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CordipinXL

modified-release tablets 40 mg
Nifedipine


Composition

1 Cordipin XL tablet contains 40 mg nifedipine. Red brownish, round, biconvex, film-coated tablets.


Action

Nifedipine is a calcium antagonist which inhibits the influx of calcium into the myocardial cells and smooth muscle cells of coronary arteries and peripheral blood vessels. It directly reduces the oxygen consumption by reducing heart work. It indirectly reduces the oxygen demand by reducing peripheral resistance and afterload and thus relieves the heart.


Nifedipine exerts a spasmolytic action on the coronary blood vessels and improves the poststenotic blood circulation in atherosclerotic obstructions. Its cardioprotective action is based on the effect of inhibition of influx and accumulation of calcium in the cell, by which the depletion of energetic reserves is prevented.


The release of nifedipine from Cordipin XL tablet is very slow; its effect lasts up to 24 hours.


Indications

All forms of hypertension, all forms of angina pectoris, especially vasospastic and stable chronic one.


Contraindications

Hypersensitivity to the drug, cardiogenic shock, severe aortic stenosis, porphyria, acute myocardial infarction, pregnancy and lactation.


Precautions

Hypotension, which is poorly tolerated by some patients, may occur occasionally, especially in the beginning of treatment and with concurrent administration of beta-blockers. Such patients should be closely monitored. In patients concomitantly receiving beta-blockers, a congestive heart failure can occur immediately after the beginning of nifedipine therapy. Nifedipine should not be used in patients with Kock pouch (ileostomy after protocolectomy). Patients with hypertrophic cardiomyopathy, unstable angina pectoris, diabetes, severe hepatic diseases and severe pulmonary hypertension as well as elderly patients should be under strict medical control during the introduction of nifedipine therapy.


Due to reflex tachycardia, an aggravation of ischemia may occur in patients with coronary disease, resulting in more frequent attacks of angina pectoris. Special caution is necessary when administering immediate-release nifedipine preparations to patients with angina pectoris or to those who have suffered of myocardial infarction. Nifedipine may affect some laboratory values and tests (alkaline phosphatase, SGOT, SGPT, LDH, positive Coombs' test). These changes are not necessarily associated with clinical signs (although cases of cholestasis and jaundice have been reported).


Nifedipine may reduce the platelet count and prolong bleeding time, yet this has no clinical significance.


Warning

There have been several reports of profound hypotension, myocardial infarction and death when immediate-release nifedipine capsules are used sublingually for acute reduction of blood pressure.

 

Drug interactions

Digoxin - Concurrent use with some calcium channel blocking agents has been reported to increase the serum concentration of digoxin. Digoxin serum concentrations should be monitored and dosage adjusted accordingly.

Cimetidine - Cimetidine may lead to increased serum concentration of calcium channel blockers due to inhibition of first-pass metabolism.

Rifampicin - Rifampicin may reduce the bioavailability of calcium channel blockers as a result of induction of first-pass metabolism. Diuretics, other antihypertensive agents including beta-blockers - Antihypertensive effects may be potentiated when these medications are used concurrently with nifedipine.

Others:
When nitroglycerin or isosorbide with prolonged action are administered concomitantly, the synergistic effect of Cordipin XL should be taken into consideration.

Concurrent administration of fentanyl causes additional reduction of blood pressure. Nifedipine therapy should be withdrawn 36 hours prior to the foreseen fentanyl anaesthesia.

Concurrent administration of nifedipine may increase serum concentrations of carbamazepine, phenytoin and theophylline.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.


Use in children

Due to lack of experience, pediatric dosage has not been established and use of nifedipine in children is generally not recommended.


Dosage

Patients should be treated individually depending on the severity of the disease and the therapeutic response. For the treatment of hypertension and angina pectoris, one Cordipin XL modified-release tablet once daily should be adequate. If necessary, the dose can be increased to 80 mg daily, given once daily or in two divided doses.


Cordipin XL tablets are to be taken after meals. They should be swallowed whole with a glass of water and must not be broken or chewed.


Side effects

Side effects are transient and mild and they usually do not necessitate a withdrawal of the drug. Headache, facial flushing, ankle edema; infrequently orthostatic hypotension, dizziness, skin eruptions, nausea, fatigue, tachycardia, palpitations, heartburn or gingival hyperplasia may occur.

 

Ankle edema is not of cardiac origin and does not respond to treatment with diuretics.


Overdosage

A sign of overdosage is hypotension.


Hypotension, shock, bradycardia, heart failure, metabolic acidosis and convulsions can be observed in the event of ingestion of a large quantity of tablets. Gastric lavage, adsorption with activated charcoal, close hemodynamic monitoring and symptomatic treatment are indicated: for hypotension, plasma

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