AMPICILLIN AND SULBACTAM injection powder for solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Hospira, Inc.

INN (국제 이름):

AMPICILLIN SODIUM

구성:

AMPICILLIN 100 mg in 1 mL

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

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 is an injectable antibacterial
combination consisting of the
semisynthetic antibacterial ampicillin sodium and the beta-lactamase
inhibitor sulbactam sodium for
intravenous 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:
16
18
3
4
8
10
5
Ampicillin and Sulbactam for Injection 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 to pale
yellow. The pH of dilute solutions remains the same.
Each sterile Pharmacy Bulk Package contains