Coriol® (Coriol®)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsppills
Composition:

1 tablet contains:

active substance: carvedilol 6.25 mg or 12.5 mg, or 25 mg;

Excipients: sucrose, lactose monohydrate, povidone, silicon dioxide colloidal anhydrous, crospovidone, magnesium stearate.

Description:

Tablets 6.25 mg: Oval, slightly biconvex white tablets labeled "S2 "on one side and with a notch on the back.

Tablets 12.5 mg: Oval slightly biconvex white tablets marked "S3" on one side and incised on the reverse side.

Tablets 25 mg: Round, slightly biconvex tablets of white color, with bevelled edges and notched on one side.

Pharmacotherapeutic group:Alpha- and beta-blocker
Pharmacodynamics:

Carvedilol blocks α1-, β1- and β2-adrenoceptors, has a vasodilating, anti-anginal and antiarrhythmic effect. Blocking α1-adrenoreceptors, the drug causes an expansion of peripheral vessels, reducing the overall peripheral vascular resistance. As a result of blockade β1-adrenoceptor moderately reduced AV-conductivity, strength and heart rate, without causing a sharp bradycardia. With blockade β2-adrenoreceptors may increase the tone of the bronchi, some vessels, as well as tonus and peristalsis of the intestine. In patients with heart failure carvedilol increases the fraction of the ejection of the left ventricle. Influence on blood pressure and heart rate is most pronounced 1-2 hours after taking the drug. Carvedilol does not have its own sympathomimetic effect.

Pharmacokinetics:After oral administration carvedilol quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is achieved after 1 h. The volume of distribution is about 2 l / kg. Penetrates through the placental barrier, excreted in breast milk. Communication with blood plasma proteins is 98-99%. Bioavailability is 25%. In the elderly, the carvedilol concentration in the blood plasma is approximately 50% higher than in young patients. Metabolised in the liver. Metabolites have a pronounced antioxidant effect. The half-life is 6-10 hours. It is excreted mainly with bile and feces. In patients with impaired liver function, bioavailability can increase to 80%. Food slows the absorption of the drug, but does not affect its bioavailability.

Indications:

Arterial hypertension (in monotherapy or in combination with other antihypertensive drugs).

Stable angina.

Chronic heart failure (as part of combination therapy).
Contraindications:

Hypersensitivity to carvedilol or other components of the drug; Decompensated heart failure; atrioventricular blockade of II and III degree; liver failure; bronchospastic syndrome; bronchial asthma; severe bradycardia; syndrome of weakness of the sinus node; severe arterial hypotension (systolic blood pressure less than 85 mm Hg), pregnancy, lactation.

Age to 18 years (effectiveness and safety not established).

Carefully:

Chronic bronchitis, emphysema, prinzmetal angina, diabetes mellitus, hypoglycemia, thyrotoxicosis, peripheral vascular occlusive diseases, pheochromocytoma, depression, myasthenia gravis, psoriasis, renal failure.

Pregnancy and lactation:

Pregnant women may prescribe the drug in exceptional cases, when the benefit to the mother exceeds the potential risk to the fetus.

Since carvedilol can be excreted in breast milk, breastfeeding is not recommended during Coriolom® treatment.
Dosing and Administration:

The drug is taken orally after a meal, with a sufficient amount of liquid.

Arterial (essential) hypertension

The dose is selected individually. The first -14 days, the recommended dose of Coriola is 12.5 mg (1 tablet of 12.5 mg) taken in the morning after breakfast. The dose can be divided into two doses of 6.25 mg of Coriola (1/2 tablets of 12.5 mg or 1 tablet of 6.25 mg). Further treatment should be done by Coriolom® at a dose of 25 mg (1 tablet of 25 mg) in the morning or divided into two doses of 12.5 mg of the drug (1 tablet of 12.5 mg). If necessary, after 14 days, you can increase the dose (up to a maximum daily dose of 50 mg)

Stable angina

The initial dose of Coriola® is 12.5 mg (1 tablet of 12.5 mg) twice daily. After 7-14 days, a dose of Coriola® can be increased to 25 mg (1 tablet of 25 mg) twice a day. After 14 days, with insufficient effectiveness and good tolerability, the dose of Coriola® can be further increased. The total daily dose of Coriola® for angina pectoris should not exceed 50 mg of the drug (2 tablets of 25 mg), administered twice a day.If the patient is older than 70 years, the daily dose Koriola® should not exceed 25 mg (1 tablet of 25 mg) twice a day.

Chronic heart failure
Treatment begins with small doses - 3,125 mg (1/2 tablet at 6.25 mg) twice a day. The dose with caution is increased to achieve the optimal therapeutic effect. The maximum recommended dose is 25 mg twice daily. If the patient's body weight above 85 kg, the maximum recommended dose Koriola® can be increased to 50 mg twice a day. It requires careful medical supervision of the patient at the beginning of treatment and with a subsequent increase in the dose of the drug. If treatment is interrupted for more than 2 weeks, then its resumption begins with a minimum dose 3,125 mg 2 times a day, followed by an increase in the dose.

Side effects:

From the side of the cardiovascular system: Occlusive peripheral circulatory disorders, the progression of congestive heart failure, bradycardia, orthostatic hypotension, syncope (including presinkopalnye), angina pectoris, atrioventricular block, "intermittent" claudication.

From the digestive system: dry mouth, nausea, abdominal pain, diarrhea or constipation, vomiting, increased activity of "liver" transaminases.

