Per 5 mg/80 mg FC tab Amlodipine 5 mg, valsartan 80 mg. Per 10 mg/160 mg FC caplet Amlodipine 10 mg, valsartan 160 mg
Indications/Uses
Essential HTN in adults whose BP is not adequately controlled on amlodipine or valsartan monotherapy.
Dosage/Direction for Use
1 tab/caplet daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Hereditary angioedema or in those in whom angioedema developed during earlier treatment w/ an ACE inhibitor or an AIIA. Severe liver impairment, biliary cirrhosis, cholestasis. Severe kidney impairment (CrCl <10 mL/min). Pregnancy & lactation.
Special Precautions
Hypotension may occur in patients receiving ARBs w/ activated renin-angiotensin system. Co-administration w/ agents blocking the renin-angiotensin system eg, ACE inhibitors or aliskiren. Patients w/ unilateral or bilateral renal artery stenosis, kidney impairment, recent kidney transplantation, acute hepatic impairment or biliary obstructive disorders, acute MI, CHF, severe obstructive CAD, aortic & mitral stenosis or obstructive hypertrophic cardiomyopathy. Monitor K & creatinine levels in patients w/ moderate renal impairment. Childn <18 yr.
Amlodipine: Increased exposure of simvastatin. Increased plasma conc w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). May enhance BP lowering effects w/ grapefruit or grapefruit juice. Valsartan: Increased incidence of hypotension, hyperkalemia & changes in renal function w/ agents blocking the renin-angiotensin system eg, ACE inhibitors or aliskiren. Concomitant use w/ K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that increase K levels may increase K level. Attenuated antihypertensive effects w/ NSAIDs. Concomitant use w/ lithium may increase (reversible) lithium plasma conc & toxicity. Increase blood valsartan level w/ uptake transporter inhibitors (rifampin, ciclosporin) or efflux transporter (ritonavir).
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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