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(via Amoxicillin, Ampicillin–Sulbactam, Amoxicillin–Clavulanate & Piperacillin–Tazobactam – Uses, Dosage, Side Effects)

Ampicillin Sodium and Sulbactam Sodium

Common Brand Names: Unasyn

Therapeutic Class: A penicillinase-resistant extended spectrum penicillin antibiotic

Common Injectable Dosage Forms:

Powder for Injection:

Unasyn 1.5 g: 1 g ampicillin as the sodium salt and 0.5 g sulbactam as the sodium salt in vials, bottles, and ADD-Vantage vials. ADD-Vantage is a trademark of Abbott Laboratories.

Unasyn 3 g: 3g ampicillin as the sodium salt and 1 g sulbactam as the sodium salt in vials, bottles, and ADD-Vantage vials. ADD-Vantage is a trademark of Abbott Laboratories.

Unasyn Pharmacy Bulk Package: 10 g ampicillin as the sodium salt and 5 g sulbactam as the sodium salt.

Dosage Ranges:

For the treatment of skin and skin structure infections due to beta-lactamase producing strains of S. aureus, E. coli, Klebsiella species, P. mirabilis, B. fragilis, Enterobacter species, and A. calcoaceticus: 1.5-3 g given by either IV or IM routes every 6 hours.

For the treatment of intra-abdominal infections caused by beta-lactamase producing strains of E. coli, Klebsiella species, Bacteroides species, and Enterobacter species: Same as above.

For the treatment of gynecological infections caused by beta-lactamase producing strains of E. coli Bacteroides species: Same as above.

Dosing in pediatric patients: 300 mg/kg given by IV route every 6 hours.

Dosing in impaired renal function: When CrC is 15-29 mL/min/1.73 m^2, decrease dosing intervals to every 12 hours. When CrC is 5-14 mL/min/1.73 m^2, decrease dosing interval to every 24 hours.

Administration and Stability: Unasyn may be given by slow injection over at least 10-15 minutes or can be delivered in greater dilutions with 50-100 mL of a compatible diluent over 15-30 minutes. Unasyn may be given by deep intramuscular injection. IM Preparation: Reconstitute with Sterile Water for Injection USP, 0.5% Lidocaine HCl Injection USP, or 2% Lidocaine HCl Injection USP. Use within 1 hour of preparation. IV Preparation: Options for IV preparation are too many to list here. Refer to manufacturer’s package insert for more information.

Pharmacology/Pharmacokinetics: Ampicillin acts by inhibiting bacterial cell wall synthesis via acylation of the transpeptidase enzyme. It is active against anaerobic, gram-negative, and gram-bacteria, although it is susceptible to cleavage by beta-lactamases. Sulbactam is an inhibitor of beta-lactamase penicillinase. It has very little antibacterial activity, but it protects ampicillin from cleavage by beta-lactamases. Peak concentration occurs immediately after an IV infusion. The plasma half-life of ampicillin is approximately 1 hour. Up to 38% is bound to plasma proteins. Excretion occurs predominantly through the urine by glomerular filtration and tubular secretion.

Drug and Lab Interactions: May inactivate aminoglycosides when mixed in the same solution. Probenecid increases blood levels of ampicillin and sulbactam. Use with allopurinol substantially increases the incidence of non allergic rash in patients. May cause false-positive urine glucose tests if Clinitest, Benedict’s Solution, or Fehling’s Solution is used.

Contraindications/Precautions: Contraindicated in patients hypersensitive to penicillins and/cephalosporins. Use bacteriologic studies to determine optimum therapy. Monitor white blood and differential cell counts, as well as AST and ALT levels, during therapy and adjust therapy as necessary. Use decreased dose in patients with renal impairment. As with all antibiotics, the possibility of superinfection should be considered, including pseudomembranous colitis. A high percentage of patients with mononucleosis who are given ampicillin develops a skin rash. Pregnancy Category B.

Adverse Effects: The most common adverse effect during use is pain at the injection site (16% for IM, 3% for IV). Diarrhea (3%) and rash (2%) are also common. Less common adverse effects include itching, nausea, vomiting, chest pain, flatulence, bloating, glossitis, urine retention, dysuria, edema, erythema, chills, tightness in throat, chest pain, epistaxis, and mucosal bleeding.

Common Clinical Applications: Effective in the treatment of skin and skin structure, intra-abdominal, and gynecological infections due to susceptible organisms.

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