Indicated for the treatment of hypertension, to lower blood pressure.

MICARDIS HCT is not indicated for initial therapy for the treatment of hypertension.

MICARDIS HCT may be used alone or in combination with other antihypertensive agents.

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

Patients whose renal function may depend in part on the activity of the renin angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing oliguria, progressive azotemia, or acute renal failure on MICARDIS HCT. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on MICARDIS HCT.

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

MICARDIS HCT is contraindicated:

• In patients with anuria
• For co-administration with aliskiren in patients with diabetes

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 initialization of treatment with MICARDIS HCT. Correct volume or salt depletion prior to administration of MICARDIS HCT.

Hydrochlorothiazide can cause hypokalemia and hyponatremia. Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Monitor serum electrolytes periodically.

Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium.

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

Because telmisartan decreases uric acid, telmisartan in combination with hydrochlorothiazide attenuates the diuretic-induced hyperuricemia.

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting 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 acute angle-closure glaucoma can lead to permanent vision loss.

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

The antihypertensive effects of hydrochlorothiazide may be enhanced in the postsympathectomy patient. 

Drugs, including telmisartan, that inhibit the renin-angiotensin system can cause hyperkalemia, particularly in patients with renal insufficiency, diabetes, or combination use with other angiotensin receptor blockers or ACE inhibitors and the concomitant use of other drugs that raise serum potassium levels.

Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of thiazide diuretics or angiotensin II receptor antagonists, including telmisartan. Monitor lithium levels in patients receiving MICARDIS HCT and lithium.

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 ARBs, including telmisartan, may result in deterioration of renal function, including possible acute renal failure.

Administration of a non-steroidal anti-inflammatory agent, including a selective COX-2 inhibitor, can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. Therefore, when MICARDIS HCT and nonsteroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.

Dual blockade of the renin-angiotensin-aldosterone system (RAS) with angiotensin blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and renal impairment.

In general, avoid combined use of RAS inhibitors.

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

Dosage adjustment of antidiabetic drugs may be required when co-administered with hydrochlorothiazide.

Stagger the dosage of hydrochlorothiazide and the resin such that hydrochlorothiazide is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.

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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue MICARDIS HCT as soon as possible.

Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia.

Limited published studies report that hydrochlorothiazide is present in human milk. 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 HCT.

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• Use in patients under 18 years of age. 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

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

Lawsuits filed for birth defects and cancer.