XBV Tablet 5/160 mg

Adult dose

The recommended dose for this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The dosage can be adjusted to 5/80 mg, 5/160 mg, or 10/160 mg depending on patients whose blood pressure is not controlled by monotherapy with amlodipine or valsartan. Patients with renal impairment may not require dosage adjustment in cases of mild or moderate impairment.

Child dose

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

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, therefore it should be discontinued immediately upon confirmation of pregnancy. It should not be administered to individuals with hypersensitivity to this drug, or to pregnant or nursing women, or to patients with severe kidney or liver disorders. There is a risk of hypotension in patients with sodium or fluid depletion, so it is important to correct this condition before administration and to carefully monitor blood pressure during treatment. Patients with hyperkalemia or those taking medications that can elevate potassium levels should use this drug cautiously and frequently check potassium levels. For patients with renal artery stenosis or those who have received kidney transplants, careful evaluation and monitoring are necessary due to the risk of worsening kidney function. If symptoms of angioedema occur, administration must be stopped immediately, and it should not be redeployed. Patients with heart failure or those recovering from a myocardial infarction should be closely monitored for changes in kidney function while administering this drug. Like other vasodilators, this medication should be used with caution in patients with aortic stenosis or mitral stenosis. Co-administration of this drug with other renin-angiotensin-aldosterone system agents is not recommended due to the increased risk of hypotension, hyperkalemia, and renal function deterioration. There may be dizziness or fatigue when driving or operating machinery, so caution is advised. In cases of overdose, symptoms such as hypotension, dizziness, and reflex tachycardia may appear, and appropriate emergency treatment should be sought if necessary. This medication is not recommended for use in pediatric patients under 18 years of age, as its safety and effectiveness have not been fully established. In elderly patients, general dosing is acceptable, but careful observation is advised based on their physical condition. Regular monitoring of liver and kidney function, blood pressure, and electrolyte levels during treatment with this medication is important.

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, shortness of breath, cold sweat, pallor, severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa, dyspnea or difficulty breathing, asthma attack, respiratory abnormality with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances,

Mild side effects

• Nasopharyngitis
• influenza
• anxiety
• headache
• dizziness
• drowsiness
• orthostatic dizziness
• paresthesia
• lightheadedness
• tinnitus

The medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is recommended to maintain a storage temperature of between 1 to 30 degrees Celsius at room temperature.

Appearance

Dark yellow oblong film-coated tablet

Package unit

28 tablets (14 tablets/PTP×2)