Ranclav Special Precautions

amoxicillin + clavulanic acid




Full Prescribing Info
Special Precautions
1-g FC tab & Susp: RANCLAV tablets and Ranclav 228.5 & 457 Suspension should be used with caution in patients with evidence of severe hepatic dysfunction; change in liver function tests have been observed in some patients receiving Amoxicillin and Clavulanic acid combination.
1-g FC tab: RANCLAV 1 G tablets should not be used in patients with moderate to severe renal impairment (creatinine clearance of ≤30 ml/min).
Susp: Ranclav 228.5 & 457 Suspension contains Aspartame and should not be used by phenylketonurics.
1-g FC tab and Susp: Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and appropriate therapy instituted.
FC tab and Susp: Laboratory value alterations: Urine glucose test: High urinary concentrations of a penicillin may produce false-positive or falsely elevated test results with copper-reduction test [Benedict's, Clinitest, or Fehling's]. Glucose enzymatic tests [Clinistix or Testape] are not affected. Direct antiglobulin (Coombs') test: False-positive result may occur during therapy with any penicillin.
625-mg FC tab: Liver function tests: A moderate rise in SGOT, SGPT, alkaline phosphatase and serum bilirubin have been reported in a few patients with use of amoxicillin & clavulanate potassium combination.
1-g FC tab and Susp: Carcinogenicity: Long-term carcinogenicity studies in animals have not been performed with amoxicillin and clavulanate potassium combination.
Mutagenicity: Long-term studies in animals have been performed to evaluate the mutagenic potential of Amoxicillin and Clavulanate Potassium combination.
Use in Children: 1-g FC tab: Paediatrics patients over 12 years of age should be dosed according to adult recommendation. There is lack of data pertaining to use of RANCLAV 625 mg / 1 G tablets in children less than 12 years of age.
Susp: No paediatrics-specific problems have been documented when given according to the recommended dosage.
Use in the Elderly: 1-g FC tab and Susp: Penicillins have been used in geriatric patients and no geriatricsĀ­ specific problems have been documented to date. However, elderly patients are more likely to have an age-related decrease in renal function, which may require an adjustment in dosage in patients receiving penicillins.
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