Ampicillin And Sulbactam
Ampicillin And Sulbactam Prescribing Information
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.
NOTE: For information on use in pediatric patients see
The safety and effectiveness of ampicillin and sulbactam for injection have been established for pediatric patients one year of age and older for skin and skin structure infections as approved in adults. Use of ampicillin and sulbactam for injection in pediatric patients is supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric pharmacokinetic studies, a controlled clinical trial conducted in pediatric patients and post-marketing adverse events surveillance (see
The safety and effectiveness of ampicillin and sulbactam for injection have not been established for pediatric patients for intra-abdominal infections.
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 for injection, 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 for injection- and cefuroxime-treated patients:
Therapeutic Regimen | Clinical Success | Clinical Failure |
| Ampicillin and Sulbactam for Injection, USP | 51/60 (85%) | 9/60 (15%) |
| Cefuroxime | 34/39 (87%) | 5/39 (13%) |
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.
* 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 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 grams (1 gram ampicillin as the sodium salt plus 0.5 grams sulbactam as the sodium salt) to 3 grams (2 grams ampicillin as the sodium salt plus 1 gram sulbactam as the sodium salt) every six hours. This 1.5 to 3 gram range represents the total of ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to a range of 1 gram ampicillin/0.5 grams sulbactam to 2 grams ampicillin/1 gram sulbactam. The total dose of sulbactam should not exceed 4 grams per day.
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.
Ampicillin and sulbactam for injection is generally well tolerated. The following adverse reactions have been reported in clinical trials.
Pain at IM injection site – 16%
Pain at IV injection site – 3%
Thrombophlebitis – 3%
Phlebitis – 1.2%
Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with ampicillin and sulbactam for injection may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with ampicillin and sulbactam for injection and allopurinol administered concurrently. Ampicillin and sulbactam for injection and aminoglycosides should not be reconstituted together due to the
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 C16H18N3NaO4S. 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 C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:
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 8.0 and 10.0.
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 1.5 grams of Ampicillin and Sulbactam for Injection, USP pharmacy bulk package (1 gram ampicillin as the sodium salt plus 0.5 grams sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium.
Ampicillin and Sulbactam for Injection, USP pharmacy bulk package is a vial 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 and sulbactam for injection for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see
Ampicillin and sulbactam for injection sterile powder for intravenous use may be reconstituted with any of the compatible diluents described in this insert. Solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization.
Ampicillin and Sulbactam for Injection, USP concentrations between 3 and 45 mg (2 to 30 mg ampicillin/1 to 15 mg sulbactam per mL) are recommended for intravenous use.
The 15 gram vial may be reconstituted with either 92 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection. The diluent should be added in two separate aliquots in a suitable work area, such as a laminar flow hood. Add 50 mL of solution, shake to dissolve. Then add an additional 42 mL and shake. The solution should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization. The resultant solution will have a final concentration of approximately 100 mg per mL ampicillin and 50 mg per mL sulbactam. The closure may be penetrated only one time after reconstitution, if needed, using a suitable sterile transfer device or dispensing set that allows for measured dispensing of the contents.
After reconstitution, use within two hours if stored at room temperature, or within four hours if stored under refrigeration.
Reconstituted Bulk Solution Should Not Be Used For Direct Infusion |
If the reconstituted bulk solution is stored for less than one hour at room temperature (20°C/68°F) prior to further dilution, the use periods indicated in Table 4apply for the diluted solutions.
If the bulk solution is stored for one to two hours at room temperature (20°C/68°F) and then diluted with Sterile Water for Injection or 0.9% Sodium Chloride Injection to the following concentrations, the use periods indicated in Table 5apply.
Any unused portions of solution that remain after the indicated time periods should be discarded.
Diluent | Maximum Concentration (mg per mL) Ampicillin and Sulbactam for Injection | Use Periods |
| Sterile Water for Injection | 45 (30/15) | 8 hrs at 21°C |
| 45 (30/15) | 48 hrs at 4°C | |
| 30 (20/10) | 72 hrs at 4°C | |
| 0.9% Sodium Chloride Injection | 45 (30/15) | 8 hrs at 21°C |
| 45 (30/15) | 48 hrs at 4°C | |
| 30 (20/10) | 72 hrs at 4°C | |
| 5% Dextrose Injection | 30 (20/10) | 2 hrs at 21°C |
| 30 (20/10) | 4 hrs at 4°C | |
| 3 (2/1) | 2 hrs at 21°C | |
| Lactated Ringer's Injection | 45 (30/15) | 8 hrs at 21°C |
| 45 (30/15) | 24 hrs at 4°C | |
| M/6 Sodium Lactate Injection | 45 (30/15) | 8 hrs at 21°C |
| 45 (30/15) | 12 hrs at 4°C | |
| 5% Dextrose in 0.45% Saline | 3 (2/1) | 4 hrs at 21°C |
| 15 (10/5) | 4 hrs at 4°C | |
| 10% Invert Sugar | 3 (2/1) | 4 hrs at 21°C |
| 30 (20/10) | 3 hrs at 4°C |
IV Solution | Maximum Concentration (mg per mL) Ampicillin and Sulbactam for Injection | Use Periods |
| Sterile Water for Injection, USP | 45 (30/15) | 4 hrs at 21°C |
| 45 (30/15) | 24 hrs at 4°C | |
| 0.9% Sodium Chloride Injection, USP | 45 (30/15) | 4 hrs at 21°C |
| 45 (30/15) | 24 hrs at 4°C |