Adult: Amlodipine 5 mg and valsartan 80 mg tab Amlodipine 5 mg and valsartan 160 mg tab Amlodipine 5 mg and valsartan 320 mg tab Amlodipine 10 mg and valsartan 160 mg tab Amlodipine 10 mg and valsartan 320 mg tab
Initially, 1 tab once daily; dose may be titrated after 1-2 weeks of treatment. Max: Amlodipine 10 mg/valsartan 320 mg once daily. Dosage is individualised and adjusted based on patient's target blood pressure and clinical response. Dosing recommendations and available preparations may vary among individual products and between countries (refer to specific product guidelines).
What are the brands available for Amlodipine + Valsartan in Malaysia?
Amlodipine + Valsartan May be taken with or without food.
Contraindications
Biliary cirrhosis or cholestasis, severe hypotension, shock (including cardiogenic shock); obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high-grade aortic stenosis), haemodynamically unstable heart failure after acute MI. Severe hepatic impairment. Pregnancy. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2).
Special Precautions
Patient with biliary obstructive disorders; volume or salt depletion; unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney; primary hyperaldosteronism; CHF, recent MI, mitral stenosis or significant aortic stenosis; idiopathic or hereditary angioedema or previous angioedema associated with ACE inhibitor therapy; diabetes mellitus. Patients undergoing surgery. Renal impairment and mild to moderate hepatic impairment. Lactation.
Adverse Reactions
Significant: Excessive hypotension, syncope; angioedema (including swelling of the larynx and glottis), peripheral oedema; worsening angina and acute MI; renal function deterioration and/or increased serum creatinine; hyperkalaemia. Cardiac disorders: Palpitations, tachycardia. Ear and labyrinth disorders: Vertigo. Eye disorders: Visual impairment. Gastrointestinal disorders: Abdominal discomfort, upper abdominal pain, nausea, constipation, diarrhoea, dry mouth. General disorders and administration site conditions: Asthenia, fatigue, facial oedema, oedema, pitting oedema. Metabolism and nutrition disorders: Anorexia, hypercalcaemia, hyperlipidaemia, hyperuricaemia, hypokalaemia, hyponatraemia. Musculoskeletal and connective tissue disorders: Arthralgia, back pain, joint swelling. Nervous system disorders: Abnormal coordination, dizziness, headache, paraesthesia, somnolence. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, influenza, cough, pharyngolaryngeal pain. Skin and subcutaneous tissue disorders: Erythema, rash. Vascular disorders: Orthostatic hypotension, flushing, hot flush.
This drug may cause dizziness or weariness, if affected, do not drive or operate machinery.
Monitoring Parameters
Correct Na or volume depletion prior to treatment initiation. Monitor blood pressure, heart rate; electrolytes (at baseline and periodically thereafter); renal and liver function. Assess for signs and symptoms of orthostasis and peripheral oedema.
Overdosage
Symptoms: Amlodipine: Excessive peripheral vasodilation, reflex tachycardia; marked and possibly prolonged systemic hypotension up to and including shock; non-cardiogenic pulmonary oedema. Valsartan: Pronounced hypotension with dizziness. Management: Perform gastric lavage and induce emesis for recent ingestion. Administer activated charcoal to decrease absorption. Monitor cardiac and respiratory function frequently; elevate the extremities and give attention to circulating fluid volume and urine output. May consider giving a vasoconstrictor for restoring vascular tone and blood pressure. Administration of IV calcium gluconate may reverse the Ca channel blockade effects.
Drug Interactions
Increased antihypertensive effect with other antihypertensive agents (e.g. diuretics, α blockers) and other drugs which cause hypotensive effects (e.g. TCAs).
Amlodipine: Significant increase in exposure with strong or moderate CYP3A4 inhibitors (e.g. protease inhibitors, azole antifungals, macrolides, verapamil, diltiazem). Concomitant use with CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin) may alter the plasma concentration of amlodipine. Increased plasma concentration of simvastatin. Increased risk of hyperkalaemia with dantrolene IV. May increase the systemic exposure of ciclosporin or tacrolimus.
