Description
Release form
, sustained-release tablets.
Packing
30 pcs
Pharmacological action
Antihypertensive, antianginal. Plendil blocks calcium channels, it inhibits the flow of calcium ions into the smooth muscle cells of arterial vessels, causes their expansion, reduces OPSS, lowers blood pressure, afterload on the heart, increases coronary blood flow, improves the balance of supply / consumption of oxygen by the myocardium.
Indications
Arterial hypertension, angina pectoris.
Contraindications
Hypersensitivity, decompensated heart failure, acute myocardial infarction, unstable angina, pregnancy, childhood.
Special instructions
Particular care must be taken in the following conditions: aortic stenosis, impaired liver function, severe renal failure (creatinine clearance less than 30 ml / min), heart failure after acute myocardial infarction, advanced age. Arterial hypotension, which in susceptible patients can cause myocardial ischemia.
The combined use of drugs that induce the CYP3A4 isoenzyme of the cytochrome P450 system leads to a significant decrease in the concentration of felodipine in the blood plasma and an insufficient therapeutic effect from taking Plendil (see the section ² ÑInteraction with other drugs and other types of drug interaction ² Ñ). Co-administration of such drugs should be avoided.
co-administration of drugs, inhibiting CYP3A4 isoenzyme, leads to a significant increase in the concentration of felodipine in blood plasma, and therefore, such combinations should be avoided.
You should avoid taking the drug with grapefruit juice due to a significant increase in the concentration of felodipine in blood plasma.
Effect on the ability to drive vehicles and other mechanisms
When driving vehicles or other mechanisms that require increased attention, the possibility of developing dizziness and weakness while taking Plendil should be considered.
At the beginning of therapy or during the period of increasing the dose, patients should refrain from engaging in hazardous activities that require concentration and speed of psychomotor reactions.
Composition
1 tab. contains 5 mg felodipine.
Dosage and administration
Plendil is recommended to be taken orally in the morning with water. Tablets must not be crushed, crushed, or chewed. Plendil can be taken on an empty stomach or after a light breakfast that does not contain a lot of fats or carbohydrates.
Initial dose – 5 mg 1 time per day. If necessary, the dose may be increased or another antihypertensive drug may be added. The usual maintenance dose of Plendil is 5 to 10 mg once daily. In elderly patients, consideration should be given to starting treatment with a daily dose of 2.5 mg.
Side effects
Often (more than 1%): headache, hot flashes, peripheral edema.
Sometimes (0.1-1%): tachycardia, palpitations, feeling tired, dizziness, paresthesia, nausea, rash, itching.
Rarely (0.01-0.1%): fainting, vomiting, arthralgia, myalgia, sexual dysfunction, impotence, urticaria.
Very rare (less than 0.01%): gingival hyperplasia, elevated liver enzymes, photosensitivity, pollakiuria, allergic reactions (fever, angioedema).
Drug interactions
Biotransformation inhibitors (cimetidine) increase the concentration in the plasma, stimulants (phenytoin, carbamazepine, barbiturates) – reduce.
Overdose
Toxicity: 10 mg of felodipine in a 2-year-old child caused minor intoxication. 150-200 mg felodipine in a 17-year-old patient and 250 mg in an adult caused minor to moderate intoxication. Felodipine is likely to have a more significant effect on peripheral circulation than on the heart compared to other drugs in this therapeutic group.
With an overdose, the symptoms of intoxication appear 12 to 16 hours after the administration of the drug, severe symptoms can occur even a few days after ingestion. The following symptoms may be noted: bradycardia (sometimes tachycardia), marked decrease in blood pressure, AV blockade I- degrees, ventricular extrasystole, atrial-ventricular dissociation, asystole, ventricular fibrillation headache, dizziness, impaired consciousness (or coma), shortness of breath, pulmonary edema (not cardiac) and apnea in adults, respiratory disease, , possibly hypocalcemia of redness of the face, accompanied by “hot flashes”, hypothermia of nausea and vomiting. With overdose, the greatest risk is represented by symptoms from the cardiovascular system.
Treatment: Activated Carbon Assignment, if necessary, gastric lavage, in some cases effective even in the late stage of intoxication.
IMPORTANT! Atropine (0.25-0.5 mg / v for adults, 10-20 mcg / kg for children) should be prescribed before gastric lavage (because of the risk of vagus nerve stimulation). ECG monitoring, correction of acid-base status and serum electrolytes should be carried out, if necessary to ensure airway patency and adequate ventilation.
In case of bradycardia and AV blockade, atropine 0.5-1 mg / adult and 20-50 mcg / kg should be administered to children (repeat the administration if necessary), or isoprenaline 0.05-0.1 mcg / kg / min should be given. . With acute intoxication at an early stage, an artificial rhythm driver may be required. The marked decrease in blood pressure should be corrected in / in the introduction of fluid, adults enter / into a solution of calcium gluconate (9 mg Ca / ml) 20-30 ml for 5 minutes or as an infusion (3-5 mg Ca / kg to children), if necessary repeat the introduction at the same dose. If necessary, epinephrine (epinephrine) or dopamine is infused. In acute intoxication, glucagon can be prescribed.
Resuscitation may require several hours for heart failure due to overdose. For convulsions, appoint diazepam, as well as other symptomatic treatment.
Storage conditions
At a temperature not exceeding 25 ° C.
Shelf life
3 years.
D ystvuyushtee substance
Felodipine
Terms and conditions
prescription
Dosage form
prolong tablets.
Possible product names
Plendil 0.005 N30 TABLE PROLONG P / O
Plendil 5 mg No. 30 tab p / pl / o prolong. Dr.
Plendil 5mg Tab. prolong. valid p / pl / rev X30
Plendil 5mg Tab. prolong. valid p / pl / rev X30 /! Until 09.13g /
Plendil tab p / p / o prolong prolong 5mg N30 fl poly ind ind
AstraZeneca, Britain
