STADOVAS 10 Tablet

- Amlodipine is used alone or in combination with other classes of antihypertensive agents in the management of hypertension.

- For the management of Prinzmetal variant angina and chronic stable angina pectoris. The drug has been used alone or in combination with other antianginal agents.

Dosage and Administration

Orally and may be given without regard to meals.

Dosage

- 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 to 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.

- Use in the elderly normal dosage regimens are recommended. Amlodipine, used at similar doses in elderly or younger patients, is equally well tolerated. Use in children safety and effectiveness of amlodipine in children have not been established.

Patients who are hypersensitive to amlodipine, to any other calcium antagonist, or any ingredient in the formulation.

The most common adverse effects of amlodipine are associated with its vasodilator action and often diminish on continued therapy. They include dizziness, flushing, headache, hypotension, peripheral oedema, tachycardia, and palpitations. Nausea and other gastrointestinal disturbances, increased micturition frequency, lethargy, eye pain, visual disturbances, and mental depression have also occurred. A paradoxical increase in ischaemic chest pain may occur at the start of treatment and in a few patients excessive fall in blood pressure has led to cerebral or myocardial ischaemia or transient blindness.

See the package insert about the details below:

- Amlodipine has been safely administered with thiazide diuretics, alpha blockers, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual glyceryl trinitrate, NSAIDs, antibiotics, and oral hypoglycaemic drugs.

- Cimetidine, grapefruit juice, antacid

- Sildenafil

- Atorvastatin, ethanol (alcohol)

- Digoxin

No clinical experience with the preparation in pregnancy or lactation.

Accordingly, amlodipine should not be administered during pregnancy, or lactation, or to women of childbearing potential unless effective contraception is used.

- Amlodipine should be used with caution in patients with hypotension, cardiac reserve is poor, heart failure.

- The drug should not be used in cardiogenic shock, in patients who have suffered a myocardial infarction in the previous 2-4 weeks, or in acute unstable angina, in treatment an anginal attack in chronic stable angina.

- In patients with severe aortic stenosis amlodipine may increase the risk of developing heart failure. Sudden withdrawal of amlodipine might be associated with an exacerbation of angina.

- The dose may need to be reduced in patients with hepatic impairment.

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.

Amlodipine inhibits calcium ion flux across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. 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.