Idaldipine 40/5 mg (Azilsartan Medoxomil Potassium, Amlodipine Besylate)

Adult dose

This medication should be taken once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., morning) if possible. 40/5 mg: Administered to patients whose blood pressure is not adequately controlled by Azilsartan Medoxomil 40 mg or Amlodipine 5 mg monotherapy. 40/10 mg: Administered to patients whose blood pressure is not adequately controlled by Azilsartan Medoxomil 40 mg or Amlodipine 10 mg monotherapy or this medication at 40/5 mg.

Child dose

The safety and efficacy of this medication in children and adolescents under 18 years of age have not been established.

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. Individuals with hypersensitivity to this drug or its components, as well as pregnant or nursing women, should not take this medication. Diabetic patients or those with moderate to severe renal impairment should not use this medication in conjunction with certain drugs. Patients with severe liver dysfunction, aortic stenosis, or cardiogenic shock should also avoid using this medication. Patients with heart failure or renal function reliant on the renin-angiotensin-aldosterone system should use this drug with caution, and blood pressure and renal function should be closely monitored. In patients with decreased blood volume, hypotension may occur after taking this medication, so volume correction should be performed prior to administration or it should be started under medical supervision. Patients at risk of hyperkalemia should regularly check their serum potassium levels and exercise particular caution when taking potassium-sparing diuretics or potassium supplements concurrently with this medication. This drug may cause side effects such as dizziness, headache, hypotension, and peripheral edema, and patients should consult healthcare professionals if symptoms are severe. In patients with impaired liver function, the metabolism of this drug may slow down, requiring dose adjustments and monitoring. There may be instances of excessively low blood pressure or deteriorating renal function, so especially in older patients or those with heart failure, it’s recommended to start with a low dose and gradually increase it. In cases of overdose, hypotension and dizziness may occur, and if needed, appropriate treatment and monitoring should be administered. This medication has not been established for safety and efficacy in children and adolescents, so its use is not recommended. During administration, drowsiness or dizziness may occur; therefore, caution should be exercised when driving or operating hazardous machinery.

Serious side effects

• Urticaria
• severe swelling (edema)
• shortness of breath
• angioedema
• hypotension
• syncope
• pre-syncope
• severe allergic reactions
• acute kidney injury
• diabetic nephropathy

Mild side effects

• Dizziness
• headache
• diarrhea
• nausea
• rash
• pruritus
• increased serum creatinine
• increased serum uric acid/hyperuricemia
• weakness
• peripheral edema

This medication should be stored in a tightly closed container as it may be sensitive to air and moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius so that the efficacy of the drug can be preserved.

Appearance

Pale red oval film-coated tablet

Package unit

30 tablets/PTP[(15 tablets*2ea)]