Nifecard HL - Instructions For Use, Tablets 30 And 60 Mg, Price, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Nifecard HL

Nifecard HL: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Nifecard XL

ATX code: C08CA05

Active ingredient: nifedipine (Nifedipine)

Manufacturer: LEK d.d. (LEK dd) (Slovenia)

Description and photo update: 01.10.2019

Prices in pharmacies: from 128 rubles.

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Nifecard CL is a drug of hypotensive and antianginal action, a calcium channel blocker.

Release form and composition

The drug is available in the form of modified release tablets, film-coated: biconvex, round, from light brownish yellow to light brownish orange, a yellow core is visible on the fracture, an inscription corresponding to the dosage is embossed on one side, for 30 mg - "NDP 30", for 60 mg - "NDP 60" (10 pcs. In blisters, in a cardboard box 2, 3 or 6 blisters and instructions for use of Nifecard HL).

Composition for 1 modified release film-coated tablet:

• active substance: nifedipine - 30 mg or 60 mg;
• auxiliary components of the tablet core: sodium lauryl sulfate, magnesium hydrosilicate, povidone, hydroxypropyl methylcellulose (for 30 mg tablets), hydroxypropyl methylcellulose 2906 and hydroxypropyl methylcellulose 2208 (for 60 mg tablets), magnesium stearate, Ludipress (crospovidone, povidone and lactose);
• film shell: macrogol, hypromellose phthalate, hydrous magnesium silicate, triethyl citrate, titanium dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose 2910, dye iron oxide yellow.

Pharmacological properties

Pharmacodynamics

Nifedipine is a selective blocker of slow calcium channels, and in terms of chemical structure it belongs to 1,4-dihydropyridine derivatives. It has antihypertensive and antianginal effects. The drug reduces the flow of extracellular calcium into the smooth muscle cells of peripheral and coronary arteries, as well as cardiomyocytes; in large doses inhibits the release of Ca ²⁺ from intracellular stores. Nifecard CL reduces the total number of functioning calcium channels, but does not affect the time of their activation, recovery and inactivation.

Nifecard CL uncouples the processes of contraction and excitation in the cardiac muscle (mediated by troponin and tropomyosin) and in the smooth muscles of blood vessels (mediated by calmodulin). In therapeutic doses, the drug normalizes the flow of calcium ions through the cell membranes, which is disturbed due to some pathological conditions (mainly due to arterial hypertension). Nifedipine has no effect on venous tone; it improves blood supply to ischemic foci of the heart muscle without the development of the syndrome of vertebral-subclavian steal (SPOS), enhances blood circulation through the blood vessels of the myocardium, activates the functioning of reserve blood pathways.

The drug reduces the force of heart contractions, improves myocardial function and reduces its oxygen demand. Due to the expansion of the peripheral arteries, blood pressure (blood pressure) decreases, the total peripheral resistance decreases, and the afterload on the heart decreases. Nifecard CL has almost no effect on the atrioventricular and sinoatrial nodes; increases blood flow in the renal arteries and vein; moderately increases the excretion of sodium in the urine.

The drug has an antiatherogenic effect (especially with prolonged therapy), inhibits platelet aggregation; has a positive effect on cerebral blood supply; reduces pressure in the pulmonary artery.

Pharmacokinetics

Due to the sustained release of the active substance Nifecard CL, its concentration in plasma increases gradually and reaches a plateau approximately 6 hours after oral administration. Then it is maintained at this level for 24 hours (with minor fluctuations).

As a result of taking the drug inside, nifedipine is rapidly and almost completely absorbed in the gastrointestinal tract (absorbed from 92 to 98%). Plasma protein binding is about 90%. Metabolism occurs in the liver, active metabolites have not been established. The half-life is approximately 2 hours. The main part of the drug is excreted by the kidneys (80%) and a small amount (about 20%) in the bile (the drug is excreted in the form of inactive metabolites). No cumulative effect was found.

Nifedipine passes through the placental and blood-brain barriers, and is also secreted in breast milk.

In patients with chronic renal failure, as well as in persons on peritoneal dialysis or hemodialysis, changes in pharmacokinetics have not been registered.

In case of impaired liver function, the clearance of nifedipine decreases, therefore, in the case of severe impairment of hepatic function, a change in the dose of Nifecard CL may be required.

In elderly patients, intravenous administration of nifedipine showed a decrease in its clearance by 33% (in comparison with healthy younger volunteers).

Long-term drug therapy can lead to the development of addiction.

