amlodipine + valsartan




Concise Prescribing Info
Amlodipine 5 mg, valsartan 80 mg
Dosage/Direction for Use
May be taken with or without food.
Hypersensitivity to amlodipine, valsartan, or to dihydropyridine compd. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy.
Special Precautions
Should not be used as a 1st-line treatment for HTN due to risk of excessive decrease in BP. Patients w/ bilateral or unilateral renal artery stenosis; hyperkalemia; cerebrovascular disease. Patients under severe limitation of salt intake. Administration w/in 24 hr before surgery is undesirable. Concomitant use w/ antihypertensive diuretic. Use of other antihypertensives after discontinuation of NIKP-Amlodipine/Valsartan. Dual blockade of renin-angiotensin-aldosterone system (RAAS) w/ combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren. May cause dizziness & lightheadedness; use w/ caution when operating hazardous machinery or driving a car. Patients undergoing hemodialysis. Patients w/ severe renal impairment; hepatic disorder, particularly w/ biliary cirrhosis & cholestasis. Avoid in elderly; during pregnancy, delivery & lactation; childn.
Adverse Reactions
Angioedema (eg, swelling of the face, lips, pharynx, tongue); fulminant hepatitis, hepatitis, hepatic impairment, jaundice; renal failure; hyperkalemia; shock, fainting, loss of consciousness; agranulocytosis, leukopenia, thrombopenia; interstitial pneumonia; hypoglycemia; AV block; rhabdomyolysis; toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme; pemphigus, pemphigoid.
Drug Interactions
Increased risk of hypotension, hyperkalemia & decreased renal function w/ ACE inhibitors, angiotensin II receptor blockers or aliskiren. Additive effect w/ other drugs w/ hypotensive action. Amlodipine: Increased blood conc w/ CYP3A4 inhibitors (eg, erythromycin & diltiazem). Decreased blood conc w/ CYP3A4 inducers (eg, rifampicin). Increased hypotensive action w/ grapefruit juice. Reports of increased AUC of simvastatin. Increased blood conc of tacrolimus. Valsartan: Risk of increased serum K levels w/ K-sparing diuretics or K supplements. Weakened antihypertensive effect & risk of worsening of renal function w/ NSAIDs & selective COX-2 inhibitors. Decreased blood conc w/ bixalomer. Increased blood conc of lithium.
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.
NIKP-Amlodipine/Valsartan 5/80 mg FC tab
10 × 10's
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