Nifekard HL

Nifekard HL – a blocker of calcium channels, drug with anti-anginal and anti-hypertensive action.

Form of release and structure

Dosage form – tablets, coated, with the modified release and tablets, coated, with controlled release: round, convex from two parties, from light - brownish-yellow to light - brownish-orange color, with the squeezed-out text of "NDP 30" (a tablet of 30 mg) or "NDP 60" (a tablet of 60 mg) on one of the parties (on 10 pieces in blisters, on 2 or 3 blisters in a pack cardboard).

Active agent: nifedipine, in 1 tablet – 30 or 60 mg.

Additional substances: sodium lauryl sulfate, magnesium stearate, povidone, magnesium hydrosilicate, ^{Ludipress® Lek} (mix of lactose of monohydrate, krospovidon and povidone in the ratio 93:3,5:3,5), gipromelloza (tablet of 30 mg), gipromelloza-2906 and gipromelloza-2208 (tablets of 60 mg).

Structure of a cover: gidroksipropilmetiltsellyuloza phthalate, polyethyleneglycol, gidroksipropilmetiltsellyuloza 2910, magnesium hydrosilicate, hydroxypropyl cellulose, titanium dioxide, triethyl citrate, dye ferrous oxide yellow NF.

Indications to use

• Coronary heart disease: vasospastic (angiospastic) stenocardia, angina of exertion (stable);
• Arterial hypertension.

Contraindications

Absolute:

• The expressed stenosis of the aortal valve;
• The expressed arterial hypotension (systolic arterial pressure is lower than 90 mm hg);
• Dekompensirovanny chronic heart failure;
• The acute period of a myocardial infarction (the period 4 weeks after an attack);
• Cardiogenic shock;
• I trimester of pregnancy;
• Lactation;
• Hypersensitivity to components of drug or other derivatives 1,4 dihydropyridines.

Relative:

• Unstable stenocardia;
• The expressed stenosis of the mouth of an aorta or the mitral valve;
• Sick sinus syndrome;
• The expressed tachycardia;
• Hypertrophic subaortic stenosis;
• Myocardial infarction with a left ventricular failure;
• Malignant arterial hypertension;
• Heavy disturbances of cerebral circulation;
• Renal failures and/or liver;
• Age up to 18 years;
• II and III trimesters of pregnancy;
• Simultaneous use of beta adrenoblockers, cardiac glycosides, rifampicin.

Route of administration and dosage

Nifekard HL should be accepted inside, swallowing of capsules entirely, not chewing and without breaking.

Treatment begin 30 mg with a daily dose. If necessary each 7-14 days increase a dose.

The most admissible daily dose – 90 mg.

Side effects

• From the central nervous system: weakness, increased fatigue, headache, drowsiness, вертиго; at long reception of high doses – extrapyramidal disturbances (the shuffling gait, a tremor of brushes and fingers of hands, constraint of movements of hands and legs, a mask-like face, the complicated swallowing, an ataxy), feeling of alarm, a depression, paresthesias of extremities;
• From cardiovascular system: an excessive vazodilatation (feeling of rushes of blood to face skin, feeling of heat, a dermahemia of the person, an asymptomatic lowering of arterial pressure), retrosternal pains, arrhythmia, heartbeat, tachycardia, peripheral hypostases; seldom – a syncope, an excessive lowering of arterial pressure, a syncope, stenocardia attacks (is more often in an initiation of treatment); in isolated cases – a myocardial infarction;
• From the alimentary system: dispepsichesky frustration (nausea, a diarrhea/lock), a loss of appetite, dryness in a mouth; seldom – a hyperplasia of gums (puffiness, morbidity, bleeding); at long reception – functional disturbances of a liver (increase in activity of hepatic transaminases, an intra hepatic cholestasia);
• From endocrine system: very seldom – increase in body weight, a galactorrhoea, a hyperglycemia; elderly people have a gynecomastia (completely disappears after drug withdrawal);
• From an urinary system: increase in a daily urine; patients with a renal failure have a deterioration in function of kidneys;
• From bodies of a hemopoiesis: Werlhof's disease, thrombocytopenia, leukopenia, asymptomatic agranulocytosis, anemia;
• From respiratory system: seldom – cough, breath difficulty; very seldom – a bronchospasm, a fluid lungs;
• From a musculoskeletal system: arthritis; seldom – a mialgiya, puffiness of joints, spasms of the lower and upper extremities, an arthralgia;
• From an organ of sight: very seldom – vision disorders (at the maximum concentration of nifedipine in blood the tranzitorny blindness is possible);
• Allergic reactions: seldom – a photodermatitis, a dieback, a skin itch, exfoliative dermatitis; in rare instances – autoimmune hepatitis.

