What is Avalide (Hydrochlorothiazide Irbesartan)?

What is the most important information I should know about Avalide (Hydrochlorothiazide Irbesartan)?

You should not use this medication if you are allergic to irbesartan or Enzyte hydrochlorothiazide (Carozide, Diaqua, Ezide HCTZ, HydroDiuril, Microzide, and others), or if you are unable to urinate.

Do not use this medication without telling your doctor if you are pregnant. Hydrochlorothiazide and irbesartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of hydrochlorothiazide and irbesartan.

In rare cases, hydrochlorothiazide and irbesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

What should I discuss with my healthcare provider before taking Avalide (Hydrochlorothiazide Irbesartan)?

You should not use this medication if you are allergic to irbesartan or hydrochlorothiazide (Carozide, Diaqua, Ezide HCTZ, HydroDiuril, Microzide, and others), or if you are unable to urinate.

Before using hydrochlorothiazide and irbesartan, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease
• liver disease
• congestive heart failure
• low or high levels of potassium in your blood
• asthma or allergies
• high cholesterol or triglyceride levels
• gout
• lupus
• diabetes; or
• an allergy to sulfa drugs

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Hydrochlorothiazide and irbesartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Do not use hydrochlorothiazide and irbesartan without your doctor's consent if you are pregnant. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

It is not known whether hydrochlorothiazide and irbesartan passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

What are the possible side effects of Avalide (Hydrochlorothiazide Irbesartan)?

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

In rare cases, hydrochlorothiazide and irbesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any other serious side effects, such as:

• feeling like you might pass out
• chest pain, feeling short of breath, even with mild exertion
• fever
• swelling, rapid weight gain
• urinating more or less than usual, or not at all
• jaundice (yellowing of the skin or eyes); or
• dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, feeling light-headed, fainting, or seizure (convulsions)

Less serious side effects may include:

• stomach pain, heartburn
• muscle pain
• dizziness, drowsiness
• headache
• runny or stuffy nose, sore throat; or
• dry cough

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.