Torval-80/Torval-160

HTN in adults & in childn & adolescents 6-18 yr. Heart failure (NYHA class II-IV) in patients receiving standard therapy eg, diuretics, digitalis & either ACE inhibitors or β-blockers but not both (presence of all these standard therapies is not mandatory). Improvement of survival following MI in clinically stable patients w/ signs, symptoms or radiological evidence of left ventricular failure &/or w/ left ventricular systolic dysfunction. In addition to lifestyle modifications to delay the progression to type 2 diabetes in hypertensive adults w/ impaired glucose tolerance at CV risk.

Adult HTN Initially 80 or 160 mg once daily, may be increased to 320 mg daily or may add diuretic if BP is not adequately controlled. Heart failure 40 mg bid. Up-titration to 80-160 mg bid should be done to the highest dose tolerated by patient. Consider reducing dose of concomitant diuretics. Max daily dose: 320 mg in divided doses. Post-MI Therapy may be initiated as early as 12 hr after MI. Initially 20 mg bid, titrated to 40 mg, 80 mg, & 160 mg bid over the next few wk. Target max dose: 160 mg bid. Hypertensive adult patient w/ impaired glucose tolerance at CV risk Initially 80 or 160 mg once daily. When starting on 80 mg, up-titration to 160 mg once daily should be done as tolerated by patient. Childn & adolescent 6-18 yr HTN Initially 80 mg once daily for ≥35 kg & 40 mg once daily for <35 kg.

May be taken with or without food.

Hypersensitivity. Concomitant use of ARBs or ACE inhibitors w/ aliskiren in patients w/ type 2 diabetes. Pregnancy.

Immediately discontinue treatment in patients who develop angioedema including swelling of the larynx, glottis, face, lips, pharynx, or tongue & do not re-administer. Correct Na &/or vol depletion (eg, patients on high-dose diuretics) before initiating therapy. Monitor blood urea & serum creatinine in patients w/ bilateral or unilateral renal artery stenosis. Caution when initiating therapy in patients w/ heart failure or post-MI. Oliguria &/or progressive azotaemia &, rarely, w/ acute renal failure &/or death in patients w/ severe heart failure whose renal function may depend on the activity of the renin angiotensin aldosterone system (RAAS). Caution w/ triple combination of ACE inhibitor & β-blocker in patients w/ heart failure; other agents blocking renin-angiotensin system (RAS) eg, ACE inhibitors or aliskiren. Avoid use in patients w/ severe renal impairment (CrCl <10 mL/min or GFR <30 mL/min). Caution in patients w/ biliary obstructive disorders. Should not be used in women planning to become pregnant or during pregnancy. Discontinue therapy as soon as possible if pregnancy is detected. Use is not advisable in breast-feeding mothers. Not recommended for treatment of heart failure or recent MI in childn & adolescents <18 yr. Safety & efficacy have not been established in childn & adolescents <18 yr. Not recommended in ped patients w/ GFR <30 mL/min/1.73 m² or undergoing dialysis. Caution in ped patients w/ renal or hepatic impairment.

Heart failure &/or post-MI: Dizziness, postural dizziness; hypotension, orthostatic hypotension; renal failure & impairment.

Increased incidence of hypotension, hyperkalemia, & changes in renal function w/ other agents acting on the RAS. Avoid concomitant use of ARBs or of ACE inhibitors w/ aliskiren in patients w/ severe renal impairment (GFR <30 mL/min). May lead to increases in serum K & in heart failure patients to increases in serum creatinine w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, or K-containing salt substitutes. Attenuation of antihypertensive effect may occur w/ NSAIDs. May lead to increased risk of worsening renal function w/ NSAIDs in patients who are elderly, vol-depleted (including those on diuretic therapy), or have compromised renal function. Reversible increases in serum lithium conc & toxicity. Systemic exposure may be increased w/ inhibitor of uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir). May increase serum K w/ other substances that inhibit the RAAS in childn & adolescents w/ HTN.

Angiotensin II Antagonists

C09CA03 - valsartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.

Rx