(ampicillin sodium, sulbactam sodium PHARMACY BULK PACKAGE)

Prescribing Information
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COMPATIBILITY, RECONSTITUTION AND STABILITY

PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION

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.

COMPATIBILITY, RECONSTITUTION AND STABILITY

When concomitant therapy with aminoglycosides is indicated, UNASYN and aminoglycosides should be reconstituted and administered separately, due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins.

Directions for Proper Use of Pharmacy Bulk Package

General Dissolution Procedures: UNASYN 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, UNASYN 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 UNASYN 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
DiluentMaximum Concentration
(mg/mL)
UNASYN (Ampicillin/Sulbactam)		Use Periods

Sterile Water for Injection

45 (30/15)
45 (30/15)
30 (20/10)

8 hours at 21°C
48 hours at 4°C
72 hours at 4°C

0.9% Sodium Chloride Injection

45 (30/15)
45 (30/15)
30 (20/10)

8 hours at 21°C
48 hours at 4°C
72 hours at 4°C

5% Dextrose Injection

30 (20/10)
30 (20/10)
3 (2/1)

2 hours at 21°C
4 hours at 4°C
2 hours at 21°C

Lactated Ringer's Injection

45 (30/15)
45 (30/15)

8 hours at 21°C
24 hours at 4°C

M/6 Sodium Lactate Injection

45 (30/15)
45 (30/15)

8 hours at 21°C
12 hours at 4°C

5% Dextrose in 0.45% Saline

3 (2/1)
15 (10/5)

4 hours at 21°C
4 hours at 4°C

10% Invert Sugar

3 (2/1)
30 (20/10)

4 hours at 21°C
3 hours at 4°C

Table 5
IV SolutionMaximum Concentration
(mg/mL)
UNASYN (Ampicillin/Sulbactam)		Use Period

Sterile Water for Injection, USP

45 (30/15)
45 (30/15)

4 hours at 21°C
24 hours at 4°C

0.9% Sodium Chloride Injection, USP

45 (30/15)
45 (30/15)

4 hours at 21°C
24 hours at 4°C

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