Ampicillin Sodium And Sulbactam Sodium (Ampicillin And Sulbactam)

Trade Name : Ampicillin and Sulbactam

Sandoz Inc

INJECTION, POWDER, FOR SOLUTION

Strength 105 g/1g/1

AMPICILLIN SODIUM; SULBACTAM SODIUM Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ampicillin Sodium And Sulbactam Sodium (Ampicillin And Sulbactam) which is also known as Ampicillin and Sulbactam and Manufactured by Sandoz Inc. It is available in strength of 10; 5 g/1; g/1 per ml. Read more

Ampicillin Sodium And Sulbactam Sodium (Ampicillin And Sulbactam) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillinu00a0and Sulbactam for Injection and other antibacterial drugs, Ampicillinu00a0andu00a0Sulbactamu00a0for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

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 parenteral administration. n
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 CHNNaOS.
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 CHNNaOS with a molecular weight of 255.22.
The structural formula is:
Ampicillin and sulbactam for injection, USP parenteral combination, is available as a white to yellowish 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.
Each sterile Pharmacy Bulk Package contains 15 g ampicillin and sulbactam for injection, USP (equivalent to 10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt). The sodium content is 1150 mg (50 mEq) sodium per Pharmacy Bulk bottle. The sodium content is 115 mg (5 mEq) sodium per 1.5 grams of Ampicillin and Sulbactam product.
Ampicillin and sulbactam for injection, USP pharmacy bulk package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin sodium/sulbactam sodium for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion n
FURTHER DILUTION IS REQUIRED BEFORE USE.

Immediately after completion of a 15-minute intravenous infusion of ampicillin and sulbactam, peak serum concentrations of ampicillin and sulbactam are attained. Ampicillin serum levels are similar to those produced by the administration of equivalent amounts of ampicillin alone. Peak ampicillin serum levels ranging from 109 to 150 mcg/mL are attained after administration of 2000 mg of ampicillin plus 1000 mg sulbactam and 40 to 71 mcg/mL after administration of 1000 mg ampicillin plus 500 mg sulbactam. The corresponding mean peak serum levels for sulbactam range from 48 to 88 mcg/mL and 21 to 40 mcg/mL, respectively.
The mean serum half-life of both drugs is approximately 1 hour in healthy volunteers.
Approximately 75 to 85% of both ampicillin and sulbactam are excreted unchanged in the urine during the first 8 hours after administration of ampicillin and sulbactam to individuals with normal renal function. Somewhat higher and more prolonged serum levels of ampicillin and sulbactam can be achieved with the concurrent administration of probenecid.
In patients with impaired renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam for injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin n n n
Ampicillin has been found to be approximately 28% reversibly bound to human serum protein and sulbactam approximately 38% reversibly bound.
The following average levels of ampicillin and sulbactam were measured in the tissues and fluids listed:
Penetration of both ampicillin and sulbactam into cerebrospinal fluid in the presence of inflamed meninges has been demonstrated after IV administration of ampicillin and sulbactam.
The pharmacokinetics of ampicillin and sulbactam in pediatric patients receiving ampicillin and sulbactam are similar to those observed in adults. Immediately after a 15-minute infusion of 50 to 75 mg ampicillin and sulbactam/kg body weight, peak serum and plasma concentrations of 82 to 446 mcg ampicillin/mL and 44 to 203 mcg sulbactam/mL were obtained. Mean half-life values were approximately 1 hour.

Ampicillin is similar to benzyl penicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of cell wall mucopeptide biosynthesis. Ampicillin has a broad spectrum of bactericidal activity against many gram-positive and gram-negative aerobic and anaerobic bacteria. (Ampicillin is, however, degraded by beta-lactamases and therefore the spectrum of activity does not normally include organisms which produce these enzymes).
A wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins have been shown in biochemical studies with cell free bacterial systems to be irreversibly inhibited by sulbactam. Although sulbactam alone possesses little useful antibacterial activity except against the , whole organism studies have shown that sulbactam restores ampicillin activity against beta-lactamase producing strains. In particular, sulbactam has good inhibitory activity against the clinically important plasmid mediated beta-lactamases most frequently responsible for transferred drug resistance. Sulbactam has no effect on the activity of ampicillin against ampicillin susceptible strains.
The presence of sulbactam in the ampicillin and sulbactam for injection formulation effectively extends the antibacterial spectrum of ampicillin to include many bacteria normally resistant to it and to other beta-lactam antibacterials. Thus, Ampicillin and sulbactam possesses the properties of a broad-spectrum antibacterial and a beta-lactamase inhibitor.
While studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections other than those included in the section has not been documented.
Gram-Positive Bacteria:n- Staphylococcus aureusn- Staphylococcus epidermidisn- Staphylococcus saprophyticusn- Streptococcus faecalisn- Streptococcus pneumoniaen- D. pneumoniaen- Streptococcus pyogenesn- Streptococcus viridans
Gram-Negative Bacteria:n- Hemophilus influenzaen- Moraxella (Branhamella) catarrhalisn- Escherichia colin- Klebsiellan- Proteus mirabilisn- Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Morganella morganii,n- Neisseria gonorrhoeae
Anaerobes:n- Clostridiumn- Peptococcusn- Peptostreptococcusn- Bacteroidesn- B. fragilis

Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infectionsn- Staphylococcus aureus, Escherichia coli,* Klebsiellan- K. pneumoniae*)n- Proteus mirabilis,* Bacteroides fragilis,* Enterobactern- Acinetobacter calcoaceticus.*
NOTE: For information on use in pediatric patients see and sections.
Intra-Abdominal Infectionsn- Escherichia coli, Klebsiellan- K. pneumoniae* n- Bacteroidesn- B. fragilisn- Enterobacter
Gynecological Infectionsn- Escherichia coli,* n- Bacteroidesn- B. fragilis*
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While ampicillin and sulbactam for injection 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 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 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.
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 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 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.

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Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Ampicillin may be removed from circulation by hemodialysis. The molecular weight, degree of protein binding and pharmacokinetics profile of sulbactam suggest that this compound may also be removed by hemodialysis.

Data from a controlled clinical trial conducted in pediatric patients provided evidence supporting the safety and efficacy of ampicillin and sulbactam for injection for the treatment of skin and skin structure infections. Of 99 pediatric patients evaluable for clinical efficacy, 60 patients received a regimen containing intravenous ampicillin and sulbactam, and 39 patients received a regimen containing intravenous cefuroxime. This trial demonstrated similar outcomes (assessed at an appropriate interval after discontinuation of all antimicrobial therapy) for ampicillin and sulbactam- and cefuroxime-treated patients:
Most patients received a course of oral antimicrobials following initial treatment with intravenous administration of parenteral antimicrobials. The study protocol required that the following three criteria be met prior to transition from intravenous to oral antimicrobial therapy: 1) receipt of a minimum of 72 hours of intravenous therapy; 2) no documented fever for prior 24 hours; and 3) improvement or resolution of the signs and symptoms of infection.
The choice of oral antimicrobial agent used in this trial was determined by susceptibility testing of the original pathogen, if isolated, to oral agents available. The course of oral antimicrobial therapy should not routinely exceed 14 days.

The pharmacy bulk package is for preparation of solutions for IV infusion only. Ampicillin and sulbactam for injection should be administered by slow intravenous injection over at least 10 to 15 minutes or can also be delivered in greater dilutions with 50 to 100 mL of a compatible diluent as an intravenous infusion over 15 to 30 minutes.
The recommended adult dosage of ampicillin and sulbactam for injection is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.

Ampicillin and Sulbactam for Injection, USP (ampicillin sodium/sulbactam sodium) is supplied as a sterile white to yellowish dry powder in glass bottles. The following packages are available:
Each Pharmacy Bulk Package contains 15 g Ampicillin and Sulbactam for Injection, USP (equivalent to 10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt). NDC 0781-3034-46
Ampicillin and Sulbactam for Injection sterile powder is to be stored at 20u00b0 to 25u00b0C (68 to 77u00b0F) [see USP Controlled Room Temperature.]
Other size packages available
Ampicillin and Sulbactam for Injection is also supplied in glass vials in the following package sizes:
Each 1.5 g vial contains 1.5 g Ampicillin and Sulbactam for Injection, USP (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). NDC 0781-3032-70
Each 3 g vial contains 3 g Ampicillin and Sulbactam for Injection, USP (equivalent to 2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt). NDC 0781-3033-70

To report SUSPECTED ADVERSE EVENTS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

46230776
Revised: May 2018
Manufactured in Austria by Sandoz GmbH,
Distributed by Lek Pharmaceuticals Inc.,
an affiliate of Sandoz Inc., Princeton, NJ 08540

NDC 0781-3034-46
Ampicillin and
Sulbactam for
Injection, USP
15 grams per Pharmacy Bulk Package
PHARMACY BULK PACKAGE u2013
NOT FOR DIRECT INFUSION
Rx only
equivalent to 10 g ampicillin plus 5 g
of sulbactam
For Intravenous Use
THIS PHARMACY BULK PACKAGE IS
NOT INTENDED TO BE DISPENSED
AS A UNIT
1 x 15 g Pharmacy Bulk Package
Sterile
SANDOZ u2013 A Novartis Division

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Ampicillin Sodium And Sulbactam Sodium (Ampicillin And Sulbactam)

Trade Name : Ampicillin and Sulbactam

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Ampicillin Sodium And Sulbactam Sodium (Ampicillin And Sulbactam)

Trade Name : Ampicillin and Sulbactam

INJECTION, POWDER, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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Fluoxetine Hydrochloride (Fluoxetine)

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