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UNASYN® (ampicillin sodium, sulbactam sodium) Other

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

DIRECTIONS FOR USE

General Dissolution Procedures

UNASYN sterile powder for intravenous and intramuscular 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.

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 4
DiluentMaximum Concentration
(mg/mL)
UNASYN (Ampicillin/Sulbactam)
Use Periods
Sterile Water for Injection45 (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 Injection45 (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 Injection30 (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 Injection45 (30/15)8 hrs at 25°C
45 (30/15)8 hrs at 4°C
5% Dextrose in 0.45% Saline3 (2/1)4 hrs at 25°C
15 (10/5)4 hrs at 4°C
10% Invert Sugar3 (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 5
DiluentMaximum Concentration (mg/mL)
UNASYN (Ampicillin/Sulbactam)
Use Period
0.9% Sodium Chloride Injection (USP)30 (20/10)8 hrs at 25°C

In 0.9% Sodium Chloride Injection, USP

The final diluted solution of UNASYN should be completely administered within 8 hours in order to assure proper potency.

Preparation for Intramuscular Injection

1.5 g and 3.0 g Standard Vials

Vials for intramuscular use may be reconstituted with Sterile Water for Injection USP, 0.5% Lidocaine Hydrochloride Injection USP or 2% Lidocaine Hydrochloride Injection USP. Consult the following table for recommended volumes to be added to obtain solutions containing 375 mg UNASYN per mL (250 mg ampicillin/125 mg sulbactam per mL). Note: Use only freshly prepared solutions and administer within one hour after preparation.

TABLE 6
UNASYN Vial SizeVolume of Diluent to be AddedWithdrawal Volume*
*
There is sufficient excess present to allow withdrawal and administration of the stated volumes.
1.5 g3.2 mL4.0 mL
3.0 g6.4 mL8.0 mL

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.

ADD-Vantage® is a registered trademark of Hospira Inc., a Pfizer company.

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