Amlodipine, Indapamide and Telmisartan

Widaplik (telmisartan/amlodipine/indapamide) is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Widaplik may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. 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 angiotensin II receptor blockers, dihydropyridine calcium channel blockers and thiazide-like diuretics. There are no controlled trials demonstrating risk reduction with Widaplik.

The active ingredients of Widaplik target 3 separate mechanisms involved in blood pressure regulation. 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-aldosterone 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.

For initial treatment of hypertension, start with Widaplik (10 mg/ 1.25 mg/0.625 mg) or Widaplik (20 mg/2.5 mg/1.25 mg) orally once daily. Titrate up to a maximum dose of Widaplik (40 mg/5 mg/2.5 mg) orally once daily. Dosage may be increased after 2 weeks to a maximum dose of 40 mg/5 mg/2.5 mg orally once daily to achieve more rapid control. Almost all of the antihypertensive effect is apparent within 2 weeks of initiating treatment.

Do not use in patients with anuria, known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or to any other component of this product. Do not co-administer aliskiren with Widaplik in patients with diabetes. Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or to any other component of this product. Anuria

Boxed warning (fetal toxicity): When pregnancy is detected, discontinue Widaplik as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus. WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue WIDAPLIK as soon as possible. • Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus Hypotension: Correct volume depletion prior to initiation. Electrolyte and Glucose Imbalances: Monitor serum electrolytes and glucose. Impaired Renal Function: Monitor renal function. Acute angle closure glaucoma can develop. Hyperuricemia may occur

The following is discussed in more detail in other sections of the labeling: • Fetal toxicity • Hypotension • Electrolyte and Glucose Imbalances • Impaired Renal Function • Acute Angle-Closure Glaucoma, Acute Myopia, and Choroidal Effusion • Hyperuricemia The most common adverse reaction is symptomatic hypotension. Low sodium and potassium values were recorded more often with Widaplik compared to placebo.

NSAIDs: Increased risk of renal impairment and loss of anti-hypertensive effect. If simvastatin is co-administered with Widaplik, do not exceed doses greater than 20 mg daily of simvastatin. Do not co-administer aliskiren with Widaplik in patients with diabetes

Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture and light. Store and dispense the product in the original container.