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INDICATIONS AND USAGE

Micardis® (telmisartan) tablets and Micardis® HCT (telmisartan/hydrochlorothiazide) tablets are angiotensin II receptor blockers (ARB) indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

MICARDIS 80 mg tablets are also indicated for risk reduction of myocardial infarction, stroke, or death from cardiovascular (CV) causes in patients ≥55 years of age at high risk of developing major CV events that are unable to take ACE inhibitors.

  • High risk for CV 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 tablets 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 retrying the ACE inhibitor after the cough resolves. Use of telmisartan with an ACE inhibitor is not recommended.

MICARDIS HCT is not indicated for initial therapy or for cardiovascular risk reduction.

IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY

See full prescribing information for complete boxed warning.

  • When pregnancy is detected, discontinue MICARDIS and MICARDIS HCT as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Contraindications:

MICARDIS tablets are contraindicated in patients with known hypersensitivity (eg, anaphylaxis or angioedema) to telmisartan or any other component of the drug.

MICARDIS HCT tablets are contraindicated in patients with known hypersensitivity to telmisartan, hydrochlorothiazide, or any other component of the drug.

MICARDIS HCT is contraindicated in patients with anuria or sensitivity to sulfonamide-derived drug.

Do not co-administer aliskiren with MICARDIS or MICARDIS HCT in patients with diabetes.

Warnings and Precautions:

Fetal Toxicity: Pregnancy Category D. 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 or MICARDIS HCT tablets as soon as possible.

Symptomatic hypotension may occur in patients with an activated renin-angiotensin system. Correct volume and/or salt depletion in patients before initiating therapy with MICARDIS or MICARDIS HCT tablets, or start treatment under close supervision with a reduced dose.

Patients taking MICARDIS or MICARDIS HCT tablets should be told not to use potassium supplements or salt substitutes that contain potassium without consulting their physician. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances.

Monitor carefully in patients with impaired hepatic or renal function and in volume-depleted patients. In patients with impaired hepatic function, initiate MICARDIS and MICARDIS HCT tablets at low doses and titrate slowly.

MICARDIS HCT tablets are not recommended for patients with severe renal or hepatic impairment.

In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system such as patients with severe congestive heart failure or renal dysfunction, treatment with ACE inhibitors and ARBs such as MICARDIS and MICARDIS HCT tablets has been associated with oliguria and/or progressive azotemia and, rarely, with acute renal failure and/or death. In patients with renal artery stenosis, increases in serum creatinine or blood urea nitrogen may occur. When adding an ACE inhibitor to an ARB, monitor renal functions closely. Use of MICARDIS or MICARDIS HCT tablets with ramipril is not recommended.

Co-administration of non-steroidal anti-inflammatory agents (NSAIDs), including COX-2 inhibitors may result in deterioration of renal function (including acute renal failure) in patients who are elderly, volume-depleted, or with compromised renal function. Monitor renal function periodically in patients receiving MICARDIS or MICARDIS HCT with NSAIDs.

  • Co-administration of MICARDIS or MICARDIS HCT with lithium or digoxin, increases in the serum levels of lithium and digoxin, respectively have been observed. When MICARDIS or MICARDIS HCT is co-administered with digoxin, monitor digoxin levels when initiating, adjusting or discontinuing telmisartan to keep the serum digoxin level within the therapeutic range.
  • When MICARDIS or MICARDIS HCT is co-administered with lithium, monitor lithium levels.

Thiazide drugs such as hydrochlorothiazide, a component of MICARDIS HCT can cause a reaction that can result in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated angle-closure glaucoma can lead to permanent vision loss. The treatment is to discontinue hydrochlorothiazide tablets as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Thiazides can exacerbate or activate systemic lupus erythematosus.

Adverse Events:

In clinical trials for hypertension the most common adverse events occurring with MICARDIS at a rate of ≥1% than placebo were upper respiratory tract infection, back pain, sinusitis, diarrhea, and pharyngitis.

In clinical trials for hypertension the most common adverse events occurring with MICARDIS HCT at a rate of ≥2% than placebo were dizziness, diarrhea, fatigue, nausea, influenza-like symptoms, sinusitis, and URTI.

