Active Substance: Amlodipine (as besylate), Valsartan.
Overview
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This medicine contains an important and useful components, as it consists of
Amlodipine (as besylate), Valsartanis available in the market in concentration
Amlodipine + Valsartan
Impaired liver or renal function, CHF, sick-sinus syndrome, severe ventricular dysfunction, hypertrophic cardiomyopathy, severe aortic stenosis. Caution when used in patients with idiopathic hypertrophic subaortic stenosis. Elderly, children. During the second and third trimesters of pregnancy, these drugs have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death Lactation: discontinue drug or do not nurse
Hypertension
Known hypersensitivity to dihydropyridines.
>10% Headache,Increased BUN (6-17%) 1-10% Peripheral edema (5-8%),Anxiety (3%),Nasopharyngitis (4%),Increased potassium (3%),Upper respiratory infection (3%),Dizziness (2%),Somnolence (3%),Diarrhea (3%),Nausea (3%),Abdominal pain (3%),Cough (2%) <1% Orthostatic hypotension,Syncope,Visual disturbance,Tinnitus,Exanthema Potentially Fatal: Hypotension, bradycardia, conductive system delay and CCF.
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Amlodipine relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the slow channels or select voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It also increases myocardial oxygen delivery in patients w/ vasospastic angina. Valsartan, an angiotensin II type 1 (AT1) receptor antagonist, produces its BP lowering effects by inhibiting angiotensin II-induced vasoconstriction, aldosterone release and renal reabsorption of Na.
Amlodipine : Plasma concentrations may be elevated w/ CYP3A4 inhibitors (e.g. azole antifungals, ritonavir). Concomitant therapy w/ simvastatin may increase risk of myopathy including rhabdomyolysis. May increase ciclosporin plasma levels and conivaptan. Valsartan : May antagonise hypotensive effects and increase the risk of renal impairment w/ NSAIDs. Increased risk of hyperkalaemia w/ K-sparing diuretics, K supplements or K-containing salt substitutes. Potentially Fatal: Increased risk of hypotension, hyperkalemia and changes in renal function (including acute renal failure) when used w/ aliskiren in patients w/ diabetes and renal impairment (GFR <60 mL/min).
Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters).