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Exforge

Exforge

amlodipine + valsartan

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 5 mg/80 mg FC tab Amlodipine besilate 5 mg, valsartan 80 mg. Per 5 mg/160 mg FC tab Amlodipine besilate 5 mg, valsartan 160 mg. Per 10 mg/160 mg FC tab Amlodipine besilate 10 mg, valsartan 160 mg
Indications/Uses
Essential HTN. May be used as initial therapy in patients who are likely to need multiple drugs to achieve BP goals.
Dosage/Direction for Use
Adult Initially 5 mg/80 mg once daily, can be increased after 1-2 wk to a max of 10 mg/320 mg once daily.
Administration
May be taken with or without food: Take w/ some water.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren in patients w/ type 2 diabetes. Pregnancy.
Special Precautions
Risk of symptomatic hypotension in patients w/ activated renin-angiotensin system (eg, salt- &/or vol-depleted patients). Correction of salt &/or vol depletion prior to administration of therapy or close medical supervision at start of treatment is recommended. Not recommended as initial therapy in patients w/ intravascular vol depletion. Reports of angioedema w/ valsartan; discontinue immediately if patient develops angioedema. Include assessment of renal function in the evaluation of patients w/ heart failure or post-MI. Risk of worsening angina pectoris & acute MI after starting or increasing dose of amlodipine in patients w/ severe obstructive CAD. Caution in patients w/ serious CHF (NYHA class III-IV); aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy; unilateral or bilateral renal artery stenosis or stenosis to solitary kidney; severe renal impairment (CrCl <10 mL/min); hepatic impairment or biliary obstructive disorders. Dual blockade of renin-angiotensin system (RAS) when ARB (including valsartan) is co-administered w/ other agents blocking the RAS eg, ACE inhibitors or aliskiren. Caution & w/ frequent monitoring of K when concomitantly used w/ K supplements, K-sparing diuretics, salt substitutes containing K, or other drugs that may increase K levels (eg, heparin). No experience of safe use in patients who have had recent kidney transplantation. Closely observe infants whose mothers have taken ARB therapy in 1st trimester. Not advisable for lactating women. Not recommended for use in childn <18 yr.
Adverse Reactions
Nasopharyngitis, flu; headache; edema (including peripheral, pitting, facial), hot flush, fatigue, flushing, asthenia.
Drug Interactions
Amlodipine: Increased exposure to simvastatin. Increased systemic exposure w/ diltiazem in elderly hypertensive patients. Increased plasma conc w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Monitor patients for adequate clinical effect when co-administered w/ CYP3A4 inducers. Valsartan: Increased incidence of hypotension, hyperkalemia & changes in renal function w/ other agents acting on RAS. Increased K levels w/ K supplements, K-sparing diuretics, salt substitutes containing K or other drugs that may increase K levels (eg, heparin). Attenuated antihypertensive effect w/ NSAIDs including selective COX-2 inhibitors. Increased risk of worsening renal function w/ NSAIDs in patients who are elderly, vol-depleted (including those on diuretic therapy), or have compromised renal function. Reversible increases in serum lithium conc & toxicity. Systemic exposure to valsartan may be increased w/ inhibitors of OATP1B1 (eg, rifampin, ciclosporin) or MRP2 (eg, 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 FC tab
Packing/Price
7's
Form
Exforge 5 mg/160 mg FC tab
Packing/Price
7's
Form
Exforge 5 mg/80 mg FC tab
Packing/Price
7's
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