Azilsartan and chlorthalidone

Name: Azilsartan and chlorthalidone

What should I discuss with my healthcare provider before taking azilsartan and chlorthalidone?

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

If you have diabetes, do not use azilsartan and chlorthalidone together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

You may also need to avoid taking azilsartan and chlorthalidone 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);

  • a history of heart disease or stroke; or

  • if you are dehydrated.

FDA pregnancy category D. Do not use if you are pregnant. Stop using 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. Use effective birth control.

It is not known whether azilsartan and chlorthalidone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine.

Azilsartan and chlorthalidone is not approved for use by anyone younger than 18 years old.

What happens if I overdose?

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

What other drugs will affect azilsartan and chlorthalidone?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with azilsartan and chlorthalidone, 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 interactions are listed in this medication guide.

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.

Renal Dose Adjustments

Mild to moderate renal dysfunction (GFR 30 to 90 mL/min/1.73 m2): No adjustment recommended
Severe renal dysfunction (GFR less than 30 mL/min/1.73 m2)): Unknown

Azilsartan medoxomil / chlorthalidone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown (azilsartan); Yes (chlorthalidone) Excreted into animal milk: Yes (azilsartan) Comments: The effects in the nursing infant are unknown.

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