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Diovan Generic Name & Formulations
Legal Class
Rx
General Description
Valsartan 40mg+, 80mg, 160mg, 320mg; +scored; tabs.
Pharmacological Class
Angiotensin II receptor blocker (ARB).
How Supplied
Tabs 40mg—30; 80mg, 160mg, 320mg—90
Manufacturer
Generic Availability
YES
Diovan Indications
Indications
Heart failure (NYHA Class II–IV). To reduce cardiovascular mortality in stable post-MI patients with left ventricular failure or dysfunction.
Diovan Dosage and Administration
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.
Diovan Contraindications
Contraindications
Concomitant aliskiren in patients with diabetes.
Diovan Boxed Warnings
Boxed Warning
Fetal toxicity.
Diovan Warnings/Precautions
Warnings/Precautions
Tabs and oral suspension are not substitutable on a mg-per-mg basis. 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. Severe hepatic or renal impairment (GFR <30mL/min/1.73m2), or children undergoing dialysis: not established. Neonates. Pregnancy: avoid. Nursing mothers: not recommended.
Diovan Pharmacokinetics
See Literature
Diovan Interactions
Interactions
See Contraindications. Concomitant renin-angiotensin system (RAS) inhibitors, K+ supplements, K+ sparing diuretics, K+-containing salt substitutes or other drugs (eg, heparin) may cause hyperkalemia and, in heart failure patients to increases in 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 RAS 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 (GFR <60mL/min): not recommended.
Diovan Adverse Reactions
Adverse Reactions
Dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue, hyperkalemia, cough, increased BUN, increased blood creatinine, neutropenia, rhabdomyolysis (rare).
Diovan Clinical Trials
See Literature
Diovan Note
Not Applicable
Diovan Patient Counseling
See Literature
Diovan Generic Name & Formulations
Legal Class
Rx
General Description
Valsartan 40mg+, 80mg, 160mg, 320mg; +scored; tabs.
Pharmacological Class
Angiotensin II receptor blocker (ARB).
How Supplied
Tabs 40mg—30; 80mg, 160mg, 320mg—90
Manufacturer
Generic Availability
YES
Diovan Indications
Indications
Hypertension.
Diovan Dosage and Administration
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
<1yr: not recommended. 1–16yrs: Initially 1mg/kg once daily (up to 40mg total), may consider an initial dose of 2mg/kg if greater BP reduction is needed; max 4g/kg (up to 160mg) once daily. If aged 1–5yrs, >5yrs who are unable to swallow tabs, or calculated dose (mg/kg) does not correspond to available tablet strengths, use suspension (see full labeling for susp preparation).
Diovan Contraindications
Contraindications
Concomitant aliskiren in patients with diabetes.
Diovan Boxed Warnings
Boxed Warning
Fetal toxicity.
Diovan Warnings/Precautions
Warnings/Precautions
Tabs and oral suspension are not substitutable on a mg-per-mg basis. 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. Severe hepatic or renal impairment (GFR <30mL/min/1.73m2), or children undergoing dialysis: not established. Neonates. Pregnancy: avoid. Nursing mothers: not recommended.
Diovan Pharmacokinetics
See Literature
Diovan Interactions
Interactions
See Contraindications. Concomitant renin-angiotensin system (RAS) inhibitors, K+ supplements, K+ sparing diuretics, K+-containing salt substitutes or other drugs (eg, heparin) may cause hyperkalemia and, in heart failure patients to increases in 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 RAS 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 (GFR <60mL/min): not recommended.
Diovan Adverse Reactions
Adverse Reactions
Headache, dizziness, viral infection, fatigue, abdominal pain, neutropenia, rhabdomyolysis (rare).
Diovan Clinical Trials
See Literature
Diovan Note
Not Applicable
Diovan Patient Counseling
See Literature
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