Ampicillin Sodium and Sulbactam Sodium

DOSAGE AND ADMINISTRATION The pharmacy bulk package is for preparation of solutions for IV infusion only. Ampicillin and Sulbactam for Injection should be administered diluted with 50 mL to 100 mL of a compatible diluent as an intravenous infusion over 1530 minutes. The recommended adult dosage of Ampicillin and Sulbactam for Injection is 1.5 g (ampicillin 1 g and sulbactam 0.5 g) to 3 g (ampicillin 2 g and sulbactam 1 g) 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 and 0.5 g sulbactam to 2 g ampicillin and 1 g sulbactam. The total dose of sulbactam should not exceed 4 g per day. Pediatric Patients 1 Year of Age or Older: The recommended daily dose of Ampicillin and Sulbactam for Injection in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of Ampicillin and Sulbactam for Injection, and corresponds to 200 mg ampicillin and 100 mg sulbactam per kg per day. The safety and efficacy of Ampicillin and Sulbactam for Injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 g per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most most pediatric patients received a course of oral antimicrobials following initial treatment with intravenous Ampicillin and Sulbactam for Injection (see CLINICAL STUDIES section). Impaired Renal Function In patients with impairment of 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 and according to the following recommendations: TABLE 3 Ampicillin and Sulbactam for Injection, USP Dosage Guide for Patients with Renal Impairment Creatinine Clearance (mL/min/1.73m 2 ) Ampicillin/Sulbactam Half-Life (Hours) Recommended Ampicillin and Sulbactam for Injection, USP Dosage 30 1 1.5 g to 3 g every 6 to 8 hours 15 - 29 5 1.5 g to 3 g every 12 hours 5 - 14 9 1.5 g to 3 g every 24 hours When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function. Males weight (kg) × (140 - age) 72 × serum creatinine Females 0.85 × above value COMPATIBILITY, RECONSTITUTION AND STABILITY When concomitant therapy with aminoglycosides is indicated, Ampicillin and Sulbactam for Injection and aminoglycosides should be reconstituted and administered separately, due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins. Intravenous Administration Directions for Proper Use of Pharmacy Bulk Package General Dissolution Procedures: 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. Reconstituted Bulk Solution Should Not be Used For Direct Infusion Prior to intravenous administration, Ampicillin and Sulbactam for Injection must be reconstituted and further diluted before use. a) Reconstitute the 15 g vial with either 92 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection, 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 total concentration of approximately 150 mg/mL (ampicillin concentration of 100 mg/mL and sulbactam concentration of 50 mg/mL). The resultant volume is approximately 100 mL. 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. b) Dilute in a suitable parental diluent (see Table 4) to yield solutions containing a total concentration between 3 mg/mL and 45 mg/mL (ampicillin concentration of 2 mg/mL to 30 mg/mL and sulbactam concentration of 1 mg/mL to 15 mg/mL) are recommended for intravenous use. Storage of Diluted Ampicillin and Sulbactam for Injection Solutions 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 4 apply 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 5 apply. Any unused portions of solution that remain after the indicated time periods should be discarded. Table 4 Diluent Maximum Concentration (mg/mL) Ampicillin and Sulbactam for Injection (Ampicillin/Sulbactam) Use Periods Sterile Water for Injection 45 (30/15) 8 hours at 21°C 45 (30/15) 48 hours at 4°C 30 (20/10) 72 hours at 4°C 0.9% Sodium Chloride Injection 45 (30/15) 8 hours at 21°C 45 (30/15) 48 hours at 4°C 30 (20/10) 72 hours at 4°C 5% Dextrose Injection 30 (20/10) 2 hours at 21°C 30 (20/10) 4 hours at 4°C 3 (2/1) 2 hours at 21°C Lactated Ringers Injection 45 (30/15) 8 hourss at 21°C 45 (30/15) 24 hours at 4°C M/6 Sodium Lactate Injection 45 (30/15) 8 hours at 21°C 45 (30/15) 12 hours at 4°C 5% Dextrose in 0.45% Saline 3 (2/1) 4 hours at 21°C 15 (10/5) 4 hours at 4°C 10% Invert Sugar 3 (2/1) 4 hours at 21°C 30 (20/10) 3 hours at 4°C Table 5 IV Solution Maximum Concentration (mg/mL) Ampicillin and Sulbactam for Injection (Ampicillin/Sulbactam) Use Periods Sterile Water for Injection, USP 45 (30/15) 4 hours at 21°C 45 (30/15) 24 hours at 4°C 0.9% Sodium Chloride Injection, USP 45 (30/15) 4 hours at 21°C 45 (30/15) 24 hourss at 4°C Animal Pharmacology: While reversible glycogenosis was observed in laboratory animals, this phenomenon was dose- and time-dependent and is not expected to develop at the therapeutic doses and corresponding plasma levels attained during the relatively short periods of combined ampicillin/sulbactam therapy in man.

See official label

INDICATIONS AND USAGE 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.