Ampicillin + sulbactam

Generic Medicine Info
Hypersensitivity (e.g. anaphylaxis, Stevens Johnson syndrome [SJS]) to ampicillin, sulbactam, or β-lactam antibiotics (e.g. penicillins, cephalosporins). History of cholestatic jaundice or hepatic dysfunction associated with ampicillin/sulbactam combination use.
Special Precautions
Patient with history of atopic allergy (e.g. asthma, eczema, urticaria). Not recommended for use in patients with infectious mononucleosis. Renal and hepatic impairment. Neonates, infants and children. Pregnancy and lactation. Monitoring Parameters Assess the allergy history of the patient before starting treatment. Evaluate for signs of anaphylaxis during the 1st dose and signs and symptoms of opportunistic infections. Monitor haematologic, renal, and hepatic function with prolonged use. Perform culture and susceptibility tests prior to treatment initiation; consult local institutional recommendation before treatment initiation due to antibiotic resistance risks.
Adverse Reactions
Significant: Fungal or bacterial superinfection, including Clostridium difficile-associated diarrhoea (CDAD) and pseudomembranous colitis (prolonged use); rash or severe cutaneous reactions (e.g. toxic epidermal necrolysis, SJS, dermatitis exfoliative, erythema multiforme, acute generalised exanthematous pustulosis). Blood and lymphatic system disorders: Anaemia, thrombocytopenia, eosinophilia, leucopenia, neutropenia. Cardiac disorders: Chest pain. Gastrointestinal disorders: Diarrhoea, vomiting, nausea, flatulence, abdominal distension, glossitis, mucosal bleeding. General disorders and administration site conditions: Inj site pain, fatigue, malaise, chills, oedema. Hepatobiliary disorders: Hyperbilirubinaemia. Investigations: Increased ALT, AST; decreased plasma concentration of total conjugated estriol, conjugated estrone, estradiol, and estriol-glucuronide (in pregnant women). Nervous system disorders: Headache. Renal and urinary disorders: Urine retention, dysuria. Respiratory, thoracic and mediastinal disorders: Epistaxis, throat tightness. Skin and subcutaneous tissue disorders: Pruritus. Vascular disorders: Phlebitis, thrombophlebitis.
Potentially Fatal: Hypersensitivity reaction (e.g. anaphylaxis), hepatotoxicity (e.g. hepatitis, cholestatic jaundice).
Drug Interactions
Increased and prolonged serum concentrations with probenecid. Ampicillin: Increased incidence of rashes with allopurinol. May enhance the effect of anticoagulants. May inactivate the effect of aminoglycosides. Bacteriostatic drugs (e.g. chloramphenicol, erythromycin, sulfonamides, tetracyclines) may interfere with the bactericidal effect of ampicillin. Diminished therapeutic efficacy of estrogen-containing oral contraceptives. Decreased clearance of methotrexate thus increase the risk of toxicity.
CIMS Class
ATC Classification
J01CG01 - sulbactam ; Belongs to the class of beta-lactamase inhibitors. Used in the systemic treatment of infections.
J01CA01 - ampicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
S01AA19 - ampicillin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 © 2023 CIMS. All rights reserved. Powered by
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