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

Pregnancy category: B Lactation: Excreted in breast milk; use caution

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.