Immunosin Special Precautions

Inosine dimepranol acedoben may cause a transient increase of baseline serum and urine concentrations of uric acid, particularly in men and in the elderly, because of the catabolic metabolism of the inosine content of Inosine dimepranol acedoben to uric acid in humans. It is not due to a fundamental drug-induced alteration of enzyme or renal clearance function. Therefore, Inosine dimepranol acedoben should be used with caution in patients with a history of gout, hyperuricemia, urolithiasis, nephrolithiasis, or in those with renal impairment. The uric acid levels of these patients should be monitored closely during Inosine dimepranol acedoben therapy.
If administered continuously for 3 months or longer, the serum and urine concentrations of uric acid, blood count, liver and renal functions should be monitored regularly in all patients.
Carcinogenicity, Mutagenicity, Impairment of Fertility: Standard mutagenicity assays and in vivo studies in mice and rats and in vitro studies in human peripheral blood lymphocytes revealed no aberrant properties.
Long-term toxicology studies in mice and rats have shown no indication of carcinogenic properties of Inosine dimepranol acedoben.
Reproduction studies in mice, rats and rabbits at continuous parenteral dosing of up to 20 times the maximum therapeutically recommended human dose (20 x 100 mg/kg/day) have shown no evidence of perinatal toxicity, embryotoxicity, teratogenicity or impaired reproductive function due to Inosine dimepranol acedoben.