Azilsartan and chlorthalidone

Azilsartan is an angiotensin II receptor antagonist. Azilsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Chlorthalidone is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Azilsartan and chlorthalidone is a combination medicine used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Azilsartan and chlorthalidone may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Hypertension:

Initial dose: Azilsartan 40 mg-Chlorthalidone 12.5 mg orally once a day

Maximum dose: Azilsartan 40 mg-Chlorthalidone 25 mg orally once a day

Comments:
-Correct any volume depletion prior to administration, especially in patients with impaired renal function or those on high diuretic doses.
-May increase dose after 2 to 4 weeks as needed to achieve blood pressure goal.
-Patients not controlled with azilsartan 80 mg monotherapy may achieve additional systolic and diastolic blood pressure reduction of 13 and 6 mmHg, respectively, when switched to the initial dose of this drug; patients not controlled with chlorthalidone 25 mg monotherapy may achieve additional systolic and diastolic blood pressure reduction of 10 and 7 mmHg, respectively, when switched to the initial dose of this drug.
-This drug may be used as initial therapy if multiple drugs are likely needed to achieve blood pressure goals.

Azilsartan and chlorthalidone combination is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Azilsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, azilsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Chlorthalidone is a thiazide-like diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

azilsartan and chlorthalidone is available only with your doctor's prescription.

In addition to the use of azilsartan and chlorthalidone, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any symptoms of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that azilsartan and chlorthalidone will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take azilsartan and chlorthalidone with or without food.

azilsartan and chlorthalidone comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Dosing

The dose of azilsartan and chlorthalidone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of azilsartan and chlorthalidone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—One tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 milligrams (mg) of azilsartan and 25 mg of chlorthalidone.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of azilsartan and chlorthalidone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect the medicine from light and moisture. Keep your medicine in the original container until you are ready to use it.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• confusion
• convulsions
• decreased urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fainting
• increased thirst
• irregular heartbeat
• loss of appetite
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• shortness of breath
• sweating
• unusual tiredness or weakness

• Ankle, knee, or great toe joint pain
• joint stiffness or swelling
• lower back, side, or stomach pain
• swelling of the feet or lower legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dizziness

• Cough
• diarrhea
• lack or loss of strength
• muscle spasm

• Headache
• loss of appetite
• rash
• stomach cramps

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• If you have an allergy to azilsartan, chlorthalidone, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are not able to pass urine.
• If you are taking a drug that has aliskiren in it and you also have high blood sugar (diabetes) or kidney problems. Check with your doctor or pharmacist if you are not sure if a drug you take has aliskiren in it.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with azilsartan and chlorthalidone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take azilsartan and chlorthalidone. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Talk with your doctor before you drink alcohol.
• It may take a few weeks to see the full effect.
• Have your blood pressure checked often. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with azilsartan and chlorthalidone.
• If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• Watch for gout attacks.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.

Applies to azilsartan medoxomil / chlorthalidone: oral tablet

Along with its needed effects, azilsartan medoxomil / chlorthalidone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking azilsartan medoxomil / chlorthalidone:

• Blurred vision
• confusion
• convulsions
• decreased urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fainting
• increased thirst
• irregular heartbeat
• loss of appetite
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• shortness of breath
• sweating
• unusual tiredness or weakness

• Ankle, knee, or great toe joint pain
• joint stiffness or swelling
• lower back, side, or stomach pain
• swelling of the feet or lower legs

Some side effects of azilsartan medoxomil / chlorthalidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dizziness

• Cough
• diarrhea
• lack or loss of strength
• muscle spasm

• Headache
• loss of appetite
• rash
• stomach cramps