Ranclav Adverse Reactions

amoxicillin + clavulanic acid




Full Prescribing Info
Adverse Reactions
625-mg FC tab: Gastrointestinal effects: Diarrhoea, nausea, vomiting, discomfort, anorexia, flatulence, dyspepsia, gastritis, stomatitis, glossitis, black or hairy tongue and enterocolitis.
Pseudomembranous colitis: Antibiotic associated pseudomembranous colitis may occur during or following discontinuance of amoxicillin & clavulanate potassium combination.
Hypersensitivity Reactions: Rash and urticaria have been reported in 3% of patients receiving amoxicillin and clavulanate potassium combination. Angioedema, serum sickness like reactions and rarely exfoliative dermatitis have been reported.
Haematopoeitic side effects: Anemia, thrombocytopenia, leukopenia and agranulocytosis have been reported during therapy with penicillins.
CNS Effects: Reversible hyperactivity, agitation, anxiety, insomnia. and dizziness have been reported rarely.
1-g FC tab and Susp: Side effect with RANCLAV are uncommon and mainly of a mild and transitory nature. Reported side effects include diarrhoea, indigestion, nausea, vomiting and mucocutaneous candidiasis.
Susp: Superficial tooth discoloration has been reported rarely, mostly with the suspension. It can usually be removed by brushing.
1-g FC tab and Susp: Occasionally moderate and asymptomatic rises in AST and/or ALT and alkaline phosphatases; and rarely hepatitis and cholestatic jaundice have been reported to occur. Signs and symptoms may occur during treatment but have been more frequently reported after cessation of therapy with a delay of up to 6 weeks.
Susp: After amoxicillin and clavulanic acid combination, hepatic reactions have been reported more frequently in males and elderly patients, particularly over 65 years of age. The risk increases with duration of treatment longer than 14 days.
These reactions have been very rarely reported in children.
1-g FC tab and Susp: Urticaria and erythematous rashes have been reported occasionally.
Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, serum sickness like syndrome, hypersensitivity vasculitis, interstitial nephritis, pseudomembranous colitis, prolongation of bleeding time and prothrombin time have been reported to occur rarely.
In common with other β-lactam antibiotics, angioedema and anaphylaxis, transient leucopenia, thrombocytopenia and haemolytic anaemia have been reported rarely.
Side effects involving the CNS which include reversible hyperactivity, dizziness, headache and convulsions may occur very rarely.
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