Indications for use

Nifecard CL is used to reduce elevated blood pressure, as well as in patients with ischemic heart disease (with vasospastic angina pectoris and stable exertional angina pectoris).

Contraindications

Absolute:

• unstable angina;
• severe arterial hypotension (with systolic blood pressure less than 90 mm Hg);
• cardiogenic shock (due to the risk of developing myocardial infarction);
• CHF (chronic heart failure) in the stage of decompensation;
• myocardial infarction in the acute stage (within the first 4 weeks after the attack);
• severe stenosis of the aortic valve (with hemodynamic disturbances);
• lactase deficiency, hereditary lactose intolerance, glucose-galactose malabsorption syndrome (due to lactose in the tablets);
• children and adolescents up to 18 years old;
• pregnancy period (up to the 20th week);
• lactation period;
• co-administration with rifampicin;
• hypersensitivity to the main or auxiliary components of the drug, as well as to other drugs from the group of 1,4-dihydropyridine derivatives.

Relative (Nifecard CL tablets are used with caution):

• severe tachycardia;
• myocardial infarction with left ventricular failure;
• mitral valve or aortic stenosis;
• malignant arterial hypertension;
• cerebrovascular diseases;
• hypertrophic obstructive cardiomyopathy;
• SSSU (sick sinus syndrome);
• diabetes;
• impaired renal and / or liver function;
• intestinal obstruction;
• hemodialysis (due to the risk of developing arterial hypotension);
• joint administration with cardiac glycosides, beta-blockers, inhibitors or inducers of the CYP3A4 isoenzyme.

Nifecard HL, instructions for use: method and dosage

Nifecard CL tablets are taken orally without chewing. They cannot be divided or crushed, or washed down with grapefruit juice. The dosage regimen of the drug is individual, but it is advisable to adhere to the intake at the same time of the day.

The recommended dose is 1 tablet (Nifecard CL 30 mg or 60 mg) once a day. The initial dose is 30 mg per day, then it is gradually increased to 60 mg per day (the interval between dose increases should be from 7 to 14 days). The maximum dose of nifedipine is 90 mg per day.

In elderly patients, the elimination of nifedipine may be slowed down, so they should be prescribed lower maintenance doses.

In case of impaired renal function, an adjustment of the daily dose is not required, and in patients with impaired liver function and severe cerebrovascular diseases, a decrease in the initial and maintenance doses of Nifecard CL may be required.

It is recommended to gradually cancel Nifecard CL with a gradual dose reduction.

Side effects

• digestive system: often - constipation; infrequently - loss of appetite, pain in the abdomen, dyspeptic disorders (diarrhea, nausea), dryness of the oral mucosa; rarely - soreness, bleeding and swelling of the gums; with an unknown frequency - insufficiency of the gastroesophageal sphincter, vomiting, erosive and ulcerative lesions of the intestinal mucosa, disorder of the act of swallowing, with prolonged treatment - the formation of lumps from the remains of undigested food in the stomach, liver dysfunction (jaundice, increased activity of liver enzymes, intrahepatic cholestasis);
• metabolism and nutrition: with an unknown frequency - an increase in blood sugar;
• respiratory system: infrequently - cough, difficulty breathing, nosebleeds, sinusitis, nasal congestion, upper respiratory tract infections; with an unknown frequency - bronchospasm, shortness of breath, pulmonary edema;
• cardiovascular system: often - hyperemia of the skin of the face, asymptomatic decrease in blood pressure, a feeling of heat, flushing of the skin of the face, peripheral edema; infrequently - a feeling of palpitations, an excessive decrease in blood pressure (especially in patients on hemodialysis with a reduced volume of circulating blood and malignant hypertension), fainting or fainting, tachycardia; very rarely - attacks of angina pectoris (especially at the beginning of treatment), requiring the cancellation of Nifecard CL; isolated cases - myocardial infarction; with an unknown frequency - worsening of the course of heart failure, chest pain;
• nervous system: often - headache; infrequently - migraine, tremor, dizziness, fatigue; rarely - perversion of receptivity in the limbs; with an unknown frequency - with long-term therapy in large doses - anxiety, increased excitability, depression, sleep disturbances (including insomnia and nightmares), extrapyramidal disorders [tremors of the fingers and hands, drowsiness, shuffling gait, decreased sensitivity to real stimuli, ataxia, difficulty swallowing, mask-like (amimic) face, stiffness of the legs and arms], decreased libido;
• sense organs: infrequently - taste disturbance, transient visual impairment, ringing in the ears; with an unknown frequency - pain in the eye area;
• musculoskeletal system: infrequently - joint swelling, gout, cramps of the lower and upper extremities, back pain; with an unknown frequency - muscle or joint pain, arthritis;
• lymphatic system and blood: with an unknown frequency - a decrease in the number of platelets and leukocytes, agranulocytosis, anemia;
• immune system: infrequently - Quincke's edema / allergic edema, allergic reactions; rarely - skin rash, hives, itching; with an unknown frequency - photodermatitis, thrombocytopenic purpura, exfoliative dermatitis, autoimmune hepatitis, toxic epidermal necrolysis, anaphylactoid / anaphylactic reactions;
• genitourinary system: infrequently - impotence, decrease or increase in daily urine output; rarely - enlargement of the mammary glands in men, completely disappearing after discontinuation of Nifecard CL (mainly in elderly patients); with an unknown frequency - deterioration of renal function, lactorrhea;
• skin and subcutaneous fat: infrequently - hyperhidrosis, hemorrhagic rash, pathological hair loss;
• other reactions: often - weakness, asthenia; infrequently - chills, fever, nonspecific pain, weight gain, facial edema and periorbital edema.

