ClavoSigma tablet

Amoxicillin 250 mg., Clavulanic acid 125 mg.

Warnings
Contraindications
Allergy to penicillins
Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate
Extended release: Hemodialysis patients and severe renal impairment (CrCl <30 mL/min)

Cautions
Allergy to cephalosporins, carbapenems
Different tablets are not interchangeable, because ratios of amoxicillin to clavulanate are different
Extended release tablets not for use in renal impairment (CrCl <30 mL/min)
Incidence of diarrhea is higher than with amoxicillin alone
Unknown safety and efficacy of extended-release tablets in patients <16 years old
Risk of Clostridium difficile-associated diarrhea (CDAD); consider in patients who present with diarrhea after antibiotic use; CDAD has been known to occur over 2 months after antibiotic therapy; if suspected, discontinue drug immediately and administer appropriate fluid/electrolyte therapy, protein supplementation, and C difficile antibiotic treatment
Risk of bacterial or fungal superinfections; if suspected, discontinue drug immediately and administer appropriate therapy
High percentage of patients with mononucleosis reported to develop rash during therapy; ampicillin-class antibiotics not recommended in these patients
Use caution in hepatic impairment; hypatic dysfunction (rare) is more common in elderly and/or males and prolonged therapy may increase risk; may occur after completing therapy