Natravox

Natravox Adverse Reactions

amoxicillin + clavulanic acid

Manufacturer:

Natrapharm

Distributor:

Natrapharm
Full Prescribing Info
Adverse Reactions
Amoxicillin/clavulanate potassium is generally well-tolerated. The majority of adverse effects observed in clinical trials were uncommon and of a mild and transitory nature and <3% of patients discontinued therapy because of drug-related adverse effects. The most frequently reported adverse effects were diarrhea/loose stools, nausea, skin rashes, urticaria, vomiting and vaginitis. The overall incidence of adverse effects, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: Abdominal discomfort, flatulence and headache.
Gastrointestinal Reactions: Diarrhea, indigestion, nausea, gastritis, stomatitis, glossitis, black "hairy" tongue, vomiting and mucocutaneous candidiasis have been reported. Antibiotic-associated colitis (including pseudomembranous colitis and hemorrhage colitis) has been reported rarely with its onset occurring during or after antibiotic treatment. Nausea, although uncommon, is more often associated with higher oral dosages. If gastrointestinal adverse effects occur with oral therapy, they may be reduced by taking co-amoxiclav at the start of meals.
Superficial tooth discoloration has been reported rarely, mostly with the suspension. It can usually be removed by brushing.
Renal and Urinary Tract Disorders: Crystalluria has been reported very rarely.
Genitourinary Effects: Vaginal itching, soreness and discharge may occur.
Hepatic Effects: Moderate and asymptomatic rises in aspartate transaminase (AST) and/or alanine transaminase (ALT) and alkaline phosphatases have been reported occasionally. Hepatitis and cholestatic jaundice have been reported rarely. These hepatic reactions have been reported more commonly with co-amoxiclav than with other penicillins.
After co-amoxiclav hepatic reactions have been reported more frequently in males and elderly patients, particularly those >65 years. The risk increases with duration of treatment >14 days. These reactions have been very rarely reported in children. Signs and symptoms usually occur during or shortly after treatment but in some cases, may not occur until several weeks after treatment has ended. Hepatic reactions are usually reversible but they may be severe and very rarely, deaths have been reported.
Hypersensitivity Reactions: Urticarial and erythematous skin rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP), serum sickness-like syndrome and hypersensitivity vasculitis have been reported. Treatment should be discontinued if one of these disorders occurs. In common with other β-lactam antibiotics, angioedema and anaphylaxis have been reported. Interstitial nephritis can occur rarely.
Hematological Effects: As with other β-lactams, transient leukopenia (including neutropenia and agranulocytosis), thrombocytopenia and hemolytic anemia have been reported rarely. Prolongation of bleeding time and prothrombin time has also been reported rarely.
Central Nervous System (CNS) Effects: CNS effects have been seen very rarely. These include reversible hyperactivity, dizziness, headache and convulsions. Convulsions may occur with impaired renal function or in those receiving high doses.
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