AMPICILLIN AND SULBACTAM injection, powder, for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

AMPICILLIN SODIUM (UNII: JFN36L5S8K) (AMPICILLIN - UNII:7C782967RD), SULBACTAM SODIUM (UNII: DKQ4T82YE6) (SULBACTAM - UNII:S4TF6I2330)

متاح من:

West-Ward Pharmaceuticals Corp.

INN (الاسم الدولي):

AMPICILLIN SODIUM

تركيب:

AMPICILLIN 100 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli* , Klebsiella spp.* (including K. pneumoniae* ), Proteus mirabilis* , Bacteroides fragilis* , Enterobacter spp.* , and Acinetobacter calcoaceticus* . NOTE: For information on use in pediatric patients see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae* ), Bacteroides spp. (including B. fragilis ), and Enterobacter spp.* Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*, and Bacteroides spp.* (including B. fragilis* ). *Efficacy for this organism in this organ system was studied in fewer than 10 infections. While Ampicil

ملخص المنتج:

Ampicillin and Sulbactam for Injection, USP, a sterile off-white dry powder, is available in Pharmacy Bulk Package containing ampicillin sodium and sulbactam sodium equivalent to 10 g ampicillin and 5 g sulbactam in a carton of 1 (NDC 0641-6121-01). Ampicillin and Sulbactam for Injection, USP sterile powder is to be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] prior to reconstitution. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

AMPICILLIN AND SULBACTAM- AMPICILLIN AND SULBACTAM INJECTION, POWDER,
FOR SOLUTION
WEST-WARD PHARMACEUTICALS CORP.
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
RX ONLY
NOVAPLUS®
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 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, USP, ampicillin
sodium/sulbactam sodium parenteral
combination, is available as a white to off-white 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.
Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL)
are essentially colorless to pale
yellow. T