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 Injection

45 (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 Injection

45 (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 Injection

30 (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 Injection

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

8 hrs at 21°C
24 hrs at 4°C

M/6 Sodium Lactate Injection

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

8 hrs at 21°C
12 hrs at 4°C

5% Dextrose in 0.45% Saline

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

4 hrs at 21°C
4 hrs at 4°C

10% Invert Sugar

3 (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, USP

45 (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.

Find UNASYN® medical information:

Find UNASYN® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

UNASYN® Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

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 Injection

45 (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 Injection

45 (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 Injection

30 (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 Injection

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

8 hrs at 21°C
24 hrs at 4°C

M/6 Sodium Lactate Injection

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

8 hrs at 21°C
12 hrs at 4°C

5% Dextrose in 0.45% Saline

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

4 hrs at 21°C
4 hrs at 4°C

10% Invert Sugar

3 (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, USP

45 (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.

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.