Medical Description
Angiotensin II receptor blocker and neprilysin inhibitor combination therapy used in the treatment of heart failure with reduced ejection fraction.
Indication & Usage
-Heart failure with reduced ejection fraction: In case of patients previously taking a moderate to high dose of an ACE inhibitor (eg, >10 mg/day of enalapril or equivalent) or ARB (eg, >160 mg/day of valsartan or equivalent): Oral: Initial: Sacubitril 49 mg/valsartan 51 mg twice daily. Double the dose as tolerated after approximately 2 weeks to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg twice daily. While in case of patients previously taking a low dose of an ACE inhibitor (eg, ≤10 mg/day of enalapril or equivalent) or ARB (eg, ≤160 mg/day of valsartan or equivalent): Oral: Initial: Sacubitril 24 mg/valsartan 26 mg twice daily. Double the dose as tolerated in approximately 2-week intervals to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg twice daily. While in case of patients not currently taking an ACE inhibitor or an ARB: Oral: Initial: Sacubitril 24 mg/valsartan 26 mg twice daily. Double the dose as tolerated in approximately 2-week intervals to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg twice daily.
-Heart failure with preserved ejection fraction: Oral: Initial: Sacubitril 24 mg/valsartan 26 mg twice daily or sacubitril 49 mg/valsartan 51 mg twice daily, depending on baseline BP. Double the dose as tolerated after approximately 2 weeks to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg twice daily.
Active Ingredients
ValsartanSacubitril
Dosage & Administration
Administer with or without food.
Side Effects
-Dizziness, increased blood urea nitrogen, hypotension, orthostatic hypotension, syncope, hyperkalemia, abdominal pain, diarrhea, nausea, upper abdominal pain, neutropenia, viral infection, fatigue, headache, orthostatic dizziness, vertigo, arthralgia, back pain, angioedema, blurred vision, increased serum creatinine, renal insufficiency and dry cough.
Safety Advice
-Should not be given to patients suffering from hypersensitivity to sacubitril or valsartan.
-During the initiation of therapy, hypotension may occur, especially in patients who are salt- or volume-depleted.
-May be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow.
-Use with caution in patients with significant aortic/mitral stenosis.
-Use with caution and reduce dosage in patients with moderate hepatic impairment; use is not recommended in patients with severe hepatic impairment.
-Use with caution in patients with unstented unilateral/bilateral renal artery stenosis.
-Avoid salt substitutes which contain potassium.
-In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
Storage
Store at room temperature.
Drug Interactions
-Alfuzosin: May enhance the hypotensive effect of blood pressure lowering agents.
-Antipsychotic Agents (Second Generation [Atypical]): blood pressure lowering Agents may enhance the hypotensive effect of Antipsychotic Agents.
-Dapoxetine: May enhance the orthostatic hypotensive effect of Angiotensin II Receptor Blockers.
-Duloxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Duloxetine.
-Heparin: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers.
-Levodopa-containing products: Blood Pressure Lowering Agents may enhance the hypotensive effect of levodopa-containing products.
-Lithium: Angiotensin II Receptor Blockers may increase the serum concentration of Lithium.
-Nicorandil: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers.
-Nonsteroidal anti-inflammatory agents: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of nonsteroidal anti-inflammatory agents.
-Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of blood pressure lowering agents.
-Potassium Salts: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers.
-Potassium-Sparing Diuretics: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Potassium-Sparing Diuretics.
-Trimethoprim: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers.
Pregnancy & Lactation
-Drugs that act directly on the renin-angiotensin system can cause injury to the developing fetus.
-It is not known if sacubitril or valsartan is present in breast milk. Due to the potential for serious adverse reactions in the breastfeeding infant, breastfeeding is not recommended during the treatment.
-Ask your physician before taking any medication during pregnancy or lactation.