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[Indications]
This medicine is an aldosterone synthase inhibitor indicated for the treatment of hypertension in adults as an adjunct to other antihypertensive agents.It is specifically intended for patients whose blood pressure is inadequately controlled with existing therapies.Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events,particularly stroke and myocardial infarction.
[Recommended Dosage]
Recommended Dose:2 mg orally once daily.
For patients at increased risk of hyperkalemia or hyponatremia,the recommended dose is 1 mg once daily.
Administration:Can be taken with or without food.
[Adverse Reactions]
The most frequently reported adverse reaction(≥5%)was hyperkalemia.
[Mechanism of Action]
This medicine is a selective inhibitor of human aldosterone synthase(CYP11B2).Aldosterone promotes sodium and water retention in the kidneys,leading to increased blood volume and elevated blood pressure,thereby contributing to hypertension.Additionally,aldosterone induces vascular dysfunction,inflammation,and tissue fibrosis.By inhibiting aldosterone synthase,this medicine effectively lowers plasma aldosterone levels,resulting in antihypertensive effects.
Pharmacologically,this medicine exhibits greater potency and selectivity for aldosterone synthase compared to the structurally related 11β-hydroxylase(the terminal enzyme in cortisol synthesis).Non-clinical and clinical studies have demonstrated that across a wide dosage range,this medicine significantly reduces aldosterone concentrations without affecting cortisol secretion or stress responses.Furthermore,it does not inhibit the synthesis of sex hormones such as testosterone or estrone.
[Storage]
Store at 20°C to 25°C(68°F to 77°F);excursions permitted between 15°C and 30°C(59°F to 86°F).
Keep the container tightly closed and store with the desiccant provided.Dispense in the original container to protect from moisture.