Sebiwon HCT Tablets 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 every day (e.g., in the morning). The maximum dosage of amlodipine/olmesartan medoxomil/hydrochlorothiazide is 10/40/25 mg. The maximum antihypertensive effect occurs within 2 weeks after administration, so dosing adjustments should be made at intervals of more than 2 weeks. The recommended dosages are as follows: - 5/20/12.5 mg: administered to patients whose blood pressure is not adequately controlled with the combination of amlodipine/olmesartan medoxomil 5/20 mg. - 5/40/12.5 mg: administered to 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: administered to patients whose blood pressure is not adequately controlled with this medication 5/40/12.5 mg. - 10/40/12.5 mg: administered to 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: administered to patients whose blood pressure is not adequately controlled with this medication 5/40/25 mg or this medication 10/40/12.5 mg. * Please refer to the dosage escalation steps outlined (listing ingredient dosages in the order 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 * Renal impairment The maximum dose for patients with mild to moderate renal impairment (creatinine clearance 30-60 mL/min) is 20/5/12.5 mg once daily. Monitoring of potassium levels and creatinine is recommended for patients with moderate renal dysfunction. This medication should not be administered to patients with severe renal impairment (creatinine clearance < 30 mL/min). * Hepatic impairment Caution should be exercised when administering this drug to patients with mild to moderate liver dysfunction. The maximum dose for patients with moderate liver impairment is 5/20/12.5 mg once daily. Blood pressure and renal function should be closely monitored in liver dysfunction patients. This medication should not be administered to patients with severe liver impairment. * Elderly patients (aged 65 years and older) Generally, treatment should start at a lower dose and dose adjustments should consider the patient’s renal function or heart function and underlying diseases. Blood pressure should be monitored more frequently in elderly patients. Especially, there is very limited experience with this medication in patients over 75 years old, so careful monitoring is essential during administration. * Pediatrics Safety and efficacy in pediatric patients under 18 years of age has not been established, thus the use of this medication is not recommended.

Child dose

Safety and efficacy in patients under 18 years of age have not been established, therefore administration is not recommended.

This medication should not be used during the second and third trimesters of pregnancy as it may cause serious harm to the fetus and newborn. It should not be administered to patients with hypersensitivity to this medication or similar drugs, pregnant or nursing women, or patients with severe hypotension. Patients with reduced blood volume, impaired renal function, or liver damage should use this medication with caution and their condition should be closely monitored during treatment. As this medication lowers blood pressure, it may cause dizziness or lightheadedness, necessitating caution when driving or operating machinery. During treatment, serum electrolyte levels and renal function should be regularly monitored to detect any electrolyte imbalances or renal dysfunction early. This drug can interact with other medications, so it is essential to inform healthcare providers of any other medications being taken, especially lithium, non-steroidal anti-inflammatory drugs, and other antihypertensives. This drug has not established safety and efficacy in pediatric patients, hence its use is not recommended. In elderly patients, starting with a lower dose is advisable considering the possibility of renal and liver function decline. In cases of overdose, symptoms such as hypotension, palpitations, and bradycardia may occur, necessitating immediate medical attention.

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty in breathing, asthma attack, cough accompanied by fever and respiratory distress, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes.

Mild side effects

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

Store this medication in a tightly closed container to prevent exposure to air or moisture, and it is advisable to store it at room temperature between 1°C and 30°C.

Appearance

White and orange round film-coated tablets

Package unit

28 tablets (14 tablets/PTP × 2)