Valsaram

Per 5 mg/80 mg FC tab Amlodipine besylate 5 mg, valsartan 80 mg. Per 5 mg/160 mg FC tab Amlodipine besylate 5 mg, valsartan 160 mg. Per 10 mg/160 mg FC tab Amlodipine besylate 10 mg, valsartan 160 mg

Essential HTN. As an initial therapy in patients who are likely to need multiple drugs to achieve BP goals.

1 tab daily. Mild & moderate hepatic disorder Max: 80 mg valsartan.

May be taken with or without food: Preferably, take at the same time every day (eg, morning).

Hypersensitivity to amlodipine, valsartan & dihydropyridine derivatives. Co-administration w/ aliskiren prep in patients w/ diabetes or moderate-severe renal impairment (GFR <60 mL/min/1.73 m²). Hereditary angioedema or w/ angioedema history when treating w/ ACE inhibitor or angiotensin II receptor blocker; idiopathic primary aldosteronism; severe aortic stenosis. Shock patients. Hepatic insufficiency, biliary cirrhosis or cholestasis. Severe renal impairment CrCl ≤10 mL/min. Pregnancy & lactation.

Not to be administered in patients w/ severe hepatic impairment, biliary cirrhotic liver & biliary obstruction-cholestasis. Dizziness & fatigue may intermittently ocur when driving & operating a machine. Not recommended in childn <18 yr. Elderly >65 yr. Amlodipine: Patients w/ CHF (NYHA class III or IV stage) or MI; aortic stenosis & mitral stenosis, obstructive cardiomyopathy. Valsartan: Discontinue immediately if angioedema (including larynx & glottis swelling) occurs. Symptomatic hypotension may occur in vol &/or salts depleted patients taking high doses of diuretics. Patients undergoing dialysis, taking diuretics, under strict salt restriction. Increased blood urea & serum creatinine in patients w/ bilateral or unilateral renal artery stenosis, or patients w/ single kidney syndrome. Hypouresis &/or progressive azotemia in patients whose renal function is dependent to activation of renin-angiotensin-aldosterone system. Kidney transplantation patients. Concomitant use w/ K adjuvant, K-sparing diuretics, salt substitute containing K or other drugs (ie, heparin). Periodically monitor K levels. Not recommended w/ concomitant therapy w/ ACE inhibitors or aliskiren; β-blocker.

Nasopharyngitis, flu; headache. Valsartan: Edema, pitting edema, face edema, peripheral edema, fatigue, blush, asthenia, hot flush.

May increase K levels w/ K adjuvant, K-sparing diuretics, salt substitute containing K or other drugs (ie, heparin).

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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