| IMPORTANT WARNING:
| IMPORTANT WARNING
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
- Azor®(as a combination product containing Amlodipine, Olmesartan)
- Tribenzor®(as a combination product containing Amlodipine, Hydrochlorothiazide, Olmesartan)
[Posted 06/24/2014]ISSUE:FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients (see previous alerts linked below). FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.
BACKGROUND:FDA safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients.
RECOMMENDATION:Patients should not stop taking olmesartan or any blood pressure medication without first discussing it with their health care professional. Recommendations for use of olmesartan remain the same, but FDA will require information about some of the studies to be included in the drug labels. For more information visit the FDA website at: Web Siteand Web Site.
Tell your doctor if you are pregnant or plan to become pregnant. Do not take olmesartan if you are pregnant. If you become pregnant while you are taking olmesartan, stop taking olmesartan and call your doctor immediately. Olmesartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.
WHY is this medicine prescribed?
Olmesartan is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years of age and older. Olmesartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.
HOW should this medicine be used?
Olmesartan comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take olmesartan, take it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take olmesartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If your child can not swallow a tablet, talk to your doctor or pharmacist. The pharmacist can prepare a liquid form of this medication for your child.
Your doctor will probably start you on a low dose of olmesartan and may increase your dose after 2 weeks.
Olmesartan controls high blood pressure but does not cure it. Your blood pressure may decrease during the first week of your treatment, but it may take up to 2 weeks before you notice the full benefit of olmesartan. Continue to take olmesartan even if you feel well. Do not stop taking olmesartan without talking to your doctor.
Are there OTHER USES for this medicine?
Olmesartan is also sometimes used to treat heart failure (condition in which the heart is unable to pump enough blood to the rest of the body) and diabetic nephropathy (kidney disease in people with diabetes and high blood pressure). Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking olmesartan,
- tell your doctor and pharmacist if you are allergic to olmesartan, any other medications, or any of the ingredients in olmesartan tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor if you have diabetes (high blood sugar) and are taking aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT, Valturna). Your doctor will probably tell you not to take olmesartan if you have diabetes and are also taking aliskiren.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: an angiotensin-converting enzyme (ACE) inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik); angiotensin II receptor antagonists (angiotensin receptor blockers; ARBs) such as azilsartan (Edarbi), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten, in Teveten HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), telmisartan (Micardis, in Micardis HCT), valsartan (Diovan, in Diovan HCT, Exforge); colesevelam (Welchol); diuretics ('water pills'); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); and potassium supplements. Your doctor may need to change the doses of your medication or monitor you carefully for side effects.
- tell your doctor if you have or have ever had heart failure, or kidney or liver disease.
- tell your doctor if you are breast-feeding.
- you should know that olmesartan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking olmesartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.
What SPECIAL DIETARY instructions should I follow?
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.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Olmesartan may cause side effects. Tell your doctor if this symptom is severe or does not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- severe diarrhea
- weight loss
- difficulty breathing or swallowing
Olmesartan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at
] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- fast or slow heartbeat
What OTHER INFORMATION should I know?
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.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: July 15, 2014.