Amloval 80/5/Amloval 160/5/Amloval 160/10

Amloval 80/5/Amloval 160/5/Amloval 160/10

amlodipine + valsartan

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Amloval 80/5 Valsartan 80 mg, amlodipine besilate 5 mg. Amloval 160/5 Valsartan 160 mg, amlodipine besilate 5 mg. Amloval 160/10 Valsartan 160 mg, amlodipine besilate 10 mg
Indications/Uses
Essential HTN; patients whose BP is not adequately controlled on valsartan or amlodipine monotherapy.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to valsartan, amlodipine or dihydropyridine derivatives. Biliary cirrhosis or cholestasis; patients undergoing dialysis; severe hepatic & renal impairment (GFR <30 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimesters).
Special Precautions
Na- &/or vol-depleted patients; patients w/ bilateral renal artery stenosis or stenosis to a solitary kidney & recent kidney transplantation. Primary hyperaldosteronism, heart failure, aortic & mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Concomitant use w/ K supplements, K-sparing diuretics, salt substitutes containing K or other products containing K. Mild to moderate hepatic impairment or biliary obstructive disorders. Monitor K levels & creatinine in moderate renal impairment. Pregnancy (1st trimester) & lactation. Childn & adolescent. Elderly ≥65 yr.
Adverse Reactions
Nasopharyngitis, influenza; headache; edema, pitting, facial & peripheral edema, fatigue, flushing, asthenia, hot flush. Amlodipine: Vomiting.
Drug Interactions
Valsartan: Reversible increases in serum conc & toxicity of lithium. Monitor K plasma levels when given w/ K-sparing diuretics, K supplements, salt substitutes containing K & other substances that may increase K levels. Attenuation of antihypertensive effect w/ NSAIDs (including selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day & nonselective NSAIDs). May increase antihypertensive effects w/ TCAs & α-blockers. Amlodipine: Inhibits metabolism w/ diltiazem. May increase plasma conc w/ CYP3A4 inhibitors ie, ketoconazole, itraconazole, ritonavir. Reduced plasma conc w/ CYP3A inducers [anticonvulsants (eg, carbamazepine, phenobarb, phenytoin, fosphenytoin, primidone), rifampicin, H. perforatum].
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
Amloval 160/10 FC tab
Packing/Price
30's (P1,260/box)
Form
Amloval 160/5 FC tab
Packing/Price
30's (P990/box)
Form
Amloval 80/5 FC tab
Packing/Price
30's (P1,260/box)
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