Orotenion Tablet 10/40 mg (Amlodipine Besilate, Olmesartan Medoxomil)

Adult dose

This medication is taken once daily, one tablet, regardless of meals, with water. It is recommended to take it at the same time daily (e.g., in the morning). The recommended dosages are as follows: - 5/20 mg: For patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: Administered to patients whose blood pressure is not adequately controlled with olmesartan medoxomil 20 mg alone.

Child dose

The safety and efficacy for pediatric patients under 18 years of age 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; therefore, it should be discontinued immediately upon confirmation of pregnancy. It should not be taken if there is an allergy to any of its components, or if one is pregnant or breastfeeding, or if there are serious liver diseases or certain heart and kidney diseases. Patients with hypotension due to a lack of fluid or salt should be cautious when starting this medication, as blood pressure can drop sharply; appropriate action should be taken immediately if symptoms occur. Caution should be exercised when administering this medication to patients with severe heart valve disease since there is a risk of rapid blood pressure drop due to vasodilation. Patients with heart diseases, such as occlusive coronary artery disease or congestive heart failure, may experience worsening of symptoms when taking this medication, necessitating careful use. Patients with impaired kidney function may experience worsening of kidney function when taking this medication and should have regular blood tests and kidney function tests. Patients with reduced liver function may also experience delayed metabolism and excretion of this medication, so caution is required during administration. Side effects such as dizziness, headache, hypotension, indigestion, and edema may occur during treatment; if severe symptoms arise, a doctor should be consulted. Pregnant women or those planning to become pregnant should use other antihypertensive medications with confirmed safety instead of this medication, as it poses a risk to the fetus during pregnancy; they must consult with a doctor before taking this medication. Breastfeeding women should consult a doctor about stopping breastfeeding or medication as this drug can pass into breast milk and affect the infant. Children under 18 years old should avoid taking this medication since its safety and efficacy have not been established. Elderly patients (over 65 years) may react more sensitively to this medication; therefore, starting with a lower dose and closely monitoring their condition is advisable. In cases of overdose, blood pressure may drop significantly, and heart rhythms may become irregular; immediate emergency treatment is required if such symptoms occur. This medication should be stored away from moisture, heat, and direct sunlight, in a place out of reach of children, and it is advisable not to transfer it to another container.

Serious side effects

Hives, severe swelling (edema), difficulty breathing, yellowing of the skin (jaundice), sudden and severe headache, seizures, confusion, visual disturbances, paralysis, significant decrease in urine output, severe edema accompanied by high blood pressure, angioedema, acute kidney failure, increased creatinine in the blood, autoimmune hepatitis, acute hypotension due to vasodilation, severe allergic reactions, severe skin adverse reactions.

Mild side effects

• Dizziness
• headache
• orthostatic hypotension
• drowsiness
• paresthesia
• decreased sensation
• palpitations
• hypotension
• orthostatic hypotension
• cough

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is advised to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will safely retain the drug's efficacy.

Appearance

Brownish-red round film-coated tablets

Package unit

28 tablets (14 tablets/PTP x 2)