Cordinorm 5 mg pills number 30 *

Author Ольга Кияница

2017-05-11

Amount in a package 30
Product form Pills
Manufacturer Actavis (Catalent Gemany, Germany)
Registration certificate UA/12371/01/02
The main medicament -
morion code 174155

Cordinorm (CORDINORM)

Storage:
active substance:
1 tablet contains 5 mg bisoprolol fumarate
or
1 tablet contains 10 mg bisoprolol fumarate;
Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, crospovidone, yellow PB 22812 (for dosing 5 mg), beige PB 27215 (for dosing 10 mg).

Medicinal form. Tablets.

Pharmacotherapeutic group. Selective blockers of beta-adrenergic receptors.

Clinical characteristics.
Indication. Chronic heart failure.

Contraindication. Hypersensitivity to the components of the drug. Cardiac insufficiency in a state of decompensation.Cardiogenic shock. Atrioventricular blockade of II and III degrees. Syndrome of weakness of sinus node. Sympathetic blockade is expressed. Symptomatic bradycardia (heart rate (HR) less than 50 beats per minute). Symptomatic arterial hypotension (systolic blood pressure below 90 mmHg). Cardiac insufficiency in a state of decompensation. Bronchial asthma and other obstructive airways diseases. Late stages of disturbance of peripheral circulation, Raynaud's disease.Concomitant administration of MAO inhibitors (with the exception of MAO inhibitors type B). Psoriasis (including family history). Untreated Feohromocytoma. Metabolic acidosis.

Method of administration and dose. Internally.
Pills are taken without chewing, drinking a little water. It is recommended to take Cordinorm in the morning at a nap or during breakfast.
The initial dose of Cordinorm is 1.25 mg once a day during the first week. During the second week of administration, 2.5 mg per day is prescribed. During the third week, the therapeutic dose is 3.75 mg per day. From the fourth to the eighth week of appointment is prescribed 5 mg (2 tablets Cordinorm). Then the dose is increased to 7.5 mg (from the 8th to the 12th week). After the twelfth week of treatment, the maximum daily dose is 10 mg of bisoprolol fumarate. The increase in the dose of Cordinorm is regulated by indicators of heart rate, blood pressure, the general condition of the patient.After starting treatment with Cordiormorum at a dose of 1.25 mg, a patient with chronic heart failure should be examined for 4 hours (arterial pressure, heart rate, conduction impairment, worsening of symptoms of heart failure). If necessary, the achieved dosage may be gradually reduced.
You can not stop treatment suddenly, the course should end slowly, with a gradual decrease in the dose. The maximum daily dose is 20 mg.
The course of treatment is prolonged. The length of the course of treatment is determined by the doctor.

Adverse reactions. Nervous system: fatigue, dizziness, headache, sleep disturbances, depression, rarely hallucinations (usually weakly expressed and disappearing within 1-2 weeks), sometimes paresthesia can occur (especially at the beginning of therapy).
Eyes: visual impairment, reduction of lacrimation (to be taken into account when using contact lenses), conjunctivitis.
Cardiovascular system: in some cases, orthostatic hypotension, bradycardia, violations of atrioventricular conduction, decompensation of heart failure with the development of peripheral edema, at the beginning of treatment, the deterioration of patients with intermittent lameness or Raynaud's syndrome.
Respiratory system: isolated cases - shortness of breath (in patients who are prone to bronchospasm), rhinitis, nasal congestion, bronchospasm.
Gastrointestinal tract: in some cases - diarrhea, constipation, nausea, abdominal pain, increased activity of the liver enzymes in blood plasma (AST, ALT), hepatitis.
Musculoskeletal system: in some cases, muscle weakness, seizures, arthropathy with lesion of one or more joints (mono-or polyarthritis).
Endocrine system: reduction of glucose tolerance (with latent diabetes mellitus) and masked signs of hypoglycemia, in some cases - increased triglycerides in the blood, impaired potency.
Skin: dermatological reactions: sometimes itching, reddening of the skin, increased sweating, rashes.
Allergic reactions: allergic rhinitis.
In the treatment of beta-receptor blockers in some cases there is an increase in liver enzymes in the blood (AST, ALT), hair loss, hearing impairment or tinnitus, weight gain, mood changes, short-term memory loss, allergic rhinitis, Induratio penis plastica .

Overdose Symptoms: bradycardia, arterial hypotension, heart failure, bronchospasm.
Treatment: gastric lavage, activated charcoal intake. In bradycardia or arterial hypotension, the administration of dobutamine, dopamine, norepinephrine, and placental substitutes are intravenous. In bronchospasm, beta2-adrenergic agents (for example, salbutamol or fenoterol) are used.

