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
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. Risk of hypotension in Na- &/or vol-depleted patients. Unilateral or bilateral renal artery stenosis, stenosis to solitary kidney or after recent kidney transplantation. Heart failure, severe chronic heart failure or other conditions w/ renin-angiotensin-aldosterone system stimulation; acute MI; severe obstructive CAD; aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy. Avoid concomitant use w/ aliskiren in patients w/ severe renal impairment. Avoid co-administration w/ ACE inhibitors. Severe renal impairment (CrCl <10 mL/min) & dialysis. Not recommended in childn <18 yr.
Adverse Reactions
Nasopharyngitis, flu, headache, peripheral, pitting & facial oedema, hot flush, fatigue, flushing, asthenia, dizziness, somnolence, postural dizziness, paraesthesia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal & abdominal pain, diarrhea, nausea, constipation, dry mouth, rash, erythema, joint swelling, back pain, arthralgia.
Drug Interactions
Amlodipine: Increased exposure of simvastatin. Increased plasma conc w/ CYP3A4 inhibitors. Valsartan: Concomitant use w/ K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that increase K levels. Attenuated antihypertensive effects w/ NSAIDs. Increased valsartan systemic exposure w/ uptake transporter inhibitors (rifampin, ciclosporin) or efflux transporter (ritonavir).
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
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