Felodip, sustained release pills 5mg 30pcs

Composition

Active ingredient:

felodipine 5 mg.

Auxiliary substances:  

lactose monohydrate,

microcrystalline cellulose,

hypromellose,

povidone,

propyl gallate,

magnesium stearate,

colloidal anhydrous silicon,

iron oxide yellow,

iron oxide red,

titanium dioxide,

talc,

propylene glycol.

Pharmacological action

Felodipine belongs to the BCC of the dihydropyridine series. It has a hypotensive, antianginal effect. Reduces Blood pressure by reducing peripheral vascular resistance. It has a dose-dependent anti-ischemic effect. Reduces the size of myocardial infarction, protects against reperfusion complications. Practically does not have a negative inotropic effect, has a minimal effect on the conducting system of the heart.

Pharmacokinetics

Suction and distribution. Delayed release of felodipine from film-coated tablets leads to an elongation of the absorption phase of the drug and provides a uniform concentration of felodipine in blood plasma for 24 hours. Felodipine is almost completely absorbed in the gastrointestinal tract. The bioavailability of the drug does not depend on the dose within the therapeutic interval and is approximately 15%.99% of felodipine binds to plasma proteins, primarily albumins.

Metabolism and elimination. Felodipine is completely metabolized in the liver, and all its metabolites are inactive. T1 / 2 of felodipine is 25 hours. With prolonged use, felodipine accumulation does not occur.

Pharmacokinetics in special patient groups

Elderly patients. In elderly patients and in cases of impaired liver function, the concentration of felodipine in blood plasma is higher than in young patients.

Impaired renal function. The pharmacokinetic parameters of felodipine do not change in patients with impaired renal function, including during hemodialysis. About 70% of the dose taken is excreted by the kidneys, and the rest by the intestines in the form of metabolites. Less than 0.5% of the dose is excreted unchanged by the kidneys. Felodipine passes through the BBB into the placenta and is excreted in breast milk.

Indications

Arterial hypertension; stable angina pectoris (including Prinzmetal angina pectoris).

Contraindications

• hypersensitivity to felodipine and other derivatives digidropiridinovmi range;
• unstable angina;
• acute myocardial infarction and for 1 month after myocardial infarction;
• cardiogenic shock,
• clinically significant aortic stenosis;
• heart failure in the stage of decompensation;
• severe hypotension;
• lactose intolerance, lactase deficiency;
• glucose-galactose malabsorption;
• pregnancy;
• breastfeeding;
• age to 18 years (efficacy and safety not established).

With caution:  liver and / or kidney failure, age over 65 years.

Side effects

The drug (as with other slow calcium channel blockers) can cause redness of the face, headache, palpitations, dizziness, and increased fatigue.

These reactions are reversible and most often occur at the beginning of treatment and with an increase in the dose of the drug. Also, depending on the dose, peripheral edema may appear, which are a consequence of precapillary vasodilation. Patients with gum disease or periodontitis may experience mild swelling of the gums. This can be prevented by careful oral hygiene.

In some cases:

Dermatological reactions: rarely-urticaria, pruritus; in isolated cases – photosensitization.

From the musculoskeletal system: in isolated cases – arthralgia, myalgia.

From the central nervous system and peripheral nervous system: headache, dizziness; in some cases – paresthesia.

From the digestive system: rarely-nausea, gum hyperplasia, increased activity of liver enzymes.

From the cardiovascular system: rarely-palpitations, tachycardia, peripheral edema.

Other: rarely-increased fatigue; in isolated cases-hypersensitivity reactions (including angioedema).

Interaction

When used concomitantly with Felodip, the concentration of digoxin in plasma increases, but a change in the dosage regimen of Felodip is not required.

When used concomitantly with cytochrome P450 inhibitors (including cimetidine, erythromycin, itraconazole, ketoconazole), the metabolism of felodipine in the liver slows down, which leads to an increase in its concentration in blood plasma.

When used concomitantly with inducers of microsomal liver enzymes (including phenytoin, carbamazepine, rifampicin, barbiturates), the concentration of felodipine in blood plasma decreases. NSAIDs do not weaken the antihypertensive 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-blockers, verapamil, tricyclic antidepressants and diuretics enhance the hypotensive effect of Felodip.

Felodipine should not be used concomitantly with grapefruit juice because of its flavonoid content, which increases the bioavailability of felodipine.

How to take, course of use and dosage

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

Use in arterial hypertension:  the dosage regimen for adults (including the elderly) is set individually. The initial dose is 5 mg 1 time/day (during the dose selection period, 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 can be used in combination with beta-blockers, ACE inhibitors or diuretics, while the hypotensive effect is enhanced (caution should be exercised due to the increased risk of hypotension ).

Use in elderly patients or patients with impaired liver function:  the initial dose is 2.5 mg / day.

Use in severe hepatic impairment:  the dose of the drug should be reduced.

Use in stable angina pectoris:  the dose is set individually. The initial dose for adults is 5 mg 1 time/day, if necessary, the dose is increased to 10 mg 1 time/day. The maximum daily dose is 20 mg 1 time/day.

Overdose

Symptoms:  severe arterial hypotension, bradycardia.

Treatment:  conduct symptomatic therapy. With severe hypotension, the patient should be given a horizontal position with raised legs. In case of bradycardia-intravenous use of atropine at a dose of 0.5-1 mg. If necessary, to increase the plasma volume, infusions of glucose, sodium chloride or dextran solution are performed. Drugs with a predominant effect on alpha-adrenergic receptors are prescribed if the above measures are ineffective.

Special instructions

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

Currently, there are no data on the feasibility 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 patients with bronchial asthma and other obstructive pulmonary diseases, with impaired renal function, diabetes mellitus, gout, hyperlipidemia, Raynaud’s syndrome, as well as after lung transplantation.

Felodip has no effect on the concentration of glucose in blood plasma and on the lipid profile.

Influence on the ability to drive motor vehicles and manage mechanisms:

patients who experience weakness and dizziness during treatment with Felodip should refrain from driving vehicles and work that requires increased attention and concentration.

Form of production

Long-acting coated tablets.

Storage conditions

Store at a temperature of 10 °C to 25 °C in a dark place.

Active ingredient

Felodipine

Conditions of release from pharmacies

By prescription

Dosage form

long-acting tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Angina