Escordi Cor tabs 5mg #30

Escordi Cor instruction for use

You can buy Escordi Cor here

Composition

2.5 mg tablets:
Active ingredient: S (-) amlodipine besylate in terms of S (-) amlodipine 2.5 mg
Excipients: microcrystalline cellulose 50 mg; lactose 41,427 mg; colloidal silicon dioxide 1.4 mg; magnesium stearate 4.2 mg; croscarmellose sodium 4.2 mg; iron oxide yellow 0.14 mg.

5 mg tablets:
Active ingredient: S (-) amlodipine besylate in terms of S (-) amlodipine 5 mg
Excipients: microcrystalline cellulose 46.367 mg; lactose 40.767 mg; colloidal silicon dioxide 1.4 mg; magnesium stearate 4.2 mg; croscarmellose sodium 4.2 mg; iron oxide yellow 0.8 mg.

Description

Tablets of 2.5 mg: flat light yellow tablets with splashes, heart-shaped with beveled edges, on one side "A", on the other - 2.5.
Tablets of 5 mg: flat yellow tablets with splashes, heart-shaped with beveled edges, on one side "A", on the other - 5.
Pharmacotherapeutic group:
Slow calcium channel blocker
ATC:
C.08.C.A

Pharmacological properties

Amlodipine is the pharmacologically active isomer of amlodipine.

Pharmacodynamics

The dihydropyridine derivative is a blocker of "slow" calcium channels, the S (-) isomer is isolated, as it has a more pronounced pharmacological effect than R (+)
amlodipine. It has antianginal and hypotensive effects. By binding to the dihydropyridine receptors S (-)
amlodipine is more potent than the R (+) isomer, blocks calcium channels, reduces the transmembrane transition of calcium ions into the cell (more so in vascular smooth muscle cells than in cardiomyocytes).

It has a long dose-dependent hypotensive effect. The hypotensive effect is due to the direct vasodilating effect on vascular smooth muscle. In case of arterial hypertension, a single dose provides a clinically significant decrease in blood pressure (BP) for 24 hours (in the patient's position "lying" and "standing"). The onset of the effect is 2-4 hours, the duration of the effect is 24 hours.

Pharmacokinetics

After ingestion (single dose of 2.5 mg), S (-) amlodipine is absorbed from the gastrointestinal tract. The average absolute bioavailability is 65%, the maximum concentration in serum (8.30 +/- 1.071 ng / ml) is observed after 2.73 +/- 0.88 hours. Equilibrium concentration is reached after 7 days of therapy. Food intake does not affect the absorption of S (-) amlodipine. The average volume of distribution is 21 l / kg body weight, which indicates that most of Escordi Cor is in the tissues, and relatively less in the blood. Most of the drug in the blood (93%) is bound to plasma proteins. S (-)
Amlodipine undergoes a slow but extensive metabolism (90%) in the liver with the formation of inactive metabolites, has the effect of "first pass" through the liver. Metabolites do not have significant pharmacological activity. After a single oral administration, the elimination half-life (T1 / 2) varies from 14.62 to 68.88 hours, with repeated administration of T1 / 2 is approximately 45 hours. About 60% of the ingested dose is excreted by the kidneys mainly in the form of metabolites, 10% unchanged, and 20-25% through the intestines, as well as with breast milk. The total clearance of S (-) amlodipine is 0.116 ml / s / kg (7 ml / min / kg, 0.42 l / h / kg). In elderly patients (over 65 years), the elimination of S (-) amlodipine is slow (T> /, 65 h) compared with young patients, but this difference has no clinical significance. Elongation of T1 / 2 in patients with hepatic insufficiency suggests that with prolonged use, the accumulation of Escordi Cor in the body will be higher (T1 / 2 up to 60 hours). Renal failure has no significant effect on the kinetics of S (-) amlodipine. The drug penetrates the blood-brain barrier. Hemodialysis is not removed.

Indications for use

Arterial hypertension of I degree (mild severity) (in monotherapy or in combination with other antihypertensive drugs).

Contraindications for Escordi Cor

- Hypersensitivity to S (-) amlodipine and other dihydropyridine derivatives;
- Prinzmetal angina pectoris;
- severe hypotension;
- collapse, cardiogenic shock;
- pregnancy and lactation;
- age up to 18 years (efficacy and safety have not been established).

Carefully

Liver dysfunction, sick sinus syndrome (severe bradycardia, tachycardia), chronic heart failure of non-ischemic etiology in the decompensation stage, moderate arterial hypotension, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute heart, cardiopulmonary heart disease, acute myeloid artery stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy ), diabetes, lipid disorders, older age.

Dosage and administration

The recommended starting dose of Escordi Cor is 2.5 mg once daily.
The maximum dose can be increased with insufficient therapeutic effect up to 5 mg once a day.

