Hydrochlorothiazide and Telmisartan

MICARDIS HCT (telmisartan and hydrochlorothiazide) is 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with MICARDIS HCT. 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.

MICARDIS HCT MICARDIS HCT is a combination of two drugs with antihypertensive properties: a thiazide diuretic, hydrochlorothiazide, and an angiotensin II receptor blocker (ARB), telmisartan. Telmisartan Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

Usual starting dose is 80 mg/12.5 mg once daily. Titrate up to 160 mg/25 mg as needed. Initiate patients with biliary obstructive disorders or hepatic insufficiency at 40 mg/12.5 mg

MICARDIS HCT is contraindicated: In patients who are hypersensitive to any component of this product. In patients with anuria. For co-administration with aliskiren in patients with diabetes. Hypersensitivity to telmisartan or any component. Anuria. Co-Administration with aliskiren in patients with diabetes

Boxed warning (fetal toxicity): When pregnancy is detected, discontinue MICARDIS HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. WARNING: FETAL TOXICITY. Avoid fetal or neonatal exposure. Correct volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension. Monitor renal function and potassium in susceptible patients. Observe for clinical signs of fluid or electrolyte imbalance. Hypersensitivity Reaction. Acute Myopia and Secondary Angle-Closure Glaucoma

The following adverse reactions are discussed elsewhere in labeling: Hypotension Renal Impairment Electrolytes and Metabolic Disorders The most common adverse reactions (≥2% of patients) were upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea

Lithium: Risk of lithium toxicity. Non-steroidal anti-inflammatory drugs (NSAIDs): Reduced diuretic, natriuretic, and antihypertensive effects, increased risk of renal impairment. Dual blockade of renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. Antidiabetic drugs: Dosage adjustment may be required. Cholestyramine and colestipol: Reduced absorption of thiazides

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).