Olmesartan is an angiotensin II receptor blocker (sometimes called an ARB).

Olmesartan is used to treat high blood pressure (hypertension) in adults and children at least 6 years old. It is sometimes given together with other blood pressure medications.

Olmesartan may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Stop using olmesartan and tell your doctor right away if you become pregnant.

If you have diabetes, do not take olmesartan with any medication that contains aliskiren (a blood pressure medicine).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take olmesartan with or without food.

For a child who cannot swallow a tablet whole, a pharmacist can mix the medicine into a liquid.

Shake the liquid before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Olmesartan doses are based on weight in children and/or teenagers. Your child's dose needs may change if the child gains or loses weight.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking olmesartan.

It may take up to 2 weeks before your blood pressure is under control. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms.

You may need to use blood pressure medicine for the rest of your life. Treatment may also include diet, exercise, lowering cholesterol, not smoking, and controlling diabetes.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

Store tablets at room temperature away from moisture and heat.

Store the liquid in a refrigerator. Throw away any liquid leftover after 4 weeks.

Usual Adult Dose for Hypertension:

20 mg orally once a day; may increase dose to 40 mg in two weeks if further blood pressure reduction is needed.

Maximum dose: 40 mg orally once a day

Comments:
-For patients with possible intravascular volume depletion (e.g., patients treated with diuretics, especially those with impaired renal function), initiate this drug under close supervision and give consideration to a lower starting dose.
-Twice daily dosing offers no additional benefit over the same total dose give once daily.

Usual Pediatric Dose for Hypertension:

6 to 16 years:
-20 to less than 35 kg: 10 mg orally once a day; may increase dose to 20 mg in two weeks if further blood pressure reduction is needed
-35 kg or more: 20 mg orally once a day; may increase dose to 40 mg in two weeks if further blood pressure reduction is needed

Comments:
-For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension.

You should not take olmesartan if you are allergic to it.

If you have diabetes, do not use olmesartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking olmesartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• a heart condition other than one being treated with olmesartan;

• kidney disease; or

• if you are on a low salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

If you plan to get pregnant, ask your doctor for a safer medicine to use before and during pregnancy. Having high blood pressure during pregnancy may cause complications in the mother and the baby.

You should not breastfeed while using olmesartan.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fast heartbeats or fainting.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Olmesartan may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urination;

• severe diarrhea and weight loss; or

• high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects of olmesartan may include:

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you take colesevelam, take your olmesartan dose 4 hours before you take colesevelam.

Tell your doctor about all your other medicines, especially:

• lithium;

• a diuretic (water pill) or other medicines that lower blood pressure; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect olmesartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to olmesartan.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Azor® (containing Amlodipine, Olmesartan)
• Tribenzor® (containing Amlodipine, Hydrochlorothiazide, Olmesartan)