Fenigidine - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Nifedipine has an antianginal and antihypertensive effect. Inhibits the intake of calcium ions, mainly in the cells of the smooth muscles of arterial vessels. Decreases spasm and dilates coronary and peripheral (mostly arterial) blood vessels, reducing blood pressure, total peripheral vascular resistance and slightly - myocardial contractility, afterload, and reduces myocardial oxygen demand. Does not affect the tone of the veins.Improves the blood supply of ischemic zones of the myocardium without the development of the phenomenon of "stealing", activates the functioning of collaterals. Increases coronary and renal blood flow. Does not have a depressing effect on the conduction system of the heart. At long reception (2-3 months) tolerance to action of a preparation develops.

Pharmacokinetics:Absorption is high (more than 90%). Bioavailability is 40-60%. Eating food increases the bioavailability of the drug. Has the effect of "first pass" through the liver. The maximum concentration in the blood plasma is achieved 1-3 hours after ingestion (65 mg / ml). Half-life is 2 hours. Do not cumulate. Penetrates through blood-brain and placental barriers, excreted in breast milk. Chronic renal failure, hemodialysis and peritoneal dialysis do not affect the pharmacokinetics. Connection with blood plasma proteins - 90%. It is completely metabolized in the liver. In patients with hepatic insufficiency, the overall clearance decreases and the half-life increases. It is excreted by the kidneys in the form of inactive metabolites (70-80% of the dose taken).

Indications:

- ischemic heart disease - stable angina (including variant angina);

- arterial hypertension (in the form of monotherapy or in combination with other antihypertensive drugs).

Contraindications:

- hypersensitivity to nifedipine and other dihydropyridine derivatives;

- acute stage of myocardial infarction (first week);

- cardiogenic shock;

- severe arterial hypotension (systolic blood pressure below 90 mm Hg);

- syndrome of weakness of the sinus node;

- severe heart failure (in the stage of decompensation);

- severe aortic or mitral stenosis;

- idiopathic hypertrophic subaortic stenosis;

- pregnancy, lactation;

- age to 18 years.

Carefully:

- with heart failure,

- severe disturbances of cerebral circulation,

- Diabetes mellitus,

- Malignant arterial hypertension, with impaired liver and / or kidney function;

- patients who are on hemodialysis (because of the risk of

arterial hypotension).

Dosing and Administration:The dosage regimen is set individually, depending on the degree of severity of the disease and the patient's response to ongoing therapy.It is recommended to take the drug during or after a meal, with a small amount of water. Initial dose: 1 tablet (10 mg) 2-3 times a day. If necessary, the dose of the drug can be increased to 2 tablets (20 mg) 1-2 times per day. The maximum daily dose is 40 mg. In elderly patients or patients receiving combined (antianginal or antihypertensive) therapy, lower doses of nifedipine (5 mg) are usually prescribed.

Side effects:

From the cardiovascular system: possibly - hyperemia of the face, a feeling of heat, tachycardia, syncope, peripheral edema, lowering of blood pressure. In some patients, especially at the beginning of treatment, angina attacks may occur, which requires the withdrawal of the drug;

From the central nervous system: headache, dizziness, fatigue, drowsiness. When applying high doses of the drug, single cases of paresthesia of the extremities, tremor, visual impairment, sleep disturbance were noted;

From the gastrointestinal tract and liver: nausea, constipation, diarrhea. With prolonged use of the drug, there may be cases of increased activity of "hepatic" transaminases, the occurrence of intrahepatic cholestasis;

Co hand hematopoiesis system: in rare cases - reversible thrombocytopenia, leukopenia, anemia;

Co hand urinary system: an increase in daily diuresis; in patients with renal failure - impaired renal function;

Allergic and immunopathological reactions: rarely - hives, itchy skin, exanthema, autoimmune hepatitis;

Other : with prolonged use - myalgia, gynecomastia, gingival hyperplasia, hyperglycemia, edema of the lower extremities, rarely - arthritis with an increase in the titer of antinuclear antibodies.

Overdose:

Symptoms: headache, hyperemia of the facial skin, lowering of arterial pressure, tachycardia, suppression of sinus node activity, bradycardia, arrhythmia.

Treatment: gastric lavage with the appointment of activated charcoal, symptomatic therapy aimed at stabilizing the activity of the cardiovascular system and respiration.

The antidote is calcium, a slow intravenous injection of 10% calcium chloride or calcium gluconate is indicated, followed by a switch to a prolonged infusion, the introduction of vasopressors. Hemodialysis is not effective.

Interaction:

- with simultaneous appointment with beta - adrenoblockers, along with an increase in the hypotensive effect, a decrease in myocardial contractility is possible;

- with the simultaneous use of nifedipine and quinidine a decrease in the concentration of quinidine in the blood plasma;

- in combination with nitrates there is an increase in antianginal and hypotensive effects;

- simultaneous reception cimetidine, other antihypertensive agents, diuretics, tricyclic antidepressants can lead to an increase in the hypotensive effect;

- with the simultaneous administration of nifedipine with digoxin and theophylline there is an increase in the concentration of digoxin and theophylline in the blood plasma, which requires correction of their dose;

- simultaneous therapy with rifampicin leads to a weakening of the effectiveness of nifedipine, tk. rifampicin induces the activity of liver enzymes, accelerating the metabolism of nifedipine;

Special instructions:

- when prescribing the drug, nursing mothers should resolve the issue of stopping breastfeeding;

- discontinuation of treatment with the drug should be made gradually because of the possible development of the "withdrawal" syndrome;

- in patients with stable angina at the beginning of treatment, there may be a paradoxical increase in anginal pain,with severe coronarosclerosis and unstable angina pectoris - aggravation of myocardial ischemia;

- during treatment with nifedipine should refrain from drinking alcohol;

- with care to prescribe the drug to drivers of vehicles and people of other professions that require a quick mental or physical reaction.

Form release / dosage:

Tablets 0.01 g. For 10 or 25 tablets in a contour mesh box made of PVC film and aluminum foil;

2 contourcell packs of 25 tablets or 5 contour cell packs of 10 tablets together with instructions for use are placed in a pack of cardboard.

Storage conditions:List B. In a dry, the dark place at a temperature of 5 to 30 °C. Keep out of reach of children.

Shelf life:

2 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015667 / 01

Date of registration:18.05.2009

The owner of the registration certificate:LUHANSKY HFZ, OJSC LUHANSKY HFZ, OJSC Ukraine

Manufacturer: & nbsp

LUHANSKY HFZ, OJSC Ukraine

Information update date: & nbsp17.05.2004

Illustrated instructions

Instructions

Phenyhydidine (Phenyhydinum)