In a clinical trial for cardiovascular risk reduction, 8.4% of patients treated with telmisartan were discontinued due to adverse events compared to 7.6% treated with placebo. Serious adverse events at least 1% more common on telmisartan than placebo were intermittent claudication (7% vs 6%) and skin ulcer (3% vs 2%).

Please see full Prescribing Information, including boxed WARNING and Patient Information, for MICARDIS and MICARDIS HCT.

IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY

See full prescribing information for complete boxed warning.

  • When pregnancy is detected, discontinue MICARDIS and MICARDIS HCT as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Contraindications:

MICARDIS tablets are contraindicated in patients with known hypersensitivity (eg, anaphylaxis or angioedema) to telmisartan or any other component of the drug.

MICARDIS HCT tablets are contraindicated in patients with known hypersensitivity to telmisartan, hydrochlorothiazide, or any other component of the drug.

MICARDIS HCT is contraindicated in patients with anuria or sensitivity to sulfonamide-derived drug.

Do not co-administer aliskiren with MICARDIS or MICARDIS HCT in patients with diabetes.

Warnings and Precautions:

Fetal Toxicity: Pregnancy Category D. 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 or MICARDIS HCT tablets as soon as possible.

Symptomatic hypotension may occur in patients with an activated renin-angiotensin system. Correct volume and/or salt depletion in patients before initiating therapy with MICARDIS or MICARDIS HCT tablets, or start treatment under close supervision with a reduced dose.

Patients taking MICARDIS or MICARDIS HCT tablets should be told not to use potassium supplements or salt substitutes that contain potassium without consulting their physician. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances.

Monitor carefully in patients with impaired hepatic or renal function and in volume-depleted patients. In patients with impaired hepatic function, initiate MICARDIS and MICARDIS HCT tablets at low doses and titrate slowly.

MICARDIS HCT tablets are not recommended for patients with severe renal or hepatic impairment.

In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system such as patients with severe congestive heart failure or renal dysfunction, treatment with ACE inhibitors and ARBs such as MICARDIS and MICARDIS HCT tablets has been associated with oliguria and/or progressive azotemia and, rarely, with acute renal failure and/or death. In patients with renal artery stenosis, increases in serum creatinine or blood urea nitrogen may occur. When adding an ACE inhibitor to an ARB, monitor renal functions closely. Use of MICARDIS or MICARDIS HCT tablets with ramipril is not recommended.

Co-administration of non-steroidal anti-inflammatory agents (NSAIDs), including COX-2 inhibitors may result in deterioration of renal function (including acute renal failure) in patients who are elderly, volume-depleted, or with compromised renal function. Monitor renal function periodically in patients receiving MICARDIS or MICARDIS HCT with NSAIDs.

  • Co-administration of MICARDIS or MICARDIS HCT with lithium or digoxin, increases in the serum levels of lithium and digoxin, respectively have been observed. When MICARDIS or MICARDIS HCT is co-administered with digoxin, monitor digoxin levels when initiating, adjusting or discontinuing telmisartan to keep the serum digoxin level within the therapeutic range.
  • When MICARDIS or MICARDIS HCT is co-administered with lithium, monitor lithium levels.

Thiazide drugs such as hydrochlorothiazide, a component of MICARDIS HCT can cause a reaction that can result in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated angle-closure glaucoma can lead to permanent vision loss. The treatment is to discontinue hydrochlorothiazide tablets as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Thiazides can exacerbate or activate systemic lupus erythematosus.

Adverse Events:

In clinical trials for hypertension the most common adverse events occurring with MICARDIS at a rate of ≥1% than placebo were upper respiratory tract infection, back pain, sinusitis, diarrhea, and pharyngitis.

In clinical trials for hypertension the most common adverse events occurring with MICARDIS HCT at a rate of ≥2% than placebo were dizziness, diarrhea, fatigue, nausea, influenza-like symptoms, sinusitis, and URTI.

In a clinical trial for cardiovascular risk reduction, 8.4% of patients treated with telmisartan were discontinued due to adverse events compared to 7.6% treated with placebo. Serious adverse events at least 1% more common on telmisartan than placebo were intermittent claudication (7% vs 6%) and skin ulcer (3% vs 2%).

Please see full Prescribing Information, including boxed WARNING and Patient Information, for MICARDIS and MICARDIS HCT.