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Cordipin®XL
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 |