Overdose

Signs of an overdose of nifedipine include hypoxia, hyperglycemia, peripheral vasodilation with a pronounced and sometimes long-term decrease in blood pressure (manifested by tachycardia and / or bradycardia, headache, bradyarrhythmia, facial flushing and inhibition of sinus node activity), cardiogenic shock (accompanied by pulmonary edema) acidosis. In the case of severe intoxication, the patient may experience loss of consciousness, in especially difficult cases to a coma.

Standard treatment: intake of activated charcoal inside and gastric lavage. In addition, it is necessary to carefully monitor the activity of the lungs, heart and kidneys, as well as to carry out measures aimed at restoring stable hemodynamic parameters.

In case of an overdose of drugs with prolonged action, first of all, the most complete elimination of drug residues from the body should be ensured. To do this, it is necessary, if possible, to flush the small intestine to prevent further absorption of nifedipine. Slow calcium channel blockers can reduce intestinal muscle tone up to complete atony, which should be taken into account when prescribing laxatives.

Hemodialysis is not effective for the elimination of nifedipine. Plasmapheresis is advisable (since the drug has a high degree of binding to plasma proteins and a relatively small volume of distribution). For the purpose of stopping bradyarrhythmias, beta-sympathomimetics and / or atropine are used, and if a bradyarrhythmia occurs that threatens the patient's life, a temporary pacemaker must be installed.

A persistent marked decrease in blood pressure caused by arterial vasodilation and cardiogenic shock is controlled by the use of calcium (1–2 g of calcium gluconate intravenously), dobutamine (up to 15 μg / kg of body weight per minute), dopamine (up to 25 μg / kg of body weight per minute), adrenaline or norepinephrine. Calcium preparations are an antidote to nifedipine.

Infusion therapy should be carried out with caution, monitoring hemodynamic parameters (to avoid possible volume overload of the heart).

special instructions

Treatment with Nifecard CL is stopped gradually. It should be borne in mind that at the beginning of therapy, the patient may develop an attack of angina pectoris, especially in the case of recent withdrawal of beta-blockers (they also cannot be abruptly canceled).

The joint administration of nifedipine and beta-blockers should be carried out only under close supervision by a doctor, since a combination of these drugs can cause an excessive decrease in blood pressure, and sometimes - an aggravation of the course of heart failure.

In patients with severe heart failure, the dosage of the drug is carried out with great care. With severe stenosis of the coronary arteries at the beginning of treatment with Nifecard CL or with an increase in the dose of the drug, an increase in the frequency and severity of anginal pain is possible, sometimes up to myocardial infarction (rarely).

Diagnostic criteria for the use of nifedipine in patients with vasospastic angina pectoris:

• spasm of the coronary arteries or ergonovine-induced angina pectoris;
• classic clinical picture with an increase in the ST segment on the ECG (electrocardiogram);
• coronary spasm detected by angiography;
• angiospasm without confirmation (for example, in the case of unstable angina pectoris or at different stress thresholds, when ECG data indicate transient angiospasm).

In persons with severe hypertrophic obstructive cardiomyopathy, the risk of an increase in the severity, duration and frequency of angina attacks after taking Nifecard CL increases, and therefore, in this case, the drug should be discontinued.

In patients with diabetes mellitus, additional monitoring of blood glucose levels may be required during treatment with Nifecard CL.

