Nifedipine

Nifedipine – a blocker of calcium channels.

Form of release and structure

Dosage form – a dragee of yellow color (on 10 pieces in blisters, in a pack of cardboard 5 blisters).

Active agent: nifedipine, in 1 dragee – 10 mg.

Excipients: starch wheat, gelatin, magnesium stearate, lactose, cellulose microcrystallic PH101, talc.

Structure of a cover: isopropanol, глицерол, a karmelloza of 7MF, acetone, arlatset 186, the water purified, N22 ethyl cellulose, titanium dioxide, K30 povidone, sugar, ethanol of 96%, a macrogoal 6000, talc, polysorbate 20, silicon dioxide colloid, Eurolake Quinoline Yellow 21 (E104) and Eurolake Sunset Yellow 22 (E110).

Indications to use

• Stenocardia of rest and tension (including alternative) at coronary heart disease;
• Arterial hypertension (as monodrug or in combination with other antihypertensives).

Contraindications

Absolute (use of drug is strictly contraindicated):

• Cardiogenic shock, collapse;
• Sick sinus syndrome;
• Dekompensirovanny heart failure;
• The expressed aortal/mitral stenosis;
• Arterial hypotension with systolic arterial pressure below 90 mm hg;
• Idiopathic hypertrophic subaortal stenosis;
• Tachycardia;
• The period 4 weeks after an acute myocardial infarction;
• Age up to 18 years;
• Pregnancy;
• Lactation;
• Hypersensitivity to drug or other derivatives of dihydropyridine.

Relative (drug has to be used with care in connection with risk of development of complications):

• Diabetes mellitus;
• Heavy disturbances of cerebral circulation;
• The expressed dysfunctions of kidneys/liver;
• Chronic heart failure;
• Malignant arterial hypertension.

Care is demanded by drug use by the patients who are on a hemodialysis.

Route of administration and dosage

Nifedipine is applied orally, swallowing of tablets entirely and washing down with enough liquid, during food or after meal.

Doses are established individually depending on weight of a course of a disease and reaction of the patient to drug.

In an initiation of treatment appoint 1 dragee 2-3 times a day, if necessary the dose is increased to 2 dragees by 1-2 times a day.

The most admissible daily dose makes 40 mg of nifedipine (4 dragees).

The dose decline is required to elderly people, patients with abnormal liver functions, heavy disturbances of cerebral circulation, and also to the patient receiving a combination therapy (hypotensive or anti-anginal).

Side effects

• Cardiovascular system: feeling of heat, hyperemia of the person, peripheral hypostases (anklebones, feet, shins), tachycardia, syncope, excessive lowering of arterial pressure, heart failure; in certain cases, especially in an initiation of treatment – the emergence of attacks of stenocardia demanding drug withdrawal;
• Central nervous system: increased fatigue, drowsiness, dizziness, headache; at prolonged use in high doses – a tremor, paresthesias of extremities;
• Digestive tract, liver: dispepsichesky frustration; at prolonged treatment – abnormal liver functions (increase in activity of hepatic transaminases, an intra hepatic cholestasia);
• Musculoskeletal system: mialgiya, arthritis;
• Urinary system: increase in a daily urine, patients with a renal failure have a deterioration in function of kidneys;
• Bodies of a hemopoiesis: thrombocytopenia, leukopenia, Werlhof's disease, anemia;
• Allergic reactions: dieback, urticaria, skin itch, autoimmune hepatitis;
• Others: to face skin, elderly people have a hyperplasia of gums, a hyperglycemia, change of visual perception, rushes of blood a gynecomastia (completely disappearing after drug withdrawal).

Special instructions

In case of the sharp termination of treatment there is a risk of development of a withdrawal therefore the dose should be reduced gradually.

During treatment by Nifedipine it is necessary to refrain from the use of alcoholic drinks, control of vehicles and performance of potentially dangerous types of the works demanding speed of psychophysical reactions and the increased concentration of attention.

Medicinal interaction

• Other hypotensive drugs, diuretics, tricyclic antidepressants, ranitidine, Cimetidinum: strengthening of expressiveness of a lowering of arterial pressure;
• Nitrates: strengthening of tachycardia and hypotensive effect of nifedipine;
• Beta adrenoblockers: risk of the expressed lowering of arterial pressure, in certain cases – aggravation of heart failure (such combined treatment should be carried out under careful medical control);
• Quinidine: decrease in its concentration in a blood plasma;
• Theophylline, digoxin: increase in their concentration in a blood plasma;
• Rifampicin: acceleration of metabolism and, as a result, weakening of effect of nifedipine.

Terms and storage conditions

To store at a temperature up to 25 ºC in the place unavailable to children protected from light and moisture.

Period of validity – 3 years.