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Ampicillin Sodium / Sulbactam Sodium

Pronunciation: AM-pi-SIL-in SOE-dee-um/sul-BAK-tam SOE-dee-um
Class: Aminopenicillin

Trade Names

Unasyn
- Injection, powder for solution 1.5 g (ampicillin 1 g plus sulbactam 0.5 g)
- Injection, powder for solution 3 g (ampicillin 2 g plus sulbactam 1 g)
- Injection, powder for solution 15 g (ampicillin 10 g plus sulbactam 5 g)

Pharmacology

Ampicillin inhibits bacterial cell wall mucopeptide synthesis. Sulbactam inhibits plasmid-mediated beta-lactamase enzymes commonly found in microorganisms resistant to ampicillin.

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Always get your pet's drug and dose recommendation from the veterinarian.

Indications and Usage

Treatment of skin and skin structure, intra-abdominal, and gynecologic infections caused by susceptible microorganisms.

Unlabeled Uses

Community-acquired pneumonia, hospital-acquired pneumonia, treatment of infective endocarditis.

Contraindications

Hypersensitivity to penicillins.

Dosage and Administration

Gynecologic infections, intra-abdominal infections
Adults

IV/IM 1.5 to 3 g every 6 h, not to exceed sulbactam 4 g/day (1.5 g of product contains sulbactam 0.5 g).

Skin and skin structure infections
Adults and children weighing at least 40 kg

IV/IM 1.5 to 3 g every 6 h, not to exceed sulbactam 4 g/day (1.5 g of product contains sulbactam 0.5 g).

Children 1 y of age or older (less than 40 kg)

IV 300 mg/kg/day (ampicillin 200 mg/sulbactam 100 mg) in divided doses every 6 h.

Renal function impairment
Adults CrCl at least 30 mL/min per 1.73 m 2

IV/IM 1.5 to 3 g every 6 to 8 h.

CrCl 15 to 29 mL/min per 1.73 m 2

IV/IM 1.5 to 3 g every 12 h.

CrCl 5 to 14 mL/min per 1.73 m 2

IV/IM 1.5 to 3 g every 24 h.

Hemodialysis

Administer the dose after dialysis

General Advice

  • Administer IV dose over at least 10 to 15 min, or further dilute solution and administer over 15 to 30 min. Rapid IV administration may cause seizures.
  • IM injection is painful; administer deep into a large muscle mass. Safety and efficacy of IM administration in children have not been established.
  • Do not routinely exceed 14 days of IV therapy in children.
  • Reconstitute and administer ampicillin/sulbactam separately from aminoglycosides.

Storage/Stability

Store at or below 86°F prior to reconstitution.

Drug Interactions

Allopurinol

Increases potential for ampicillin-induced skin rash. If a skin rash develops, consider discontinuing one or both drugs.

Contraceptives, oral

May reduce efficacy of oral contraceptives. Use of alternative methods of contraception is advisable.

Live vaccines

Ampicillin/sulbactam may decrease the effectiveness of live vaccines. Use of live vaccines with ampicillin/sulbactam is not recommended.

Methotrexate

Methotrexate plasma concentrations may be elevated, increasing the risk of toxicity. Monitor patients for methotrexate toxicity and measure methotrexate concentrations. The dose and duration of leucovorin rescue may need to be increased. Consider use of alternative antibiotic treatment.

Probenecid

Renal tubular secretion of ampicillin and sulbactam may be decreased, resulting in increased and prolonged levels of ampicillin and sulbactam. It may be necessary to administer ampicillin/sulbactam less frequently when probenecid is coadministered.

Tetracyclines

May impair bactericidal effects of ampicillin/sulbactam. If possible, avoid coadministration of these agents.

Warfarin

The risk of bleeding may be increased, especially with large IV doses of ampicillin. Monitor coagulation status and adjust the warfarin dose as needed.

Laboratory Test Interactions

May cause false-positive urine glucose test results with Benedict solution, Fehling solution, or Clinitest tablets (enzyme-based tests [eg, Clinistix , Tes-tape ] are recommended). Ampicillin administration to pregnant women may result in a transient decrease in plasma concentration of total conjugated estriol, conjugated estrone, estradiol, and estriol-glucuronide.

Adverse Reactions

Dermatologic

Rash (less than 2%); erythema multiforme, exfoliative dermatitis, urticaria.

GI

Diarrhea (3%); black, hairy tongue; Clostridium difficile –associated diarrhea; enterocolitis; gastritis; pseudomembranous colitis; stomatitis.

Genitourinary

Increased BUN and creatinine; presence of RBCs and hyaline casts in urine.

Hematologic

Agranulocytosis; decreased Hct, Hgb, lymphocytes, neutrophils, RBC, platelets, and WBC; increased basophils, eosinophils, lymphocytes, monocytes, and platelets; positive direct Coombs tests.

Hypersensitivity

Hypersensitivity (anaphylactic) reactions (sometimes fatal).

Local

Pain at IM injection site (16%); pain at IV injection site, thrombophlebitis at injection site (3%).

Metabolic

Elevated serum alkaline phosphatase, ALT, AST, and LDH; reduced serum albumin and total proteins.

Precautions

Monitor

Monitor patient for hypersensitivity reactions and superinfection. Monitor patients who develop diarrhea for the development of C. difficile –associated diarrhea.


Pregnancy

Category B .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established for children younger than 1 y of age or children with intra-abdominal or gynecologic infections.

Hypersensitivity

Reactions range from mild to life-threatening. Use cautiously in cephalosporin-sensitive patients because of possible cross-allergenicity.

Renal Function

Use cautiously with altered dosing interval.

Superinfection

May result in overgrowth of nonsusceptible bacterial or fungal organisms.

C. difficile –associated diarrhea

Has been reported and may range in severity from mild diarrhea to fatal colitis.

Mononucleosis

Do not administer to patients with mononucleosis.

Overdosage

Symptoms

Convulsive seizures, neurologic reactions.

Patient Information

  • Explain rationale for hospitalization during course of therapy.
  • Inform patients of potential adverse reactions and encourage them to report any problems.
  • Inform diabetic patients that this medication may cause false-positive glucose urine test results and identify types that will be more reliable.
  • If therapy is changed because of allergic reaction, explain significance of penicillin allergy and inform of potential sensitivity to cephalosporins.
  • Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted and not to treat at home.

Copyright © 2009 Wolters Kluwer Health.

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