Amocla Adverse Reactions

Gastrointestinal reactions: Diarrhoea, pseudomembranous colitis, indigestion, nausea, and vomiting may occur. Candidiasis and antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis) have been reported rarely. Nausea, although uncommon, is more often with higher oral dosages. If gastrointestinal side effects occur with oral therapy they may be reduced by taking AMOCLA at the start of meals. As with other antibiotics the incidence of gastrointestinal side effects may be raised in children under two years. In clinical trials, however, only 4% of children under two years were withdrawn from treatment.
Hepatic effects: Sometimes rise in AST, ALT, and Al-P have been reported. Hepatitis and cholestatic jaundice have been reported rarely. These have been reported more frequently in the adult, elderly, and male. Signs and symptoms usually occur during treatment, but in some case may not occur until six weeks after treatment has ended. Hepatic reactions are usually reversible but very rarely, deaths have been reported. Hepatic reactions have been reported more frequently in males and elderly patients, and they are estimated to be related to long-term treatment.
Hypersensitivity reactions: Urticarial and erythematous rashes sometimes occur. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and exfoliative dermatitis have been reported rarely. Treatment should be discontinued if one of these disorders occurs. In common with other β-lactam antibiotics angioedema, anaphylaxis, serum sickness-like syndrome and hypersensitive vasculitis have been reported.
Skin and subcutaneous tissue disorders: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported very rarely.
Haematological effects: As with other β-lactams transient leucopenia (including eosinopenia and deficiency disease of granulocytes), transient thrombocytopenia, haemolytic anaemia, thrombocytopenic purpurea, eosinophilia, leukopenia and agranulocytosis have been reported rarely.
CNS effects: CNS effects have been seen very rarely. They include reversible hyperactivity, dizziness, headache and convulsions. Convulsions may occur with impaired renal function or in those receiving high doses.
Renal effects: Severe renal dysfunction such as acute renal failure, and interstitial nephritis may occur rarely.
Thus, renal function should be evaluated periodically. Whenever abnormalities occur, the drug should be discontinued and the patients are properly treated.
Nervous system disorders: Very rare: Aseptic meningitis.