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Micardis

Generic Name: Telmisartan
Drug Category: ARB
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 5 years.

Approved Uses

Indicated for:

Hypertension:

• The treatment of hypertension, to lower blood pressure It may be used alone or in combination with other antihypertensive agents.

Cardiovascular Risk Reduction:

• 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.

Studies of telmisartan in this setting do not exclude the possibility that telmisartan 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 MICARDIS with ramipril, ACE inhibitors or aliskiren is not recommended.

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

Avoid concomitant use of aliskiren with MICARDIS in patients with renal impairment (GFR <60 mL/min/1.73 m2).

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. When additional blood pressure reduction beyond that achieved with 80 mg MICARDIS is required, a diuretic may be added. 

As a consequence of inhibiting the renin-angiotensin-aldosterone system, anticipate changes in renal function in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or renal dysfunction), 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.

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen were observed. There has been no long-term use of MICARDIS in patients with unilateral or bilateral renal artery stenosis, but anticipate an effect similar to that seen with ACE inhibitors.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including telmisartan, may result in deterioration of renal function, including possible acute renal failure.

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.

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. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances, particularly in patients at risk.

In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors.

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including MICARDIS.

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including MICARDIS.

The antihypertensive effect of angiotensin II receptor antagonists, including telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

When MICARDIS was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.

When co-administering telmisartan and ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence of telmisartan.

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

There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production. Telmisartan is present in the milk of lactating rats. Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with MICARDIS.

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Off-label Uses

• Use in patients under the age of 18. GoToSource

• Dosage greater than 80 mg per day. GoToSource

• Metabolic syndrome. GoToSource

• Diabetic nephropathy. GoToSource

• Marfan syndrome. GoToSource

• Improve walking distance and endothelial function in patients with peripheral artery disease. GoToSource

• Nonalcoholic fatty liver disease. GoToSource

• Prevention of migraines. GoToSource

Adverse Events

Fetal injury and death. GoToSource

Increased risk of lung cancer. GoToSource

Myalgia (muscle pain), rhabdomyolysis (destruction of muscle tissue) and increased CPK (indicating stress or injury to heart or other muscles). GoToSource

Urticarial vasculitis (inflammation of small blood vessels). GoToSource

Sprue-like enteropathy (intestinal disorder). GoToSource

Angioedema (deep tissue swelling) and hypotension (low blood pressure). GoToSource

Upper respiratory tract infection, urinary tract infection, hyperkalemia (high blood potassium level), bradycardia (slow heart rate) and kidney failure. GoToSource 

Symmetrical drug-related intertriginous and flexural exanthema (adverse skin reaction). GoToSource

Litigation

Lawsuits filed for birth defects and cancer. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024