Aitenelm Extended-release Tablet 10/500 mg

Adult dose

This medication is generally administered once daily with the evening meal, and the doses are gradually adjusted to minimize gastrointestinal side effects associated with metformin. The 20/1000 mg extended-release tablet is taken once daily, 1 tablet per dose. For patients taking the 10/750 mg or 10/500 mg extended-release tablets, 1 dose of 2 tablets should be taken at the same time once daily. For patients not achieving sufficient blood sugar control with metformin monotherapy, the initial dose of this medication should provide 20 mg of teneligliptin once daily alongside the existing dose of metformin. For patients switching to this medication from combination therapy with teneligliptin and metformin, the dosage can be initiated with the existing doses of teneligliptin and metformin. When converting from immediate-release metformin to an extended-release formulation, blood sugar control should be closely monitored and dosage adjustments made as needed. When used in conjunction with sulfonylureas, a reduction in the dosage of sulfonylureas may be considered to minimize the risk of hypoglycemia. The maximum recommended daily dose is 20 mg of teneligliptin and 2000 mg of extended-release metformin. The safety and efficacy of this medication have not been specifically evaluated in patients switching from other hypoglycemic agents. Any changes should be conducted under careful monitoring, as they can cause changes in blood sugar control in patients with type 2 diabetes. To maintain the extended-release properties, this medication should not be broken, crushed, ground, or chewed, and should be swallowed whole.

This medication can rarely cause a serious metabolic complication called lactic acidosis. Lactic acidosis is particularly dangerous in patients with decreased kidney function or poor heart and liver function, thus this medication should not be administered to such patients. Moreover, caution is needed as the risk of hypoglycemia may increase when used with insulin or sulfonylureas. Proper measures, such as immediate sugar intake, should be taken if hypoglycemic symptoms occur. Administration is prohibited in patients with moderate or severe renal impairment, heart failure, patients at risk of acute renal failure, patients with acute or chronic metabolic acidosis, patients with liver dysfunction, pregnant women, and women with potential for pregnancy. Before and after surgery, in severe infections or traumatic systemic disorders, administration should be temporarily halted and resumed only after renal function has returned to normal. Side effects such as abdominal pain, vomiting, constipation, liver dysfunction, pneumonia, skin rash, acute pancreatitis may occur occasionally, thus consult a physician immediately if any of these symptoms arise. During treatment, regular kidney function and blood tests should be conducted to check for abnormalities, and periodic assessments are needed as vitamin B12 levels may decrease. Excessive alcohol consumption can increase the risk of lactic acidosis, therefore, alcohol should be avoided during treatment. Symptoms such as dizziness, headache, and fatigue may occur, so caution is required when engaging in hazardous activities such as working at heights or driving. Lastly, this medication has not been established for safety and efficacy in children, so it should not be used in this population.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough + fever, jaundice (skin or eyes turning yellow), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urination

Mild side effects

• Hypoglycemia
• constipation
• dizziness
• abdominal distention
• abdominal discomfort
• nausea
• abdominal pain
• flatulence
• stomatitis
• gastric polyps

This medication should be stored in an airtight container to prevent air ingress, ideally at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the medication's effectiveness over time.

Appearance

Orange oval-shaped extended-release film-coated tablet

Package unit

30 tablets/bottle