Valsartan


Full Generic Medicine Info
Dosage/Direction for Use

Oral
Hypertension
Adult: Initially, 80 mg once daily. Dosage is individualised and may be increased to 160 mg once daily according to clinical response. Max: 320 mg once daily.
Child: 6-18 years <35 kg: 20 mg once daily. Max dose: 40 mg daily; > 35 kg: 40 mg once daily. Max dose: 80 mg daily. Individualised dosing according to clinical response.
Hepatic impairment: Mild to moderate: Max: 80 mg once daily. Severe: Contraindicated.

Oral
Heart failure
Adult: Initially, 40 mg bid, may increase to 80 mg bid may further titrate to 160 mg bid according to clinical response. Dosage is individualised and may be increased at least 2 weeks interval. Max: 320 mg daily in divided doses.
Hepatic impairment: Mild to moderate: Max: 80 mg once daily. Severe: Contraindicated.

Oral
Post myocardial infarction
Adult: May start as early as 12 hours after MI in clinically stable patients: Initially, 20 mg bid. Dose may be doubled at intervals over few weeks up to 160 mg twice daily based on clinical response. Max: 160 mg bid.
Hepatic impairment: Mild to moderate: Max: 80 mg once daily. Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Biliary cirrhosis, cholestasis. Concomitant use with aliskiren in patient with diabetes mellitus or renal impairment (GFR<60 mL/min/1.73 m2). Severe hepatic impairment. Pregnancy.
Special Precautions
Patients with aortic or mitral stenosis, severe CHF, hypertrophic obstructive cardiomyopathy, post MI, heart failure, ascites due to cirrhosis, refractory ascites, unstented unilateral or bilateral renal artery stenosis, Na- and/or volume-, primary hyperaldosteronism, diabetes mellitus, idiopathic or hereditary angioedema. Patients undergoing major surgery or during anaesthesia. Renal and mild to moderate hepatic impairment. Children. Lactation. Patient Counselling This drug may cause dizziness or weariness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood pressure, electrolytes levels e.g. serum K levels, urinalysis and renal function prior to treatment initiation, during therapy, and periodically thereafter. Assess for signs of angioedema.
Adverse Reactions
Significant: Hypotension, hyperkalaemia, orthostatic hypotension. Rarely, hepatitis. Blood and lymphatic system disorders: Neutropenia, thrombocytopenia. Cardiac disorders: Dyspnoea, palpitation. Gastrointestinal disorders: Diarrhoea, abdominal pain, nausea, dyspepsia, flatulence. General disorders and administration site conditions: Fatigue, asthenia. Infections and infestations: Viral infection. Musculoskeletal and connective tissue disorders: Back pain, myalgia, arthralgia. Nervous system disorders: Dizziness, headache, vertigo, postural dizziness, paraesthesia. Psychiatric disorders: Insomnia, anxiety. Reproductive system and breast disorders: Impotence. Respiratory, thoracic and mediastinal disorders: Cough. Skin and subcutaneous tissue disorders: Rash, pruritus. Vascular disorders: Syncope, vasculitis.
Potentially Fatal: Renal function deterioration characterised by oliguria, progressive azotaemia, and acute renal failure; hepatic injury, cardiac failure. Rarely, angioedema.
Overdosage
Symptoms: Marked hypotension, tachycardia or bradycardia, depressed level of consciousness, circulatory collapse and/or shock. Management: Symptomatic and supportive treatment. Administration of activated charcoal following ingestion. If hypotension occurs, place the patient in supine position then administer normal saline IV infusion to facilitate blood volume correction.
Drug Interactions
Increased risk of hyperkalaemia with K-sparing diuretics (e.g. spironolactone, triamterene, amiloride), K supplements or K-containing salt substitutes (e.g. heparin. May increase serum lithium concentration and toxicity. May antagonise hypotensive effect and deteriorate renal function with aspirin, NSAIDs including selective COX-2 inhibitors. Increased systemic exposure with rifampicin, ciclosporin, and ritonavir.
Potentially Fatal: Increased risk of hypotension, hyperkalaemia and reduced renal function including acute renal failure with aliskiren in patients with diabetes mellitus. Increased risk of angioedema with ACE inhibitors.
Food Interaction
May reduce bioavailability with food.
Lab Interference
May result to false-negative aldosterone/renin ratio (ARR).
Action
Valsartan is an angiotensin II receptor antagonist producing its BP lowering effects by selectively blocking the binding of angiotensin II to AT1 receptors, thereby antagonising angiotensin I-induced vasoconstriction, aldosterone release, catecholamine release, arginine vasopressin release, water intake, and hypertrophic responses.
Onset: Approx 2 hours.
Duration: 24 hours.
Absorption: Rapidly absorbed from the gastrointestinal tract. Reduced rate and extent of absorption with food. Bioavailability: Approx 23% (tab); approx 39% (oral solution). Time to peak plasma concentration: 2-4 hours (tab); 1-2 hours (oral solution).
Distribution: Volume of distribution: 17 L. Plasma protein binding: 95% mainly to serum albumin.
Metabolism: Metabolised minimally in the liver by CYP2C9 to inactive valeryl 4-hydroxy valsartan metabolite.
Excretion: Mainly via faeces (approx 83%); urine (approx 13% as unchanged drug). Elimination half-life: Approx 6 hours.
Storage
Oral: Store at 25°C. Protect from moisture.
CIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA03 - valsartan ; Belongs to the class of angiotensin II antagonists. Used in the treatment of cardiovascular disease.
Disclaimer: This information is independently developed by CIMS based on valsartan from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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