Ampicillin-Sulbactam (ampicillin sodium/sulbactam sodium)

Ampicillin/sulbactam is commercially available for parenteral administration as a sterile powder containing a 2:1 ratio of ampicillin to sulbactam. The ampicillin component is provided as ampicillin sodium and the sulbactam component is provided as sulbactam sodium; potency of each component is expressed in terms of the base.

Dosage of ampicillin/sulbactam usually is expressed in terms of the total (sum) of the dosage of both components of the fixed combination (i.e., dosage of ampicillin plus dosage of sulbactam); pediatric dosage of ampicillin/sulbactam also has been expressed in terms of the ampicillin content.

The manufacturer's dosage recommendations for adults are the same for IM and IV administration; however, higher serum concentrations usually are attained with IV administration of the drug, and this route generally is preferred, especially for severe infections.

Because the pharmacokinetics of both ampicillin and sulbactam are affected to the same degree in patients with renal impairment, the recommended 2:1 ratio of the drugs remains the same regardless of the degree of renal impairment.

The manufacturer recommends that patients with renal impairment receive the usually recommended doses of ampicillin/sulbactam, but doses should be given less frequently than usual and the dosing intervals should be based on the patient's creatinine clearance. The manufacturer recommends that patients with creatinine clearances of 30 mL/minute per 1.73 m2 or greater receive 1.5 g (1 g of ampicillin and 0.5 g of sulbactam) to 3 g (2 g of ampicillin and 1 g of sulbactam) of the drug every 6-8 hours and that patients with creatinine clearances of 15-29 or 5-14 mL/minute per 1.73 m2 receive these doses every 12 or 24 hours, respectively.

Because ampicillin and sulbactam are removed by hemodialysis, some clinicians suggest that patients undergoing hemodialysis receive 1.5 g (1 g of ampicillin and 0.5 g of sulbactam) to 3 g (2 g of ampicillin and 1 g of sulbactam) once every 24 hours and that the dose preferably should be given immediately after dialysis.

No dosing information is available for this tab.

No dosing information is available for this tab.

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For further information on these and other drug interactions reported with aminopenicillins, see Drug Interactions in the Aminopenicillins General Statement 8:12.16.08. In addition, while not all drug interactions reported with other penicillins have been reported with aminopenicillins, the possibility that they could occur with these drugs should be considered.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

There are no adequate or controlled studies using ampicillin/sulbactam in pregnant women. Reproduction studies in mice, rats, and rabbits using ampicillin and sulbactam doses up to 10 times the usual human dose have not revealed evidence of impaired fertility or harm to the fetus due to ampicillin/sulbactam. Because animal reproduction studies are not always predictive of human response, ampicillin/sulbactam should be used during pregnancy only when clearly needed.

Although the clinical importance is unclear, administration of ampicillin alone to pregnant women has resulted in a transient decrease in plasma concentrations of total conjugated estriol, estriol glucuronide, conjugated estrone, and estradiol; this effect also may occur following administration of ampicillin/sulbactam. IV administration of ampicillin to guinea pigs has resulted in decreased uterine tone and decreased frequency, height, and duration of uterine contractions. It is not known whether use of ampicillin/sulbactam in humans during labor or delivery could have any immediate or delayed adverse effects on the fetus, prolong the duration of labor, or increase the likelihood of forceps delivery, other obstetrical intervention, or resuscitation of the neonate.

Because ampicillin and sulbactam are distributed into milk in low concentrations, ampicillin/sulbactam should be used with caution in nursing women.

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