Es Corinth (EsCordi Cor)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLevamladipineLevamladipine
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  • Es Corinth
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    AKTAVIS GROUP, AO     Iceland
    • Dosage form: & nbsppills
    Composition:

    Tablets 2.5 mg:

    Active substance: S(-) amlindipina besylate in terms of S(-) amlodipine 2.5 mg

    Excipients: cellulose microcrystalline 50 mg; lactose 41.427 mg; silicon dioxide colloidal 1,4 mg; magnesium stearate 4.2 mg; croscarmellose sodium 4.2 mg; iron oxide yellow 0.14 mg.

    Tablets 5 mg:

    Active substance: S(-) amlindipina besylate in terms of S(-) amlodipine 5mg

    Excipients: cellulose microcrystalline 46.367 mg; lactose 40.767 mg; silicon dioxide colloidal 1,4 mg; magnesium stearate 4.2 mg; croscarmellose sodium 4.2 mg; iron oxide yellow 0.8 mg.

    Description:

    Tablets 2.5 mg: flat light yellow tablets with impregnations, cordate-shaped with beveled edges, on one side "A", on the other - 2.5.

    Tablets 5 mg: flat yellow tablets with impregnations, heart-shaped with beveled edges, on one side "A", on the other - 5.

    Pharmacotherapeutic group:The blocker of "slow" calcium channels
    ATX: & nbsp

    C.08.C.A   Dihydropyridine derivatives

    C.08.C.A.01   Amlodipine

    Pharmacodynamics:

    Pharmacological properties

    S (-) amlodipine is the pharmacologically active isomer of amlodipine.

    Pharmacodynamics

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

    Has a long-term dose-dependent hypotensive effect. The hypotensive effect is due to a direct vasodilating effect on smooth muscle vessels. With 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 time of onset of the effect is 2-4 hours, the duration of the effect is 24 hours.

    Pharmacokinetics:

    After oral administration (a 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. The equilibrium concentration is achieved after 7 days of therapy.Eating does not affect absorption S (-) amlodipine. The average volume of distribution is 21 l / kg body weight, indicating that most of the drug is in the tissues, and relatively less in the blood. Most of the drug in the blood (93%) binds to blood plasma proteins. S (-) Amlodipine is subjected to a slow but extensive metabolism (90%) in the liver with the formation of inactive metabolites, has the effect of a "first pass" through the liver. Metabolites do not have significant pharmacological activity. After a single oral intake, the period half-life (T1/2) varies from 14.62 to 68.88 hours, with a reappointment of T1/2 is approximately 45 hours. About 60% of the dose taken internally is excreted by the kidneys mainly in the form of metabolites, 10% in the unchanged form, and 20-25% through the intestine, as well as with breast milk. Overall clearance S(-) Amlodipine is 0.116 ml / s / kg (7 ml / min / kg, 0.42 l / h / kg). In elderly patients (over 65 years), excretion S(-) Amlodipine is slowed (T> /, 65 h) compared with younger patients, but this difference is not clinically significant. The elongation T1/2 in patients with hepatic insufficiency, it is assumed that with prolonged administration, the accumulation of the drug in the body will be higher (T1/2 up to 60 hours).Renal failure does not have a significant effect on kinetics S (-) amlodipine. The drug penetrates the blood-brain barrier. When hemodialysis is not removed.

    Indications:

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

    Contraindications:

    - Hypersensitivity to S(-) amlodipine and other dihydropyridine derivatives;

    - angina of Prinzmetal;

    - severe arterial hypotension;

    - collapse, cardiogenic shock;

    - pregnancy and lactation;

    - age to 18 years (efficacy and safety not established).

    Carefully:Violation of the function of the liver, from(expressed bradycardia, tachycardia), chronic heart failure of non-ischemic etiology in the stage of decompensation, moderate arterial hypotension, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and within 1 month after), diabetes mellitus , lipid profile disorder, elderly age.
    Pregnancy and lactation:
    Dosing and Administration:

    The recommended initial dose of EsCordi Cora is 2.5 mg once daily.

    Dose as much as possible can be increased with insufficient therapeutic effect up to 5 mg once a day.
    Side effects:

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

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

    From the digestive system: nausea, vomiting, epigastric pain; rarely - increased levels of "liver" enzymes and jaundice (caused by cholestasis), pancreatitis, dry mouth, flatulence, gingival hyperplasia, constipation or diarrhea, very rarely - gastritis, increased appetite, a violation of taste.

    From the genitourinary system: rarely - pollakiuria, painful urge to urinate, nocturia, decreased potency; very rarely - dysuria, polyuria.

    From the skin: very rarely - xeroderma, alopecia, dermatitis, purpura, discoloration.

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

    From the musculoskeletal system: rarely - arthralgia, arthrosis, myalgia (with prolonged use); very rarely - myasthenia gravis.

    Other: rarely - gynecomastia, polyuricemia, increase / decrease in body weight, thrombocytopenia, leukopenia, hyperglycemia, visual impairment, conjunctivitis, diplopia, eye pain, ringing in the ears, back pain, dyspnoea, epistaxis, increased sweating, thirst; very rarely - cold sticky sweat, cough, rhinitis, parosmia, accommodation disorder, xerophthalmia.

    Overdose:

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

    Treatment: gastric lavage, the appointment of activated carbon to maintain the function of the cardiovascular system, the control performance of the heart and lungs, an elevated position of the limbs, control of blood volume and diuresis.To restore the vascular tone - the use of vasoconstrictor (in the absence of contraindications to their use); to eliminate the effects of calcium channel blockade - intravenous 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 inductors of microsomal liver enzymes - reduce.

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

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

    Amiodarone, quinidine, alpha1 - adrenoblockers, antipsychotics (antipsychotics) and blockers of "slow" calcium channels can increase the hypotensive effect.

    Does not affect the pharmacokinetic parameters of digoxin and warfarin. Cimetidine does not affect the pharmacokinetics of amlodipine.

    When combined with lithium preparations, it is possible to enhance the appearance of their neurotoxicity (nausea, vomiting, diarrhea, ataxia,tremor, noise in the ears).

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

    Procainamide, hinanddin and other drugs that cause lengthening of the interval QT, reinforce the negative inotropic effect and may increase risk of significant lengthening of the interval QT.

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

    Special instructions:

    During the period of treatment with EsCord Cor, control of body weight and sodium intake is necessary, and the appropriate diet is prescribed. It is necessary to maintain dental hygiene and frequent visits to the dentist (prevention of soreness, bleeding and gum proliferation). In elderly patients, the period may be longer elimination half-life and clearance of the drug. Dosage regimen for the elderly is the same as for patients of other age groups. When increasing the dose, careful monitoring of elderly patients is necessary. Despite the lack of "slow" calcium channels of the syndrome of "cancellation" in blockers, a gradual decrease in doses is recommended before cessation of treatment.

    Effect on the ability to drive transp. cf. and fur:

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

    Form release / dosage:Tablets of 2.5 and 5 mg.
    Packaging:

    For 10 tablets in a blister of aluminum foil and PVC film. For 3 or 5 blisters with instructions for use in a cardboard box.

    Storage conditions:

    In a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003270/07
    Date of registration:17.10.2007
    The owner of the registration certificate:AKTAVIS GROUP, AO AKTAVIS GROUP, AO Iceland
    Manufacturer: & nbsp
    Representation: & nbspAktavis, Open Company Aktavis, Open Company
    Information update date: & nbsp16.11.2015
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