Patients on hemodialysis with high blood pressure, reduced blood volume and irreversible renal dysfunction are prescribed the drug with caution, since a sharp drop in blood pressure is possible.

In case of impaired liver function, the patient is monitored and, if necessary, the dose is reduced and / or nifedipine is used in other dosage forms.

In patients with severe stenosis of any part of the gastrointestinal tract, intestinal obstruction may develop. It is very rare for bezoars (stones in the stomach) to appear, which can sometimes only be removed with surgery. Signs of intestinal obstruction in isolated cases can occur in patients who do not have any pathologies of the gastrointestinal tract. The likelihood of the appearance of bezoars is greater in patients with decreased intestinal motility, diverticulitis, vertical gastroplasty, intestinal tumors, inflammatory bowel diseases, gastric bypass surgery, after colostomy and partial resection of the small intestine, as well as in patients who take anticholinergics, opiates together with nifedipine, laxatives (laxatives), H blockers_2- histamine receptors, muscle relaxants or non-steroidal anti-inflammatory drugs.

In a few reports, there was information about the adhesion of tablets to the walls of the intestine, which led to the formation of ulcers with further hospitalization of patients and surgery. Consideration should be given to the likelihood of false-positive symptoms of a polyp (the so-called filling defect) when X-ray examination of the intestine with barium.

Before carrying out surgical operations under general anesthesia, it is necessary to warn the anesthesiologist about taking Nifecard CL.

Slow calcium channel blockers, including nifedipine, can inhibit platelet aggregation in vitro, but there are few data on a statistically significant increase in bleeding time and a decrease in platelet aggregation.

In patients receiving Nifecard CL, an increase in the titer of antinuclear antibodies is possible, as well as a positive result when conducting a direct Coombs test.

Influence on the ability to drive vehicles and complex mechanisms

During treatment with Nifecard CL, care must be taken when driving a car or other transport, as well as performing work that requires a high concentration of attention and a quick reaction.

Application during pregnancy and lactation

Slow calcium channel blockers can cause reversible biochemical changes in the sperm head, which can lead to dysfunction. In men who have repeatedly had problems with conception during IVF (in vitro fertilization), the use of nifedipine may be one of the possible reasons, if no other explanation is found.

Nifecard CL is contraindicated in women before the 20th week of pregnancy, since fetal / embryotoxicity and teratogenicity of nifedipine have been shown in animal studies. After the 20th week of pregnancy, the use of the drug is possible only in a hospital setting (for timely monitoring of the blood pressure of a pregnant woman and regular ultrasound examination of the viability and development of the embryo) and in cases where the benefit to the mother clearly outweighs the possible risk to the fetus. If anomalies appear, Nifecard CL should be discontinued.

If the use of Nifecard CL during lactation is necessary, breastfeeding should be discontinued.

Pediatric use

Tablets Nifecard CL 60 mg and 30 mg are contraindicated in children and adolescents under the age of 18, since the efficacy and safety of nifedipine for patients of this age category has not been established.

With impaired renal function

Nifecard CL is used with caution in patients with impaired renal function, however, no adjustment of the daily dose is required.

For violations of liver function

Patients with impaired liver function Nifecard CL are prescribed with caution.

Use in the elderly

In the elderly, elimination of the drug may be slowed down. In this case, it is necessary to use lower maintenance doses.

Drug interactions

The main isoenzyme involved in the metabolism of nifedipine is CYP3A4. Medicines that induce or inhibit this isoenzyme are capable of altering the clearance and first-pass metabolism of Nifecard CL.

With the combined use of nifedipine with inducers of the isoenzyme CYP3A4, the following changes are possible:

• rifampicin: there is a significant decrease in the bioavailability of nifedipine, which does not allow to achieve an effective plasma concentration of the drug;
• phenytoin: bioavailability decreases and the effectiveness of Nifecard CL decreases (an increase in its dose may be required);
• phenobarbital and carbamazepine: a decrease in the plasma concentration of nifedipine is possible.

With the simultaneous use of Nifecard CL with inhibitors of the isoenzyme CYP3A4, the following interactions are possible:

• macrolide antibiotics (erythromycin, etc.): can increase the plasma concentration of nifedipine;
• inhibitors of HIV protease (ritonavir, indinavir, saquinavir, amprenavir, nelfinavir, etc.): an increase in the concentration of nifedipine in plasma is possible;
• imidazole derivatives (fluconazole, itraconazole, ketoconazole): reliable interaction studies have not been conducted, but there is a possibility of an increase in the concentration of nifedipine in plasma;
• fluoxetine, nefazodone, dalfopristin / quinupristine: an increase in the plasma concentration of nifedipine cannot be ruled out;
• valproic acid: a decrease in the concentration of nifedipine in blood plasma is possible;
• cimetidine: the plasma concentration of nifedipine increases and its antihypertensive effect increases;
• grapefruit juice: the presystemic metabolism of nifedipine decreases and its concentration in plasma increases, which increases the bioavailability of the drug and increases the risk of unstable angina and heart attack (drinking grapefruit juice during treatment is not recommended).

