AHFS Class:

8:12.16.08 Aminopenicillins

Generic Name

• Ampicillin Sodium-Sulbactam Sodium

Generic Name

• Ampicillin Sodium-Sulbactam Sodium

Ampicillin sodium-sulbactam sodium is available as a powder in vials and piggyback bottles containing 1.5 g (ampicillin 1 g plus sulbactam 0.5 g) or 3 g (ampicillin 2 g plus sulbactam 1 g) as the sodium salts.³²⁸⁵ Ampicillin sodium-sulbactam sodium also is available in a pharmacy bulk package containing 15 g (ampicillin 10 g plus sulbactam 5 g as the sodium salts).⁴⁰⁰⁷

For intramuscular injection, reconstitute vials with sterile water for injection or lidocaine hydrochloride 0.5 or 2% in the following amounts:³²⁸⁵

^aSufficient excess is present to permit withdrawal of the volume noted.^bAmpicillin 250 mg plus sulbactam 125 mg per mL.

For intravenous use, ampicillin sodium-sulbactam sodium may be reconstituted with sterile water for injection; sodium chloride 0.9%; dextrose 5%; Ringer's injection, lactated; sodium lactate M, or dextrose 5% in sodium chloride 0.45%.³²⁸⁵ Reconstitute piggyback bottles directly with a compatible diluent to the desired concentration between 3 and 45 mg/mL (ampicillin 2 to 30 mg plus sulbactam 1 to 15 mg per mL).³²⁸⁵ Standard vials of 1.5 and 3 g may be reconstituted with 3.2 and 6.4 mL of sterile water for injection, respectively, to yield 375-mg/mL solutions (ampicillin 250 mg plus sulbactam 125 mg per mL).³²⁸⁵ The reconstituted solution should be diluted immediately in a compatible infusion solution to yield the desired concentration between 3 and 45 mg/mL.³²⁸⁵ Allow reconstituted solution to stand so that any foaming may dissipate before inspecting them visually to ensure complete dissolution.³²⁸⁵

The 15-g pharmacy bulk package should be reconstituted with 92 mL of sterile water for injection or sodium chloride 0.9% to yield a solution containing ampicillin 100 mg and sulbactam 50 mg per mL.⁴⁰⁰⁷ Add the diluent in 2 separate aliquots (e.g., 50 mL followed by 42 mL) and shake after addition of each aliquot.⁴⁰⁰⁷ Allow reconstituted solution to stand so that any foaming may dissipate to permit visual inspection for complete dissolution.⁴⁰⁰⁷ The reconstituted solution must be further diluted for intravenous infusion.⁴⁰⁰⁷

pH

Reconstituted solutions and diluted solutions: 8 to 10.³²⁸⁵; ⁴⁰⁰⁷

Sodium Content

Each 1.5 g (ampicillin 1 g plus sulbactam 0.5 g as the sodium salts) contains approximately 115 mg (5 mEq) of sodium.³²⁸⁵

Each 3 g (ampicillin 2 g plus sulbactam 1 g as the sodium salts) contains approximately 230 mg (10 mEq) of sodium.³²⁸⁵

Trade Name(s)

Unasyn

Ampicillin sodium-sulbactam sodium may be administered by deep intramuscular injection or intravenous injection or infusion.³²⁸⁵ For direct intravenous injection, the drug should be given slowly over at least 10 to 15 minutes.³²⁸⁵ For intravenous infusion, the drug may be diluted in 50 to 100 mL of compatible diluent and infused over 15 to 30 minutes.³²⁸⁵

Intact vials should be stored at or below 30°C.³²⁸⁵; ⁴⁰⁰⁷ Ampicillin sodium-sulbactam sodium is available as a white to off-white powder that forms a pale yellow to yellow solution upon reconstitution.³²⁸⁵; ⁴⁰⁰⁷ Dilute solutions are colorless to pale yellow.³²⁸⁵; ⁴⁰⁰⁷ The manufacturer recommends that intramuscular solutions be used within 1 hour after preparation.³²⁸⁵

Reconstituted solutions prepared from pharmacy bulk packages should be further diluted for intravenous infusion within 2 hours if stored at room temperature (20°C) or within 4 hours if stored under refrigeration.⁴⁰⁰⁷ If the reconstituted bulk solution has been stored for less than 1 hour at room temperature, resulting diluted solutions should be used within the time periods indicated in Table 1.⁴⁰⁰⁷ If the reconstituted bulk solution has been stored for 1 to 2 hours at room temperature, resulting diluted solutions should be used within the time periods indicated in Table 2.⁴⁰⁰⁷

Table 1: Use Periods for Diluted Ampicillin Sodium-Sulbactam Sodium Solutions Prepared from Reconstituted Bulk Solutions That Have Been Stored 1 Hour at Room Temperature⁴⁰⁰⁷

Diluent	Maximum Concentration (ampicillin/sulbactam) (mg/mL)	Storage Temperature 21°C	Storage Temperature 4°C
Sterile water for injection	45 (30/15)	8 hours	48 hours
Sterile water for injection	30 (20/10)		72 hours
Sodium chloride 0.9%	45 (30/15)	8 hours	48 hours
Sodium chloride 0.9%	30 (20/10)		72 hours
Dextrose 5%	30 (20/10)	2 hours	4 hours
Dextrose 5%	3 (2/1)	2 hours
Ringer’s injection, lactated	45 (30/15)	8 hours	24 hours
Sodium lactate M	45 (30/15)	8 hours	12 hours
Dextrose 5% in sodium chloride 0.45%	3 (2/1)	4 hours
Dextrose 5% in sodium chloride 0.45%	15 (10/5)		4 hours

Table 2: Use Periods for Diluted Ampicillin Sodium-Sulbactam Sodium Solutions Prepared from Reconstituted Bulk Solutions That Have Been Stored 1-2 Hours at Room Temperature⁴⁰⁰⁷

Central Venous Catheter

Ampicillin sodium-sulbactam sodium (Pfizer-Roerig) 5 plus 2.5 mg/mL in sodium chloride 0.9% was found to be compatible with the ARROWg+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Essentially complete delivery of the drug was found with little or no drug loss occurring. Furthermore, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter.²³³⁵

Solution Compatibility

Additive Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions December 5, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.