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Zynor

Amlodipine

 

COMPOSITION

Zynor 5mg : Each tablet contains Amlodipine Besylate equivalent to Amlodipine 5mg

Zynor 10mg : Each tablet contains Amlodipine Besylate equivalent to Amlodipine 10mg

 

PHARMACODYNAMICS

Amlodipine is a calcium ion influx inhibitor of the dihydrophyridine group ( slow channel blocker or calcium ion antagonist ) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.

 

The mechanism of the anihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle. The precise mechanism by which amlodipine relieves anglina has not been fully determined but amlodipine reduces total ischaemic burden by the following two actions:

 

1. Amlodipine dilates peripheral arterioles and thus, reduces the total peripheral resistance ( afterload ) against which the heart works. Since the heart rate remains stable, this unloading of the heart reduces myocardial energy consumption and oxygen requirements.

 

2. The mechanism of action amlodipine also probably involves dilatation of the main coronary arteries and coronary arterioles, both in normal and ischaemic regions. This dilatation increases myocardial oxygen delivery in patients with coronary artery spasm ( Prinzmetal's or variant angina ).

 

In patients with hypertension, once daily dosing provides clinically significant reductions of blood pressure in both the supine and standing positions throughout the 24 hour interval. Due to he slow onset of action, acute hypotension is not a feature of amlodipine administration.

 

In patients with angina, once daily administration of amlodipine increases total exercise time, time to angina onset, and time to 1mm ST segment depression, and decreases both angina attack frequency and nitroglycerine tablet consumption.

 

Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids and is suitable for use in patients with asthma, diabetes, and gout.

 

PHARMACOKINETICS

Absorption, distribution, plasma protein binding : After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels between 6-12 hours post dose. The absorption of amlodipine is unaffected by the concomitant intake of food. Absolute bioavailability has been estimated to be between 64 and 80%. The volume of distribution is approximately 21 l/kg. In vitro studies have shown that approxiately 97.5% of circulating amlodipine is bound to plasma proteins.

 

Biotransformation/elimination : The terminal plasma elimination half life is about 35-50 hours and is consistent with once daily dosing. Steady state plasma levels are reached after 7-8 days of consecutive dosing. Amlodipine is extensively metabolised by the liver to inactive metabolites with 10% of the parent compound and 60% of metabolites excreted in the urine.

 

Use in the elderly : The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects. Amlodipine clearance tends to be decreased with resulting increases in AUC and elimination half-life in elerly patients. Increases in AUC and elimination half-life in patients with congestive heart failure were as expected for the patient age group studied.

 

INDICATIONS

Hypertension : Zynor is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of Zynor, which has been used in combination with a thiazide diuretic, alpha blockers, beta adrenoceptor blocking agent, or an angiotensin converting enzyme inhibitor.

 

Myocardial Ischemia : Zynor is indicated for the first line treatment of myocardial ischemia, whether due to fixed obstruction ( stable angina ) and/or vasospasm/vasoconstriction ( Prinzmetal's or variant angina ) of coronary vasculature. Zynor may be used where the clinical presentation suggests a possible vasopastic/vasoconstrictive component but vasospastic/vasoconstrictive has not been confirmed. Zynor may be used alone, as monotherapy, or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of beta blockers.

 

DOSAGE AND ADMINISTRATION

Adults : For both hypertension and angina the usual initial dose is 5mg Zynor once daily which may be increased to a maximum dose of 10mg depending on the individual patient's response.

 

No dose adjustment of Zynor is required upon concomitant administration of thiazide diuretic, beta blockers and angiotensin-converting enzyme inhibitors.

 

In children : Not recommended

 

In the elderly : Normal dosage regimens are recommended. Amlodipine, used at similar doses in elderly or younger patients, is equally well tolerated.

 

Patients with hepatic impairment : See section Precautions.

 

Patients with renal impairment : Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialyzable.

 

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