Vivanta 50 Tablet: Each film coated tablet contains Sacubitril-Valsartan Sodium Hydrate Complex INN equivalent to Sacubitril 24 mg and Valsartan 26 mg.
Vivanta 100 Tablet: Each film coated tablet contains Sacubitril-Valsartan Sodium Hydrate Complex INN equivalent to Sacubitril 49 mg and Valsartan 51 mg.
Vivanta 200 Tablet: Each film coated tablet contains Sacubitril-Valsartan Sodium Hydrate Complex INN equivalent to Sacubitril 97 mg and Valsartan 103 mg.
Vivanta® (sacubitril and valsartan) is a combination of a nепriysin inhibitor and an angiotensin II receptor blocker. Vivanta® is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan.
Adult Heart Failure
The recommended starting dose of Vivanta® is 49/51 mg orally twice daily. Double the dose of Vivanta® after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
Reduce the starting dose to 24/26 mg twice daily for:
Pediatric Heart Failure
Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.
Table 1: Recommended Dose Titration
Titration Step Dose (twice daily).
Starting.
Second.
Final.
Pediatric Patients Less than 40 kg*.
1.6 mg/kg.
2.3 mg/kg.
3.1 mg/kg.
Pediatric Patients At least 40 kg, less than 50 kg.
24/26 mg.
49/51 mg.
72/78 mg**.
Pediatric Patients At least 50 kg.
49/51 mg.
72/78 mg**.
97/103 mg.
** Doses of 72/78 mg can be achieved using three 24/26 mg tablets.
Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEI, aliskiren in patients.
The most common side effects are Angioedema, Hypotension, impaired Renal Function, Hyperkalemia, Cough, Dizziness.
Vivanta® can cause fetal harm when administered to a pregnant woman.
Lactation: Not recommended during lactation.
Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.
Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥ 65 years) or very elderly (≥ 75 years) patients compared to the overall population.
Hepatic Impairment: No dose adjustment is required when administering Vivanta® to patients with mild hepatic impairment (Child-Pugh A classification). Vivanta® is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.
Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR < 30 ml/min/1.73 m2) is 24/26 mg twice daily.
Vivanta® may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEI or ARB therapy and in patients with hereditary angioedema.
Vivanta® lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt Vivanta® in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.
Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of Vivanta® may be required.