BOXED WARNING Fetal toxicity — discontinue as soon as pregnancy is detected; RAAS-acting drugs can injure and kill the developing fetus.
FDA dosing
Population
Start
Target
Max
Hypertension
Adult
10 mg QD (5 mg QD if on a diuretic)
20-40 mg/day (QD or two divided doses)
80 mg/day
Hypertension
Peds ≥6 y, GFR >30 mL/min/1.73m²
0.2 mg/kg QD
titrate to effect
0.6 mg/kg QD (≤40 mg)
Renal Initiate 5 mg QD if GFR <30 mL/min/1.73m² (or hemodialysis); no adjustment if CrCl >30
Hepatic Undefined
Instructions
Take once daily or in two divided doses
Discontinue as soon as pregnancy is detected
Do not use within 36 h of switching to/from sacubitril/valsartan
Oral suspension (2 mg/mL) may be compounded from tablets
Contraindications
History of angioedema (hereditary, idiopathic, or prior ACE inhibitor-related)
Concomitant use with a neprilysin inhibitor (e.g., sacubitril); do not use within 36 h of sacubitril/valsartan
Co-administration with aliskiren in patients with diabetes
Cautions
Fetal toxicity — discontinue when pregnancy detected (boxed)
Angioedema (head/neck and intestinal); higher rate in Black patients; anaphylactoid reactions during desensitization, dialysis with high-flux membranes, or LDL apheresis
Impaired renal function/acute renal failure in RAAS-dependent patients
Symptomatic hypotension; hyperkalemia; hepatic failure (cholestatic jaundice progressing to necrosis)
Adverse reactions
Headache (6%)
Dizziness (4%)
Somnolence, postural dizziness (2%)
Cough
Fatigue
Pregnancy Can cause fetal harm (RAAS effects: oligohydramnios, renal failure, death); discontinue when pregnancy detected
Lactation Minimal amounts in breast milk (<0.1% of maternal dose)
⚠ BOXED WARNING
Fetal toxicity; discontinue as soon as pregnancy is detected