Zemiglo Special Precautions

Renal Impairment: No adjustment is required. (See Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Cardiac Impairment: There is limited clinical experience in patients with New York Heart Association (NYHA) Class I cardiac status. Therefore, gemigliptin should be used with caution in this population. Gemigliptin is not recommended in patients with NYHA Class II-IV cardiac status.
Hepatic Impairment: No dose adjustment is necessary for patients with mild or moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment. Therefore, caution should be exercised in this population.
Hypersensitive Reaction: Care should be taken when administering in patients with allergic and hypersensitive reactions to any of the ingredients in Gemigliptin tablet 50 mg (see Adverse Reactions).
Acute Pancreatitis: In the clinical trials conducted with gemigliptin, no adverse reactions of acute pancreatitis related to gemigliptin have been reported. However, there have been reports of acute pancreatitis in patients taking other dipeptidyl peptidase (DDP-4) receptor inhibitors. Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis is suspected, gemigliptin should be discontinued and should not be restarted. Caution should be exercised in patients with a history of pancreatitis.
Use with Medicinal Products Known to Cause Hypoglycaemia: Sulfonylurea is known to cause hypoglycaemia. Therefore, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycaemia when used in combination with gemigliptin.
Severe and Disabling Arthralgia: There have been postmarketing reports of severe and disabling arthralgia in patients taking other DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor.
Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate.
Excipient warnings: Gemigliptin tablet 50 mg contains sunset yellow FCF which may cause allergic reactions.
Effects on ability to drive and use machines: Gemigliptin tablet 50 mg has no known influence on the ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia when Gemigliptin is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. sulfonylureas).