Ampicillin + Sulbactam


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Susceptible infections 375-750 mg bid for 5-14 days or longer. Uncomplicated gonorrhoea 2.25 g w/ probenecid 1 g as a single dose. IM/IV Susceptible infections 1.5-3 g 6 hrly. Max: 12 g/day.
Dosage Details
Oral
Intra-abdominal infections, Pyelonephritis, Respiratory tract infections, Urinary tract infections
Adult: Each tab contains 375 mg (ampicillin 220 mg and sulbactam 147 mg) or 750 mg (ampicillin 440 mg and sulbactam 294 mg), as tosilate: 375-750 mg bid for 5-14 days, or longer as necessary.
Child: <30 kg: Each 5 mL susp contains 250 mg: 25-50 mg/kg daily in 2 divided doses; ≥30 kg: Same as adult dose.

Oral
Uncomplicated gonorrhoea
Adult: Each tab contains 375 mg (ampicillin 220 mg and sulbactam 147 mg) or 750 mg (ampicillin 440 mg and sulbactam 294 mg), as tosilate: 2.25 g w/ probenecid 1 g as a single 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.
Child: ≥1 yr 300 mg/kg daily (ampicillin 200 mg and sulbactam 100 mg) in divided doses 6 hrly by IV infusion.
Renal Impairment
Oral:
CrCl (mL/min) Dosage
≤30 Reduce dosing frequency.
Parenteral:
Haemodialysis patient: 1.5-3 g once 24 hrly immediately after dialysis.
CrCl (mL/min) Dosage
5-14 1.5-3 g 24 hrly.
15-29 1.5-3 g 12 hrly.
Administration
May be taken with or without food.
Reconstitution
Powd for oral susp: Add water according to manufacturer's instructions, to provide a susp containing 250 mg/5 mL. IM: Add 3.2 mL or 6.4 mL of sterile water for inj or lidocaine HCl 0.5% or 2% inj to vials containing 1.5 g or 3 g, respectively, to provide a soln containing 375 mg per mL (ampicillin 250 mg and sulbactam 125 mg per mL). IV inj or infusion: Add 3.2 mL or 6.4 mL of sterile water for inj to vials containing 1.5 g or 3 g, respectively, to provide a soln containing 375 mg per mL. Further dilute w/ a compatible IV soln to yield soln containing 3-45 mg per mL (ampicillin 2-30 mg and sulbactam 1-15 mg per mL). ADD-Vantage® vial: Add NaCl 0.9% diluents provided according to manufacturer's directions.
Incompatibility
Y-site: Aminoglycosides, amiodarone, amphotericin B cholesteryl sulfate complex, ciprofloxacin, idarubicin, nicardipine, ondansetron.
Contraindications
Hypersensitivity to ampicillin, sulbactam or other β-lactam antibacterials (e.g. penicillins, cephalosporins). History of cholestatic jaundice/hepatic dysfunction associated w/ ampicillin and sulbactam.
Special Precautions
Patient w/ infectious mononucleosis. Hepatic and renal impairment. Pregnancy and lactation.
Adverse Reactions
Diarrhoea, nausea, vomiting, flatulence, abdominal discomfort/distension, rectal bleeding, glossitis, gastritis, stomatitis, black/hairy tongue, rash, urticaria, pruritus, dry skin, erythema multiforme, exfoliative dermatitis, cholestatic hepatitis and cholestasis; pain, phlebitis, thrombophlebitis and inflammation at inj site.
Potentially Fatal: Anaphylaxis, Clostridium difficile-associated diarrhoea, hepatotoxicity.
Parenteral/PO: B
MonitoringParameters
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.
Overdosage
Symptoms: Neurological effects including convulsions. Management: May be removed by haemodialysis.
Drug 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.
Lab Interference
False positive urine glucose test using cupric sulfate (e.g. Clinitest®, Benedict's soln, Fehling's soln).
Action
Description: 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 β-lactamases and extends the spectrum of ampicillin to include β-lactamase producing organisms.
Pharmacokinetics:
Absorption: Ampicillin: Moderately well absorbed from the GI tract. Time to peak plasma concentration: Approx 1-2 hr. Sulbactam: Poorly absorbed from the GI tract.
Distribution: Ampicillin: Widely distributed; therapeutic conc achieved in ascitic, pleural and joint fluids; a little diffusion into CSF except when meninges are inflamed. It crosses the placenta and enters breast milk (small amounts). Plasma protein binding: Approx 20%. Sulbactam: Widely distributed in bile, blister and tissue fluids; distributed in CSF when meninges are inflamed. Plasma protein binding: 38%.
Metabolism: Ampicillin: Converted to some extent to penicilloic acid. Sulbactam: Undergoes enterohepatic recycling.
Excretion: Ampicillin: Via urine (approx 20-40% of oral dose as unchanged drug); faeces. Plasma half-life: Approx 1-1.5 hr. Sulbactam: Via urine (approx 75-85% as unchanged drug). Elimination half-life: 1-1.3 hr.
Storage
Tab (375 mg): Store below 30°C. Powd for oral susp/tab (750 mg): Store below 25°C. Reconstituted oral susp: Store between 2-8°C. Powd for inj: Store between 20-25°C. Reconstituted soln: IV: 45 mg/mL soln: Store at 25°C; 30 mg/mL soln: Store at 4°C; ADD-Vantage® vial: Store at 25°C.
MIMS Class
Disclaimer: This information is independently developed by MIMS based on Ampicillin + Sulbactam from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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