Keep from freezing.ĭo not keep outdated medicine or medicine no longer needed.Īsk your healthcare professional how you should dispose of any medicine you do not use.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. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. If you miss a dose of this medicine, take it as soon as possible. However, the dose is usually not more than 10 mg of amlodipine and 40 mg of olmesartan per day.Ĭhildren-Use and dose must be determined by your doctor. Your doctor may increase your dose if needed. 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.Īdults-One tablet containing 5 milligrams (mg) of amlodipine and 20 mg of olmesartan once a day. The amount of medicine that you take depends on the strength of the medicine. If your dose is different, do not change it unless your doctor tells you to do so. The following information includes only the average doses of this medicine. Follow your doctor's orders or the directions on the label. The dose of this medicine will be different for different patients. If you are also using colesevelam (Welchol®), take it at least 4 hours after taking Azor®. You may take this medicine with or without food. 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 have to take high blood pressure medicine for the rest of your life. ![]() You must continue to take it as directed if you expect to lower your blood pressure and keep it down. Remember that this medicine will not cure your high blood pressure, but it does help control it. 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. ![]() View the full FDA Drug Safety Communication on FDA.Many patients who have high blood pressure will not notice any signs of the problem. The second was a DSC update in April 2011. The first, in June 2010, described the ongoing review of olmesartan and cardiovascular events. outpatient retail pharmacies.įDA posted two previous Drug Safety Communications (DSCs) on this issue. In 2013, there were approximately 1.8 million patients who received a dispensed prescription for olmesartan-containing products from U.S. Olmesartan is a type of blood pressure medicine called an angiotensin receptor blocker, or ARB. ![]() Thus, the collective evidence available at this time does not support changing our recommendations for olmesartan use and does not support recommending that its use be avoided in patients with diabetes. Overall, we have determined that these studies do not clearly show an increased cardiovascular risk. While data from the ROADMAP trial and the Medicare study have suggested that high-dose olmesartan may increase cardiovascular risk in diabetic patients, when considering the data from all trials and studies, they are not conclusive. To evaluate these findings, we reviewed additional studies, including a large study in Medicare patients. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. 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. 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. This safety review was prompted by the results of the ROADMAP trial. Do not stop taking olmesartan or any blood pressure medication without first discussing it with your health care professional. It is important to take olmesartan and other blood pressure medicines because uncontrolled high blood pressure increases the risks of cardiovascular problems such as heart disease and stroke, as well as kidney failure and other health problems. ![]() Patients should discuss any questions they have with their health care professionals. As a result, our recommendations for use of olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same, but we will require information about some of the studies to be included in the drug labels. Food and Drug Administration (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.
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