AMLOLIFE Tablet

1. Hypertension: Amlodipine besilate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.

2. Chronic Stable Angina: Amlodipine besilate tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besilate tablets may be used alone or in combination with other antianginal agents.

3. Vasospastic Angina (Prinzmetal’s or Variant Angina): Amlodipine besilate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besilate tablets may be used as monotherapy or in combination with other antianginal drugs.

Dosage and directions for use

The tablets should be taken with a glass of water independently from meals.

In adults

For treatment of both hypertension and angina pectoris the usual initial dose is 5mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks this dose may be increased to a maximum dose of 10mmg daily (as single dose) depending or as directed by the physician.

Children with hypertension from 6 years to 17 years of age

The recommended antihypertensive oral dose in pediatric patients ages 6-17 years is 2.5mg once daily as a starting dose, up-titrated to 5mg once daily. If blood pressure goal is not achieved after 4 weeks. Doses in excess of 5mg daily have not been studied in pediatric patients. The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.

The 2.5mg dose cannot be obtained with Amlodipine tablets 5mg as these tablets are not manufactured to break into two equal halves.

In the elderly

Normal dosage regiments are recommended in the elderly, however, increase of the dosage should take place with care.

In patients with renal impairment

Amlodipine is not dialysable. In these patients amlodipine can be used in the normal dosage.

In patients with hepatic impairment

A dosage regimen for patients with hepatic impairment has not been established, therefore amlodipine should be administered with caution.

In patients with:

severe hypotension

shock, including cardiogenic shock

hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients

heart failure after acute myocardial infarction (during the first 28 days)

obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis)

unstable angina pectoris

Very common:

swelling of the ankles

Common:

headache, feeling tired, dizziness, weakness, feeling sick, stomach-ache, indigestion, flushing of the face, palpitations (a quicker or irregular heart beat)

Uncommon:

feeling unwell, dry month tremor (shaking), pins and needles, increased sweating, difficulty sleeping, irritability, depression, shortness of breath, rhinitis (runny nose), vomiting (being sick), diarrhoea or constipation, swelling or soreness of the gums, muscle cramps, back pain, muscle or joint pain, increased need to urinate (pass water), changes in your weight, inability to obtain an erection, fainting, chest pains, increased heart rate, low blood pressure, skin rash, itching, local swelling causing wheals on the skin (“nettle rash”), hair loss, discolouration of the skin, visual disturbances, enlargement of male breasts.

Rare:

confusion, mood changes including anxiety, taste changes, tinnitus (ringing in the ears), inflammation of the liver (hepatitis) or liver doesn’t work properly, yellowing of the skin and eyes (jaundice).

Very rare:

inflammation of the stomach, vasculitis (inflammation of blood vessels, often with skin rash)

certain blood disorders which may increase the risk of bleeding, bruising or infections numbers i fingers or toes cough inflamed pancreas which causes severe pain in the abdomen and back, allergic reactions

In vitro data indicate that amlodipine has not effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin.

Effect of Amlodipine on Other Agents: (see the package insert about the details.)

Atorvastatin

Digoxin

Ethanol (alcohol)

Warfarin

In clinical trials, amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, NSAIDs, antibiotics, and oral hypoglycemic drugs.

There are no adequate data from the use of amlodipine in pregnant women. Animal studies have shown reproductive toxicity at high doses. The potential risk for humans is unknown. Amlodipine should not be used during pregnancy unless clearly necessary.

It is not known whether amlodipine is excreted in breast milk. It is advised to stop breastfeeding during treatment with amlodipine.

Amlodipine should be administered with caution to patients with low cardiac reserve. There are no data to support the use of amlodipine alone, during or within one month of myocardial infarction. The safety and efficacy of amlodipine in hypertensive crisis has not been established.

Patients with cardiac failure:

Patients with cardiac failure should be treated with caution. In a long-term study including patients suffering from severe heart failure (NYHA gradeⅢand Ⅳ) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group, but this was not indicating an aggravation of the heart failure.

Use in patients with impaired hepatic function:

Amlodipine’s half-life is prolonged in patients with impaired liver function; dosage recommendations have not been established. Amlodipine should therefore be administered with caution in these patients.

Use in elderly patients:

In the elderly, increase of the dosage should take place with care.

Use in children (under 18 years of age);

Amlodipine should not be given to children due to insufficient clinical experience.

Amlodipine is a calcium antagonist and inhibits the influx of calcium ions into cardiac and vascular smooth muscle. The mechanism of the antihypertensive action is due to a direct relaxant effort on vascular smooth muscle. The precise mechanism by which amlodipine relieves angina has not been fully determined but the following 2 actions play a role:

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

2. The mechanism of action also probably involves dilatation of the main coronary arteries and coronary arterioles. This dilation increases the supply in oxygen to myocardiac muscle in patients with Prinzmetal anginal attack.

In patients with angina, once daily administration of amlodipine increases total exercise time, the delay of occurrence of anginal attack and the delay of the occurrence of a 1-mm ST interval. Amlodipine decreases both angina attack frequency and glyceryl trinitrate tablet consumption.

Patients with cardiac failure

See the package insert about the details.