AMPICILLIN AND SULBACTAM injection, powder, for solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Hikma Pharmaceuticals USA Inc.

INN (International Nazwa):

AMPICILLIN SODIUM

Skład:

AMPICILLIN 1 g in 1.5 g

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.

Podsumowanie produktu:

Ampicillin and Sulbactam for Injection, USP is supplied as a sterile off-white dry powder in glass vials. The following packages are available: Single-dose vials containing 1.5 g (NDC 0641-6116-10) equivalent of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) Single-dose vials containing 3 g (NDC 0641-6117-10) 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.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

AMPICILLIN AND SULBACTAM- AMPICILLIN AND SULBACTAM INJECTION, POWDER,
FOR
SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
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 g of Ampic