amlodipine + valsartan




Four Star
Concise Prescribing Info
Per 5/80 mg tab Amlodipine besylate 5 mg, valsartan 80 mg. Per 5/160 mg tab Amlodipine besylate 5 mg, valsartan 160 mg. Per 10/160 mg tab Amlodipine besylate 10 mg, valsartan 160 mg
Essential HTN in adult patients whose BP is not adequately controlled by monotherapy.
Dosage/Direction for Use
May be taken with or without food: Do not take w/ grapefruit or grapefruit juice.
Hypersensitivity to amlodipine, valsartan or dihydropyridine derivatives. Severe hepatic impairment, biliary cirrhosis or cholestasis. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hypotension; shock; obstruction of the outflow of left ventricle eg, hypertrophic obstructive cardiomyopathy & high grade aortic stenosis. Haemodynamically unstable heart failure after acute MI. Pregnancy (2nd & 3rd trimester).
Special Precautions
Symptomatic hypotension may occur in Na- &/or vol-depleted patients receiving high doses of diuretics. Concomitant use w/ K supplements, K-sparing diuretics, salt substitutes containing K or other drugs that may increase K levels (eg, heparin). Monitor K levels regularly. Renal artery stenosis. Kidney transplantation. Mild to moderate hepatic impairment or biliary obstructive disorders. Monitor K levels & creatinine in moderate renal impairment patients. Patients w/ primary hyperaldosteronism should not be treated w/ valsartan. Angioedema; heart failure/post-MI, aortic or mitral stenosis. Dual blockade of the renin-angiotensin-aldosterone system. Mild to moderate influence on the ability to drive & use machines. Do not initiate during pregnancy. Lactation. Elderly ≥65 yr. Childn <18 yr.
Adverse Reactions
Nasopharyngitis, flu, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema or peripheral oedema, fatigue, flushing, asthenia, hot flush.
Drug Interactions
Increased antihypertensive effect w/ TCAs, α-blockers, diuretics. Amlodipine: Increased bioavailability w/ grapefruit/grapefruit juice. Increased exposure w/ CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides, verapamil, diltiazem. Decreased conc w/ CYP3A4 inducers eg, anticonvulsants, rifampicin, H. perforatum. Increased exposure of simvastatin. Avoid co-administration w/ dantrolene (infusion). Valsartan: Increased lithium conc. Increased K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes & other substances that may increase K levels. Attenuated antihypertensive effect w/ NSAIDs including selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day) & nonselective NSAIDs. Increased systemic exposure w/ inhibitors of uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir). Dual blockade of the renin-angiotensin-aldosterone system w/ ACE inhibitors, angiotensin receptor blockers, or aliskiren.
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists
ATC Classification
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.
Exforge 10/160 mg film-coated tab
Exforge 5/160 mg film-coated tab
Exforge 5/80 mg film-coated tab
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