Edarbyclor contains a combination of azilsartan and chlorthalidone. Azilsartan is an angiotensin II receptor blocker (sometimes called an ARB).

Chlorthalidone is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Edarbyclor is used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

You should not use Edarbyclor if you are unable to urinate.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Ask your doctor about a blood pressure medication that is safer to use during pregnancy.

If you have diabetes, do not use Edarbyclor together with any medication that contains aliskiren (a blood pressure medicine - e.g. Amturnide, Tekturna, Tekamlo, Valturna).

Before taking this medicine

You should not use Edarbyclor if you are allergic to azilsartan or chlorthalidone, or if you are unable to urinate.

If you have diabetes, do not use Edarbyclor together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking Edarbyclor with aliskiren if you have kidney disease.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver or kidney disease;

• gout;

• an electrolyte imbalance (such as low levels of potassium in your blood);

• heart disease or a stroke; or

• if you are dehydrated.

Do not use Edarbyclor if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

Azilsartan and chlorthalidone can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. However, having high blood pressure during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). Ask your doctor about a blood pressure medication that is safer to use during pregnancy.

You should not breastfeed while you are using this medicine.

Edarbyclor is not approved for use by anyone younger than 18 years old.

Take Edarbyclor exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Edarbyclor with or without food.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store in the original container at room temperature, away from moisture, heat, and light.

Usual Adult Dose for Hypertension:

Initial dose: Azilsartan 40 mg-Chlorthalidone 12.5 mg orally once a day

Maximum dose: Azilsartan 40 mg-Chlorthalidone 25 mg orally once a day

Comments:
-Correct any volume depletion prior to administration, especially in patients with impaired renal function or those on high diuretic doses.
-May increase dose after 2 to 4 weeks as needed to achieve blood pressure goal.
-Patients not controlled with azilsartan 80 mg monotherapy may achieve additional systolic and diastolic blood pressure reduction of 13 and 6 mmHg, respectively, when switched to the initial dose of this drug; patients not controlled with chlorthalidone 25 mg monotherapy may achieve additional systolic and diastolic blood pressure reduction of 10 and 7 mmHg, respectively, when switched to the initial dose of this drug.
-This drug may be used as initial therapy if multiple drugs are likely needed to achieve blood pressure goals.

You should not use Edarbyclor if you are allergic to azilsartan or chlorthalidone, or if you are unable to urinate.

If you have diabetes, do not use Edarbyclor together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking Edarbyclor with aliskiren if you have kidney disease.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver or kidney disease;

• gout;

• an electrolyte imbalance (such as low levels of potassium in your blood);

• heart disease or a stroke; or

• if you are dehydrated.

Do not use Edarbyclor if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

Azilsartan and chlorthalidone can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. However, having high blood pressure during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). Ask your doctor about a blood pressure medication that is safer to use during pregnancy.

You should not breastfeed while you are using this medicine.

Edarbyclor is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction to Edarbyclor: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• feeling like you might pass out;

• little or no urination;

• swelling, weight gain, feeling short of breath; or

• signs of electrolyte imbalance - dry mouth, extreme thirst, weakness, drowsiness, restless feeling, confusion, increased or decreased urination, nausea and vomiting, constipation, muscle pain or weakness, fast heart rate, or seizure (convulsions).

Common Edarbyclor side effects may include:

• dizziness; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• digoxin;

• lithium;

• a diuretic or "water pill"; or

• other heart or blood pressure medicines.

This list is not complete. Other drugs may interact with azilsartan and chlorthalidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.