Description
COMPOSITION: Each tablet contains amlodipine besylate equivalent to 10 mg amlodipine.
PHARMACOLOGICAL PROPERTIES: A long-acting calcium channel blocker. Inhibits the trans –
membrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Causes vaso–
dilation in the peripheral and coronary system. Reduces peripheral and vascular resistance. Re –
duces cardiac load. Increases coronary blood flow. Has no effect on the SA or AV nodes. Increases
renal blood flow and glomerular filtration rate. Low side effect profile.
INDICATIONS: MONOVAS tablet is indicated in the treatment of mild to moderate arterial hyper–
tension. Stable or vasospastic angina pectoris due to coronary artery vasoconstriction.
CONTRAINDICATIONS: MONOVAS tablet should not be used in patients hypersensitive to dihy –
dropyridine.
WARNINGS AND PRECAUTIONS: Since amlodipine is slowly metabolised in the liver, elimination
half life is prolonged in patients with impaired hepatic function. There are no dose recommen –
dations for such patients; therefore, the drug should be carefully administered in these patients
and they should be closely monitored. Amlodipine can be administered to patients with renal im–
pairment at doses recommended for normal patients. Amlodipine is not eliminated by dialysis. In
elderly patients, the normally recommended adult dosage is used. Pregnancy category is C.
DOSAGE AND ADMINISTRATION: MONOVAS tablet is used orally. The recommended initial dose
in the treatment of hypertension and angina pectoris is 5 mg once daily with a maximum dose
of 10 mg once daily. MONOVAS tablet can be safely administered with thiazides, ACE inhibitors,
betablockers, long-acting nitrates, and/or sublingual nitroglycerin.
STORAGE CONDITIONS: Should be kept out of reach of children, at room temperature (<25ºC)
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