Special instructions

Nifekard HL needs to be applied with care at treatment of the persons which are on a hemodialysis, patients with high arterial pressure, patients with the irreversible renal failure which is followed by decrease in total quantity of blood as perhaps sharp falling of arterial pressure.

In an initiation of treatment there is a probability of development of stenocardia, especially after the previous sharp cancellation of beta adrenoblockers (therefore it is necessary to cancel them gradually).

The combined use of Nifekard of HL with beta adrenoblockers has to be carried out under careful medical control since perhaps excessive lowering of arterial pressure, and some patients have an aggravation of symptoms of heart failure.

With extra care it is necessary to dose drug at the expressed heart failure.

To patients at vasospastic stenocardia this medicine is appointed at the following diagnostic criteria: existence of a classical clinical picture of a disease with increase in a segment of ST, emergence of a spasm of coronary arteries or the ergonovin-induced stenocardia, identification of a coronary spasm at an angiography or an angiospastic component without confirmation (for example, at a different threshold of tension or at unstable stenocardia in cases when these electrocardiograms confirm development of a passing vasomotor spasm).

In need of performing surgery during treatment by drug it is necessary to inform the anesthesiologist on the received therapy surely.

During Nifekard's reception HL is possible receiving positive takes when conducting laboratory tests on definition of antinuclear antibodies and when carrying out forward reaction of Koombs.

Patients with abnormal liver functions during therapy have to be under careful medical control (if necessary it is necessary to reduce a dose of nifedipine and/or to apply other dosage forms of this substance).

Patients with a heavy subaortic stenosis treat risk group of increase in frequency, duration and weight of attacks of stenocardia after Nifekard's reception of HL.

It is necessary to cancel nifedipine gradually.

During treatment it is necessary to be careful at control of motor transport and performance of potentially dangerous types of the works requiring special attention and high speed of reactions.

Medicinal interaction

• Other anti-hypertensive drugs, beta adrenoblockers, inhalation anesthetics, tricyclic antidepressants, diuretics, nitrates, Cimetidinum, to a lesser extent ranitidine: anti-hypertensive effect of nifedipine amplifies;
• Quinidine: its concentration in a blood plasma, and after nifedipine cancellation perhaps sharp increase in level decreases;
• Digoxin, theophylline: their concentration in a blood plasma increases (it is necessary to control concentration in blood and clinical effect);
• Inductors of microsomal enzymes of a liver (including rifampicin): concentration of nifedipine decreases;
• Nitrates: tachycardia amplifies;
• Non-steroidal anti-inflammatory drugs, calcium drugs, sympathomimetics, are oestrogenic: anti-hypertensive effect of nifedipine decreases;
• Vincristinum: its removal is slowed down, side effects amplify (decrease in its dose is necessary);
• Lithium drugs: toxic effects of lithium (nausea, vomiting, diarrhea, a tremor, an ataxy, a sonitus) amplify;
• Cephalosporins (for example, tsefiksy): bioavailability of cephalosporin increases by 70%;
• The drugs which are characterized by high extent of linkng with proteins (anticonvulsants, non-steroidal anti-inflammatory drugs, salicylates, coumarin, quinine, Sulfinpyrazonum, индандион): their concentration in a blood plasma increases.

Grapefruit juice suppresses metabolism of nifedipine in an organism therefore its concomitant use with Nifekard is contraindicated to HL.

Terms and storage conditions

To store at a temperature up to 25 °C. To protect from children.

Period of validity – 3 years.