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Posology: Use in adults: The recommended dose of SUGANON is 5 mg once daily as monotherapy or combination therapy, and the maximum daily dose of SUGANON is 5 mg.
Use in pregnancy and nursing mothers: 1) Use in pregnant women: No comparative study result is available in pregnant women. Results of animal studies showed that evogliptin was detected in the blood stream of fetus across the placenta up to 61.7% in pregnant rats and 14.1% in pregnant rabbits 2 hours after administration. Therefore, use in pregnant women is not recommended.
2) Use in nursing mothers: It is not evaluated whether SUGANON is excreted in human milk. Since animal studies confirmed that evogliptin is secreted in the milk, SUGANON should not be used in nursing mothers.
Use in Pediatrics: Safety and efficacy in pediatrics have not been established.
Use in the elderly: There were 119 elderly patients (22.6%) aged 65 years or older out of a total of 527 patients in the phase II and III clinical studies of SUGANON. The administration in elderly patients has not been fully investigated. Since the elderly generally have decreased physiological functions such as hepatic and renal functions, caution needs to be exercised during administration while monitoring the patient's condition.
Use in patients with renal impairment: Dose adjustment is not necessary in patients with mild renal impairment.
Method of administration: For oral use.