Use during pregnancy or breastfeeding. Do not use Cordyornorm during pregnancy and lactation (breastfeeding) due to lack of reliable clinical data confirming the safety of the drug. In exceptional cases, the use of Cordiormorum during pregnancy should be stopped 72 hours before the expected term of delivery due to the possibility of bradycardia, hypoglycemia and respiratory depression of the newborn. If the withdrawal of the drug is impossible, then after delivery, the newborn should be under close observation. Symptoms of hypoglycaemia can be expected within the first 3 days.

Children. Cordinorm was not used by children.

Application features. In some cases, beta-receptor blockers can cause flaky lichen (Psoriasis vulgaris), worsen the course of the disease, or cause skin lesions (psoriatic) similar to the flap. Patients taking beta-receptor blockers may experience complicated forms of high-sensitivity reactions as a result of increased anaphylactic reaction and decreased adrenergic inverse regulation.
Treatment of high blood pressure with this drug requires regular medical control.

Ability to influence the reaction speed when driving or working with other mechanisms. Due to the individual nature of various reactions, the ability to take an active part in street traffic or service mechanisms may be reduced. To a greater extent this relates to the initial stage of treatment and drug modification, as well as the interaction with alcohol.

Interaction with other drugs and other types of interactions.
With the simultaneous use of Cordinorm may increase the effect of antihypertensive drugs.
With the simultaneous use of Cordiormorum and reserpine, alpha methyl dopes, clonidine or guanfacin, a sharp decrease in heart rate may occur.
At simultaneous application of Cordiormorum and clonidine, dermatological preparations, as well as guanfacin, a possible conduction impairment.
With the simultaneous use of Cordiormorum and sympathomimetics (those contained in cough agents, drops in the nose and eye drops), the effect of bisoprolol may decrease.
When simultaneous use of nifedipine and other calcium channel blockers, dihydropyridine derivatives can enhance the antihypertensive effect of Cordyourum.
Concomitant use of Cordiormorm and verapamil or diltiazem and other antiarrhythmic drugs may reduce blood pressure, reduce heart rate, and also develop arrhythmias and / or heart failure (prevent intravenous administration of calcium channel blockers and antiarrhythmic drugs against the background of Cordinorm therapy).
At the same time, the use of ergotamine derivatives (including ergotamine-mediated migraine preparations) and Cordinorm may increase the symptoms of peripheral circulation disorder.
The concomitant use of Cordiormorum and rifampicin may slightly reduce the half-life of bisoprolol (an increase in Cordyranorma is usually not required).
When concomitant use of Cordiormorum and insulin or oral hypoglycemic agents, the symptoms of hypoglycemia are masked or mitigated (regular blood glucose monitoring is required).

Pharmacological properties.
Pharmacodynamics. Selective beta1 - an adrenoblocker. When applied in therapeutic doses, it has no internal sympathomimetic activity and clinically expressed membrane-stabilizing properties. Has antianginal effect: reduces the need for myocardium in oxygen due to reduced heart rate, decreased cardiac output and reduced blood pressure, increases the supply of myocardium with oxygen by reducing the end-diastolic pressure and prolonged diastole.
Relieves hypotensive effect by reducing cardiac output, inhibiting renin secretion by the kidneys, and also affecting the baroreceptors of the arc of the aorta and carotid sinus. In chronic heart failure, Cordinorm inhibits the activity of sympathoadrenal and renin-angiotensin-aldosterone systems. Cordinorm has a low affinity for beta2-receptors of smooth muscle of bronchi and blood vessels, as well as from beta-2 receptors of the endocrine system. In a single use, the effect of Cordyornorm is maintained for up to 24 hours.
Pharmacokinetics. Absorption. After taking the drug internally bisoprolol is well adsorbed from the gastrointestinal tract.Bioavailability is about 90% and does not depend on food intake. Сmax is reached in 1-3 hours. Binding to plasma proteins is about 30%.
Metabolism and withdrawal.
The effect of the "first passage" through the liver is slightly (less than 10%). In the liver biotransformed about 50% of the dose with the formation of inactive metabolites. About 98% is excreted from the body by the kidneys, 50% - unchanged, the latter - in the form of metabolites, approximately 2% of the dose - through the intestines. Timeout is 10-12 hours.
Pharmacokinetics in special clinical cases.
Pharmacokinetics of bisoprolol is linear, its parameters are independent of age.
Dose adjustment is not required for patients with impaired hepatic or renal function in patients with mild to moderate severity.

Pharmaceutical characteristics.
Basic physicochemical properties: tablets with a dose of 5 mg: pale yellow, marble, round, convex, without shell. With engraving "VI" and "5" on both sides of the line of discontinuity on one side of the tablet, flat on the other side of the tablet.
10 mg dose tablets: beige, marble, round, convex, uncoated. With engraving "VI" and "10" on both sides of the line of discontinuity on one side of the tablet, flat on the other side of the tablet.

Expiration date. 3 years.

Storage conditions. Store at a temperature not exceeding 30 o C. Keep out of reach of children.

Packaging. 10 tablets in the blister. There are 3 blister boxes in the box.

Category of departure. By prescription.


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