconstitution. Ampicillin and
Sulbactam for Injection 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.
Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL)
are essentially colorless t