Indications of Amlopin 10 mg Tablet

Amlodipine is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of Hypertension and Coronary Artery Disease (such as Chronic Stable Angina, Vasospastic Angina and Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%).

Pharmacology of Amlopin 10 mg Tablet

Amlodipine is a long-acting calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Thus it causes a reduction in peripheral vascular resistance and contractile process in cardiac muscle and reduces blood pressure. The mechanism of the antihypertensive action is due to a 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 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.

▪ The mechanism of action of Amlodipine also probably involves dilatation of the main coronary arteries and coronary arterioles, both in normal and ischemic regions. This dilation increases myocardial oxygen delivery in patients with coronary artery spasm (prinzmetals or variant angina).

Amlopin 10 mg Tablet Dosage & Administration

Adult: Starting dose 5 mg once daily with maximum dose 10 mg once daily.

Pediatric: Starting dose 2.5 mg to 5 mg once daily.Small, Fragile and Elderly patients or patients with hepatic insufficiency: Starting dose 2.5 mg once daily.

Interaction of Amlopin 10 mg Tablet

Amlopin 10 mg Tablet has been safely administered with thiazide diuretics, alpha blockers, beta blockers, angiotensin[1]converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerine, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs. Amlodipine has no effect on protein binding of digoxin, phenytoin, warfarin, or indomethacin. Administration of Amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects.

Contraindications of Amlopin 10 mg Tablet

It is contraindicated in patients with known sensitivity to Amlodipine.

Amlopin 10 mg Tablet Side Effects

The most common side effects are headache and edema which occurred in a dose-related manner. Other side effects not dose-related but reported with an incidence >1.0% are headache, fatigue, nausea, abdominal pain, and somnolence.

Pregnancy & Lactation

Pregnancy Category C. There are no adequate and well[1]controlled studies of Amlodipine in pregnant women. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Amlopin 10 mg Tablet is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while Amlopin 10 mg Tablet is administered.

Precautions & Warnings

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, because of the gradual onset of action, acute hypotension is unlikely. Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Amlodipine, particularly in patients with severe obstructive coronary artery disease. Titrate slowly when administering calcium channel blockers to patients with severe hepatic impairment.

Therapeutic Class of Amlopin 10 mg Tablet

Calcium-channel blockers

Storage Conditions

keep in a dry place away from light and heat. Keep out of the reach of children.