Orosartan Tablet 5/80 mg

Adult dose

The recommended dosage for this medication is 1 tablet once a day, taken with water regardless of meals. It is recommended to take it at the same time each day if possible (e.g., in the morning). For patients with renal impairment: Dose adjustments are not required for mild to moderate renal impairment (creatinine clearance greater than 10 mL/min), but for severe renal impairment (creatinine clearance less than 10 mL/min), this medication should not be used.

Child dose

Safety and efficacy for pediatric patients under the age of 18 have not been established, and use 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, so it should be discontinued immediately if pregnancy is confirmed. It is also safe to avoid this medication if there are allergies to any of the components or similar drugs, if the patient is pregnant or breastfeeding, or if there is severe renal or liver disease. Patients with sodium or volume depletion may experience hypotension; their condition should be managed before taking the drug, and blood pressure should be closely monitored during treatment. Patients with high potassium levels or those taking potassium-containing medications should have their potassium levels monitored regularly. Patients with renal vascular problems or who have recently received a kidney transplant must carefully check kidney function when using this medication and should discontinue it immediately if symptoms of angioedema occur. Patients with heart failure or myocardial infarction may experience renal function changes and hypotension when taking this drug, requiring close monitoring by a healthcare professional. This medication may cause dizziness or fatigue when driving or operating machinery, so caution is advised, especially during the initial period of use. When taken in combination with other antihypertensive agents, diuretics, potassium-sparing diuretics, certain anti-inflammatory medications (NSAIDs), or lithium, there may be an increased risk of side effects due to drug interactions, so consultation with a physician is necessary. This drug should not be used during pregnancy due to potential harm to the fetus, and breastfeeding women should also avoid taking this medication. This medication is not recommended for children under the age of 18 due to insufficient evidence of safety and efficacy. In the event of an overdose, hypotension, dizziness, and in severe cases, shock may occur, requiring immediate medical attention for appropriate treatment. It is important to consult healthcare professionals immediately if abnormal symptoms or side effects arise while taking this medication.

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin exfoliation, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme overall fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, and visual disturbances.

Mild side effects

• Pharyngitis
• influenza
• visual disturbances
• anxiety
• headache
• dizziness
• drowsiness
• orthostatic dizziness
• paresthesia
• vertigo

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's efficacy and safety over time.

Appearance

Dark yellow round film-coated tablet

Package unit

30 tablets/PTP, 300 tablets/bottle