ARBI-S Tablets 10 mg (Olmesartan Medoxomil)

Adult dose

The recommended initial dose for adults is 10 mg once daily, regardless of meals. If blood pressure is not adequately controlled, the dose may be increased to 20 mg once daily, with a maximum dose of up to 40 mg daily. The antihypertensive effect appears within 2 weeks of treatment initiation, with maximum effects observed after about 8 weeks. Can be co-administered with thiazide diuretics such as hydrochlorothiazide. Patients with renal impairment should be closely monitored and start treatment at lower doses if there is potential for intravascular volume depletion (e.g., in patients receiving diuretics, especially those with renal impairment). <Elderly> No dosage adjustment is necessary when administering to elderly patients aged 65 years and older. Overall differences in efficacy and safety have not been observed between older and younger patients, but sensitivity to this medication may be greater in some elderly patients. <Renal impairment> For patients with mild to moderate renal impairment (creatinine clearance of 20-60 mL/min), the maximum dose is 20 mg once daily. <Liver impairment> For patients with mild liver impairment, no dosage adjustment is necessary. For those with moderate liver impairment, the recommended initial dose is 10 mg once daily, which can be increased to a maximum of 20 mg daily. There is no experience with severe liver impairment, so its use is not recommended. <Pediatrics> Safety and efficacy in pediatric patients have not been established.

Child dose

Safety and efficacy in pediatric patients have not been established.

This medication can cause serious harm or death to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately once pregnancy is confirmed. Patients allergic to any components of this medication, those who are pregnant or breastfeeding, patients undergoing renal dialysis, patients with severe liver impairment, patients with biliary obstruction, and patients with lactose intolerance should not take this medication. Caution is necessary for patients with low blood volume or sodium, as hypotension may occur upon first dose, and appropriate treatment should be received if hypotension symptoms arise. Patients with weak kidney function or those who have had a kidney transplant should regularly check kidney function and electrolyte status through blood tests and should not take this medication if they have severe kidney impairment. Special caution should be exercised when taking this medication in patients with aortic or mitral stenosis and obstructive heart disease, as blood pressure may drop sharply. This medication can cause hyperkalemia, so patients with high potassium levels should regularly monitor their blood potassium levels. Dizziness may occur, so caution is needed when driving or operating dangerous machinery. During the use of this medication, rare side effects such as chest pain, peripheral edema, dizziness, indigestion, palpitations, arthralgia, rashes, among others, may occur. If chronic diarrhea or weight loss persists, the medication should be discontinued and a physician consulted. Caution is advised if taken together with other antihypertensive drugs, potassium-sparing diuretics, or potassium supplements as it may increase serum potassium levels. Combining with non-steroidal anti-inflammatory drugs may impair kidney function, requiring careful monitoring of fluid intake and kidney function tests. During pregnancy, the drug can have serious effects on the fetus; if pregnancy is discovered, it should be discontinued immediately, and caution is advised during breastfeeding as side effects may occur in the infant. Safety in pediatrics has not been established, so it is preferable not to administer it to children. Elderly patients may have increased body drug concentration, so caution is necessary during dosage. In the case of overdose, hypotension and palpitations may occur, and if symptoms are severe, immediate medical attention is required. Although this medication has been reported to have a low risk of carcinogenicity or genotoxicity with long-term use, it is important to consult a physician if unusual symptoms occur during its use.

Serious side effects

Hives, severe swelling (angioedema), chest pain (tightness), difficulty breathing (including asthma attacks), hives, allergic reactions (anaphylaxis), severe rash with high fever, skin peeling, pain in mouth/eyes mucosa, liver function abnormalities (increase in liver enzymes and bilirubin levels, jaundice), acute kidney failure, severe swelling, hyperkalemia, elevated serum creatinine, severe neurological symptoms (consciousness confusion, visual disturbances,

Mild side effects

• Dizziness
• headache
• palpitations
• back pain
• bronchitis
• diarrhea
• hematuria
• hyperglycemia
• hypertriglyceridemia
• influenza-like symptoms

This medication may be sensitive to air and humidity, so it should be stored in a tightly sealed container. It is advisable to keep the storage temperature between 1 to 25 degrees Celsius at room temperature.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle