Telmisartan, Amlodipine And Indapamide

1 INDICATIONS AND USAGE 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.

6 ADVERSE REACTIONS The following is discussed in more detail in other sections of the labeling: • Fetal toxicity [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Electrolyte and Glucose Imbalances [see Warnings and Precautions ( 5.3 )] • Impaired Renal Function [see Warnings and Precautions ( 5.4 )] • Acute Angle-Closure Glaucoma, Acute Myopia, and Choroidal Effusion [see Warnings and Precautions ( 5.5 )] • Hyperuricemia [see Warnings and Precautions ( 5.6 )] The most common adverse reaction is symptomatic hypotension. Low sodium and potassium values were recorded more often with Widaplik compared to placebo ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc.

8.1 Pregnancy Risk Summary Widaplik can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin-aldosterone system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death ( see Clinical Considerations ). Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin-aldosterone system from other antihypertensive agents.

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Widaplik as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume depletion prior to initiation ( 5.2 ) Electrolyte and Glucose Imbalances: Monitor serum electrolytes and glucose ( 5.3 ) Impaired Renal Function: Monitor renal function ( 5.4 ) Acute angle closure glaucoma can develop ( 5.5 ) Hyperuricemia may occur ( 5.6 ) 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin-aldosterone 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. 4 CONTRAINDICATIONS 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 [see Drug Interactions ( 7.1 )] .