Cordaflex RD, 40 mg 30 pcs

CORDAFLEX RD is a selective slow calcium channel blocker, 1,4-dihydropyridine derivative. It has antihypertensive and antianginal action. Nifedipine reduces flow of extracellular calcium ions inside cardiomyocytes and smooth muscle cells of coronary and peripheral arteries.

In therapeutic doses it normalizes the transmembrane flow of calcium ions which is disturbed in a number of pathological conditions, especially in arterial hypertension. It reduces spasm and dilates coronary and peripheral arterial vessels, decreases PPS, reduces post-load and myocardial oxygen demand. At the same time, it improves blood supply to ischemic myocardial areas without development of the “bypass” syndrome and increases the number of functioning collaterals.

Nifedipine has almost no effect on sinoatrial and AV nodes and has neither pro- nor antiarrhythmic action. It has no effect on venous tone. Nifedipine increases renal blood flow, causing moderate natriuresis. At high doses, it inhibits the release of calcium ions from intracellular depots. It decreases quantity of functioning calcium channels without affecting time of their activation, inactivation and recovery.

After single use of Cordaflex in the form of sustained-action tablets the clinical effect is developed in 20 minutes, the duration of clinical effect is 12-24 hours.

Indications

Active ingredient

Composition

Nifedipine

Auxiliary substances:

Microcrystalline cellulose,

Lactose monohydrate,

Sodium croscarmellose,

hydroxypropyl cellulose,

polyvinylbutyral B 30 T,

talc,

magnesium stearate.

How to take, the dosage

The dosage regimen is determined individually depending on the degree of disease severity and the patient’s response to the therapy.

Adults, Cordaflex® in form of coated tablets are prescribed 10 mg (1 tablet) 3 times per day. If necessary the dose can be increased to 20 mg (2 tablets) 1 to 2 times per day. The maximum daily dose is 40 mg. The interval between the doses of the drug must be at least 2 hours.

To increase the drug effect at the beginning of an attack of angina or hypertensive crisis the tablet should be chewed, held in the mouth for some time and then swallowed with some water.

If it is necessary to increase a dose up to 80-120 mg/day for treatment of angina pectoris or arterial hypertension it is recommended to change a patient to therapy in a form of sustained release tablets.

During the course of therapy it is recommended to use Cordaflex® in a form of sustained release tablets. The initial dose is 20 mg (1 tablet) twice a day at 12-hour intervals. If necessary, the dose is gradually increased until optimal clinical effect is achieved. For long-term maintenance therapy, it is usually sufficient to take 20-40 mg (1-2 tablets) 2 times a day. The maximum daily dose is 120 mg.

In elderly patients the pharmacokinetics of nifedipine changes, therefore the initial dose is reduced by half and lower doses may be required to maintain therapeutic effect.

In moderate hepatic or renal impairment no dosage adjustment is required. In case of severe hepatic impairment the maximum daily dose should not exceed 40 mg.

The preparation in the form of tablets containing 10 mg of nifedipine is taken orally before a meal, in the form of sustained release tablets – regardless of meals, without chewing and with plenty of water.

Interaction

The combination of Cordaflex with beta-adrenoblockers, diuretics, ACE inhibitors, nitrates is rational in terms of increasing antihypertensive and antianginal action. All combinations mentioned above are safe and effective in most clinical situations since they result in summation or potentiation of effects, however in some cases there is a risk of significant decrease of BP and increase of heart failure symptoms.

Combination of Cordaflex with clonidine, methyldopa, octadine, prazosin is possible by indications but may cause severe orthostatic hypotension.

Strengthening of the hypotensive effect is also observed in combination therapy with cimetidine, ranitidine and tricyclic antidepressants.

Nifedipine increases the concentration of digoxin and theophylline in blood plasma, in connection with which the clinical effect and/or plasma content of digoxin and theophylline should be controlled.

Procaine, quinidine and other drugs that cause prolongation of the QT interval increase the negative inotropic effect and increase the risk of QT interval prolongation. Under the influence of nifedipine, serum quinidine concentration decreases significantly, which seems to be due to the decrease in its bioavailability, as well as the induction of quinidine inactivating enzymes. When nifedipine is withdrawn, a transient increase in quinidine concentration (approximately 2-fold) is observed, which reaches its maximum level on day 3-4. Caution should be exercised when using such combinations, especially in patients with impaired left ventricular function.

Nifedipine may displace drugs characterized by a high degree of binding to proteins (including

In concomitant administration with rifampicin, phenytoin and calcium preparations the effect of nifedipine is weakened.

