Exforge

Exforge

amlodipine + valsartan

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
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
Indications/Uses
Essential HTN in patients whose BP is inadequately controlled by monotherapy.
Dosage/Direction for Use
Adult 1 tab daily, may be increased after 1-2 wk to max: 10 mg/320 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren in diabetic type 2 patients. Severe hepatic impairment, biliary cirrhosis & cholestasis. Pregnancy.
Special Precautions
Discontinue immediately & not to be re-administered in patients w/ history of or angioedema. Not recommended as initial therapy in patients w/ intravascular vol depletion. Unilateral or bilateral renal artery stenosis, stenosis to solitary kidney; after recent kidney transplantation. Serious CHF (NYHA class III-IV), angina pectoris & acute MI; severe obstructive CAD; aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy. Correct Na &/or vol depletion prior to treatment. Monitor serum K, LFTs, renal function. Concomitant use w/ K supplements, K-sparing diuretics, K-containing salt substitutes, or other drugs increasing serum K (eg, heparin). Co-administration w/ renin-angiotensin system blockers eg, ACE inhibitors or aliskiren. Avoid concomitant use w/ aliskiren in patients w/ severe renal impairment. Mild to moderate hepatic impairment w/o cholestasis. Severe renal impairment (CrCl <10 mL/min) & dialysis. Not to be used in women of childbearing potential. Not to be used during pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Nasopharyngitis, flu; headache; pitting, facial & peripheral oedema, fatigue, flushing, asthenia, hot flush.
Drug Interactions
Amlodipine: Increased exposure of simvastatin. Increased plasma conc w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Valsartan: Increased incidence of hypotension, hyperkalaemia & 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 increasing K levels. Attenuated antihypertensive effect w/ NSAIDs including COX-2 inhibitors. Increased systemic exposure w/ uptake transporter (eg, rifampin, ciclosporin) or efflux transporter (eg, ritonavir) inhibitors. Reversible increased in serum lithium conc & toxicity.
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.
Presentation/Packing
Form
Exforge 10/160 mg FC tab
Packing/Price
14's;28's;7's
Form
Exforge 5/160 mg FC tab
Packing/Price
14's;28's;7's
Form
Exforge 5/80 mg FC tab
Packing/Price
14's;28's;7's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in