Coram (Amlodipine) is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist and inhibits the transmembrane influx of calcium ions into cardiac and smooth muscle).The mechanism of the antihypertensive action of amlodipine is due to direct relaxant effect on vascular smooth muscle. The precise mechanism by which amlodipine relieves angina has not been fully determined but amlodipine reduces total ischemic burden by the following two actions.
Amlodipine dilates peripheral arterioles thus, reduces the total peripheral resistance (after load) against which the heart works. Since there is no associated reflex tachycardia, this unloading f the heart reduces myocardial energy consumption and oxygen requirements and probably accounts for the effectiveness of amlodipine in myocardial ischemia.
Dilatation of the main coronary arteries and coronary arterioles both in normal and ischemic regions. This increases myocardial oxygen delivery in patients with coronary artery spasm (Prinzmetal’s or variant angina).After oral administration of therapeutic doses, Coram (Amlodipine) is well absorbed with peak blood levels attaining between 6-12 hours postdose. 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 excreted in the urine. In patients with hypertension once daily dosing provides clinically significant reduction of blood pressure in both the supine and standing positions throughout the 24 hours interval.
In patients with angina, once daily administration of amlodipine increases total exercise time and decreases both angina attack frequency and nitroglycerine tablet consumption. Coram (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.In vitro studies have shown that approximately 97.5% of circulating amlodipine is bound to plasma proteins.

PRESENTATION:
Coram 5 : Pack of 2 x 10’s tablets.
Coram 10 : Pack of 2 x 10’s tablets.

COMPOSITION:
Coram 5 : Each tablet contains amlodipine ( as besylate) ............. 5 mg.
Coram 10 : Each tablet contains amlodipine (as besylate) .............10 mg.


INDICATION:
Coram (Amlodipine) 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.Coram (Amlodipine) 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.

DOSAGE AND ADMINISTRATION:
For both hypertension and angina, the usual initial dose is 5mg amlodipine once daily which may be increased to a maximum dose of 10mg depending on the individual patient’s response. No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin converting enzyme inhibitors.

SIDE EFFECTS:
Coram (Amlodipine) is well tolerated; the most commonly observed side effects were headache, edema, fatigue, nausea, flushing and dizziness.


CONTRA-INDICATION:
Coram (Amlodipine) is contraindicated in patients with a known hypersensitivity to dihydropyridines.

PRECAUTIONS:
Use in Elderly:
Coram (Amlodipine) used at similar doses in elderly or younger patients, is equally well tolerated. Therefore, normal dosage regimens are recommended.

Use in Renal Failure:
Changes in Coram (Amlodipine) plasma concentrations are not correlated with degree of renal impairment. Coram (Amlodipine) may be used in such patients at normal doses. Coram (Amlodipine) is not dialysable.

Use in Patients with Impaired hepatic Function:
Coram (Amlodipine) half life is prolonged in patients with impaired liver function, the drug should therefore be administered with caution in these patients.

Use in Pregnancy & Lactation:
Safety of Coram (Amlodipine) in human pregnancy or lactation has not been established. Accordingly, use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and

Drug Interactions:
Coram (Amlodipine) has been safely administered with thiazide diuretics, beta blockers, angiotensin converting enzyme inhibitors, long acting nitrates, sublingual nitroglycerine, non-steroidal antiinflammatory drugs, antibiotics, and oral hypoglycemic drugs. The co-administration of Coram (Amlodipine) with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers, and the co-administration of cimetidine did not alter the pharmacokinetics of Coram (Amlodipine).

Over Dosage:
Since Coram (Amlodipine) absorption is slow, gastric lavage may be worthwhile in some cases. The gross overdosage could result in excessive peripheral vasodilatation with subsequent marked and probably prolonged systemic hypotension. Since Coram (Amlodipine) is highly protein bound, dialysis is not likely to be of benefit.

Storage:
Store below 30 C.
Protect from light and moisture.