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Ampicillin and Sulbactam (Ampicillin Sodium / Sulbactam Sodium) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Ampicillin and Sulbactam for Injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.

Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, [Efficacy for this organism in this organ system was studied in fewer than 10 infections.] Klebsiella spp. (including K. pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter spp., and Acinetobacter calcoaceticus.

NOTE: For information on use in pediatric patients see PRECAUTIONS - Pediatric Use and CLINICAL STUDIES sections.

Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp. (including B. fragilis), and Enterobacter spp.

Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis).

While Ampicillin and Sulbactam for Injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection should not require the addition of another antibiotic.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection.

Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin and Sulbactam for Injection and other antibacterial drugs, Ampicillin and Sulbactam for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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 Preparation for Intramuscular Injection.)

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. (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 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 Dosage
≥ 3011.5-3 g q    6h-q 8h
15-2951.5-3 g q 12h
5-1491.5-3 g q 24h

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.

COMPATIBILITY, RECONSTITUTION AND STABILITY

Ampicillin and Sulbactam for Injection sterile powder is to be stored at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] prior to reconstitution.

When concomitant therapy with aminoglycosides is indicated, Ampicillin and Sulbactam and aminoglycosides should be reconstituted an 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 foamin to dissipate in order to permit visual inspection for complete solubilization.

Preparation for Intravenous Use

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.)

DiluentMaximum Concentration (mg/mL)
ampicillin and sulbactam
Use Periods
Sterile Water for Injection45 (30/15)8 hrs @ 25°C
45 (30/15)48 hrs @ 4°C
30 (20/10)72 hrs @ 4°C
0.9% Sodium Chloride Injection45 (30/15)8 hrs @ 25°C
45 (30/15)48 hrs @ 4°C
30 (20/10)72 hrs @ 4°C
5% Dextrose Injection30 (20/10)2 hrs @ 25°C
30 (20/10)4 hrs @ 4°C
3 (2/1)4 hrs @ 25°C
Lactated Ringer's Injection45 (30/15)8 hrs @ 25°C
45 (30/15)24 hrs @ 4°C
M/6 Sodium Lactate Injection45 (30/15)8 hrs @ 25°C
45 (30/15)8 hrs @ 4°C
5% Dextrose in 0.45% Saline3 (2/1)4 hrs @ 25°C
15 (10/5)4 hrs @ 4°C
10% Invert Sugar3 (2/1)4 hrs @ 25°C
30 (20/10)3 hrs @ 4°C

Initially, the vials may be reconstituted with Sterile Water for Injection to yield solutions containing 375 mg Ampicillin and Sulbactam 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 per mL (2 to 30 mg ampicillin/1 to 15 mg sulbactam/per mL).

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 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 Vial SizeVolume of Diluent to be AddedWithdrawal VolumeThere is sufficient excess present to allow withdrawal and administration of the stated volumes.
1.5 g3.2 mL4 mL
3 g6.4 mL8 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.

HOW SUPPLIED

Ampicillin and Sulbactam for Injection (ampicillin sodium/sulbactam sodium) is supplied as a sterile white to yellowish dry powder in glass vials. The following packages are available:

Each 1.5 gram vial contains 1.5 g Ampicillin and Sulbactam for Injection (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). NDC 0781-3032-70

Each 3 gram vial contains 3 g Ampicillin and Sulbactam for Injection (equivalent to 2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt). NDC 0781-3033-70

Other size packages available

Each Pharmacy Bulk Package contains 15 g Ampicillin and Sulbactam for Injection (equivalent to 10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt). NDC 0781-3034-46

Ampicillin and Sulbactam for Injection steril powder is to be stored at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

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