RiteMED Valsartan

RiteMED Valsartan



Sun Pharma Industries


Concise Prescribing Info
Treatment of HTN as monotherapy or in combination w/ other antihypertensive agents. Treatment of heart failure (NYHA class II-IV). Reduces CV mortality in clinically stable patients w/ left ventricular failure or left ventricular dysfunction following MI.
Dosage/Direction for Use
Adult HTN Initially 80 or 160 mg once daily. May increase to a max of 320 mg or a diuretic may be added if additional antihypertensive effect is required. Heart failure Initially 40 mg bid. Up titration to 80 & 160 mg bid should be done to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. Max: 320 mg in divided doses. Post-MI Initially 20 mg bid as early as 12 hr after MI. May up-titrate w/in 7 days to 40 mg bid until target maintenance dose of 160 mg bid is reached. May be given w/ other standard post-MI treatment, including thrombolytics, aspirin, β-blockers, statins & diuretics. Childn 6-18 yr HTN Initially 1.3 mg/kg once daily (up to 40 mg total).
May be taken with or without food.
Hypersensitivity. Severe hepatic impairment, biliary cirrhosis & cholestasis. Do not co-administer w/ aliskiren in patients w/ diabetes.
Special Precautions
Hypotension may occur in patients w/ an activated renin-angiotensin system eg, vol- &/or salt-depleted patients receiving high doses of diuretics. Patients w/ renal artery stenosis, CKD, severe CHF, or vol depletion. Hyperkalemia. Primary hyperaldosteronism, aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy. Discontinue if angioedema develops. Post-MI, heart failure. Closely monitor renal function & serum K. Na &/or vol depleted patients. Kidney transplantation. Concomitant use w/ K supplements, K-sparing diuretics, salt substitutes containing K or other agents that may increase K levels (eg, heparin) is not recommended. Patients w/ diabetes. Dizziness or weariness may occur when driving vehicles or operating machines. Severe renal impairment (CrCl ≤30 mL/min). Mild to moderate hepatic impairment w/o cholestasis. Pregnancy (2nd & 3rd trimester) & lactation. Childn <6 yr. Childn w/ GFR <30 mL/min/1.73 m2 & undergoing dialysis, heart failure & recent MI in childn & adolescents <18 yr. Neonates w/ a history of in utero exposure to valsartan.
Adverse Reactions
Adult HTN: Headache, dizziness, viral infection, fatigue & abdominal pain, upper resp infection, cough, diarrhea. Ped HTN: GI disorders (like abdominal pain, nausea, vomiting) & dizziness. Heart failure: Dizziness, hypotension, diarrhea, arthralgia, fatigue, back pain, postural dizziness, hyperkalemia, postural hypotension. Post-MI: Hypotension, cough, increased blood/serum creatinine, rash.
Drug Interactions
May increase systemic exposure w/ uptake transporter inhibitors (eg, rifampin & cyclosporine) or efflux transporter (eg, ritonavir). May increase serum K w/ other agents that block the renin-angiotensin system, K sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, or salt substitutes containing K. Deterioration of renal function including possible acute renal failure & increase in serum K w/ NSAIDs including COX-2 inhibitors, ASA >3 g/day & non-selective NSAIDs. Increased risk of hypotension, hyperkalemia & changes in renal function (including acute renal failure) w/ dual blockade of the renin-angiotensin system w/ angiotensin receptor blockers eg, ACE inhibitors or aliskiren. Increases serum lithium conc & toxicity.
ATC Classification
C09CA03 - valsartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
RiteMED Valsartan FC tab 80 mg
RiteMED Valsartan FC tab 160 mg
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