Cordaflex, 10 mg 100 pcs

Indications

– arterial hypertension of various genesis, including hypertensive crises (for 10 mg tablets);
– CHD: for the prevention of attacks in various forms of angina pectoris, including angiospastic (Prinzmetal angina);
– Raynaud’s syndrome (for tablets with prolonged action).

Active ingredient

Composition

1 tablets.:

– nifedipine 10 mg

Supplementary substances:

Polyvinylbutyral,

Magnesium stearate,

talc,

Hydroxypropylcellulose,

sodium croscarmellose,

lactose monohydrate,

microcrystalline cellulose,

titanium dioxide,

iron oxide yellow,

hypromellose.

How to take, the dosage

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

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

In order to speed up the action of the drug at the beginning of an attack of angina or hypertensive crisis, the tablet should be chewed, held in the mouth for a while, and then swallowed with a little water.

If it is necessary to increase the dose to 80-120 mg/day to treat angina or arterial hypertension, it is recommended that the patient be transferred to the drug in the form of sustained release tablets.

In case of course therapy it is recommended to use Cordaflex® in the 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 starting dose of the drug is reduced by half and lower doses may be required to maintain the therapeutic effect.

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

The drug in tablet form containing 10 mg of nifedipine is taken orally before meals.

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 lead to summation or potentiation of effects, however, in some cases there is a risk of significant decrease of BP and increase of heart failure symptoms.

The combination of Cordaflex with clonidine, methyldopa, octadine, prazosin is indicated, but may cause severe orthostatic hypotension.

Augmentation of the hypotensive effect is also observed with combined therapy with cimetidine, ranitidine and tricyclic antidepressants.

Nifedipine increases plasma concentrations of digoxin and theophylline; therefore, the clinical effect and/or plasma levels of digoxin and theophylline should be monitored.

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 indirect anticoagulants – coumarin and indandion derivatives, NSAIDs), resulting in possible increase of their plasma concentrations.

In concomitant administration with rifampicin, phenytoin and calcium preparations the effect of nifedipine is weakened.
Nifedipine inhibits vincristine excretion and may cause increase of vincristine side effects, if necessary the vincristine dose is reduced.

Diltiazem inhibits nifedipine metabolism 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 plasma concentration of nifedipine and enhances its effects

As 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 (angina pectoris due to paradoxical ischemia) may occur at the beginning 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 pectoris 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 (ricochet phenomenon).

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

– acute stage of myocardial infarction;
– cardiogenic shock;
– severe arterial hypotension (systolic BP below 90 mm Hg).);
– significant aortic or mitral stenosis, idiopathic hypertrophic subaortic stenosis;
– severe heart failure;
– 1st trimester of pregnancy;

Side effects

Cardiovascular system disorders: facial hyperemia, marked arterial hypotension, peripheral edema, tachycardia; rarely – increased angina pectoris attacks (drug withdrawal is required), increased heart failure, fainting.

CNS and peripheral nervous system disorders: headache, dizziness, fatigue, sleep disorders (somnolence or insomnia); in single cases – mood swings, vision disorders; with prolonged use in high doses – numbness in extremities, tremor.

Digestive system disorders: diarrhea, constipation, nausea, heartburn; rarely (with long-term use of the drug) – dry mouth, flatulence, intrahepatic cholestasis, increased activity of liver transaminases; in single cases – gingivitis, anorexia.

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; in single cases – arthritis.

Endocrine system disorders: in single cases – gynecomastia, hyperglycemia (disappear completely after discontinuation of the drug), weight changes, galactorrhea.

Allergic reactions: rare – urticaria, exanthema, pruritus; in some cases – autoimmune hepatitis.

Others: fever; in single cases – weakness, sweating, fever, chills, photodermatitis.

Overdose

Symptoms: severe arterial hypotension, tachycardia, chest pain (angina pectoris), headache, collapse, loss of consciousness, nodal or ventricular extrasystole due to sinus node suppression, bradycardia, syncope. In severe cases, there may be disorders of consciousness with transition to coma, hyperkalemia, metabolic alkalosis, hypoxia, cardiogenic shock with pulmonary edema.

Treatment: given the lack of a specific antidote, in cases of early detoxification, gastric lavage with the administration of activated charcoal is carried out. If necessary, small bowel lavage may be performed, which is more appropriate in cases of overdose of controlled-release drugs. When prescribing laxatives, it should be taken into account that administration of slow calcium channel blockers suppress intestinal motility to complete atony.
Since nifedipine is largely bound to blood plasma proteins, hemodialysis is not effective, but plasmapheresis may be effective.

Symptomatic therapy is indicated. Symptoms of abnormal heart rhythm with bradycardia may be treated by administration of beta-adrenomimetics and/or atropine. In life-threatening bradycardia an artificial pacemaker should be used. Infusion of normal doses of norepinephrine (noradrenaline) or epinephrine (adrenaline) is indicated for severe BP decline; dopamine (maximum dose 25 µg/kg body weight/min), dobutamine (maximum dose 15 µg/kg body weight/min), isoprenaline and 10% calcium gluconate solution (10-20 ml IV) can be used. If symptoms of heart failure develop, IV administration of rapid-acting cardiac glycosides is recommended.

Pregnancy use

Cordaflex® is contraindicated for use in the first trimester of pregnancy.

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

Because nifedipine is excreted with breast milk, use of Cordaflex during lactation should be avoided or breastfeeding should be stopped during drug therapy.

Similarities