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DIOVAN
CHF and arrhythmias
Hypertension
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Drug Name:

DIOVAN Rx

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

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

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:

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:

Not recommended.

Contraindications:

Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. CHF. Post-MI. Correct salt/volume depletion prior to initiation. Monitor renal function in renal artery stenosis, chronic kidney disease, severe CHF, or volume depletion. Monitor for hyperkalemia in renal insufficiency. Hepatic or renal impairment (monitor). Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:

See Contraindications. Concomitant K+ supplements, K+ sparing diuretics, K+-containing salt substitutes may cause hyperkalemia and, in heart failure patients, increased serum creatinine. May increase lithium levels; monitor. 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 MRP2 (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, in general, avoid combined use of RAS inhibitors. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended.

Pharmacological Class:

Angiotensin II receptor blocker (ARB).

Adverse Reactions:

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

Metabolism:

Hepatic (CYP2C9); 95% protein bound.

Elimination:

Fecal, renal.

Generic Availability:

YES

How Supplied:

Tabs 40mg—30; 80mg—90, 14000; 160mg—90, 7000; 320mg—90, 3500

Indications for DIOVAN:

Hypertension.

Adult:

Monotherapy and not volume-depleted: initially 80mg or 160mg once daily; max 320mg once daily. Or, add a diuretic (more effective than increasing dose above 80mg).

Children:

<6yrs or CrCl<30mL/min: not recommended. 6–16yrs: Initially 1.3mg/kg once daily (up to 40mg total); max 2.7mg/kg (up to 160mg) once daily. If unable to swallow tabs, or calculated dose (mg/kg) does not correspond to available tablet strengths, use suspension (see full labeling for susp preparation).

Contraindications:

Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. CHF. Post-MI. Correct salt/volume depletion prior to initiation. Monitor renal function in renal artery stenosis, chronic kidney disease, severe CHF, or volume depletion. Monitor for hyperkalemia in renal insufficiency. Hepatic or renal impairment (monitor). Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:

See Contraindications. Concomitant K+ supplements, K+ sparing diuretics, K+-containing salt substitutes may cause hyperkalemia and, in heart failure patients, increased serum creatinine. May increase lithium levels; monitor. 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 MRP2 (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, in general, avoid combined use of RAS inhibitors. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended.

Pharmacological Class:

Angiotensin II receptor blocker (ARB).

Adverse Reactions:

Headache, dizziness, viral infection, fatigue, abdominal pain, neutropenia, rhabdomyolysis (rare).

Metabolism:

Hepatic (CYP2C9); 95% protein bound.

Elimination:

Fecal, renal.

Generic Availability:

YES

How Supplied:

Tabs 40mg—30; 80mg—90, 14000; 160mg—90, 7000; 320mg—90, 3500

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