68, Shyllon Street. Ilupeju, Onipanu, Lagos, Nigeria
CENTAUR PHARMACEUTICALS PVT. LTD Plant 1, Plot No.3, Tivim Industrial Estate,Karaswada, Mapusa, Goa-403 526. INDIA.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet(NRN:A4-5069): Amiotrust 2.5 Each uncoated tablet contains: Amlodipine Besilate BP equivalent to Amlodipine 2.5 mg. Colour: Quinoline Yellow; Amiotrust 5 Each uncoated tablet contains: Amlodipine Besilate BP equivalent to Amlodipine 5 mg; Amiotrust 10 Each uncoated tablet contains: Amlodipine Besilate BP equivalent to Amlodipine 10 mg. Colour: Lake of Sunset Yellow FCF
Pack size: Amiotrust 2.5/5/10 is available in Blister of 10 tablets each. Box of 1 x 10’s/3 x 10’s/10 x 10’s.
Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Serum calcium concentration however is not affected by amlodipine.
Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
The precise mechanisms by which amlodipine relieves angina have not been fully defined, but are thought to include the following:
Exertional Angina: Amlodipine reduces the total peripheral resistance (afterload) against which the heart works and thus myocardial oxygen demand, at any given level of exercise.
Vasospastic Angina: Amlodipine has been demonstrated to block constriction and restore blood flow in coronary arteries. This action is responsible for the effectiveness of Amlodipine in vasospastic (Prinzmetal's or variant) angina.
Amiotrust is indicated for hypertension, chronic stable angina and vasospastic angina (Prinzmetal's or variant angina), as monotherapy or in combination with other antihypertensive or antianginal drugs.
Known hypersensitivity to Amlodipine.
Rarely, patients with severe obstructive CAD, have developed increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
Since the vasodilation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, caution, as with any other peripheral vasodilator, should be exercised when administering Amlodipine, particularly in patients with severe aortic stenosis.
Congestive Heart Failure: Use with caution in patients with CHF.
Hepatic Failure: Since Amlodipine is extensively metabolized by the liver and the plasma elimination half-life is 56 hours, caution should be exercised when administering Amlodipine in patients with impaired hepatic function.
Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
It is not known whether Amlodipine is excreted in human milk. Hence it is recommended that nursing be discontinued while Amlodipine is administered.
The effect of Amlodipine on blood pressure in patients less than 6 years of age is not known.
In clinical trials, Amlodipine has been safely administered with thiazide diuretics, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, NSAIDs, antibiotics, atorvastatin and oral hypoglycemic drugs.
Amlodipine is well tolerated.
Side effects include headache, edema, dizziness, flushing, palpitations, fatigue, somnolence, nausea, and abdominal pain.
Less commonly observed side effects are: pruritus, rash, dyspnea, asthenia, muscle cramps and dyspepsia.
Dosage & Administration
Hypertension: initial dose of Amiotrust is 5 mg once dally with a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Amiotrust to other antihypertensive therapy.
Chronic Stable or Vasospastic Angina: recommended dose is 5-10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.
Coronary Artery Disease: recommended dose range is 5-10 mg once daily. In clinical studies the majority of patients required 10 mg.
The effective antihypertensive oral dose in children ages 6 -17 years is 2.5 to 5 mg once daily. Doses in excess of 5 mg daily have not been studied.
Store at temperature between 15 - 30°C in a dark place.
Keep medicines out of the reach of children