Description
Lusefi is indicated in the treatment of type 2 diabetes mellitus to improve glycemic control in adults as: Monotherapy: When diet and exercise alone do not provide adequate glycemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Add-on combination therapy: In combination with glucose-lowering medicinal products including insulin preparations in adult patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise plus monotherapy does not provide adequate glycemic control. (For study results with respect to combinations and effects on glycemic control see Pharmacology: Pharmacodynamics: CLINICAL STUDIES: Add-on combination therapy under Actions).
Usually for adults, 2.5 mg as luseogliflozin should be orally administered once daily before or after breakfast. When the effect is insufficient, the dose can be increased to 5 mg once daily while closely monitoring the clinical course.
Patients with Renal Impairment:Β The efficacy of luseogliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment. Lusefi is not recommended for use in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2).
Patients with Hepatic Impairment:Β No dosage adjustment is necessary for patients with mild or moderate hepatic impairment.
Elderly:Β Because physiological function is generally impaired in elderly patients, Lusefi should be administered carefully while monitoring the conditions of patients.
Because detection of the symptoms of dehydration (including thirst) may be delayed in elderly patients, caution should be exercised.
Pediatric Population:Β The safety and efficacy of luseogliflozin in children aged 0 to < 20 years have not yet been established. No data are available.
