MICARDIS and MICARDIS HCT for HypertensionTake Control—Help Lower Blood Pressure in Your Hypertensive PatientsThe antihypertensive effects of Micardis® (telmisartan) Tablets have been demonstrated in 6 principal placebo-controlled clinical trials, studying a range of 20-160 mg; one of these examined the antihypertensive effects of telmisartan and hydrochlorothiazide in combination. The studies involved a total of 1773 patients with mild to moderate hypertension (diastolic blood pressure of 95-114 mmHg), 1031 of whom were treated with telmisartan. CLINICAL STUDY RESULTS Following once-daily administration of telmisartan, the magnitude of blood pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6-8/6 mmHg for 20 mg, 9-13/6-8 mmHg for 40 mg, and 12-13/7-8 mmHg for 80 mg. Larger doses (up to 160 mg) did not appear to cause a further decrease in blood pressure. Upon initiation of antihypertensive treatment with telmisartan, blood pressure was reduced after the first dose, with a maximal reduction by about 4 weeks. With cessation of treatment with MICARDIS tablets, blood pressure gradually returned to baseline values over a period of several days to 1 week. During long term studies (without placebo control), the effect of telmisartan appeared to be maintained for up to at least 1 year. The antihypertensive effect of telmisartan is not influenced by patient age, gender, weight, or body mass index. Blood pressure response in black patients (usually a low-renin population) is noticeably less than that in Caucasian patients. This has been true for most, but not all, angiotensin II antagonists and ACE inhibitors. In a controlled study, the addition of telmisartan to hydrochlorothiazide produced an additional dose-related reduction in blood pressure that was similar in magnitude to the reduction achieved with telmisartan monotherapy. Hydrochlorothiazide also had an added blood pressure effect when added to telmisartan. The onset of antihypertensive activity occurs within 3 hours after administration of a single oral dose. At doses of 20, 40, and 80 mg, the antihypertensive effect of once-daily administration of telmisartan is maintained for the full 24-hour dose interval. With automated ambulatory blood pressure monitoring and conventional blood pressure measurements, the 24-hour trough-to-peak ratio for 40-80-mg doses of telmisartan was 70-100% for both systolic and diastolic blood pressure. The incidence of symptomatic orthostasis after the first dose in all controlled trials was low (0.04%). There were no changes in the heart rate of patients treated with telmisartan in controlled trials. |
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Micardis® (telmisartan) Tablets are indicated for the treatment of hypertension. MICARDIS 80 mg is also indicated for cardiovascular risk reduction in patients unable to take ACE inhibitors. Micardis® HCT (telmisartan and hydrochlorothiazide) Tablets are indicated for the treatment of hypertension. MICARDIS HCT is not indicated for initial therapy.
* Only Micardis® (telmisartan) 80-mg Tablets are indicated for cardiovascular risk reduction. All other MICARDIS and Micardis® HCT (telmisartan and hydrochlorothiazide) Tablets dosages are indicated for the treatment of hypertension only. MICARDIS 80 mg is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors. High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack or high-risk diabetes (insulin-dependent or non-insulin-dependent) with evidence of end-organ damage. MICARDIS can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy). Studies of telmisartan in this setting do not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves. Use of telmisartan with an ACE inhibitor is not recommended.1
† Dosage must be individualized. In the treatment of hypertension, the usual starting dose of MICARDIS Tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20-80 mg. For patients who need even greater efficacy, MICARDIS HCT is available in 40/12.5-mg, 80/12.5-mg, and 80/25-mg tablets. Available as a unit dose. In the treatment of cardiovascular risk reduction, the recommended dose of MICARDIS is 80 mg once a day. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing the risk of cardiovascular morbidity and mortality. When initiating MICARDIS therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended and, if appropriate, adjustment of medications that lower blood pressure may be necessary.1
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