Clamentin

Clamentin Adverse Reactions

amoxicillin + clavulanic acid

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Full Prescribing Info
Adverse Reactions
Clamentin Film Coated Tablet: Infections and infestations: Common: Mucocutaneous candidiasis.
Blood and lymphatic system disorders: Rare: Reversible leucopenia (including neutropenia) and thrombocytopenia. Very rare: Reversible agranulocytosis and haemolytic anaemia. Prolongation of bleeding time and prothrombin time.
Immune system disorders: Very rare: Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis.
Nervous system disorders: Uncommon: Dizziness, headache.
Very rare: Reversible hyperactivity and convulsions. Convulsions my occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disorders: Adults: Very common: Diarrhoea.
Common: Nausea, vomiting.
Children: Common: Diarrhoea, nausea, vomiting.
All populations: Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking Clamentin Film Coated Tablet 1,000 mg at the start of a meal.
Uncommon: Indigestion. Very rare: Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis). Black hairy tongue.
Hepatobiliary disorders: Uncommon: A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam class antibiotics, but the significance of these findings is unknown.
Very rare: Hepatitis and cholestatic jaundice. These events have been noted with other penicillins and cephalosporins.
Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. Signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be severe and in extremely rare circumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.
Skin and subcutaneous tissue disorders: Uncommon: Skin rash, pruritus, urticaria.
Rare: Erythema muliforme. Very Rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative-dermatitis, acute generalised exanthemous pustulosis (AGEP).
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued.
Renal and urinary disorders: Very rare: Interstitial nephritis, crystalluria.
Clamentin Powder for Injection: Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature.
Gastrointestinal reactions: Diarrhea, indigestion, nausea, vomiting, candidiasis and antibiotic-associated colitis have been reported rarely. Nausea, although uncommon, is more often associated with higher oral dosages.
Hepatic effects: A moderate rise in AST and/or ALT has been noted in patients with beta-lactam class antibiotics, but the significance of these findings is unknown. Hepatitis and cholestatic jaundice have been reported rarely. They may, however, be severe and continue for several months. They are reported as occurring predominantly in adult or elderly patients and slightly more frequently in males. Signs and symptoms may occur during treatment but are more frequently reported after cessation of therapy with a delay of up to six weeks. The hepatic events are usually reversible. However, in extremely rare circumstances, deaths have been reported.
Hypersensitivity reactions: Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis have been reported. Treatment should be discontinued if one of these types of rash appears. In common with other β-lactam antibiotics, angioedema, oedema, anaphylaxis, serum sickness-like syndrome and hypersensitivity vasculitis have been reported.
Interstitial nephritis can occur rarely.
Haematological effects: As with other β-lactams, reversible leucopenia, reversible thrombocytopenia and haemolytic anemia have been reported rarely.
CNS effects: Hyperactivity, dizziness, and headache are rare. Convulsions may occur with impaired renal functions or in those receiving high doses.
Local effects: Thrombophlebitis at the site of injection.
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