Possible drug interactions of Nifecard CL with other drugs:

• cisapride, cyclosporine: when used together, they can increase the plasma concentration of nifedipine;
• diltiazem: the clearance of nifedipine decreases and its concentration in plasma increases.
• antihypertensive drugs (beta-blockers, diuretics, angiotensin II receptor antagonists, alpha-blockers, alpha-methyldopa, angiotensin-converting enzyme inhibitors, phosphodiesterase-5 inhibitors, other slow calcium channel blockers): the antihypertensive effect of the listed drugs may be enhanced;
• digoxin: nifedipine increases the serum concentration of digoxin (a dose change of the latter may be required);
• quinidine: its plasma concentration decreases, at the same time the concentration of nifedipine in plasma may increase (it is recommended to control blood pressure and, if necessary, adjust the doses of both drugs);
• vincristine: the excretion of vincristine slows down and its dose may need to be reduced;
• tacrolimus: may slow down the metabolism of tacrolimus (a dose reduction is required);
• magnesium sulfate: a pronounced decrease in blood pressure is possible;
• phenytoin: the toxic effect of phenytoin increases due to a slowdown in its metabolism;
• cephalosporins: the concentration of cephalosporins in plasma increases;
• theophylline: increases the plasma concentration of theophylline;
• nitrates: when used simultaneously with nitrates, a synergistic effect is observed;
• fentanyl: development of severe arterial hypotension is possible (it is advisable to cancel Nifecard CL at least 36 hours before anesthesia);
• indirect anticoagulants: there are rare reports of an increase in prothrombin time.

Acetylsalicylic acid, ranitidine, benazepril, rosiglitazone, doxazosin, omeprazole, triamterene / hydrochlorothiazide, candesartan, irbesartan, orlistat, derisoquin and pantoprazole have no effect on the pharmacokinetics of Nifecard CL.

In patients receiving nifedipine, with the spectrophotometric method for the determination of vanilyl mandelic acid in urine, false-positive results are possible, therefore it is recommended to measure in another way.

Analogs

Analogs of Nifecard CL are Adalat, Kordaflex, Kordipin retard, Kordipin CL, Kordaflex RD, Kaltsigard retard, Korinfar UNO, Korinfar retard, Corinfar, Osmo-Adalat, Nifedipin, Nifedipin-Akrikhin, Fenigidin, etc.

Terms and conditions of storage

Keep out of the reach of children. Store at room temperature no more than 25 ° C.

The shelf life of the drug is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Nifeckard HL

According to reviews, Nifecard CL is a high-quality and effective drug for lowering high blood pressure. The tablets are convenient to take and are available at pharmacies. The drug helps from the first dose, and the effect of the treatment is quite long.

The disadvantages of Nifecard CL, according to patients, include the existing contraindications and possible side effects. Some users did not like the specific taste and smell, as well as the rather large size of the tablets, but despite this, most of the reviews are positive.

Price for Nifecard CL in pharmacies

Approximate prices for Nifecard CL, film-coated tablets with modified release, in pharmacies are as follows:

• Nifecard CL 30 mg: 30 pcs. in the package - 170-190 rubles; 60 pcs. in the package - 330-340 rubles;
• Nifecard CL 60 mg: 30 pcs. in the package - 300-520 rubles; 60 pcs. in the package - 490-500 rubles.

Nifecard HL: prices in online pharmacies

Drug name Price Pharmacy

Nifecard HL 60 mg film-coated tablets with controlled release 30 pcs. RUB 128 Buy

Nifecard HL tablets p.o. with mod. release 30mg 30 pcs. 161 r Buy

Nifecard HL 30 mg film-coated tablets with modified release 30 pcs. 161 r Buy

Nifecard HL 30 mg film-coated tablets with modified release 60 pcs. 309 RUB Buy

Nifecard xl tab. with mod. exs. p / o film. 30 mg No. 60 RUB 315 Buy

Nifecard HL 60 mg film-coated tablets with modified release 60 pcs. 509 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!