Valgen-AM

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 patients whose BP is inadequately controlled by monotherapy.

1 tab daily, may be increased after 1-2 wk to max: 10/320 mg daily. Mild to moderate hepatic impairment w/o cholestasis Not to exceed 5/80 mg daily.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ aliskiren in type 2 diabetic patients. Severe hepatic impairment, biliary cirrhosis & cholestasis. Pregnancy.

Discontinue immediately & not to be re-administered if angioedema develops. Not recommended as initial therapy in patients w/ intravascular vol depletion. Uni- or bilateral renal artery stenosis, stenosis to solitary kidney; recent kidney transplantation; serious CHF (NYHA class III-IV); worsening angina pectoris & acute MI, severe obstructive CAD; aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy. Correct Na &/or vol depletion prior to treatment. Monitor LFTs, BP, renal function & electrolytes. Avoid use w/ aliskiren in severe renal impairment (GFR <30 mL/min). Concomitant use w/ K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs increasing K levels eg, heparin. Co-administration w/ renin-angiotensin-aldosterone system (RAAS) blockers eg, ACE inhibitors or aliskiren. May affect ability to drive & use machines. Mild to moderate hepatic impairment w/o cholestasis. Severe renal impairment (CrCl <10 mL/min). Not to be used in women of childbearing potential, during pregnancy & lactation. Not recommended in ped patients <18 yr.

Nasopharyngitis, flu; headache; oedema, pitting, facial & peripheral oedema, fatigue, flushing, asthenia, hot flush.

Amlodipine: Increased exposure to simvastatin. Increased plasma conc w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir; grapefruit juice. Concomitant use w/ CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Valsartan: Increased incidence of hypotension, hyperkalaemia & renal function changes w/ RAAS blockers eg, ARBs, ACE inhibitors or aliskiren. Increased K levels w/ K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs increasing K levels eg, heparin. Attenuated antihypertensive effect w/ NSAIDs including COX-2 inhibitors. Reversible increased serum lithium conc & toxicity. Increased systemic exposure w/ uptake (eg, rifampin, ciclosporin) or efflux (eg, ritonavir) transporter inhibitors.

Angiotensin II Antagonists / Calcium Antagonists

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.

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