Formulary
Sacubitril with valsartan: Indications, Dosing, Side Effects and Interactions
For sacubitril with valsartan Sacubitril (a prodrug) inhibits the breakdown of natriuretic peptides resulting in varied effects including increased diuresis,...
MedNext Academy | 6 min read
Sacubitril with valsartan: Indications, Dosing, Side Effects and Interactions
For sacubitril with valsartan Sacubitril (a prodrug) inhibits the breakdown of natriuretic peptides resulting in varied effects including increased diuresis,...
Drug action
For sacubitril with valsartan Sacubitril (a prodrug) inhibits the breakdown of natriuretic peptides resulting in varied effects including increased diuresis, natriuresis, and vasodilation.
Indications and dose
**Symptomatic chronic heart failure with reduced ejection fraction [in patients not currently taking an ACE inhibitor or angiotensin II receptor antagonist, or stabilised on low doses of either of these agents]**
- **Adult** (By Mouth): Initially 50 mg twice daily for 3-4 weeks, dose to be given using 24/26 mg strength tablet, increased if tolerated to 100 mg twice daily for 3-4 weeks, dose to be given using 49/51 mg strength tablet, then increased if tolerated to 200 mg twice daily, dose to be given using 97/103 mg strength tablet.
**Symptomatic chronic heart failure with reduced ejection fraction [in patients currently stabilised on an ACE inhibitor or angiotensin II receptor antagonist]**
- **Adult** (By Mouth): Initially 100 mg twice daily for 2-4 weeks, dose to be given using 49/51 mg strength tablet, if systolic blood pressure between 100-110 mmHg consider an initial dose of 50 mg twice daily for 2-4 weeks (dose to be given using 24/26 mg strength tablet), increased to 100 mg twice daily for 2-4 weeks (dose to be given using 49/51 mg strength tablet), then increased if tolerated to 200 mg twice daily, dose to be given using 97/103 mg strength tablet.
**Symptomatic chronic heart failure with left ventricular systolic dysfunction [in patients not currently taking an ACE inhibitor or angiotensin II receptor antagonist, or stabilised on low doses of either of these agents] (dose rounded to the closest combination of full 6/6 mg and/or 15/16 mg strength capsules containing granules) for sacubitril with valsartan**
- **Child 1-17 years (body-weight up to 40 kg)** (By mouth using granules): Initially 0.8 mg/kg twice daily for 3-4 weeks, increased if tolerated to 1.6 mg/kg twice daily (max. per dose 50 mg) for 3-4 weeks, increased if tolerated to 2.3 mg/kg twice daily for 3-4 weeks, then increased if tolerated to 3.1 mg/kg twice daily.
**Symptomatic chronic heart failure with left ventricular systolic dysfunction [in patients not currently taking an ACE inhibitor or angiotensin II receptor antagonist, or stabilised on low doses of either of these agents] for sacubitril with valsartan**
- **Child 1-17 years (body-weight 40-49 kg)** (By mouth): Initially 0.8 mg/kg twice daily for 3-4 weeks, dose rounded to the closest combination of full 6/6 mg or 15/16 mg strength capsules containing granules, increased if tolerated to 50 mg twice daily for 3-4 weeks, dose to be given using 24/26 mg strength tablet, increased if tolerated to 100 mg twice daily for 3-4 weeks, dose to be given using 49/51 mg strength tablet, then increased if tolerated to 150 mg twice daily, dose to be given using 24/26 mg plus 49/51 mg strength tablets.
- **Child 1-17 years (body-weight 50 kg and above)** (By mouth): Initially 50 mg twice daily for 3-4 weeks, dose to be given using 24/26 mg strength tablet, increased if tolerated to 100 mg twice daily for 3-4 weeks, dose to be given using 49/51 mg strength tablet, increased if tolerated to 150 mg twice daily for 3-4 weeks, dose to be given using 24/26 mg plus 49/51 mg strength tablets, then increased if tolerated to 200 mg twice daily, dose to be given using 97/103 mg strength tablet.
**Symptomatic chronic heart failure with left ventricular systolic dysfunction [in patients currently stabilised on an ACE inhibitor or angiotensin II receptor antagonist] (dose rounded to the closest combination of full 6/6 mg or 15/16 mg strength capsules containing granules) for sacubitril with valsartan**
- **Child 1-17 years (body-weight up to 40 kg)** (By mouth using granules): Initially 1.6 mg/kg twice daily (max. per dose 50 mg) for 2-4 weeks, increased if tolerated to 2.3 mg/kg twice daily for 2-4 weeks, then increased if tolerated to 3.1 mg/kg twice daily.
**Symptomatic chronic heart failure with left ventricular systolic dysfunction [in patients currently stabilised on an ACE inhibitor or angiotensin II receptor antagonist] for sacubitril with valsartan**
- **Child 1-17 years (body-weight 40-49 kg)** (By mouth): Initially 50 mg twice daily for 2-4 weeks, dose to be given using 24/26 mg strength tablet, increased if tolerated to 100 mg twice daily for 2-4 weeks, dose to be given using 49/51 mg strength tablet, then increased if tolerated to 150 mg twice daily, dose to be given using 24/26 mg plus 49/51 mg strength tablets.
- **Child 1-17 years (body-weight 50 kg and above)** (By mouth): Initially 100 mg twice daily for 2-4 weeks, dose to be given using 49/51 mg strength tablet, increased if tolerated to 150 mg twice daily for 2-4 weeks, dose to be given using 24/26 mg plus 49/51 mg strength tablets, then increased if tolerated to 200 mg twice daily, dose to be given using 97/103 mg strength tablet.
Cautions
For sacubitril with valsartan Serum-potassium concentration above 5.4 mmol/litre (do not initiate-may increase risk of hyperkalaemia); systolic BP less than 100 mmHg (do not initiate-limited data available)
Contraindications
For sacubitril with valsartan Concomitant use with an ACE inhibitor (risk of angioedema-do not initiate until at least 36 hours after the last dose when switching treatment); concomitant use with an angiotensin II receptor antagonist; hereditary or idiopathic angioedema; known history of angioedema related to previous ACE inhibitor or angiotensin II receptor antagonist
Side effects
For sacubitril with valsartan Common or very common Anaemia; asthenia; cough; diarrhoea; dizziness; electrolyte imbalance; gastritis; headache; hypoglycaemia; hypotension; nausea; renal impairment; syncope; vertigo Uncommon Angioedema; skin reactions Rare or very rare Hallucinations; paranoia; sleep disorder Frequency not known Psychiatric disorder
Pregnancy
For sacubitril with valsartan Avoid-toxicity with sacubitril in animal studies. M
Breast feeding
For sacubitril with valsartan Avoid-present in milk in animal studies. M
Hepatic impairment
For sacubitril with valsartan Caution in moderate impairment or if hepatic transaminases exceed 2 times the upper limit of normal (limited information available); avoid in severe impairment, biliary cirrhosis, or cholestasis (no information available). M Dose adjustments Start with 50 mg twice daily (dose to be given using 24/26 mg strength tablet) in moderate impairment or if hepatic transaminases exceed 2 times the upper limit of normal. M
Renal impairment
For sacubitril with valsartan Caution (increased risk of hypotension; limited information available in severe impairment); avoid in end-stage renal disease (no information available). M Dose adjustments Start with 50 mg twice daily (dose to be given using 24/26 mg strength tablet) if eGFR less than 30 mL/minute/1.73m 2 . Also consider this starting dose if eGFR 30-60 mL/minute/1.73m 2 . M See Prescribing in renal impairment .
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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