Ampicillin and Sulbactam (Page 5 of 5)
Preparation for Intravenous Use
1.5 grams and 3 grams vials: Ampicillin and sulbactam for injection sterile powder in vials may be reconstituted directly to the desired concentrations using any of the following parenteral diluents.
Reconstitution of ampicillin and sulbactam for injection, 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) Ampicillin and Sulbactam for Injection (Ampicillin/Sulbactam) | Use Periods |
| Sterile Water for Injection | 45 (30/15) 45 (30/15) 30 (20/10) | 8 hrs at 25±2°C 48 hrs at 5±3°C 72 hrs at 5±3°C |
| 0.9% Sodium Chloride Injection | 45 (30/15) 45 (30/15) 30 (20/10) | 8 hrs at 25±2°C 48 hrs at 5±3°C 72 hrs at 5±3°C |
| 5% Dextrose Injection | 30 (20/10) 30 (20/10) 3 (2/1) | 2 hrs at 25±2°C 4 hrs at 5±3°C 4 hrs at 25±2°C |
| Lactated Ringer’s Injection | 45 (30/15) 45 (30/15) | 8 hrs at 25±2°C 24 hrs at 5±3°C |
| M/6 Sodium Lactate Injection | 45 (30/15) 45 (30/15) | 8 hrs at 25±2°C 8 hrs at 5±3°C |
| 5% Dextrose in 0.45% Saline | 3 (2/1) 15 (10/5) | 4 hrs at 25±2°C 4 hrs at 5±3°C |
| 10% Invert Sugar | 3 (2/1) 30 (20/10) | 4 hrs at 25±2°C 3 hrs at 5±3°C |
Initially, the vials may be reconstituted with Sterile Water for Injection to yield solutions containing 375 mg ampicillin and sulbactam for injection 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 ampicillin and sulbactam for injection per mL (2 to 30 mg ampicillin/1 to 15 mg sulbactam/per mL).
Preparation for Intramuscular Injection
1.5 grams and 3 grams 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 ampicillin and sulbactam for injection per mL (250 mg ampicillin/125 mg sulbactam per mL). Note: Use only freshly prepared solutions and administer within one hour after preparation.
| *There is sufficient excess present to allow withdrawal and administration of the stated volumes. | ||
| Ampicillin and Sulbactam for Injection Vial Size | Volume of Diluent to be Added | Withdrawal Volume* |
| 1.5 grams | 3.2 mL | 4 mL |
| 3 grams | 6.4 mL | 8 mL |
Discard unused portion.
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.
HOW SUPPLIED
Ampicillin and Sulbactam for Injection, USP is supplied as follows:
| NDC | Ampicillin and Sulbactam for Injection, USP | Package Factor |
| 25021-142-20 | 1.5 grams equivalent of Ampicillin and Sulbactam for | 10 vials per carton |
| Injection, USP (1 gram ampicillin as the sodium salt | ||
| plus 0.5 gram sulbactam as the sodium salt) in a | ||
| Single-Dose Vial | ||
| 25021-143-30 | 3 grams equivalent of Ampicillin and Sulbactam for | 10 vials per carton |
| Injection, USP (2 grams ampicillin as the sodium salt | ||
| plus 1 gram sulbactam as the sodium salt) in a | ||
| Single-Dose Vial |
Ampicillin and Sulbactam for Injection, USP is a sterile off-white dry powder.
Storage Conditions
Prior to reconstitution, store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
OTHER SIZE PACKAGE AVAILABLE
Ampicillin and Sulbactam for Injection, USP is also available in a Pharmacy Bulk Package supplied as follows:
| NDC | Ampicillin and Sulbactam for Injection, USP | Package Factor |
| 25021-144-99 | 15 grams equivalent of Ampicillin and Sulbactam for | 1 bottle per carton |
| Injection, USP (10 grams ampicillin as the sodium salt | ||
| plus 5 grams sulbactam as the sodium salt) in a | ||
| Pharmacy Bulk Bottle |
Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
Brands listed are the trademarks of their respective owners.
SAGENT®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in Italy©2020 Sagent Pharmaceuticals, Inc.
Revised: November 2020
SAGENT Pharmaceuticals®
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
NDC 25021-142-20
Rx only
Ampicillin and Sulbactam for Injection, USP
1.5 grams per vial
Equivalent to 1 gram ampicillin as the sodium salt plus 0.5 grams sulbactam as the sodium salt
Sterile
For Intravenous or Intramuscular Use
Single-Dose Vial
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
NDC 25021-143-30
Rx only
Ampicillin and Sulbactam for Injection, USP
3 grams per vial
Equivalent to 2 grams ampicillin as the sodium salt plus 1 gram sulbactam as the sodium salt
Sterile
For Intravenous or Intramuscular Use
Single-Dose Vial
| AMPICILLIN AND SULBACTAM ampicillin and sulbactam injection, powder, for solution | |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| AMPICILLIN AND SULBACTAM ampicillin and sulbactam injection, powder, for solution | |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| Labeler — Sagent Pharmaceuticals (796852890) |
Revised: 01/2022 Sagent Pharmaceuticals
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/ampicillin-and-sulbactam-3/page/5/