Azilsartan/ chlorthalidone

Generic Name: azilsartan/chlorthalidone (AY-zil-SAR-tan/klor-THAL-i-done)
Brand Name: Edarbyclor

Azilsartan/chlorthalidone may cause injury or death to the fetus if taken while you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are planning to become pregnant, talk with your doctor about other treatment options.


Azilsartan/ chlorthalidone is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Azilsartan/chlorthalidone is an angiotensin II receptor blocker (ARB) and diuretic combination. The ARB works by relaxing blood vessels. The diuretic helps the kidneys to eliminate fluid and sodium from the body. This helps to lower blood pressure.

Do NOT use azilsartan/ chlorthalidone if:

  • you are allergic to any ingredient in azilsartan/chlorthalidone
  • you are pregnant
  • you are unable to urinate
  • you are also taking aliskiren and you have either diabetes or kidney problems
  • you are taking ketanserin

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Newly Approved Weight Loss Drugs: Can They Help You?

Before using azilsartan/ chlorthalidone:

Some medical conditions may interact with azilsartan/chlorthalidone. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness), including after taking any other ARB (eg, valsartan) or an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)
  • if you have a history of heart problems (eg, heart failure), blood vessel problems, blood flow problems, liver problems, diabetes, or kidney problems (eg, renal artery stenosis)
  • if you have a history of a stroke or a recent heart attack
  • if you are dehydrated or have low blood volume
  • if you have electrolyte problems (eg, high or low blood potassium levels, low blood sodium levels), high blood cholesterol levels, gout, vomiting or diarrhea, or are on a low-salt (sodium) diet
  • if you take other medicines for high blood pressure or heart problems

Some MEDICINES MAY INTERACT with azilsartan/chlorthalidone. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased
  • ACE inhibitors (eg, enalapril) or aliskiren because the risk of certain side effects (eg, kidney problems, high blood potassium levels, low blood pressure) may be increased
  • Potassium-sparing diuretics (eg, spironolactone, triamterene) or potassium supplements because the risk of high blood potassium levels may be increased
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin, celecoxib) because they may decrease azilsartan/chlorthalidone's effectiveness and the risk of serious kidney problems may be increased
  • Diazoxide, digitalis glycosides (eg, digoxin), ketanserin, or lithium because the risk of their side effects may be increased by azilsartan/chlorthalidone

This may not be a complete list of all interactions that may occur. Ask your health care provider if azilsartan/chlorthalidone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use azilsartan/ chlorthalidone:

Use azilsartan/chlorthalidone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with azilsartan/chlorthalidone. Talk to your pharmacist if you have questions about this information.
  • Take azilsartan/chlorthalidone by mouth with or without food.
  • Taking azilsartan/chlorthalidone at the same time each day will help you remember to take it.
  • Take azilsartan/chlorthalidone on a regular schedule to get the most benefit from it.
  • Continue to take azilsartan/chlorthalidone even if you feel well. Do not miss any doses.
  • If you miss a dose of azilsartan/chlorthalidone, take the missed dose if you remember the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take more than 1 dose in a day.

Ask your health care provider any questions you may have about how to use azilsartan/chlorthalidone.

Important safety information:

  • Azilsartan/chlorthalidone may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use azilsartan/chlorthalidone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Azilsartan/chlorthalidone may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Report any light-headedness or fainting to your doctor immediately. Your risk of light-headedness or fainting may be increased if you experience diarrhea, vomiting, or excessive sweating, if you do not drink enough fluids, or if you are on a low-salt (sodium) diet.
  • It may take up to 2 to 4 weeks to get the full benefit from azilsartan/chlorthalidone. Do not stop using azilsartan/chlorthalidone or change your dose of azilsartan/chlorthalidone without checking with your doctor.
  • Check with your doctor before you use a salt substitute or a product that has potassium in it.
  • Tell your doctor or dentist that you take azilsartan/chlorthalidone before you receive any medical or dental care, emergency care, or surgery.
  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
  • If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
  • Lab tests, including blood pressure, blood electrolyte levels, and heart or kidney function, may be performed while you use azilsartan/chlorthalidone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use azilsartan/chlorthalidone with caution in the ELDERLY; they may be more sensitive to its effects.
  • Azilsartan/chlorthalidone should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Azilsartan/chlorthalidone may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if azilsartan/chlorthalidone is found in breast milk. Do not breast-feed while taking azilsartan/chlorthalidone.

Possible side effects of azilsartan/ chlorthalidone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; confusion; fast or irregular heartbeat; increased thirst; muscle pain, weakness, or cramping; seizures; severe or persistent constipation, dry mouth, nausea, or vomiting; sluggishness; symptoms of low blood pressure (eg, fainting, severe or persistent dizziness or light-headedness); unusual drowsiness, restlessness, tiredness, or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle aches, cramps, pain, spasms, or weakness; seizures; unusual loss of appetite or vomiting); symptoms of low blood pressure (eg, fainting, severe or persistent dizziness or light-headedness); weakness.

Proper storage of azilsartan/chlorthalidone:

Store azilsartan/chlorthalidone at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store azilsartan/chlorthalidone in its original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep azilsartan/chlorthalidone out of the reach of children and away from pets.

General information:

  • If you have any questions about azilsartan/chlorthalidone, please talk with your doctor, pharmacist, or other health care provider.
  • Azilsartan/chlorthalidone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take azilsartan/chlorthalidone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about azilsartan/chlorthalidone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to azilsartan/chlorthalidone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using azilsartan/chlorthalidone.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web2)