Universal reference book for medicines
Product name: FELODIP

Active substance: felodipine

Type: Calcium channel blocker

Manufacturer: Teva Pharmaceutical Industries (Israel) manufactured by TEVA Czech Industries (Czech Republic)
Composition, form of production and packaging
Long-acting tablets coated with a film coating of
yellow color, round, biconvex, with engraving "2.5" on one side, odorless;
on the fracture - the core is white or almost white.
1 tab.

felodipine 2.5 mg

Excipients: lactose monohydrate - 25.2 mg, microcrystalline cellulose (type Avicel PH101) - 51.75 mg, hypromellose (Methocel E50LV) - 110 mg, povidone (type K-25) 7.35 mg, propyl gallate - 0.067 mg, microcrystalline cellulose (type Emcocel 90M) - 8 mg, silicon dioxide colloid - 1.3 mg, magnesium stearate - 0.833 mg.

Composition of the film membrane: hypromellose (type Pharmacoat 606) - 6.149 mg, iron oxide oxide yellow (E172) 0.192 mg, titanium dioxide (E171) 0.954 mg, talc 0.93 mg, propylene glycol 1.074 mg.

10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
Long-acting tablets coated with a filmy coating of light pink color, round, biconvex, engraved "5" on one side, odorless;
on the fracture - the core is white or almost white.
1 tab.

felodipine 5 mg

Excipients: lactose monohydrate - 23.95 mg, microcrystalline cellulose (type Avicel PH101) - 50.5 mg, hypromellose (Methocel E50LV) - 110 mg, povidone (type K-25) - 7.35 mg, propyl gallate - 0.067 mg, microcrystalline cellulose (type Emcocel 90M) - 8 mg, silicon dioxide colloid - 1.3 mg, magnesium stearate - 0.833 mg.

The composition of the film sheath: hypromellose (type Pharmacoat 606) is 6.666 mg, iron oxide red (E172) 0.019 mg, iron oxide yellow (E172) 0.007 mg, titanium dioxide (E171) 0.435 mg, talc -1.008 mg, propylene glycol 1.165 mg.

10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
Tablets of prolonged action, covered with a film membrane of red-brown color, round, biconcave, with engraving "10" on one side, odorless;
on the fracture - the core is white or almost white.
1 tab.

felodipine 10 mg

Auxiliary substances: lactose monohydrate - 21.45 mg, microcrystalline cellulose (type Avicel PH101) - 48 mg, hypromellose (Methocel E50LV) - 110 mg, povidone (type K-25) 7.35 mg, propyl gallate - 0.067 mg, microcrystalline cellulose (type Emcocel 90M) - 8 mg, silicon dioxide colloid - 1.3 mg, magnesium stearate - 0.833 mg.

Composition of the film membrane: hypromellose (type Pharmacoat 606) - 6.572 mg, iron oxide red (E172) 0.081 mg, iron oxide oxide yellow (E172) - 0.044 mg, titanium dioxide (E171) 0.467 mg, talc 0.992 mg, propylene glycol 1.144 mg.

10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Blocker of slow calcium channels from the group of dihydropyridine derivatives.
Has hypotensive, antianginal action.
Reduces blood pressure by reducing OPSS.
Has a dose-dependent anti-ischemic effect. Reduces the size of myocardial infarction, protects against complications of reperfusion.
Virtually does not have a negative inotropic effect, has a minimal effect on the conductive system.

PHARMACOKINETICS

Suction and distribution

After taking the drug inside, felodipine is almost completely absorbed from the digestive tract.
Due to the peculiarities of the dosage form, the delayed release of felodipine leads to an extension of the suction phase and ensures a uniform concentration of felodipine in the blood plasma for 24 hours. The bioavailability of the drug is dose-independent (in the therapeutic dose range) and is about 15%.
The binding with plasma proteins, mainly with albumins, is about 99%.
Penetrates through the BBB and placental barrier, excreted in breast milk. With prolonged use of cumulation, felodipine does not occur.
Metabolism

Felodipine is almost completely metabolized in the liver with the formation of inactive metabolites.

Excretion

T 1/2 of felodipine is 25 hours. It is excreted as metabolites: about 70% of the dose taken with urine, the rest - with feces.
In unchanged form, less than 0.5% of the dose is excreted in the urine.
Pharmacokinetics in specific patient groups

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

Pharmacokinetic parameters of felodipine do not change in patients with impaired renal function, incl.
and during hemodialysis.
INDICATIONS

- arterial hypertension;

- Stable angina (including angina of Prinzmetal).

