UNASYN® Other
(ampicillin sodium, sulbactam sodium)
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).
| Diluent | Maximum Concentration (mg/mL) UNASYN (Ampicillin/Sulbactam) | Use Periods |
|---|---|---|
Sterile Water for Injection | 45 (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 Injection | 45 (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 Injection | 30 (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 Injection | 45 (30/15) | 8 hrs at 25°C |
45 (30/15) | 8 hrs at 4°C | |
5% Dextrose in 0.45% Saline | 3 (2/1) | 4 hrs at 25°C |
15 (10/5) | 4 hrs at 4°C | |
10% Invert Sugar | 3 (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).
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.
| UNASYN Vial Size | Volume of Diluent to be Added | Withdrawal Volume* |
|---|---|---|
| ||
1.5 g | 3.2 mL | 4.0 mL |
3.0 g | 6.4 mL | 8.0 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.
For medical information about UNASYN, please visit www.pfizermedinfo.com or call 1-800‑438-1985.
To report SUSPECTED ADVERSE EVENTS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
LAB-0017-24.0
Revised October 2024
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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).
| Diluent | Maximum Concentration (mg/mL) UNASYN (Ampicillin/Sulbactam) | Use Periods |
|---|---|---|
Sterile Water for Injection | 45 (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 Injection | 45 (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 Injection | 30 (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 Injection | 45 (30/15) | 8 hrs at 25°C |
45 (30/15) | 8 hrs at 4°C | |
5% Dextrose in 0.45% Saline | 3 (2/1) | 4 hrs at 25°C |
15 (10/5) | 4 hrs at 4°C | |
10% Invert Sugar | 3 (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).
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.
| UNASYN Vial Size | Volume of Diluent to be Added | Withdrawal Volume* |
|---|---|---|
| ||
1.5 g | 3.2 mL | 4.0 mL |
3.0 g | 6.4 mL | 8.0 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.
For medical information about UNASYN, please visit www.pfizermedinfo.com or call 1-800‑438-1985.
To report SUSPECTED ADVERSE EVENTS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
LAB-0017-24.0
Revised October 2024
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Report Adverse Event
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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.