Irbesartan/hydrochlorothiazide (By mouth)

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney problems, liver disease (including cirrhosis), asthma, congestive heart failure, diabetes, glaucoma, gout, high cholesterol, or lupus. Tell your doctor if you have an electrolyte imbalance (high or low calcium, potassium, magnesium, or sodium in the blood), or if you are experiencing diarrhea or vomiting. Tell your doctor if you are on dialysis treatment.
• This medicine may make you dizzy, lightheaded, or drowsy, especially when you first begin to use it. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you. If you faint, stop using this medicine and contact your doctor right away.
• Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, a fast heartbeat, severe nausea, vomiting, or diarrhea. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration or electrolyte imbalances (loss of potassium, magnesium, or sodium in the body).
• Stop using this medicine and check with your doctor right away if eye pain, blurred vision, or any other change in vision occurs. Your eyes may need to be checked by an eye doctor.
• Even if you feel well, do not stop using this medicine without asking your doctor. This medicine will not cure your high blood pressure, but it will help keep it in normal range. You may have to take blood pressure medicine for the rest of your life.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Blood in the urine, lower back pain, side pain, or sharp back pain just below the ribs
• Blurred vision and eye pain
• Chest pain
• Confusion, body weakness, and muscle twitching
• Decrease in how much or how often you urinate
• Dry mouth, increased thirst, or muscle cramps
• Fast, slow, pounding, or uneven heartbeat
• Lightheadedness, dizziness, or fainting
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Numbness or tingling in your hands, feet, or lips
• Rapid weight gain
• Swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Dizziness or tiredness
• Muscle or joint pain

Introduction

Hydrochlorothiazide (hye-droe-klor-oh-THYE-a-zide), Irbesartan (ir-be-SAR-tan)

Treats high blood pressure. This medicine is a combination of an angiotensin receptor blocker (ARB) and a diuretic (water pill).

Brand Name(s)

Avalide

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Be sure to drink plenty of fluids if you exercise, sweat more than usual, or have diarrhea or vomiting while you are using this medicine.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using digoxin (Lanoxin®), lithium (Eskalith®, Lithobid®), norepinephrine, a diuretic or water pill (such as amiloride, furosemide, triamterene, Dyazide®, Lasix®, or Maxzide®), other blood pressure medicine (such as atenolol, lisinopril, metoprolol, quinapril, Accupril®, Cozaar®, Diovan®, Lotrel®, Norvasc®, Toprol®, or Zestril®), or a pain or arthritis medicine (such as aspirin, celecoxib, diclofenac, ibuprofen, naproxen, rofecoxib, valdecoxib, Advil®, Aleve®, Bextra®, Celebrex®, Ecotrin®, Motrin®, or Vioxx®).
• Tell your doctor if you are using muscle relaxers (such as tubocurarine), a medicine to lower cholesterol (such as cholestyramine, colestipol, Colestid®, or Questran®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), or insulin or diabetes medicine that you take by mouth (such as glyburide, glipizide, metformin, Actos®, Amaryl®, Avandia®, Glucophage®, Glucotrol®, or Glucovance®).
• Drinking alcohol or taking narcotic pain relievers or sleeping pills with this medicine may intensify feeling lightheaded, dizzy, or faint. Tell your doctor if you drink alcohol or use pain relievers or sleeping pills.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088