Ampicillin and Sulbactam (Page 4 of 5)

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 (see DIRECTIONS FOR USE, Preparation for Intramuscular Injection section).

The recommended adult dosage of ampicillin and sulbactam for injection is 1.5 grams (1 gram ampicillin as the sodium salt plus 0.5 gram sulbactam as the sodium salt) to 3 grams (2 grams ampicillin as the sodium salt plus 1 gram sulbactam as the sodium salt) every six hours. This 1.5 to 3 gram range represents the total of ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to a range of 1 gram ampicillin/0.5 gram sulbactam to 2 grams ampicillin/1 gram 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 (see CLINICAL STUDIES section).

Impaired Renal Function

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:

TABLE 3 Ampicillin and Sulbactam for Injection Dosage Guide for Patients with Renal Impairment
Creatinine Clearance(mL/min/1.73m2) Ampicillin/SulbactamHalf-Life (Hours) RecommendedAmpicillin and Sulbactamfor Injection Dosage
≥30 1 1.5 g to 3 g q6h to q8h
15 to 29 5 1.5 g to 3 g q12h
5 to 14 9 1.5 g to 3 g q24h

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

COMPATIBILITY, RECONSTITUTION AND STABILITY

Ampicillin and sulbactam for injection sterile powder is to be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) prior to reconstitution.

When concomitant therapy with aminoglycosides is indicated, ampicillin and sulbactam for injection and aminoglycosides should be reconstituted and administered separately, due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins.

DIRECTIONS FOR USE

General Dissolution Procedures

Ampicillin and sulbactam for injection 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 gram and 3 gram vials: ampicillin and sulbactam sterile powder 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.)

TABLE 4
Maximum Concentration (mg/mL)
Diluent Ampicillin and Sulbactam for Injection 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

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 gram and 3 gram 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.

TABLE 5
Ampicillin and Sulbactam for InjectionVial Size Volume of Diluent to be Added Withdrawal Volume *
*
There is sufficient excess present to allow withdrawal and administration of the stated volumes.
1.5 gram 3.2 mL 4.0 mL
3 grams 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.

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