Amlodipine 10 mg / Telmisartan 80 mg
MESARTANVEROSE (telmisartan/amlodipine) tablets are indicated for the treatment of hypertension,alone or with other antihypertensive agents to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including angiotensin II receptor blockers and dihydropyridine calcium channel
blockers. There are no controlled trials demonstrating risk reduction with telmisartan & amlodipine tablets .
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management,antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such
patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart
failure, or diabetic kidney disease). These considerations may guide selection of therapy.
MESARTANVEROSE tablets may also be used as initial therapy in patients who are likely to need
multiple drugs to achieve their blood pressure goals.
General Considerations Telmisartan is an effective treatment of hypertension in once daily doses of 20 to 80 mg while amlodipine is effective in doses of 2.5 to 10 mg. Dosage must be individualized and may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. The maximum recommended dose of telmisartan & amlodipine tablets is 80/10 mg once daily. The adverse reactions of telmisartan are uncommon and independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter [see Adverse Reactions].
MESARTANVEROSE may be taken with or without food.
Replacement Therapy Patients receiving amlodipine and telmisartan from separate tablets may instead receive telmisartan & amlodipine tablets containing the same component doses once daily. When substituting for individual components, increase the dose of telmisartan & amlodipine tablets if blood pressure control has not been satisfactory.
Add-on Therapy for Patients with Hypertension Not Adequately Controlled on Antihypertensive Monotherapy Telmisartan & amlodipine tablets may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amlodipine who experience any dose-limiting adverse reactions such as edema, may be switched to telmisartan & amlodipine 40/5 mg tablets once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response [see Adverse Reactions].
Initial Therapy A patient may be initiated on telmisartan & amlodipine tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose of telmisartan & amlodipine tablets is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started on telmisartan & amlodipine 80/5 mg tablets once daily. Initial therapy with telmisartan & amlodipine tablets is not recommended in patients ≥75 years old or with hepatic impairment [see Dosage and Administration , Warnings and Precautions , and Use in Specific Populations]. Correct imbalances of intravascular volume- or salt-depletion, before initiating therapy with telmisartan & amlodipine tablets [see Warnings and Precautions ].
Renal Impairment No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.
Hepatic Impairment In most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients with hepatic impairment. Patients 75 Years of Age and Older In most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients 75 years of age and older.