Adult Dosing
Hypertension
- Recommended dose: 80 mg PO qd
- Start with 40 mg PO qd for patients receiving high dose diuretics
Heart failure (Non-FDA Approved)
- Note that similar dosing to that used for hypertension is typically used for this indication
Note:
- May be administered with other anti-hypertensive agents, if blood pressure is not controlled by azilsartan alone
- Take with or without food
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Drugs that act directly on the renin-angiotensin system may be associated with fetal and neonatal morbidity and death when used during the second and third trimesters of pregnancy. Potential neonatal adverse reactions include hypotension, skull hypoplasia, anuria, renal failure, and death. Discontinue therapy as soon as the pregnancy is detected during therapy [US Black Box Warning]
- Closely monitor infants with histories of in utero exposure to azilsartan for hypotension, oliguria, and hyperkalemia; support blood pressure and renal function if oliguria or hypotension occurs
- Oligohydramnios associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development may occur with azilsartan use during second and third trimesters of pregnancy
- Closely observe infants with histories of in utero exposure to an angiotensin II receptor antagonist for hypotension, oliguria, and hyperkalemia
- Symptomatic hypotension may occur after administration of azilsartan, especially in volume- or salt-depleted patients. Correct volume or salt depletion prior to therapy initiation or initiate therapy at 40 mg. Place the patient in supine position and, if indicated, give IV infusion of normal saline if hypotension occurs
- In patients whose renal function may depend upon the activity of the renin-angiotensin system (e.g., severe CHF, renal artery stenosis, or volume depletion), therapy may be associated with oliguria or progressive azotemia and rarely with acute renal failure and death
- Increase in serum creatinine or blood urea nitrogen (BUN) have been reported during therapy in patients with unilateral or bilateral renal artery stenosis
Cautions: Use cautiously in
- Renal artery stenosis
- Volume depletion
- Hyponatremia
- Congestive heart failure
Supplemental Patient Information
- Advise female patients of childbearing age about the consequences of exposure to azilsartan during pregnancy; inform these patients to promptly report pregnancies to their physicians as soon as possible
- Discuss other treatment options with female patients planning to become pregnant
Pregnancy Category:D
Breastfeeding: Safety unknown. An alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 August 2011). According to the manufacturer's data, due to the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Edarbi 40 MG TABS [Bottle] (TAKEDA PHARMACEUTICALS)
30 mg = $85.99
90 mg = $239.97 - Edarbi 80 MG TABS [Bottle] (TAKEDA PHARMACEUTICALS)
30 mg = $89.99
90 mg = $247.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