Nifedipine inhibits excretion of vincristine from the body and may cause increased side effects of vincristine, if necessary the dose of vincristine is reduced.

Diltiazem inhibits the metabolism of nifedipine in the body, if necessary the dose of nifedipine is reduced.

Grapefruit juice, erythromycin and antifungal drugs of azole group (fluconazole, intraconazole, ketoconazole) may inhibit nifedipine metabolism and therefore increase its effects.

Similarly, concomitant use of Cordaflex and cimetidine increases the concentration of nifedipine in blood plasma and enhances its effects; however, concomitant use with ranitidine does not significantly increase the concentration of nifedipine in blood plasma.

Since nifedipine is metabolized by CYP3A4 isoenzyme, any inhibitor or inducer of this enzyme may affect nifedipine metabolism. Cyclosporine is also a substrate of the CYP3A4 isoenzyme; therefore, when cyclosporine and nifedipine are used together, each may increase the duration of effect of the other.

Special Instructions

The antihypertensive effect of Cordaflex is enhanced in hypovolemia. Decreased pulmonary artery pressure and hypovolemia after dialysis may also enhance the effects of the drug, in this regard, reduction of the drug dose is recommended.

In rare cases, chest pain may occur at the start of treatment with Cordaflex or when the dose is increased shortly after taking the drug. If a causal association between taking the drug and angina is found, treatment should be discontinued.

In arterial hypertension or coronary artery disease, abrupt withdrawal of nifedipine may cause a hypertensive crisis or myocardial ischemia.

If the patient requires surgery under general anesthesia during therapy, the anesthesiologist should be informed about the therapy with Cordaflex.

In elderly patients, decreased cerebral blood flow due to acute peripheral vasodilation is more likely.
Drinking alcoholic beverages is not recommended during the course of treatment with Cordaflex because of the risk of excessive BP decrease.

Pediatric use

In the absence of sufficient clinical data, the drug is not recommended for use in children and adolescents under the age of 18 years.

Impact on driving and operating machinery

In the initial, individually determined period of use of Cordaflex, driving and engaging in other potentially hazardous activities requiring quick psychomotor reactions are not allowed. During further treatment, the degree of restriction is determined depending on the patient’s individual response to the drug.

Contraindications

Side effects

Cardiovascular system: at the beginning of treatment – facial hyperemia, marked BP decrease, tachycardia; peripheral edema; rarely – increased frequency of angina attacks, heart failure.

CNS and peripheral nervous system disorders: headache, dizziness, increased fatigue, somnolence; with long-term use in high doses – paraesthesia in extremities, tremor.

Digestive system disorders: nausea, heartburn, diarrhea or constipation; intrahepatic cholestasis and increased liver transaminase activity are rare with long-term use; in single cases – gingival hyperplasia.

The hematopoietic system: rare – thrombocytopenia, thrombocytopenic purpura, leukopenia; in rare cases – anemia.

Urinary system: increased daily diuresis; rarely – deterioration of renal function in patients with chronic renal failure.

Muscular system disorders: myalgia; very rare – arthritis, arthralgia.

Allergic reactions: rare – urticaria, exanthema, itching, very rare – photodermatitis.

Others: in some cases – visual disturbances, gynecomastia, hyperglycemia, weight changes, galactorrhea.

In the vast majority of cases the drug Cordaflex® RD is well tolerated by patients.

Overdose

Symptoms: headache, arterial hypotension, and impaired myocardial energy supply.

Treatment: immediately after an overdose, as first aid remedies, the stomach may be flushed and activated charcoal may be given. If necessary, small bowel lavage may be done, which is especially useful in case of overdose of controlled-release drugs.

Because nifedipine is highly bound to plasma proteins, dialysis is not effective, but plasmapheresis may be.

The symptoms of abnormal heart rhythm with bradycardia can be managed by administration of beta-sympathomimetics. In life-threatening bradycardia, an artificial pacemaker should be used.

In severe arterial hypotension, infusion of norepinephrine (noradrenaline) in standard doses is indicated. In the development of symptoms of heart failure, IV infusion of rapid-acting foxglove glycosides is recommended.

In the absence of a specific antidote, symptomatic therapy is indicated. Dopamine, isoprenaline and 10% calcium gluconate (10-20 ml w/v) may be used as antidotes.

Pregnancy use

Cordaflex® is contraindicated in the first trimester of pregnancy.

The use of Cordaflex in pregnant women is indicated only in cases when BP normalization is not possible with the use of other hypotensive drugs.

As nifedipine is excreted with breast milk you should avoid use of Cordaflex during lactation or discontinue breast-feeding during the drug therapy.

Similarities