Preparation for Intravenous Use
1.5 g and 3.0 g Bottles: UNASYN sterile powder in piggyback units may be reconstituted directly to the desired concentrations using any of the following parenteral diluents. Reconstitution of UNASYN, at the specified concentrations, with these diluents provide stable solutions for the time periods indicated in the following table: (After the indicated time periods, any unused portions of solutions should be discarded).
TABLE 4Diluent | Maximum Concentration (mg/mL) UNASYN (Ampicillin/Sulbactam) | Use Periods |
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Sterile Water for Injection | 45 (30/15) | 8 hrs at 25°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 25°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 25°C |
| 30 (20/10) | 4 hrs at 4°C |
| 3 (2/1) | 4 hrs at 25°C |
Lactated Ringer's Injection | 45 (30/15) | 8 hrs at 25°C |
| 45 (30/15) | 24 hrs at 4°C |
M/6 Sodium Lactate Injection | 45 (30/15) | 8 hrs at 25°C |
| 45 (30/15) | 8 hrs at 4°C |
5% Dextrose in 0.45% Saline | 3 (2/1) | 4 hrs at 25°C |
| 15 (10/5) | 4 hrs at 4°C |
10% Invert Sugar | 3 (2/1) | 4 hrs at 25°C |
| 30 (20/10) | 3 hrs at 4°C |
If piggyback bottles are unavailable, standard vials of UNASYN sterile powder may be used. Initially, the vials may be reconstituted with Sterile Water for Injection to yield solutions containing 375 mg UNASYN per mL (250 mg ampicillin/125 mg sulbactam per mL). An appropriate volume should then be immediately diluted with a suitable parenteral diluent to yield solutions containing 3 to 45 mg UNASYN per mL (2 to 30 mg ampicillin/1 to 15 mg sulbactam/per mL).
1.5 g ADD-Vantage Vials: UNASYN in the ADD-Vantage system is intended as a single dose for intravenous administration after dilution with the ADD-Vantage Flexible Diluent Container containing 50 mL, 100 mL or 250 mL of 0.9% Sodium Chloride Injection, USP.
3 g ADD-Vantage Vials: UNASYN in the ADD-Vantage system is intended as a single dose for intravenous administration after dilution with the ADD-Vantage Flexible Diluent Container containing 100 mL or 250 mL of 0.9% Sodium Chloride Injection, USP.
UNASYN in the ADD-Vantage system is to be reconstituted with 0.9% Sodium Chloride Injection, USP only. See INSTRUCTIONS FOR USE OF THE ADD-Vantage® VIAL section. Reconstitution of UNASYN, at the specified concentration, with 0.9% Sodium Chloride Injection, USP provides stable solutions for the time period indicated below:
TABLE 5Diluent | Maximum Concentration (mg/mL) UNASYN (Ampicillin/Sulbactam) | Use Period |
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0.9% Sodium Chloride Injection (USP) | 30 (20/10) | 8 hrs at 25°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.