Felodip, 10 mg 30 pcs

Felodip is a slow calcium channel blocker from the group of dihydropyridine derivatives.

It has hypotensive, antianginal action, reduces BP by reducing PPS.

It has a dose-dependent anti-ischemic effect.

Limits the size of myocardial infarction, protects against reperfusion complications.

It has almost no negative inotropic effect and has minimal effect on the conductive system.

Indications

– Arterial hypertension.

– Angina pectoris (including Prinzmetal’s angina).

Active ingredient

Composition

1 sustained release coated tablet contains:

Felodipine 10 mg.

Auxiliary substances:

lactose monohydrate,

microcrystalline cellulose,

p> hypromellose,

povidone,

propyl gallate,

magnesium stearate,

colloidal anhydrous silicon,

iron oxide yellow,

Iron oxide red,

Titanium dioxide,

Talc,

Propylene glycol.

How to take, the dosage

The drug is recommended to be taken in the morning before meals or after a light breakfast. Coated tablets must not be crushed, split or crushed.

Application in arterial hypertension: the dosage regimen for adults (including elderly persons) is determined individually. The initial dose is 5 mg 1 time per day (during dose selection it is recommended to use 2.5 mg tablets). If necessary, the dose can be increased, the average dose for maintenance therapy is 5-10 mg/day. Felodip may be used in combination with beta-adrenoblockers, ACE inhibitors or diuretics, which increase the hypotensive effect (caution should be exercised because of increased risk of arterial hypotension).

Perhaps in elderly patients or patients with hepatic impairment: the initial dose is 2.5 mg/day.
Application in patients with severe hepatic impairment: The drug dose should be reduced.

Application in stable angina pectoris: The dose is determined individually. The initial dose for adults is 5 mg 1 time per day; if necessary, the dose is increased to 10 mg 1 time per day. The maximum daily dose is 20 mg once daily.

Interaction

Concomitant use with Felodip increases plasma concentrations of digoxin, but there is no need to change the dosing regimen of Felodip.

In concomitant use with cytochrome P450 inhibitors (including cimetidine, erythromycin, itraconazole, ketoconazole), felodipine metabolism in the liver is slowed, which leads to increased plasma concentrations.

Concomitant use with inducers of microsomal liver enzymes (including phenytoin, carbamazepine, rifampicin, barbiturates) decreases the plasma concentration of felodipine.

The NSAIDs do not weaken the hypotensive effect of Felodip. The high degree of binding of felodipine to plasma proteins does not affect the binding of free fractions of other drugs (including warfarin).

Beta-adrenoblockers, verapamil, tricyclic antidepressants and diuretics increase the hypotensive effect of Felodip.

Felodip should not be used concomitantly with grapefruit juice because of the flavonoid in it, which increases the bioavailability of felodipine.

Special Instructions

Felodip (like other vasodilators) may in rare cases cause significant arterial hypotension, which in predisposed patients may lead to the development of myocardial ischemia.

There are currently no data on the appropriateness of using the drug as a secondary prevention of myocardial infarction.

Felodip is effective and well tolerated by patients regardless of gender and age as well as by patients with bronchial asthma and other obstructive pulmonary diseases, with impaired renal function, diabetes, with gout, hyperlipidemia, Raynaud’s syndrome and after lung transplantation.

Felodip has no effect on plasma glucose concentration and lipid profile.

Impact on driving and operating machinery: patients who experience weakness and dizziness during treatment with FELODIP should avoid driving motor transport and work requiring increased attention and concentration.

Contraindications

– Unstable angina pectoris.
– Acute myocardial infarction and the period up to 1 month after the myocardial infarction.
– Cardiogenic shock.
– Clinically significant aortic stenosis.
– Cardiac insufficiency in decompensation.
– Severe arterial hypotension.
– Pregnancy.
– Lactation (breastfeeding).
– Child and adolescent age under 18 years (effectiveness and safety has not been established).
– Hypersensitivity to the drug or to other dihydropyridine derivatives.

The drug is used with caution in hepatic and/or renal failure.

Side effects

The drug (as with other slow calcium channel blockers) may cause facial redness, headache, palpitations, dizziness, increased fatigue. These reactions are reversible and most often occur at the beginning of treatment and when increasing the dose of the drug.

Depending on the dose, peripheral edema may also occur, which is a consequence of precapillary vasodilation. Patients with inflamed gums or periodontitis may have mild swelling of the gums. This may be counteracted by good oral hygiene.

In individual cases:

Dermatological reactions: rarely, urticaria, itching; in isolated cases, photosensitization.

Muscular system disorders: in single cases – arthralgia, myalgia.

CNS and peripheral nervous system: headache, dizziness; in single cases – paraesthesia.

Digestive system disorders: rarely – nausea, gum hyperplasia, increased liver enzymes activity.

Cardiovascular system: rare – palpitations, tachycardia, peripheral edema.

Others: rarely – fatigue; in single cases – hypersensitivity reactions (including angioedema).

Overdose

Symptoms: marked arterial hypotension, bradycardia.

Treatment: symptomatic therapy is carried out. In severe arterial hypotension the patient should be put in horizontal position with elevated legs. In bradycardia – intravenous injection of atropine in a dose of 0.5-1 mg.

If necessary to increase plasma volume, infusion of glucose solution, sodium chloride or dextran shall be carried out. Drugs with a predominant effect on α-adrenoreceptors are prescribed if the above measures are ineffective.

Similarities