Azilsartan

Class
Antihypertensives
Subclass
Angiotensin receptor blockers
Substance name
Azilsartan kamedoxomil
Brand names
Edarbi®
Common formulations
Tablet
Contained in
Azilsartan / chlorthalidone (Edarbyclor®)
Dosage and administration
Adults patients
Treatment of hypertension
•
80 mg PO daily
Consider starting at 40 mg in patients taking high doses of diuretics.
Indications for use
Labeled indications
Adults
•
Treatment of hypertension
Safety risks
Boxed warnings
Fetal toxicity
•
Do not use in pregnant patients. Discontinue azilsartan as soon as possible when pregnancy is detected.
Contraindications
Hypersensitivity to azilsartan or its components
Concomitant use of aliskiren in patients with diabetes
Warnings and precautions
Hypotension
•
Use caution in patients with volume or salt depletion.
Renal failure
•
Use caution in patients with renal artery stenosis, renal impairment, CKD, severe congestive HF, or volume depletion.
Specific populations
Renal impairment
CrCl 0-90 mL/min
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Continuous renal replacement
•
Use acceptable. No dose adjustment required.
Intermittent hemodialysis
•
Use acceptable. No dose adjustment required.
Peritoneal dialysis
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Do not use. Evidence of fetal harm in humans. Discontinue azilsartan when pregnancy is detected.
•
Use of RAAS inhibitors during the second and third trimesters can cause reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia, and skeletal deformations, including skull hypoplasia, hypotension, and death.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Diarrhea
Uncommon < 1%
•
Angioedema, ↑ WBC count, anemia, skin rash, pruritus, ↓ platelet count, nausea, muscle cramps, asthenia, dizziness, cough, fatigue
Unknown frequency
•
Hypotension, orthostatic hypotension, ↑ serum creatinine, ↑ BUN, renal failure
Interactions
Drug(s)
Check Interactions
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