Azilsartan

Azilsartan is a prescription medication used to treat the symptoms of high blood pressure (hypertension). 

• Azilsartan is available under the following different brand names: Edarbi

Common side effects of Azilsartan include:

• Diarrhea

Serious side effects of Azilsartan include:

• Painful or difficult urination,
• Little or no urination,
• Feeling tired,
• Shortness of breath,
• Lightheadedness, and
• Swelling in the feet or ankles

Rare side effects of Azilsartan include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 40 mg
• 80 mg

Hypertension

Adult and geriatric dosage

• 80 mg orally once a day
• Coadministration with high-dose diuretics: 40 mg orally once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Azilsartan has severe interactions with the following drug:
  • Aliskiren
• Azilsartan has serious interactions with the following drugs:
  • Benazepril
  • Captopril
  • Enalapril
  • Fosinopril
  • Lisinopril
  • Lithium
  • Lofexidine
  • Moexipril
  • Perindopril
  • Potassium phosphates, iv
  • Quinapril
  • Ramipril
  • Trandolapril
• Azilsartan has moderate interactions with at least 61 other drugs.
• Azilsartan has minor interactions with the following drug:
  • Entecavir

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Do not coadminister with aliskiren in patients with diabetes 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Azilsartan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Azilsartan?”

Cautions

• Abnormally high serum creatinine values are more likely reported in patients aged 75 or older
• Caution with hyperkalemia
• NSAIDs may attenuate the antihypertensive response
• Coadministration with NSAIDs increases the risk of renal impairment including acute renal failure
• Hypotension in volume- or salt-depleted patients
• In patients with an activated renin-angiotensin system, such as volume and/or salt-depleted patients (. g, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment
• Correct volume or salt depletion before administration of therapy, or start treatment at 40 mg
• If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline
• Transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized
• Impaired renal function
  • Because of inhibiting the renin-angiotensin system, changes in renal function may be anticipated in susceptible individuals receiving therapy
  • In patients whose renal function may depend on the activity of the renin-angiotensin system (. g, patients with severe congestive heart failure, renal artery stenosis, or volume depletion)
  • Treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death
  • In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported; there has been no long-term use of the drug in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected
• Drug interaction overview
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or who have compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, may result in deterioration of renal function, including possible acute renal failure; these effects are usually reversible
  • Monitor renal function periodically in patients receiving azilsartan and NSAID therapy; the antihypertensive effect of angiotensin II receptor antagonists may be attenuated by NSAIDs, including selective COX-2 inhibitors
  • Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy
  • Most patients receiving a combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy; in general, avoid combined use of RAS inhibitors; closely monitor blood pressure, renal function, and electrolytes in patients receiving therapy and other agents that affect the RAS
  • Do not coadminister aliskiren with azilsartan in patients with diabetes; avoid the use of aliskiren with azilsartan in patients with renal impairment (GFR below 60 mL/min)
• Pregnancy and Lactation
• Use with caution if benefits outweigh risks. (1st trimester); use in LIFE-THREATENING emergencies when no safer drug available (2nd and 3rd trimesters)
• Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death.
• Lactation
  • Unknown whether distributed in breast milk, decide on alternate antihypertensive therapy or do not breastfeed.