Zemimet SR Dosage/Direction for Use

Posology (refer to Pharmacology: Pharmacodynamics: Clinical Efficacy and Safety under Actions): Dosage of Zemimet SR must be individualized on the basis of the patient's current regimen, effectiveness, and tolerability. The dosage should be gradually escalated to reduce the gastrointestinal side effects associated with the metformin component.
Zemimet SR should generally be administered once daily with a meal in the evening.
The recommended starting dose of Zemimet SR in patients who need 50 mg of gemigliptin and who are not currently treated with metformin is 50 mg gemigliptin and 500 mg metformin extended-release once daily with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.
For patients with inadequate glycemic control on metformin monotherapy or for patients with inadequate glycemic control on dual combination of metformin and sulfonylurea, or for patients with inadequate glycemic control on dual combination of metformin and insulin, or for patients with inadequate glycemic control on dual combination of metformin and dapagliflozin, the recommended daily dose of Zemimet SR is 50 mg gemigliptin and the dose of metformin already being taken.
When used in combination with a sulfonylurea or insulin, a lower dose of the sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.
For patients switching from co-administration of gemigliptin and metformin, Zemimet SR should be initiated at the dose of gemigliptin and metformin already being taken.
When switching from metformin immediate release to extended release, glycemic control should be closely monitored and the dose adjusted on the basis of blood glucose measurements.
No studies have been performed specifically examining the safety and efficacy of Zemimet SR in patients previously treated with other oral anti-hyperglycemic agents and switched to Zemimet SR. 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 is 50 mg gemigliptin and 2,000 mg metformin extended-release.
Special populations: Renal impairment: A GFR should be assessed before initiation of treatment with metformin containing products 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.
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin in patients with GFR <60 ml/min. If no adequate strength of Zemimet SR is available, individual monocomponents should be used instead of the fixed dose combination. (See Table 1.)

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Hepatic Impairment: Zemimet SR should not be used in patients with hepatic impairment.
Elderly: As metformin and gemigliptin are excreted by the kidney, Zemimet SR should be used with caution as age increases. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. Clinical experience with patients ≥65 years of age is limited and caution should be exercised when treating this population.
Cardiac Impairment: There is limited clinical experience in patients with New York Heart Association (NYHA) Class I-II cardiac status. Therefore, gemigliptin should be used with caution in this population. Zemimet SR is not recommended in patients with NYHA Class III-IV cardiac status.
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: Oral: Zemimet SR should generally be given once daily with a dinner meal to reduce the gastrointestinal adverse reactions associated with metformin.
Zemimet SR 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.