Sevitera HCT Tablet 5/20/12.5 mg

Adult dose

This medication should be taken once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The dosage should be adjusted considering the patient's blood pressure response at intervals of more than 2 weeks. The maximum dose is 10/40/25 mg of amlodipine/olmesartan medoxomil/hydrochlorothiazide. The recommended dosages are as follows: - 5/20/12.5 mg: For patients whose blood pressure is not adequately controlled with the combination of amlodipine/olmesartan medoxomil 5/20 mg. - 5/40/12.5 mg: For patients whose blood pressure is not adequately controlled with the combination of amlodipine/olmesartan medoxomil 5/40 mg or this medication 5/20/12.5 mg. - 5/40/25 mg: For patients whose blood pressure is not adequately controlled with this medication 5/40/12.5 mg. - 10/40/12.5 mg: For patients whose blood pressure is not adequately controlled with the combination of amlodipine/olmesartan medoxomil 10/40 mg or this medication 5/40/12.5 mg. - 10/40/25 mg: For patients whose blood pressure is not adequately controlled with this medication 5/40/25 mg or this medication 10/40/12.5 mg. ※ Refer to the dosage titration steps (indicating the amounts of each individual component of amlodipine/olmesartan medoxomil/hydrochlorothiazide). 5/20/0 mg → 5/20/12.5 mg ↓ 5/40/0 mg → 5/40/12.5 mg → 5/40/25 mg ↓ ↓ 10/40/0 mg → 10/40/12.5 mg → 10/40/25 mg ● In patients with renal impairment For patients with mild to moderate renal impairment (creatinine clearance 30-60 mL/min), the maximum dose of this medication is 20/5/12.5 mg once daily. Monitoring potassium and creatinine levels is recommended for patients with moderate renal impairment. This medication should not be administered to patients with severe renal impairment (creatinine clearance < 30 mL/min). ● In patients with liver impairment Caution should be used when administering this medication to patients with mild to moderate liver impairment. The maximum dose for patients with moderate liver impairment is 5/20/12.5 mg once daily. Blood pressure and kidney function should be closely monitored in liver patients. This medication should not be administered to patients with severe liver impairment. ● In elderly patients (65 years and older) In general, treatment should start at a lower dose, and dosage adjustments should consider the patient's kidney or heart function and other health conditions. Elderly patients should have their blood pressure monitored more frequently. Experience with this medication in patients aged 75 years or older is very limited, so careful monitoring is essential when administering this medication. ● In children Safety and efficacy in pediatric patients under 18 years of age have not been established, so the use of this medication is not recommended.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established, so the use of this medication is not recommended.

This medication can cause serious harm to the fetus and newborn, especially during the second and third trimesters of pregnancy, and should be discontinued immediately upon confirmation of pregnancy. Patients with hypersensitivity to this medication or similar medicines, pregnant women, nursing mothers, patients with severe hypotension, and patients with severe renal or liver impairment should not take this medication. Patients with reduced blood volume, patients dependent on kidney function, liver patients, and those with certain heart diseases should use this medication with caution, and observe for changes in blood pressure or kidney function. This medication lowers blood pressure, so symptoms of excessively low blood pressure or dizziness may occur, requiring caution when driving or operating dangerous machinery. During treatment with this medication, regular checks of electrolyte levels, kidney function, and blood pressure should be performed to ensure there are no abnormalities. Particularly, the diuretic component of this medication may cause electrolyte imbalances, thus requiring attention to symptoms of hypokalemia, hyperkalemia, and hyponatremia. This medication may interact with other drugs, so patients should inform their physician or pharmacist of any other medications being taken. Use during breastfeeding is not recommended, and if necessary, breastfeeding should be stopped or medication discontinued. Safety and efficacy in pediatric patients have not been established, so its use is not recommended. In case of overdose, symptoms such as hypotension, palpitations, and electrolyte abnormalities may occur, requiring immediate medical attention. Store this medication away from direct sunlight and moisture, in a place inaccessible to children.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough accompanied by fever and breathing abnormalities, jaundice (skin or eyes turning yellow), extreme fatigue, sudden and very severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, death.

Mild side effects

• Peripheral edema
• headache
• dizziness
• upper respiratory infection
• nasopharyngitis
• urinary tract infection
• sialadenitis
• leukopenia
• thrombocytopenia
• bone marrow suppression

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1°C and 30°C. Proper storage helps preserve the medication's effectiveness for a longer time.

Appearance

White-orange round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2) / carton