Tablet: Changes in liver function tests have been observed in some patients receiving INDCLAV*. The clinical significance of these changes is uncertain but INDCLAV* should be used with caution in patients with evidence of hepatic dysfunction. Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for up to six weeks after treatment has ceased.
In patients with moderate or severe renal impairment, INDCLAV* dosage should be adjusted as recommended in the Dosage & Administration section.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity (see Contraindications). Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin. INDCLAV*, should be avoided if glandular fever is suspected.
Prolonged use may also occasionally result in overgrowth of non -susceptible organisms.
Further Information: Resistance to many antibiotics is caused by bacterial enzymes, which destroy the antibiotic before it can act on the pathogen. The clavulanic acid in INDCLAV* anticipates this mechanism by blocking the beta-lactamase enzymes, thus rendering the organisms sensitive to amoxicillin's rapid bactericidal effect of concentrations readily attainable in the body. Clavulanic acid by itself has little antibacterial activity. However, in association with amoxicillin as INDCLAV*, it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice. The pharmacokinetics of the two components of INDCLAV* are closely matched. Peak serum levels of both occur about 1 hour after oral administration and about 70% remains free in the serum. Doubling the dosage of INDCLAV* approximately doubles the serum levels achieved.
INDCLAV* is also available as INDCLAV* intravenous for the short-term treatment of bacterial infections and for prophylaxis against infection which may be associated with major surgical procedures. INDCLAV* intravenous is described in a separate pack insert. INDCLAV* is also available as a syrup for two times daily for administration to children under the age of 12 years for the treatment of bacterial infections. INDCLAV* syrup is described in a separate Pack Insert.