Dilution Unasyn®- Ampicillin Sulbactam

AMPICILLIN/SULBACTAM (UNASYN ®)

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Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

[0 - 1.5 grams/ 50 ml] [30 min]
[Over 1.5 grams/ 100 ml] [30 min]

Stability / Miscellaneous

Label: Refrigerate.

DOSAGE AND ADMINISTRATION
Ampicillin and Sulbactam for Injection may be administered by either the IV or the IM routes. For IV administration, the dose can be given by slow intravenous injection over at least 10-15 minutes or can also be delivered, in greater dilutions with 50-100 mL of a compatible diluent as an intravenous infusion over 15-30 minutes.

Ampicillin and Sulbactam for Injection may be administered by deep intramuscular injection. (See Preparation for Intramuscular Injection.)

The recommended adult dosage of Ampicillin and Sulbactam for Injection is 1.5 g to 3 g every six hours. The total dose of sulbactam should not exceed 4 grams per day.

Impaired Renal Function

Creatinine Clearance (mL/min/1.73m2)	Ampicillin/Sulbactam Half-Life (Hours)	Recommended Ampicillin and Sulbactam Dosage
≥ 30	1	1.5 - 3g q6h - q8h
15-29	5	1.5 - 3g q12h
5-14	9	1.5 - 3g q24h

DIRECTIONS FOR USE
General Dissolution Procedures.
Ampicillin and Sulbactam for Injection 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
Reconstitution of Ampicillin and Sulbactam for Injection, 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.)

Stability
Diluent	Maximum Concentration (mg/mL) ampicillin and sulbactam	Use Periods
Sterile Water for Injection	45 (30/15)	8 hrs @ 25°C
	45 (30/15)	48 hrs @ 4°C
	30 (20/10)	72 hrs @ 4°C
0.9% Sodium Chloride Injection	45 (30/15)	8 hrs @ 25°C
	45 (30/15)	48 hrs @ 4°C
	30 (20/10)	72 hrs @ 4°C
5% Dextrose Injection	30 (20/10)	2 hrs @ 25°C
	30 (20/10)	4 hrs @ 4°C
	3 (2/1)	4 hrs @ 25°C
Lactated Ringer's Injection	45 (30/15)	8 hrs @ 25°C
	45 (30/15)	24 hrs @ 4°C
5% Dextrose in 0.45% Saline	3 (2/1)	4 hrs @ 25°C
	15 (10/5)	4 hrs @ 4°C

Initially, the vials may be reconstituted with Sterile Water for Injection to yield solutions containing 375 mg Ampicillin and Sulbactam 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 Ampicillin and Sulbactam per mL (2 to 30 mg ampicillin/1 to 15 mg sulbactam/per mL).

Preparation for Intramuscular Injection
1.5 g and 3 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 ampicillin and sulbactam per mL (250 mg ampicillin/ 125 mg sulbactam per mL).

Note: Use only freshly prepared solutions and administer within one hour after preparation.

Ampicillin and Sulbactam Vial Size	Volume of Diluent to be Added	Withdrawal Volume There is sufficient excess present to allow withdrawal and administration of the stated volumes.
1.5 g	3.2 mL	4 mL
3 g	6.4 mL	8 mL

Revised: June 2006
Manufactured in Austria by Sandoz GmbH,
Distributed by Lek Pharmaceuticals Inc.
an affiliate of Sandoz Inc., Princeton, NJ 08540