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Ampicillin/sulbactam  (UNASYN ©) - Renal Dosing

Usual Dosing (Adults)

DOSAGE AND ADMINISTRATION
Ampicillin and sulbactam for injection may be administered by either the IV or the IM routes.

For IV administration, the dose can be given by slow intravenous injection over at least 10-15 minutes or can also be delivered, in greater dilutions with 50-100 mL of a compatible diluent as an intravenous infusion over 15-30 minutes.

Ampicillin and sulbactam for injection may be administered by deep intramuscular injection.

Preparation for Intramuscular Injection
1.5 g and 3 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 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.
 Ampicillin and Sulbactam for Injection Vial Size  Volume of Diluent to be Added  Withdrawal Volume*
 1.5 g  3.2 mL  4 mL
 3 g  6.4 mL  8 mL
 * There is sufficient excess present to allow withdrawal and administration of the stated volumes.


The recommended adult dosage of ampicillin and sulbactam for injection is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.

Pediatric Patients 1 Year of Age or Older:
The recommended daily dose of ampicillin and sulbactam for injection in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of ampicillin and sulbactam for injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous ampicillin and sulbactam for injection.

Renal Dosing

dialysis IV:
[CRCL >30]: 1.5-3.0 grams q6-8h

[15-30]: 1.5-3.0 grams q12h

[5-14 ]: 1.5-3.0 grams q24 hours

In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam for injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:

 Ampicillin And Sulbactam For Injection Dosage Guide
For Patients With Renal Impairment
 Creatinine Clearance
(mL/min/1.73m2)
 Ampicillin/ Sulbactam
Half-Life (Hours)
 Recommended
Ampicillin And Sulbactam
For Injection Dosage
 geq 30  1  1.5-3 g q 6 h-q 8 h
 15-29  5  1.5-3 g q 12 h
 5-14  9  1.5-3 g q 24 h

When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

 Males  

weight (kg) × (140 - age)
-------------------
72 × serum creatinine

 Females  0.85 × above value

Hemodialysis

dialysis Hemodialysis: 
1.5 - 3.0 grams q24 hours – give dose after dialysis when patient is being dialyzed.

PD: 1.5 - 3.0 grams q24 hours

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer
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