Telmisartan

What is Telmisartan?

• Telmisartan (Micardis) is an angiotensin II receptor blocker (ARB) used in the therapy of hypertension, Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors.

Telmisartan

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What are the uses of this medicine?

Telmisartan (Micardis) is a prescription medicine used:

• to treat high blood pressure (hypertension)
• in certain high risk people aged 55 years and older to help lower their risk of having certain cardiovascular problems such as stroke, heart attack, or death

Hypertension:

• Blood pressure is the force in your blood vessels when your heart beats and when your heart rests.
• You have high blood pressure when the force is too much.
• MICARDIS tablets can help your blood vessels relax so your blood pressure is lower.
• High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels.
• If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

Cardiovascular Risk:

• Patients older than 55 years of age who have been diagnosed with blood vessel disease in the heart, legs, or brain (coronary, peripheral, or cerebral vascular disease) or diabetes with end organ damage (for example: kidney, heart, and brain) are at higher risk of cardiovascular events (for example: death from cardiovascular causes, stroke, and/or heart attack).

How does this medicine work?

• Telmisartan (tel" mi sar' tan) is an angiotensin II receptor blocker (ARB) used alone or in combination with other agents for therapy of hypertension.
• Telmisartan inhibits the renin-angiotensin system by blocking the angiotensin II type 1 receptor (AT1), which prevents the vasoconstriction and volume expansion induced by circulating angiotensin II which accounts for its potent antihypertensive activity.

What drug interactions can this medicine cause?

• When MICARDIS was co-administered with digoxin, median increases in digoxin peak plasma concentration.
• Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including MICARDIS. Therefore, monitor serum lithium levels during concomitant use.
• NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect.
• Concomitant use of MICARDIS and ramipril is not recommended.

Is this medicine FDA approved?

• Telmisartan was approved for use in the United States for treatment of hypertension in 1998 and indications were subsequently broadened to include reduction in risk of cardiovascular events in patients unable to take ACE inhibitors for this use.

How should this medicine be used?

Recommended dosage: Hypertension:

• Dosage must be individualized.
• The usual starting dose of MICARDIS tablets is 40 mg once a day.
• Blood pressure response is dose-related over the range of 20 to 80 mg.

Cardiovascular Risk Reduction:

• The recommended dose of MICARDIS tablets is 80 mg once a day and can be administered with or without food.
• It is not known whether doses lower than 80 mg of telmisartan are effective in reducing the risk of cardiovascular morbidity and mortality.

Administration:

• Take MICARDIS tablets exactly as your doctor tells you to take it.
• Your doctor will tell you how much MICARDIS to take and when to take it.
• Do not change your dose unless your doctor tells you to.
• Take MICARDIS one time each day at the same time.
• Take MICARDIS tablets with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you take too much MICARDIS, call your doctor, or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 20 mg, 40 mg, 80 mg

This medicine is available in fallowing brand namesː

• MICARDIS

What side effects can this medication cause?

The most common side effects of this medicine include: Hypertension:

• back pain
• sinusitis, and diarrhea.

Cardiovascular risk reduction:

• intermittent claudication
• skin ulcer

What special precautions should I follow?

• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue MICARDIS as soon as possible.
• In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of therapy with MICARDIS. Either correct this condition prior to administration of MICARDIS, or start treatment under close medical supervision with a reduced dose.
• Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium levels.
• As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance.
• Treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results have been reported with MICARDIS. Monitor carefully in patients with impaired hepatic or renal function.
• As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function (including acute renal failure) have been reported. Dual blockade of the renin-angiotensin-aldosterone system (e.g., by adding an ACE-inhibitor to an angiotensin II receptor antagonist) should include close monitoring of renal function. Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension
• dizziness
• tachycardia
• bradycardia could occur from parasympathetic (vagal) stimulation

Treatment of overdosage:

• If symptomatic hypotension should occur, supportive treatment should be instituted.
• Telmisartan is not removed by hemodialysis.

Can this medicine be used in pregnancy?

• MICARDIS can cause harm or death to an unborn baby.
• If you get pregnant while taking MICARDIS, tell your doctor right away.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: telmisartan
• Inactive Ingredients: sodium hydroxide, meglumine, povidone, sorbitol, and magnesium stearate

Who manufactures and distributes this medicine?

Distributed by:

• Boehringer Ingelheim Pharmaceuticals, Inc.
• Ridgefield, CT USA

What should I know about storage and disposal of this medication?

• Store MICARDIS tablets between 59°F to 86°F (15°C to 30°C).
• Do not remove MICARDIS tablets from blisters until right before you take them.

The common ARBS are the following:

• Azilsartan
• Candesartan
• Eprosartan
• Irbesartan
• Losartan
• Olmesartan
• Telmisartan
• Valsartan

Common ACE inhibitors include the following:

• Benazepril
• Captopril
• Enalapril
• Fosinopril
• Lisinopril
• Moexipril
• Perindopril
• Quinapril
• Ramipril
• Trandolapril

• Dailymed label info on Telmisartan
• FDA Telmisartan

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