Inspra中文版说明书

Chinese version manual

Generic name: eplerenone

Product name:Planep

Full names: eplerenone, Inspra, eplerenone, Planep

Indications:

Inspra is indicated for congestive heart failure after acute myocardial infarction.

Used to treat high blood pressure.

Mechanism of action:

Inspra binds to mineralocorticoid receptors, thereby blocking the binding of aldosterone, a component of the renin-angiotensin-aldosterone system (RAAS). Aldosterone synthesis occurs primarily in the adrenal gland and is regulated by multiple factors, including angiotensin II and non-RAAS mediators such as adrenocorticotropic hormone (ACTH) and potassium. Aldosterone binds to mineralocorticoid receptors in epithelial tissues (such as the kidneys) and non-epithelial tissues (such as the heart, blood vessels, and brain) and increases blood pressure by inducing sodium reabsorption and possibly other mechanisms.

Usage and dosage:

  Usual dosage for adults with congestive heart failure

Initial dose: 25 mg orally once daily; gradually increase to target dose within 4 weeks as tolerated by the patient.

Target dose: 50 mg orally, once daily;

Common dosages for adults with high blood pressure

Eplerenone can be used alone or in combination with other antihypertensive drugs.

Initial dose: 50 mg orally once daily;

Maintenance dose: 50 mg orally, 1-2 times daily;

Maximum dose: 100 mg/day;

Obvious antihypertensive effects appear within four weeks of taking the drug. Patients whose blood pressure responds inadequately to the initial dose may be increased to 50 mg twice daily.

Taboo:

Serum potassium at the beginning is >5.5meq/L; CrCl (creatinine clearance rate) ≤30ml/min; strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, nefazodone, ditroleandomycin, clarithromycin, ritonavir, nelfinavir) are used at the same time.

The following additional contraindications apply to patients with hypertension: type 2 diabetes mellitus (non-insulin-dependent, NIDDM) with microalbuminuria; serum creatinine >2.0 mg/dL in men or >1.8 mg/dL in women; CrCl <50 mL/min; concurrent use of potassium supplements or potassium-sparing diuretics (eg, amiloride, spironolactone, triantiline).

Hypersensitivity to Inspra or any component of the formulation; initial serum potassium >5 meq/L; severe hepatic impairment (Child-Pugh class C); clinically significant hyperkalemia; concurrent use with potassium supplements or potassium-sparing diuretics.

The following additional contraindications apply to patients with hypertension: serum creatinine >1.5 mg/dL [132 micromol/L] in men and >1.3 mg/dL [115 micromol/L] in women.

Storage:

Requires storage at 25°C (77°F); deviations from 15°C to 30°C (59°F to 86°F) allowed.