Composition:

Amlodipine Al Fares 5: Each tablet contains amlodipine besilate equivalent to 5 mg amlodipine.

Amlodipine Al Fares 10: Each tablet contains amlodipine besilate equivalent to 10 mg amlodipine.

Mechanism of action:

Amlodipine is a calcium antagonist (calcium ion antagonist or slow-channel blocker) that 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 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.

Amlodipine reduces the total peripheral resistance (afterload) against which the heart works and reduces the rate pressure product, 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 and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane A2 analog .

Indications:

Amlodipine is indicated for the treatment of these cases alone or in combination with other drugs:

• Hypertension.
• Coronary Artery Disease (CAD):

• Chronic Stable Angina.
• Vasospastic Angina (Prinzmetal’s or Variant Angina).
• Angiographically Documented CAD.

Dosage and administration :

Adults: The usual initial antihypertensive oral dose of Amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Amlodipine to other antihypertensive therapy.

Adjust dosage according to each patient’s need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient’s response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

Angina: The recommended dose for chronic stable or vasospastic angina of Amlodipine is 5 to 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 :The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg.

Children: The effective antihypertensive oral dose in pediatric patient’s ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.

Effect of Amlodipine on blood pressure in patients less than 6 years of age is not known.

Geriatric :

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40–60%, and a lower initial dose may be required .

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How supplied:

Amlodipine Al Fares 5: Pack of 30 tablets.

Amlodipine Al Fares 10: Pack of 30 tablets.