Valsartan: May enhance hyperkalaemic effects with other agents that block the renin-angiotensin system, K supplements, K-sparing diuretics, salt substitutes containing K or other agents that may increase K levels (e.g. heparin). Increased serum concentration of lithium. Concomitant use with NSAIDs (including COX-2 inhibitors, acetylsalicylic acid [>3g/day] and non-selective NSAIDs) may attenuate the antihypertensive effect of valsartan, increase the risk of worsening renal function, and increase serum K. Increased systemic exposure with inhibitors of uptake transporter (e.g. ciclosporin, rifampicin) or efflux transporter (e.g. ritonavir). Potentially Fatal: Valsartan: Increased risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure) with ACE inhibitors, other ARBs or aliskiren.
Food Interaction
Amlodipine: Increased antihypertensive effect with grapefruit or grapefruit juice. May alter plasma concentration with St. John's wort.
Action
Description: Mechanism of Action: Amlodipine is a dihydropyridine Ca channel blocker. It acts directly on vascular smooth muscle which causes a reduction peripheral vascular resistance and blood pressure.
Valsartan is an angiotensin II receptor antagonist. It inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the angiotensin II type 1 receptor in tissues such as vascular smooth muscle and the adrenal gland. Consequently, by preventing the actions of angiotensin II, valsartan reduces systemic vascular resistance with minimal impact on heart rate. Onset: Amlodipine: Antihypertensive effect: Approx 24-48 hours.
Valsartan: Approx 2 hours. Duration: Amlodipine: Antihypertensive effect: Approx 24 hours.
Valsartan: 24 hours. Pharmacokinetics: Absorption: Amlodipine: Well absorbed. Bioavailability: Approx 64-90%. Time to peak plasma concentration: 6-12 hours.
Valsartan: Rapidly absorbed after oral administration. Reduced exposure and peak plasma concentration with food. Bioavailability: 25% (range: 10-35%). Time to peak plasma concentration: 2-4 hours. Distribution: Amlodipine: Crosses the placenta and enters breast milk. Volume of distribution: 21 L/kg. Plasma protein binding: Approx 93%.
Valsartan: Plasma protein binding: 94-97%, mainly to serum albumin. Metabolism: Amlodipine: Extensively metabolised in the liver into inactive metabolites.
Valsartan: Metabolised minimally in the liver by CYP2C9 into the inactive valeryl 4-hydroxy valsartan metabolite. Excretion: Amlodipine: Via urine (10% as unchanged drug, 60% as metabolites). Terminal elimination half-life: Approx 30-50 hours.
Valsartan: Via faeces (approx 83%); urine (approx 13% as unchanged drug). Elimination half-life: Approx 6 hours.
Chemical Structure
Amlodipine Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 2162, Amlodipine. https://pubchem.ncbi.nlm.nih.gov/compound/Amlodipine. Accessed Feb. 25, 2025.
Valsartan Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 60846, Valsartan. https://pubchem.ncbi.nlm.nih.gov/compound/Valsartan. Accessed Jan. 30, 2025.
C09DB01 - valsartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.
References
Amlodipine and Valsartan. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 12/03/2025.Amlodipine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 12/03/2025.Amlodipine/Valsartan Mylan 10 mg/160 mg Film-coated Tablets (Generics [UK] Limited t/a Mylan). MHRA. https://products.mhra.gov.uk. Accessed 12/03/2025.Brayfield A, Cadart C (eds). Amlodipine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/03/2025.Brayfield A, Cadart C (eds). Valsartan. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/03/2025.Exforge Tablet, Film Coated (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/03/2025.Joint Formulary Committee. Amlodipine with Valsartan. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/03/2025.Valgen-AM 160 mg + 5 mg and 160 mg + 10 mg Film-coated Tablets (Genpharma Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/03/2025.Valsartan. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 12/03/2025.
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