Sign Out
Diutropan 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.
Carcinogenicity, Mutagenicity & 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 pregnancy: Pregnancy Category B: Reproduction studies in the hamster, rat and mouse have shown no definite impairment of fertility or harm to the animal fetus. The safety of Diutropan administered to women who are or who may become pregnant has not been established, therefore, Diutropan should not be given to pregnant women unless, in the judgment of the physicians, the probable benefits outweigh the possible hazards.
Use in lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Diutropan is administered to a nursing woman.
Use in children: The safety and efficacy of Diutropan administration have been demonstrated for children ≥5 years (see Dosage & Administration). However, as there is insufficient clinical data for children <5 years, Diutropan is not recommended for this age group.
