Ampicillin + Sulbactam

Indications

Ampicillin + Sulbactam is used for: Gynaecological infections; Intra-abdominal infections; Skin and skin structure infections, Orbital Cellulitis, Pelvic Inflammatory Disease, Pneumonia, Urinary Tract Infections

Adult Dose

Parenteral Gynaecological infections; Intra-abdominal infections; Skin and skin structure infections Adult: Each vial contains 1.5 g (ampicillin 1 g and sulbactam 0.5 g) or 3 g (ampicillin 2 g and sulbactam 1 g): 1.5-3 g 6 hrly by deep IM or slow IV inj over 10-15 min or infusion over 15-30 min. Max: 12 g (8 g ampicillin and 4 g sulbactam) daily. Orbital Cellulitis 3 g (2 g ampicillin + 1 g sulbactam) IV q6hr Pelvic Inflammatory Disease 3 g (2 g ampicillin + 1 g sulbactam) IV q6hr Pneumonia Aspiration or community acquired: 1.5 g (1 g ampicillin + 0.5 g sulbactam) to 3 g (2 g ampicillin + 1 g sulbactam) IV q6hr for 5 or more days Hospital acquired: 3 g IV q6hr for 5 or more days Urinary Tract Infections Pyelonephritis: 3 g (2 g ampicillin + 1 g sulbactam) IV q6hr for 14 days

Child Dose

Parenteral Gynaecological infections; Intra-abdominal infections; Skin and skin structure infections Child: >1 yr 300 mg/kg daily (ampicillin 200 mg and sulbactam 100 mg) in divided doses 6 hrly by IV infusion.

Renal Dose

Renal impairment: Haemodialysis patient: 1.5-3 g once 24 hrly immediately after dialysis. CrCl (ml/min) Dosage Recommendation 5-14 1.5-3 g 24 hrly. 15-29 1.5-3 g 12 hrly.

Administration

IV/IM Preparation Reconstitute with SWI or 0.5% or 2% lidocaine injection (IM) to obtain a 250 mg ampicillin-125 mg sulbactam/mL solution IM: Use within 1 hr after preparation IV: Further dilute to 3-45 mg/mL with appropriate diluent IV/IM Administration Administer around-the-clock to promote less variation in peak and trough serum levels Slow IV injection over at least 10-15 min or infusion over 15-30 min IM: Deep into large muscle mass

Contra Indications

Hypersensitivity to ampicillin, sulbactam or other β-lactam antibacterials (e.g. penicillins, cephalosporins). History of cholestatic jaundice/hepatic dysfunction associated w/ ampicillin and sulbactam.

Precautions

Patient w/ infectious mononucleosis. Hepatic and renal impairment. Pregnancy and lactation. Monitoring Parameters Monitor haematologic, renal and hepatic function w/ prolonged therapy. Monitor for signs of anaphylaxis during 1st dose. Regular monitoring of hepatic function in patients w/ pre-existing hepatic impairment at regular intervals. Lactation: Excreted in breast milk; use caution

Pregnancy-Lactation

Interactions

Increased and prolonged serum levels w/ probenecid. Increased incidence of rashes w/ allopurinol. May reduce effectiveness of oestrogen-containing OC. May increase risk of methotrexate toxicity. Bacteriostatic drugs (e.g. chloramphenicol) may interfere w/ the bactericidal effect of ampicillin. Additive effect w/ anticoagulants.

Adverse Effects

Side effects of Ampicillin + Sulbactam : >10% IM injection site pain (16%) 1-10% Diarrhea (3%),IV injection site pain (3%),Thrombophlebitis (3%),Rash ( < 2%) <1% Abdominal distention,Black, "hairy" tongue,Candidiasis,Chest pain,Chills,Dysuria,Edema,Epistaxis,Erythema,Fatigue,Flatulence,Glossitis,Headache,Itching,Malaise,Mucosal bleeding,Nausea Pseudomembranous colitis,Seizure,Tightness in throat,Thrombocytopenia,Urine retention,Vomiting

Mechanism of Action

Ampicillin binds to 1 or more of the penicillin-binding proteins (PBPs), thus inhibiting the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls. Sulbactam inhibits the activity of beta-lactamases and extends the spectrum of ampicillin to include beta-lactamase producing organisms.