Exforge

Exforge

amlodipine + valsartan

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 5/80 mg FC tab Amlodipine besilate 5 mg, valsartan 80 mg. Per 5/160 mg FC tab Amlodipine besilate 5 mg, valsartan 160 mg. Per 10/160 mg FC tab Amlodipine besilate 10 mg, valsartan 160 mg
Dosage/Direction for Use
Adult Initially 5/80 mg once daily, increased after 1-2 wk to a max of 10/320 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren in type 2 diabetes. Pregnancy.
Special Precautions
Risk of hypotension in Na- &/or vol-depleted patients. Severe renal impairment (CrCl <10 mL/min) & dialysis. Unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation. Hepatic impairment or biliary obstructive disorders. Discontinue immediately & do not re-administer in patients experiencing angioedema or having history of angioedema w/ other drugs. Heart failure, severe chronic heart failure or other conditions w/ stimulation of the RAAS. Acute MI. Aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy. Avoid concomitant use w/ aliskiren in patients w/ severe renal impairment (GFR <30 mL/min). Concomitant use w/ other agents blocking RAS eg, ACE inhibitors or aliskiren. Not to be used in women planning to become pregnant. Pregnancy & lactation. Not recommended in patients <18 yr.
Adverse Reactions
Nasopharyngitis, flu; headache, edema (peripheral, pitting, facial), hot flush, fatigue, flushing, asthenia; dizziness, postural dizziness, somnolence, vertigo; tachycardia, palpitations, orthostatic hypotension; cough; pharyngolaryngeal pain; diarrhea, nausea, abdominal pain, constipation; dry mouth; rash, erythema; joint swelling, back pain, arthralgia.
Drug Interactions
May increase incidence of hypotension, hyperkalemia & changes in renal function w/ other agents blocking the RAS eg, ACE inhibitors or aliskiren. May increase K levels w/ K supplements, K-sparing diuretics, salt substitutes containing K or other drugs (eg, heparin). May decrease antihypertensive effects w/ NSAIDs including COX-2 inhibitors; vol-depleted or compromised renal function in elderly. May increase amlodipine plasma conc w/ CYP34A inhibitors (eg, ketoconazole, itraconazole, ritonavir). CYP3A4 inducers (eg, rifampicin, H. perforatum). May increase systemic exposure to valsartan w/ inhibitors of the uptake transporter (eg, rifampin, ciclosporin) or efflux transporter (eg, ritonavir). May increase 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
7's
Form
Exforge 5/160 mg FC tab
Packing/Price
7's
Form
Exforge 5/80 mg FC tab
Packing/Price
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