Diutropan Special Precautions

Diutropan (oxybutynin chloride) should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease. Diutropan may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmia, hiatal hernia, tachycardia, hypertension, and may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious complication of the disease.
Carcinogenesis, Mutagenesis, Impairment of Fertility: A 24-month study in rat at dosage up to approximately 400 times the recommended human dosage showed no evidence of carcinogenicity.
Diutropan showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae and Salmonella typhimurium test systems. Reproduction studies in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility.
Use in Children: The safety and efficacy of Diutropan administration have been demonstrated for children 5 years of age and older (see Dosage & Administration). However, as there is insufficient clinical data for children under age of 5, Diutropan is not recommended for this age group.