Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

IRBESARTAN W/ HYDROCHLOROTHIAZIDE - ORAL

(ir-be-SAR-tan WITH HI-dro-klor-oh-THIGH-uh-zide)

COMMON BRAND NAME(S): Avalide

WARNING: This drug can cause serious fetal harm (possibly death) if used during the last six months of pregnancy. If you become pregnant or think you may be pregnant, contact your doctor immediately.

Uses

This drug is used to treat high blood pressure (hypertension). This medication is a combination of two drugs (an angiotensin receptor blocker and a thiazide "water pill"/diuretic). Irbesartan blocks the hormone angiotensin thereby relaxing blood vessels, causing them to widen. The thiazide diuretic increases the amount of urine you make, therefore decreasing excess water and salt in your body. High blood pressure reduction helps prevent strokes, heart attacks, and kidney problems.

OTHER

Uses

This drug may also be used to treat congestive heart failure and to help protect the kidneys from damage due to diabetes.

How To Use

Take this medication by mouth, usually once daily or as directed by your doctor. You may take this drug with or without food. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Drink adequate fluids to prevent from becoming dehydrated. If you are on restricted fluid intake, consult your doctor for further instructions. Do not take potassium supplements or salt substitutes containing potassium without talking to your doctor or pharmacist first. This medicine can infrequently raise or lower your potassium blood levels, which rarely can cause serious side effects such as muscle weakness/cramping or very slow heartbeats. Tell your doctor immediately if these effects occur. The dosage is based on your medical condition and response to therapy. For the treatment of high blood pressure, it may take 2-4 weeks before the full benefit of this drug occurs. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. If you are also taking cholestyramine or colestipol, take irbesartan/hydrochlorothiazide at least 2 hours before either of these drugs.

Side Effects

You may experience dizziness, lightheadedness, blurred vision, stomach upset, or heartburn as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual thirst, weakness, confusion, fast heartbeat, chest pain, fainting, decreased sexual ability. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: unusual change in the amount of urine (after the first several days of starting this drug), seizures, stomach/abdominal pain, severe nausea, yellowing eyes or skin, dark urine, unusual fatigue. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling (especially of the face, lips, tongue, or throat), severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: urinary problems (inability to make urine or anuria). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, heart problems, severe loss of body fluids (dehydration through excessive sweating, vomiting, or diarrhea), mineral/electrolyte problems (e.g., imbalance of sodium, potassium, magnesium, calcium), diabetes, gout, lupus, high levels of fats in the blood (high cholesterol or triglycerides), asthma, any allergies (especially to sulfa drugs or ACE inhibitors such as captopril, lisinopril). This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Before having surgery, tell your doctor or dentist that you are taking this medication. Hydrochlorothiazide may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the dizziness effect. This medication should be used only when clearly needed during the first three months of pregnancy. It is not recommended for use during the last six months of the pregnancy due to the risk for fetal harm. Discuss the risks and benefits with your doctor. See also the Warning section. Hydrochlorothiazide passes into breast milk. Breast-feeding is not recommended due to the potential harm to the nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

This drug should not be used with the following medications because very serious interactions may occur: cisapride, dofetilide. If you are currently using any of these medications, tell your doctor or pharmacist before starting irbesartan/hydrochlorothiazide. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: ACE inhibitors (e.g., captopril, lisinopril), antidiabetic drugs (e.g., insulin, glipizide), beta-blockers (e.g., atenolol, metoprolol), cholestyramine, colestipol, corticosteroids (e.g., prednisone), diazoxide, drugs which can increase dizziness (e.g., phenobarbital, narcotic analgesics), drugs which are affected by the acid level in the urine (e.g., amphetamine, methenamine, quinidine), other heart drugs (e.g., digoxin), other high blood pressure medications, lithium, non-steroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin), potassium supplements (e.g., potassium chloride) or salt substitutes, probenecid. Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include unusually fast or slow heartbeat, severe dizziness or 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 (e.g., kidney function, potassium blood level) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home. Discuss this 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 between 59 and 86 degrees F (15 to 30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).