Exforge

Exforge

amlodipine + valsartan

Manufacturer:

Novartis

Distributor:

DCH Auriga

Marketer:

IQVIA
Concise Prescribing Info
Contents
Per 5 mg/80 mg tab Amlodipine besylate 5 mg, valsartan 80 mg. Per 5 mg/160 mg tab Amlodipine besylate 5 mg, valsartan 160 mg. Per 5 mg/320 mg tab Amlodipine besylate 5 mg, valsartan 320 mg. Per 10 mg/160 mg tab Amlodipine besylate 10 mg, valsartan 160 mg. Per 10 mg/320 mg tab Amlodipine besylate 10 mg, valsartan 320 mg
Dosage/Direction for Use
1 tab/day. Initial therapy, usual starting dose: 5/80 mg once daily. May be increased after 1-2 wk to a max dose of one 10/320 mg tab once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use of aliskiren in patients w/ type 2 diabetes. Pregnancy.
Special Precautions
Excessive hypotension in patients w/ Na &/or vol depletion. Severe renal impairment (GFR <30 mL/min). Concomitant use w/ K supplements, K-sparing diuretics, salt substitutes containing K or other drugs that may increase K levels (eg, heparin). Monitor K levels regularly. Patients w/ unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney, kidney transplantation, serious CHF, oliguria &/or progressive azotemia, heart failure/post MI, acute MI; aortic & mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Discontinue if angioedema develops. Concomitant use w/ other agents blocking the renin angiotensin system (RAS) eg, ACE inhibitors or aliskiren. Hepatic impairment or biliary obstructive disorders. Renal impairment. Childn <18 yr.
Adverse Reactions
Nasopharyngitis, flu; headache; oedema (pitting, facial, peripheral), fatigue, flushing, asthenia, hot flush.
Drug Interactions
Amlodipine: Simvastatin, CYP3A4 inducers & inhibitors; grapefruit juice. Valsartan: Increased incidence of hypotension, hyperkalemia & changes in renal function w/ other agents acting on the RAS eg, ARBs/ACE inhibitors & aliskiren. K supplements, K-sparing diuretics, K-containing salt substitutes & other substances that may increase K levels. Attenuation of antihypertensive effect w/ NSAIDs including selective COX-2 inhibitors. May increase serum lithium conc & toxicity. May increase the systemic exposure w/ uptake transporter (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 mg/160 mg tab
Packing/Price
28's
Form
Exforge 10 mg/320 mg tab
Packing/Price
28's
Form
Exforge 5 mg/160 mg tab
Packing/Price
28's
Form
Exforge 5 mg/320 mg tab
Packing/Price
28's
Form
Exforge 5 mg/80 mg tab
Packing/Price
28's
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