Side effects of Escordi Cor

Since the cardiovascular system: palpitations, shortness of breath, marked reduction in blood pressure, fainting, vasculitis, edema (swelling of the ankles and feet), "flushing" of the blood to the face, rarely - rhythm disturbance (bradycardia, ventricular tachycardia, atrial fibrillation), pain in thorax, orthostatic hypotension, very rarely - development or aggravation of heart failure, migraine.

From the side of the central nervous system: dizziness, headache, fatigue, drowsiness, change of mood; rarely - convulsions, loss of consciousness, hypersthesia, nervousness, parasthesia, tremor, vertigo, asthenia, malaise, insomnia, depression, extraordinary dreams, very rarely - ataxia, apathy, agitation, amnesia.

On the part of the digestive system: nausea, vomiting, epigastric pain; rarely, elevated liver enzymes and jaundice (caused by cholestasis), pancreatitis, dry mouth, flatulence, gingival hyperplasia, constipation or diarrhea, very rarely, gastritis, increased appetite, and taste disturbances.

On the part of the urinary system: rarely - pollakiuria, painful urge to urinate, nocturia, reduced potency; very rarely - dysuria, polyuria.

On the part of the skin: very rarely - xerodermia, alopecia, dermatitis, purpura, discoloration of the skin.

Allergic reactions: pruritus, rash (including erythematous, maculopapular rash, urticaria), angioedema.

On the part of the musculoskeletal system: rarely - arthralgia, arthrosis, myalgia (with prolonged use); very rarely - myasthenia.

Other: rarely - gynecomastia, polyurikemia, increase / decrease in body weight, thrombocytopenia, leukopenia, hyperglycemia, blurred vision, conjunctivitis, diplopia, eye pain, tinnitus, back pain, dyspnea, nasal bleeding, increased sweating, thirst; very rarely - cold sticky sweat, cough, rhinitis, parosmia, accommodation disturbance, xerophthalmia.

Overdose

Symptoms: marked reduction in blood pressure, tachycardia, excessive peripheral vasodilation.

Treatment: gastric lavage, the appointment of activated carbon, maintaining the function of the cardiovascular system, monitoring the performance of the heart and lungs, the elevated position of the limbs, monitoring the volume of circulating blood and diuresis. To restore vascular tone - the use of vasoconstrictor agents (in the absence of contraindications to their use); to eliminate the effects of calcium channel blockade, intravenous administration of calcium gluconate.

Hemodialysis is not effective.

Interaction

Inhibitors of microsomal oxidation increase the concentration of amlodipine in the blood plasma, increasing the risk of side effects, and inducers of microsomal liver enzymes - reduce.

The hypotensive effect is weakened by alpha-adrenergic stimulants, estrogens (sodium retention), and sympathomimetics.

Thiazide and "loopback" diuretics, beta-blockers, verapamil, angiotensin-converting enzyme (ACE) inhibitors and nitrates enhance antianginal and hypotensive effects.

Amiodarone, quinidine, alpha1-adrenergic blockers, antipsychotics (neuroleptics), and blockers of "slow" calcium channels may enhance the hypotensive effect.

No effect on the pharmacokinetic parameters of digoxin and warfarin.
Cimetidine does not affect the pharmacokinetics of amlodipine.

When combined with the use of lithium drugs may increase the appearance of their neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).

Calcium preparations can reduce the effect of blockers of "slow" calcium channels.

Procainamide, quinidine, and other drugs that prolong the QT interval increase the negative inotropic effect and may increase the risk of significant prolongation of the QT interval.

Grapefruit juice can reduce the concentration of amlodipine in the blood plasma, but this decrease is so small that it does not significantly change the effect of amlodipine.

Special instructions for Escordi Cor

During the period of treatment with Escordi Cor, control of body weight and sodium intake is necessary, the appointment of an appropriate diet. It is necessary to maintain dental hygiene and frequent visits to the dentist (prevention of pain, bleeding and gum overgrowth). Elderly patients may prolong the half-life and clearance of Escordi Cor. Dosing regimen for the elderly is the same as for patients of other age groups. Increasing the dose requires careful monitoring of elderly patients. Despite the fact that the blockers do not have “slow” calcium channels of the syndrome of “withdrawal”, gradual reduction of doses is recommended before stopping treatment.

Influence on ability to drive a vehicle

In some patients, predominantly at the beginning of treatment, drowsiness and dizziness may occur. When they occur, the patient must observe special precautions when driving and working with machinery.

Packing

On 10 tablets in the blister from aluminum foil and the PVC film. On 3 or 5 blisters with the application instruction in a cardboard pack.

Storage conditions

In a dry place at a temperature not higher than 25 ° C. Keep out of the reach of children.
Shelf life - 3 years.
Do not use after expiration date.

Pharmacy sales terms

You don't need a prescription to buy Escordi Cor.