UNASYN® Other

(ampicillin sodium, sulbactam sodium PHARMACY BULK PACKAGE)

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 USE

Intravenous Administration

Directions for Proper Use of Pharmacy Bulk Package

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.

UNASYN concentrations between 3 and 45 mg (2 to 30 mg ampicillin/1 to 15 mg sulbactam/mL) are recommended for intravenous use.

The 15 gram vial may be reconstituted with either 92 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection. The diluent should be 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 final concentration of approximately 100 mg/mL ampicillin and 50 mg/mL sulbactam. 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.

Reconstituted Bulk Solution Should Not be Used For Direct Infusion

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 Injection45 (30/15)
45 (30/15)
30 (20/10)
8 hrs at 21°C
48 hrs at 4°C
72 hrs at 4°C
0.9% Sodium Chloride Injection45 (30/15)
45 (30/15)
30 (20/10)
8 hrs at 21°C
48 hrs at 4°C
72 hrs at 4°C
5% Dextrose Injection30 (20/10)
30 (20/10)
3 (2/1)
2 hrs at 21°C
4 hrs at 4°C
2 hrs at 21°C
Lactated Ringer's Injection45 (30/15)
45 (30/15)
8 hrs at 21°C
24 hrs at 4°C
M/6 Sodium Lactate Injection45 (30/15)
45 (30/15)
8 hrs at 21°C
12 hrs at 4°C
5% Dextrose in 0.45% Saline3 (2/1)
15 (10/5)
4 hrs at 21°C
4 hrs at 4°C
10% Invert Sugar3 (2/1)
30 (20/10)
4 hrs at 21°C
3 hrs 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 hrs at 21°C
24 hrs at 4°C
0.9% Sodium Chloride Injection, USP45 (30/15)
45 (30/15)
4 hrs at 21°C
24 hrs 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.

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Other

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 USE

Intravenous Administration

Directions for Proper Use of Pharmacy Bulk Package

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.

UNASYN concentrations between 3 and 45 mg (2 to 30 mg ampicillin/1 to 15 mg sulbactam/mL) are recommended for intravenous use.

The 15 gram vial may be reconstituted with either 92 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection. The diluent should be 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 final concentration of approximately 100 mg/mL ampicillin and 50 mg/mL sulbactam. 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.

Reconstituted Bulk Solution Should Not be Used For Direct Infusion

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 Injection45 (30/15)
45 (30/15)
30 (20/10)
8 hrs at 21°C
48 hrs at 4°C
72 hrs at 4°C
0.9% Sodium Chloride Injection45 (30/15)
45 (30/15)
30 (20/10)
8 hrs at 21°C
48 hrs at 4°C
72 hrs at 4°C
5% Dextrose Injection30 (20/10)
30 (20/10)
3 (2/1)
2 hrs at 21°C
4 hrs at 4°C
2 hrs at 21°C
Lactated Ringer's Injection45 (30/15)
45 (30/15)
8 hrs at 21°C
24 hrs at 4°C
M/6 Sodium Lactate Injection45 (30/15)
45 (30/15)
8 hrs at 21°C
12 hrs at 4°C
5% Dextrose in 0.45% Saline3 (2/1)
15 (10/5)
4 hrs at 21°C
4 hrs at 4°C
10% Invert Sugar3 (2/1)
30 (20/10)
4 hrs at 21°C
3 hrs 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 hrs at 21°C
24 hrs at 4°C
0.9% Sodium Chloride Injection, USP45 (30/15)
45 (30/15)
4 hrs at 21°C
24 hrs 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.

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