Generic Name and Formulations:
Valsartan 40mg+, 80mg, 160mg, 320mg; +scored; tabs.

Company:
Novartis Pharmaceuticals Corp

Indications for DIOVAN:
Heart failure (NYHA Class II–IV). To reduce cardiovascular mortality in stable post-MI patients with left ventricular failure or dysfunction.

Adult Dose for DIOVAN:
Heart failure: initially 40mg twice daily, increase to 80mg twice daily, then to 160mg twice daily as tolerated. Post-MI: may start 12hrs post-MI; initially 20mg twice daily, increase within 1 wk to 40mg twice daily; target maintenance: 160mg twice daily as tolerated. Low BP or renal dysfunction: reduce dose.

Children's Dose for DIOVAN:
Not recommended.

Pharmacological Class:
Angiotensin II receptor blocker.

Contraindications:
Concomitant aliskiren in diabetics.

Warnings/Precautions:
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct hypovolemia before beginning therapy (may need to reduce diuretic) or monitor closely for hypotension. Hepatic or renal impairment (monitor). Renal artery stenosis. Severe CHF (if renal function depends on renin-angiotensin-aldosterone system). Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:
Concomitant K+ supplements, K+ sparing diuretics, K+ containing salt substitutes may lead to hyperkalemia and, in heart failure patients, increased serum creatinine. May be antagonized by, and renal toxicity potentiated by, NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume depleted). May be potentiated by inhibitors of OATP1B1 (eg, rifampin, cyclosporine) or MPR2 (eg, ritonavir). Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended.

Adverse Reactions:
Dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue, hyperkalemia, increased BUN, neutropenia, rhabdomyolysis (rare).

Metabolism:
Hepatic (CYP2C9); 95% protein bound.

Elimination:
Fecal, renal.

Generic Availability:
NO

How Supplied:
Tabs 40mg—30; 80mg, 160mg, 320mg—90