BOXED WARNING Fetal toxicity — discontinue as soon as pregnancy is detected; drugs acting on the renin-angiotensin system can cause fetal injury and death.
FDA dosing
Population
Start
Target
Max
Hypertension
Adults
80–160 mg QD
80–320 mg QD
320 mg QD
Hypertension
Peds 1–16 y
1 mg/kg QD (up to 40 mg)
1–4 mg/kg QD (up to 160 mg)
160 mg QD
Heart failure
Adults
40 mg BID
40–160 mg BID
160 mg BID
Post-myocardial infarction
Adults
20 mg BID
20–160 mg BID
160 mg BID
Renal Undefined
Hepatic Undefined
Instructions
Tablets and oral suspension are not substitutable mg-per-mg (suspension AUC ~60% higher); do not combine dosage forms
Oral suspension recommended for peds 1–5 y and those who cannot swallow tablets
Contraindications
Concomitant aliskiren in patients with diabetes
Cautions
Hypotension (volume-/salt-depleted patients)
Impaired renal function/acute renal failure
Hyperkalemia (monitor potassium)
Adverse reactions
Headache
Dizziness
Viral infection
Fatigue
Abdominal pain
Hypotension, diarrhea, arthralgia, back pain, hyperkalemia (heart failure)
Pregnancy Can cause fetal harm; discontinue as soon as pregnancy is detected.
Lactation Breastfeeding is not recommended.
⚠ BOXED WARNING
Fetal toxicity; discontinue as soon as pregnancy is detected
Principal riskHyperkalemia and acute kidney injury