DOSING MODE

The drug is taken orally, in the morning before meals or after a light breakfast.
Tablets, covered with a film shell, can not be bitten, divided or crushed.
With arterial hypertension, the dosing regimen for adults (including elderly patients) is set individually.
The initial dose is 5 mg 1 time / day (during the selection of the dose, 2.5 mg tablets are recommended). If necessary, the dose can be increased, the average dose for maintenance therapy is 5-10 mg / day.
For elderly patients or patients with impaired liver function, the initial dose is 2.5 mg / day.

With stable angina, the dose is set individually.
The initial dose for adults is 5 mg 1 time / day, if necessary, increase the dose to 10 mg 1 time / day. The maximum daily dose is 20 mg 1 time / day.
Felodip can be used in combination with beta-blockers, ACE inhibitors or diuretics, with the hypotensive effect increasing (caution due to the increased risk of arterial hypotension).

In patients with severe impairment of liver function, the dose of the drug should be reduced.

SIDE EFFECT

The drug (as with other slow calcium channel blockers) can cause redness of the face, headache, palpitation, dizziness, increased fatigue.
These reactions are reversible and are most often manifested 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 gingival inflammation or periodontitis may experience mild swelling of the gums. This can be prevented by observing the thorough oral hygiene.
The frequency of side effects is determined according to the recommendations of the World Health Organization: very often (? 10%);
often (? 1%, <10%); infrequently (? 0.1%, <1%); rarely (? 0.01%, <0.1%); very rarely, including isolated cases (<0.01%).
Allergic reactions: rarely - hives;
very rarely - hypersensitivity reactions, angioedema.
From the nervous system: often - headache;
infrequently - dizziness, paresthesia; rarely - faint.
From the cardiovascular system: very often - peripheral edema;
often - "tides"; rarely - a feeling of palpitations, tachycardia.
From the digestive system: infrequently - nausea, abdominal pain;
rarely vomiting; very rarely - gingival hyperplasia, gingivitis, increased activity of hepatic transaminases.
From the urinary system: very rarely - pollakiuria.

From the skin and subcutaneous tissues: infrequent - rash, itchy skin;
very rarely - the reaction of photosensitization, leukocytoclastic vasculitis.
From the musculoskeletal system: rarely - arthralgia, myalgia.

Other: infrequently - fatigue;
rarely - a violation of sexual function.
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;

- the period of lactation (breastfeeding);

- age under 18 years (effectiveness and safety not established);

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;

- Hypersensitivity to the components of the drug or to other dihydropyridine derivatives.

Caution should be given to patients with hepatic and / or renal insufficiency.

PREGNANCY AND LACTATION

Felodip is contraindicated for use in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Pharmacokinetic parameters of felodipine do not change in patients with impaired renal function, incl.
and during hemodialysis.
With caution, the drug is used for renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

For patients with impaired liver function, the initial dose is 2.5 mg / day.
In patients with severe liver dysfunction, the dose of the drug should be reduced.
With caution, the drug is used for liver failure.

APPLICATION FOR CHILDREN

Contraindication: children and adolescents under 18 years of age (efficacy and safety not established).

APPLICATION IN ELDERLY PATIENTS

For elderly patients, the initial dose is 2.5 mg / day.

SPECIAL INSTRUCTIONS

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

At present, there is no evidence of the advisability 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 lung diseases, with renal dysfunction, diabetes, gout, hyperlipidemia, Raynaud's syndrome, and also after lung transplantation.

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

Impact on the ability to drive vehicles and manage mechanisms

Patients who have weakness and dizziness on the background of treatment with Felodip are advised not to drive vehicles and work that requires an increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: excessive decrease in blood pressure, bradycardia.

Treatment: symptomatic therapy.
If the blood pressure is too low, the patient should be moved to a horizontal position with a low head. With bradycardia - intravenous injection of atropine in a dose of 0.5-1 mg. If necessary, to increase bcc-infusion of a solution of dextrose (glucose), sodium chloride or dextran. Preparations with a predominant effect on β-adrenoreceptors are prescribed if the above measures are ineffective.
DRUG INTERACTION

With simultaneous application with felodipine, the concentration of digoxin in the plasma is increased, however, a change in the dosage regimen of the preparation of Felodip is not required.

When used simultaneously 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 the blood plasma.

With the simultaneous use with inductors of microsomal liver enzymes (including those with phenytoin, carbamazepine, rifampicin, barbiturates), the concentration of felodipine in the blood plasma decreases.

NSAIDs do not relieve the hypotensive effect of felodipine.

A 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 felodipine.

With the 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 should not be used simultaneously with grapefruit juice because of the flavonoid contained in it, which increases the bioavailability of felodipine.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

FLDP-RU-00010-DOK-PHARM-14082016

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a place protected from light and inaccessible to children at a temperature of 10 ° to 25 ° C.
Shelf life - 4 years.
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