Tareg Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Valsartan

Indications/Uses

HTN in adults, childn, & adolescents 6-18 yr. Heart failure (NYHA class II-IV) in adults receiving standard therapy eg, diuretics, digitalis & either ACE inhibitors or β-blockers but not both; presence of all these standard therapies is not mandatory. Improve survival following MI in clinically stable adults 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.

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Dosage/Direction for Use

Adult HTN 80 or 160 mg once daily. Patient whose BP is not adequately controlled Dose can be increased to 320 mg or a diuretic may be added. Heart failure Initially 40 mg bid, can be up-titrated to 80 or 160 mg bid. Post-MI 20 mg bid initiated as early as 12 hr after MI. Titrate to 40, 80, & 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. If starting on 80 mg, up-titrate dose to 160 mg once daily. Childn & adolescent 6-18 yr ≥35 kg Initially 80 mg once daily; <35 kg Initially 40 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Concomitant use w/ aliskiren in patients w/ type 2 diabetes. Pregnancy.

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Special Precautions

Na &/or vol depletion should be corrected before starting treatment. Caution when initiating therapy in patients w/ heart failure or post-MI; always include renal function assessment in the evaluation. Discontinue immediately in patients who develop angioedema. Dual blockade of renin-angiotensin system (RAS) w/ other agents blocking RAS eg, ACE inhibitors or aliskiren. Avoid concomitant use w/ aliskiren in patients w/ severe renal impairment (GFR <30 mL/min). Patients w/ unilateral or bilateral renal artery stenosis; severe renal impairment (CrCl <10 mL/min); biliary obstructive disorders. Not advisable in breast-feeding mothers. Closely monitor renal function & serum K in ped patients. Not recommended in ped patients w/ GFR <30 mL/min/1.73 m² & undergoing dialysis. Limited clinical experience in ped patients w/ mild to moderate hepatic impairment.

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Use In Pregnancy & Lactation

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Adverse Reactions

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

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Drug Interactions

Increased incidence of hypotension, hyperkalemia & changes in renal function w/ other agents acting on RAS. Concomitant use w/ K-sparing diuretics, K supplements, salt substitutes containing K, or other drugs that may increase K levels (eg, heparin) may increase serum K & in heart failure patients, increase serum creatinine. Attenuation of antihypertensive effect & increased risk of worsening of renal function w/ NSAIDs including selective COX-2 inhibitors. Increased serum lithium conc & toxicity. Increased systemic exposure w/ inhibitors of OATP1B1 (rifampin, ciclosporin) or MRP2 (ritonavir).

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Storage

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Description

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Action

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MIMS Class

Angiotensin II Antagonists

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

Tareg film-coated tab 160 mg

Packing/Price

14's;28's

Form

Tareg film-coated tab 80 mg

Packing/Price

28's

Tareg

valsartan

Manufacturer:

Sandoz

Distributor:

Sandoz