Valsartan

Diovan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults. Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults

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. Diovan (valsartan) 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. There is also an AT 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis.

*As tolerated by patient Indication Starting Dose Dose Range* Hypertension Adults 80 mg to 160 mg once daily 80 mg to 320 mg once daily 1 to 16 years 1 mg/kg once daily Up to 40 mg daily 1 mg/kg to 4 mg/kg once daily Up to 160 mg daily Heart Failure 40 mg twice daily 40 mg to 160 mg twice daily Post-Myocardial Infarction 20 mg twice daily 20 mg to 160 mg twice daily

Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with Diovan in patients with diabetes. Known hypersensitivity to any component.

Boxed warning (fetal toxicity): When pregnancy is detected, discontinue Diovan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Observe for signs and symptoms of hypotension. Monitor renal function and potassium in susceptible patients Fetal Toxicity Diovan can cause fetal harm when administered to a pregnant woman. 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 Diovan as soon as possible.

Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain. Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia. Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine

Potassium-sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine. Non-Steroidal Anti-Inflammatory Drug (NSAID) use may lead to increased risk of renal impairment and loss of antihypertensive effect. Dual inhibition of the Renin-Angiotensin System (RAS): Increased risk of renal impairment, hypotension, and hyperkalemia. Lithium: Increases in serum lithium level and lithium toxicity

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.