Novartis Healthcare


Concise Prescribing Info
Adult: HTN, heart failure, post-MI & in addition to lifestyle modifications for delay of progression to type 2 diabetes in hypertensive patients w/ impaired glucose tolerance (IGT) at CV risk. Childn & adolescent 6-18 yr: HTN.
Dosage/Direction for Use
Adult HTN 80 or 160 mg once daily. May be increased to 320 mg once daily or add another antihypertensive (eg, diuretic) if BP reduction is inadequate. Heart failure Initially 40 mg bid, up-titrated to 80 & 160 mg bid as tolerated. Max: 320 mg daily in divided doses. Post-MI Initially 20 mg bid, up-titrated to a max of 160 mg bid as tolerated. Hypertensive patient w/ IGT at CV risk Progression of type 2 diabetes 80 or 160 mg once daily. When started on 80 mg, up-titrate to 160 mg as tolerated. Childn & adolescent 6-18 yr HTN Initially 40 mg (<35 kg) or 80 mg (≥35 kg) once daily.
May be taken with or without food.
Hypersensitivity. Concomitant use w/ aliskiren in type 2 diabetes. Pregnancy.
Special Precautions
Risk of hypotension in Na- &/or vol-depleted patients. Renal artery stenosis, severe renal impairment (CrCl <10 mL/min), biliary cirrhosis or obstruction. Initiation of therapy in patients w/ heart failure or post-MI. Triple combination w/ ACE inhibitor & β-blocker. Risk of renal function impairment in patients w/ severe heart failure. Patients w/ history of angioedema or are experiencing angioedema; discontinue immediately & do not re-administer. Monitor renal function & serum K especially in presence of fever & dehydration. Avoid concomitant use w/ aliskiren in patients w/ severe renal impairment (GFR <30 mL/min). Concomitant use w/ ACE inhibitors. Women planning to get pregnant. Pregnancy & lactation. Childn w/ biliary obstructive disorders. Elderly.
Adverse Reactions
Dizziness, postural dizziness; hypotension, orthostatic hypotension; renal failure & impairment.
Drug Interactions
May increase incidence of hypotension, hyperkalemia & changes in renal function w/ other agents blocking the RAS eg, ACE inhibitors or aliskiren. May increase serum K levels w/ K-sparing diuretics, K supplements, salt substitutes containing K or other drugs that may increase K levels (eg, heparin). May decrease antihypertensive effects w/ NSAIDs including COX-2 inhibitors. May increase systemic exposure w/ inhibitors of uptake transporter (rifampin, ciclosporin) or efflux transporter (ritonavir). May increase lithium conc & toxicity. May increase serum K in childn w/ concomitant use of valsartan & other substances inhibiting the renin angiotensin aldosterone system.
ATC Classification
C09CA03 - valsartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Diovan FC tab 80 mg
Diovan FC tab 320 mg
Diovan FC tab 160 mg
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