Mediroten Tablet 5/80 mg (Amlodipine Besilate, Valsartan)

Adult dose

The recommended dose of this medication is one tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., in the morning). Doses of 5/80 mg, 5/160 mg, or 10/160 mg should be administered based on blood pressure control status. Patients with renal impairment do not need dosage adjustment for mild to moderate renal impairment, but those with severe renal impairment or those on dialysis should not receive this medication.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, so administration is not recommended.

This medication can cause serious harm to the fetus if taken during the second or third trimester of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Patients with allergies to this drug or similar medications, pregnant or breastfeeding women, patients with severe kidney or liver diseases, and those with certain heart diseases should not take this drug. Patients with low sodium or body fluid levels should correct their condition before taking this medication, and careful monitoring is needed as hypotension may occur during treatment. Patients with elevated potassium levels should frequently check their potassium levels when taking this medication along with drugs that can increase potassium. Patients with renal vascular abnormalities or those who have received kidney transplants should use this medication cautiously, as renal function may decline. If vascular edema occurs during treatment with this drug, administration should be stopped immediately and not restarted. Patients with heart failure or those recovering from myocardial infarction should regularly monitor kidney function and blood pressure while taking this medication, with particular caution for patients with severe heart failure. Patients with acute myocardial infarction or certain heart valve diseases should be cautious, as symptoms may worsen while taking this medication. It is not recommended to take this medication along with other drugs that act on the renin-angiotensin-aldosterone system. Dizziness or fatigue may occur while driving or operating machinery, so caution is advised. In case of overdose, severe hypotension or cardiac abnormalities may occur, requiring immediate contact with a medical institution and, if necessary, suitable emergency treatment. This medication is not recommended for children under 18 years of age, as safety and efficacy have not been sufficiently established. Elderly patients may use the same dose as adults, but careful monitoring considering their physical condition is required. During the treatment with this medication, regular checks for blood pressure, kidney function, electrolyte levels, etc., should be performed to identify any abnormalities. Women who are pregnant or planning to become pregnant must consult a doctor, and breastfeeding women are advised to avoid taking this medication.

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances,

Mild side effects

• Headache
• dizziness
• drowsiness
• orthostatic dizziness
• sensory disturbances
• vertigo
• tinnitus
• tachycardia
• palpitations
• syncope

This medication may be sensitive to air or humidity; therefore, it should be stored in a tightly closed container. Avoid storing in extremely hot or cold places, and it is advisable to keep it at room temperature between 1 degrees and 30 degrees.

Appearance

Dark yellow round film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP x 2]