IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
IRBESARTAN/HYDROCHLOROTHIAZIDE – ORAL
COMMON BRAND NAME(S): Avalide
WARNING: This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately.
USES: 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 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.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to treat heart failure and to help protect the kidneys from damage due to diabetes.
HOW TO USE: 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.
The dosage is based on your medical condition and response to treatment.
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.
Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings increase).
SIDE EFFECTS: 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.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
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, decreased urination.
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).
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.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to irbesartan or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, liver disease, lupus, severe loss of body water and minerals (volume depletion, dehydration).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged diarrhea or vomiting to your doctor. To prevent dehydration, drink plenty of fluids unless your doctor directs you otherwise.
If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
This product may affect your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the effects of this drug, especially dizziness, kidney effects.
This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)
It is unknown if irbesartan passes into breast milk. Hydrochlorothiazide passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use and Precautions sections.
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, lithium, drugs that may increase the level of potassium in the blood (such as 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.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting.
NOTES: Do not share this medication with others.
Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.
Laboratory and/or medical tests (such as kidney function, potassium levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Check your blood pressure regularly while taking this medication. Learn how to monitor your own blood pressure, and share the results with your doctor.
MISSED DOSE: 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.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.