On the part of the respiratory system: bronchospasm, dyspnea (in predisposed patients) sneezing, nasal congestion.

From the side of the central nervous system: headache, dizziness, depression, parasthesia.

From the genitourinary system: severe renal dysfunction, edema, rarely - decreased potency.

On the part of the organs of hematopoiesis: thrombocytopenia, leukopenia Allergic reactions: skin allergic reactions (exanthema, urticaria, pruritus, rashes) exacerbation of psoriatic eruptions.

From the endocrine system: possibly hypo- or hyperglycemia, hypercholesterolemia.

Other: pain in the extremities, a decrease in lacrimation (important for patients wearing contact lenses), muscle weakness (usually at the beginning of treatment), weight gain.

Overdose:

Overdose can mainly cause a marked decrease in blood pressure (accompanied by dizziness or even fainting) and bradycardia. Usually it is required to reduce the dose or temporarily cancel the drug.

In addition, overdose can lead to shortness of breath caused by bronchospasm, vomiting, heart failure, in severe cases, to cardiogenic shock, impairment of consciousness up to coma, generalized convulsions, impaired conduction and cardiac arrest.

Measures taken: If the patient is conscious, it is necessary to induce vomiting to empty the stomach and put the patient on his back so that his head is lowered and his legs slightly elevated. The unconscious patient must be laid on his side. Vital functions of the body should be carefully monitored in the intensive care unit in the hospital.

Treatment: symptomatic and with the use of adrenoreceptor agonists. Orciprenaline and / or glucagon to maintain heart function and circulation; atropine and, if necessary, a pacemaker with a bradycardia; β2-sympathomimetics with bronchospasm; norepinephrine or norfenefrin with peripheral vasodilation; diazepam with convulsions. The duration of treatment depends on the degree of intoxication. In severe intoxication, the excretion time of carvedilol may be prolonged.Patients should be monitored until complete stabilization of the condition.

Interaction:

Coriol® should not be given to patients receiving verapamil or diltiazem intravenously, as this can lead to a pronounced slowing of the rhythm of heartbeats and a pronounced decrease in blood pressure.

Some antiarrhythmic drugs, drugs for anesthesia, antihypertensive drugs, antianginal drugs, other β-blockers (for example, in the form of eye drops), monoamine oxidase inhibitors, sympatholytics (reserpine) and cardiac glycosides can enhance the effect of carvedilol. Simultaneously, the administration of carvedilol and digoxin can lead to an increase in the concentration of digoxin in the blood plasma. Diuretics increase the hypotensive effect.

The pharmacokinetics of carvedilol may change with simultaneous administration with drugs stimulating or blocking the activity of liver enzymes (CYP2D6): eg, cimetidine increases the concentration of carvedilol in the serum, and rifampicin reduces it.

Simultaneous use with ergot alkaloids worsens the peripheral circulation.

When canceling the simultaneous therapy with Coriol® and clonidine, it is first necessary to stop treatment with Coriol and only after a few days to cancel clonidine.

Coriol® can enhance the effect of hypoglycemic drugs and mask the manifestations of hypoglycemia. Therefore, regular monitoring of blood sugar levels is recommended.

Special instructions:

At the beginning of treatment with Coriol ® and with an increase in the dose of the drug in patients, there may be an excessive decrease in blood pressure, especially when getting up. Dizziness and sometimes even fainting may occur, especially in the elderly, patients with heart failure or with simultaneous treatment with other antihypertensive drugs or diuretics.

Treatment with Coriol® should not abruptly cease, especially in patients with angina. Dose reduction should be gradual within 1-2 weeks.

It is recommended to monitor renal function in patients with renal insufficiency, coronary heart disease, diffuse peripheral vascular disease, very low blood pressure and / or heart failure. If the kidney function deteriorates, Coriol® should be discarded.

β-adrenoblockers can weight the clinical picture of angiopathies of peripheral arteries, psoriasis and anaphylactic reactions, as well as reduce the sensitivity of allergic samples.

β-adrenoblockers can weight the angina of Prinzmetal (provoke the appearance of pain).

Since β-adrenoblockers slow the heart rate, they can mask signs of hyperglycemia in patients with diabetes mellitus and thyrotoxicosis in patients with thyroid disease.

Caution is required when performing general anesthesia using drugs that inhibit cardiac muscle activity (eg, ether, cyclopropane, trichlorethylene). Before extensive surgical interventions, gradual elimination of Coriola® is recommended.

Care must be taken when using the drug in case of severe metabolic acidosis.

Patients with pheochromocytoma can be prescribed β-adrenoreceptor blockers only if they have previously started taking α-blockers. Clinical experience with carvedilol in pediatric practice is lacking.When the progression of heart failure on the background of treatment is recommended to increase the dose of diuretics, with renal failure, the dose is regulated depending on the functional state of the kidneys. During the treatment with the drug, ethanol is excluded.

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

When taking carvedilol, it is not recommended to drive and should refrain from other activities associated with the need for high concentration of attention and rapid psychomotor reactions.

Form release / dosage:

Tablets 6.25 mg, 12.5 mg and 25 mg.

Packaging:

Tablets 6.25 mg, 12.5 mg and 25 mg: 10 tablets in a blister.

3 blisters in the package, together with instructions for use.

Storage conditions:

At a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the date shown on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N014037 / 01
Date of registration:21.11.2007
Date of cancellation:2018-02-06
The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Manufacturer: & nbsp
KRKA, d.d. Slovenia
Representation: & nbspKRKA KRKA Slovenia
Information update date: & nbsp06.02.2018
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