Avalide (Irbesartan and HCTZ)

Bristol-Myers Squibb Company

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Angiotensin II Inhibitors with Thiazides Diuretic

High Blood Pressure

This drug is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains two medications: irbesartan and hydrochlorothiazide. Irbesartan is an angiotensin receptor blocker (ARB) and works by relaxing blood vessels so that blood can flow more easily. Hydrochlorothiazide is a "water pill" (diuretic) that causes you to make more urine, which helps your body get rid of extra salt and water. This drug may also be used to treat heart failure.

Take this medication by mouth as directed by your doctor, usually once daily with or without food. If this medication causes you to urinate more frequently, it is best to take it at least 4 hours before your bedtime to prevent having to get up to urinate. If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take irbesartan/hydrochlorothiazide at least 4 hours before or at least 4 to 6 hours after these medications. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

Dizziness, lightheadedness, or upset stomach may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion. Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, decrease in vision, eye pain, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), signs of kidney problems (such as change in the amount of urine). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: aliskiren, dofetilide, lithium, drugs that may increase the level of potassium in the blood (such as ACE inhibitors including benazepril/lisinopril, birth control pills containing drospirenone). Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure or worsen your heart failure. Ask your pharmacist for more details. This medication may interfere with certain laboratory tests (including parathyroid function), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Symptoms of overdose may include: severe dizziness, fainting. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.