Felodip coated pills 2,5mg N30
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Active ingredients
Felodipine
Release form
Pills
Composition
Active ingredient: Felodipine (Felodipine) Active ingredient concentration (mg): 2.5
Pharmacological effect
Blocker of slow calcium channels from the group of dihydropyridine derivatives. It has a hypotensive, antianginal effect. Reduces hell by reducing ops. 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.
Pharmacokinetics
Absorption and distribution After taking the drug inside, felodipine is almost completely absorbed from the gastrointestinal tract. Due to the peculiarities of the dosage form, the sustained release of felodipine leads to a lengthening of the absorption phase and ensures a uniform concentration of felodipine in the blood plasma for 24 hours. The bioavailability of the drug does not depend on the dose (in the range of therapeutic doses) and is about 15%. Plasma protein binding, mainly albumin is about 99%. It penetrates the BBB and placental barrier, is excreted in breast milk. With long-term use, celulation of felodipine does not occur. Metabolism Felodipine is almost completely metabolized in the liver to form inactive metabolites. Excretion of T1 / 2 felodipine is 25 hours. It is derived as metabolites: about 70% of the dose taken is with urine, the rest is feces. In an unchanged form, less than 0.5% of the dose is excreted in the urine. The pharmacokinetics in special groups of patients in elderly people and in patients with impaired liver function felodipine plasma concentration is higher than in younger patients. The pharmacokinetic indicators of felodipine do not change in patients with impaired renal function, including and during hemodialysis.
Indications
- Arterial hypertension. - Angina pectoris (including Prinzmetal angina pectoris).
Contraindications
- Unstable angina. - Acute myocardial infarction and a period of up to 1 month after myocardial infarction. - Cardiogenic shock. - Clinically significant aortic stenosis. - Heart failure in the stage of decompensation. - Severe arterial hypotension. - Pregnancy. - Lactation (breastfeeding).- Children and adolescents under 18 years of age (efficacy and safety have not been established). - Hypersensitivity to the drug or to other dihydropyridine derivatives. With caution, use the drug for liver and / or renal failure.
Precautionary measures
The drug should be stored in a dark place, out of reach of children at a temperature of from 10 ° to 25 ° C.
Use during pregnancy and lactation
Felodip is contraindicated for use during pregnancy and lactation (breastfeeding).
Dosage and administration
The drug is recommended to take in the morning before a meal or after a light breakfast. Coated pills should not be cracked, divided or crushed. Use in case of arterial hypertension: the dosage regimen for adults (including the elderly) is set individually. The initial dose is 5 mg 1 time / day (during the selection of the dose is recommended to use 2.5 mg pills). 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 must be exercised due to the increased risk of arterial hypotension). Use in elderly patients or patients with impaired liver function: the initial dose is 2.5 mg / day. Use for severe violations of the liver: the dose should be reduced. Use with stable angina: 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.
Side effects
The drug (as with the use of other slow calcium channel blockers) can cause facial flushing, 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 occur, which are the result of precapillary vasodilation. Patients with gum disease or periodontitis may experience mild swelling of the gums.This can be prevented by observing thorough oral hygiene. In some cases: Dermatological reactions: rarely - urticaria, itching; in isolated cases - photosensitivity. On the part of the musculoskeletal system: in isolated cases - arthralgia, myalgia. On the side of the central nervous system and peripheral nervous system: headache, dizziness; in rare cases - paresthesia. From the digestive system: rarely - nausea, gingival hyperplasia, increased activity of liver enzymes. From the cardiovascular system: rarely - palpitations, tachycardia, peripheral edema. Others: rarely - increased fatigue; in isolated cases - hypersensitivity reactions (including angioedema).
Overdose
Symptoms: excessive decrease in blood pressure, bradycardia. Treatment: symptomatic therapy. With an excessive decrease in blood pressure of the patient should be transferred to a horizontal position with a low head. With bradycardia - in / in the introduction of atropine in a dose of 0.5-1 mg. If necessary, to increase the BCC - infusion of a solution of dextrose (glucose), sodium chloride or dextran. Preparations with a predominant effect on α-adrenoreceptors are prescribed for the ineffectiveness of the above measures.
Interaction with other drugs
With simultaneous use with felodipine, the concentration of digoxin in plasma increases, however, changing the dosing regimen of drug Felodip is not required. When used simultaneously with cytochrome P450 inhibitors (including with cimetidine, erythromycin, itraconazole, ketoconazole), felodipine metabolism in the liver slows down to an increase in its concentration in blood plasma. With simultaneous use of microsomal liver enzymes with inducers (including phenytoin, carbamazepine, rifampicin, barbiturates), The concentration of felodipine in the blood plasma. NPVS do not weaken the hypotensive effect of felodipine. The high degree of felodipine binding to plasma proteins does not affect the binding of free fractions of other drugs (including warfarin). Beta-adrenergic blockers, verapamil, tricyclic antidepressants and diuretics. Felodipine's hypotensive effect. With simultaneous use of felodipine with tacrolimus, it is possible to increase the concentration of the latter in the blood plasma, which may require correction of the dose of tacrolimus. Felodip does not It should be used simultaneously with grapefruit juice because of the flavonoid in it, which increases felodipine's bioavailability.
special instructions
Felodip (like other vasodilators) can rarely cause significant arterial hypotension, which in susceptible patients can lead to myocardial ischemia. regardless of gender and age, as well as patients with bronchial asthma and other lung diseases, with impaired renal function, diabetes mellitus, gout, with hyperlipide mission, Raynaud's syndrome, as well as after lung transplantation. Felodip does not affect plasma glucose concentration and lipid profile. Impact on ability to drive vehicles and control mechanismsPatients who have weakness and dizziness during treatment with Felodip can from driving vehicles and work requiring increased concentration of attention and speed of psychomotor reactions.