Azilsartan/chlorthalidone (By mouth)

Introduction

Azilsartan Medoxomil (ay-zil-SAR-tan me-DOX-oh-mil), Chlorthalidone (klor-THAL-i-done)

Treats high blood pressure. A lower blood pressure will reduce the risk of stroke and heart attack. This medicine is a combination of an angiotensin receptor blocker (ARB) and a diuretic or water pill.

Brand Name(s)

Edarbyclor

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.
• Carefully follow your doctor's instructions about any special diet.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

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• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.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 also using digoxin (Lanoxin®), lithium (Eskalith®, Lithobid®), or a diuretic (water pill, such as hydrochlorothiazide [HCTZ], furosemide, torsemide, Demadex®, or Lasix®). Tell your doctor if you are also using an NSAID pain or arthritis medicine, such as aspirin, celecoxib, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Ecotrin®, or Motrin®.
• Make sure your doctor knows if you follow a low-salt diet.

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.
• Tell your doctor if you are breastfeeding, or if you have liver disease, kidney problems, or gout. Make sure your doctor know about any heart disease or problem with circulation, such as congestive heart failure or stoke.
• Tell your doctor if you have low potassium or salt levels in your blood. Tell your doctor if you are dehydrated, or if you have diarrhea, vomiting, or unusual sweating. These conditions may cause your blood pressure to drop.
• Tell your doctor right away if you feel dizzy, faint, or confused, or if you have muscle pain, weakness, or a fast heartbeat. These could be symptoms of low potassium levels.
• Do not stop using this medicine without asking your doctor, even if you feel well. This medicine will not cure your high blood pressure, but it will help lower it and keep it down. You may have to take blood pressure medicine for the rest of your life.
• This medicine may make you feel dizzy, lightheaded, or faint when you stand or sit up suddenly. Move slowly when you stand or sit up. These symptoms are more likely to occur when you first take this medicine, or when the dose is increased. Drink plenty of water if you exercise or if the weather is hot. Heavy sweating can cause dehydration.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.You may need blood and urine tests to check for unwanted effects.

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
• Change in how much or how often you urinate
• Confusion, weakness in hands and feet, uneven heartbeat, or shortness of breath
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Joint pain or swelling
• Lightheadedness, dizziness, or fainting
• Unusual tiredness or weakness

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

• Mild dizziness or lightheadedness
• Mild tiredness

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