Zemimet SR Dosage/Direction for Use

Posology: Adult patients with type 2 diabetes mellitus: Zemimet SR 50/1000 mg should generally be administered once daily with a meal preferably in the evening in patients who need 50 mg of gemigliptin and who are currently treated with metformin 1000 mg or to be needed metformin 1000 mg.
For patients with inadequate glycemic control on metformin monotherapy or dual combination of metformin and sulfonylurea: Zemimet SR 50/1000 mg should generally be administered once daily with a meal preferably in the evening.
When switching from metformin immediate-release to Zemimet SR 50/1000 mg, glycemic control should be closely monitored.
When used in combination with sulfonylurea, a lower dose of the sulfonylurea may be required to reduce the risk of hypoglycemia.
No studies have been performed specifically examining the safety and efficacy of Zemimet SR 50/1000 mg in patients previously treated with other oral anti-hyperglycemic agents and switched to Zemimet SR 50/1000 mg. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
The maximum recommended daily dose of Zemimet SR 50/1000 mg is 1 tablet.
Special populations: Renal impairment: An estimated glomerular filtration rate (eGFR) should be assessed before initiation of treatment with Zemimet SR 50/1000 mg and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
It is not recommended to initiate treatment with Zemimet SR 50/1000 mg in patients with an eGFR ≥ 30 mL/min/1.73 m² and eGFR < 45 mL/min/1.73m². If eGFR falls to levels persistently below 45 mL/min/1.73m² during treatment, assess the benefit and risk of continuing therapy. Factors that may increase the risk of lactic acidosis (see Precautions) should be reviewed before considering initiation of Zemimet SR 50/1000 mg in patients with eGFR < 60 mL/min/1.73 m².
Hepatic Impairment: Since impaired hepatic function has been associated with some cases of lactic acidosis, Zemimet SR 50/1000 mg should not be used in patients with hepatic impairment (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions).
Cardiac Impairment: There is limited clinical experience in patients with New York Heart Association (NYHA) Class I, II cardiac status in the case of gemigliptin. Therefore, Zemimet SR 50/1000 mg should be used with caution in this population. Zemimet SR 50/1000 mg should be avoided in patients with NYHA Class III, IV cardiac status (see Precautions).
Elderly: Clinical experience with patients ≥ 65 years of age is limited and caution should be exercised when treating this population (see Contraindications and Precautions). Of the total number of patients (N=1473) in Phase II and III clinical studies, 243 (16.5%) were 65 years and over. The efficacy and safety of gemigliptin were not different between young and elderly patients. However, Zemimet SR 50/1000 mg should be used with caution in elderly patient because physiological functions including liver and kidney are usually decreased in this population. As metformin and gemigliptin are excreted by the kidney, and the impaired hepatic function is associated with some cases of metformin-related lactic acidosis, Zemimet SR 50/1000 mg should be used with caution as age increases. Monitoring of renal and hepatic function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly.
Pediatric Population: Safety and effectiveness in children and adolescents below 18 years of age have not been established. No data are available.
Method of Administration: Zemimet SR 50/1000 mg should generally be given once daily with a dinner meal to reduce the gastrointestinal adverse reactions associated with metformin.
Zemimet SR 50/1000 mg should be swallowed as a whole and it must not be split, crushed, or chewed before swallowing.
If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.