AMPICILLIN AND SULBACTAM injection, powder, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Hikma Pharmaceuticals USA Inc.

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 ampici

Přehled produktů:

Ampicillin and Sulbactam for Injection, USP is supplied as a sterile off-white dry powder in glass vials. The following packages are available: Vials containing 1.5 g (NDC 0641-6119-10) equivalent of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) Vials containing 3 g (NDC 0641-6120-10) equivalent of Ampicillin and Sulbactam for Injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) 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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

AMPICILLIN AND SULBACTAM- AMPICILLIN AND SULBACTAM INJECTION, POWDER,
FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
NOVAPLUS®
RX ONLY
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. The pH of dilute solutions remains the same.
1.5