Information about ARNI
Strength 24/26mg film coated tablets:
Each film-coated tablet contains: 24.3 mg sacubitril and 25.7 mg valsartan (assacubitril valsartan sodium salt complex).
Strength 49/51mg film coated tablets:
Each film-coated tablet contains: 48.6 mg sacubitril and 51.4 mg valsartan(assacubitril valsartan sodium salt complex).
Strength 97/103mg film coated tablets:
Each film-coated tablet contains: 97.2 mg sacubitril and 102.8 mg valsartan (assacubitril valsartan sodium salt complex).
Mechanism of action
This product exhibits the mechanism of action by simultaneously inhibiting neprilysin (neutral endopeptidase: NEP ) via LBQ657. The active metabolite of the prodrugsacubitril, and by blocking the angiotensin Π type-1 (AT1) receptor viavalsartan which is also inhibits angiotensin II – dependent aldosterone release.
It is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction and it reduce the risk of cardiovascular death and hospitalization for heart failure patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
DOSAGE AND ADMINISTRATION:
It may be administrated with or without food. The tablets must be swallowed with a glass of water
The recommended starting dose is one tablet of 49/51 mg twice-daily, except in the situations described below
The dose should be doubled at 2-4 weeks to the target dose of one tablet of 97/103 mg twice-daily, as tolerated by the patient
If Patients experience tolerability issue(systolic blood pressure [SBP] ≤ 95mmHg, symptomatic hypotension, hyperkalemia,renal dysfunction), adjustment of concomitant medicinal product, temporary down-titration or discontinuation of the drug is recommended.
There is limited experience in patients not currently taking an ACE inhibitor or an ARB or taking low doses of these medicinal products, therefore a Starting dose of 24 mg/26mg twice daily and slow dose titration (doubling every 3-4 weeks) are recommended in these patients.
Treatment should not be initated in patients with serum potassium level > 5,4 mmol/l or with SBP < 100 mm Hg. A starting dose of 24 mg / 26 mg twice daily should be considered for patients with SBP≥ 100 to 110 mmHg.
If a dose is missed, the patient should take the next dose at the scheduled time.
Use in Elderly patients: The dose should be in line with the renal function of the elderly patient
carton pack of 30 film coated tablets.