Edarbi

Edarbi

Generic Name: azilsartan medoxomil

Date of Approval: February 25, 2011

Company: Takeda Pharmaceuticals America, Inc.

Treatment for: Hypertension

FDA Approves Edarbi

The U.S. Food and Drug Administration has approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.

Edarbi is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.

Edarbi Patient Information

Read this Patient Information leaflet before you start taking Edarbi and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

Important information about Edarbi

Taking Edarbi during your second and third trimester can cause harm and even death to your unborn baby. If you think that you are pregnant, stop taking Edarbi and tell your doctor right away. If you plan to become pregnant, talk to your doctor about other ways to lower your blood pressure.

What is Edarbi?

Edarbi is a prescription medicine called an angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension) in adults.

Your doctor may prescribe other medicines for you to take along with Edarbi to treat your high blood pressure.

It is not known if Edarbi is safe and effective in children under 18 years of age.

Before taking Edarbi

Before you take Edarbi, tell your doctor if you:

have been told that you have abnormal body salt (electrolytes) levels in your blood

are pregnant or plan to become pregnant

are breastfeeding or plan to breastfeed. It is not known if Edarbi passes into your breast milk. You and your doctor should decide if you will take Edarbi or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Edarbi.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

other medicines used to treat your high blood pressure or heart problem

water pills (diuretic)

Ask your doctor if you are not sure if you are taking a medicine listed above.

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I take Edarbi?

Your doctor will tell you how much Edarbi to take and when to take it. Follow his/her instructions.

Edarbi can be taken with or without food.

If you take too much Edarbi, call your doctor, or go to the nearest hospital emergency room right away.

Edarbi side effects

Edarbi may cause side effects, including:

Harm or death to your unborn fetus if taken in the second or third trimester.

Low blood pressure (hypotension) and dizziness is most likely to happen if you also:

take water pills (diuretics)

are on a low-salt diet

take other medicines that affect your blood pressure

get sick with vomiting or diarrhea

do not drink enough fluids

If you feel faint or dizzy, lie down and call your doctor right away.

These are not all the possible side effects with Edarbi. Tell your doctor if you have any side effect that bothers you or that does not go away.

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

See also: Edarbi side effects (in more detail)

How do I store Edarbi?

Store Edarbi at 59°F to 86°F (15°C to 30°C).

Store Edarbi in the original container that you received from your pharmacist or doctor. Do not put Edarbi into a different container.

Keep Edarbi in a tightly closed container, and keep Edarbi out of the light.

Keep Edarbi and all medicines out of the reach of children.

General information about Edarbi

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not give Edarbi to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Edarbi. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Edarbi that is written for health professionals.

For more information, go to www.edarbi.com or call 1-877-825-3327.

What is high blood pressure (hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great.

High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. Edarbi tablets can help your blood vessels relax so your blood pressure is lower.

Medicines that lower your blood pressure may lower your chance of having a stroke or heart attack.

What are the ingredients in Edarbi?

Active ingredient: azilsartan medoxomil

Inactive ingredients: mannitol, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.