Carvedilol-Vertex, tablets 25 mg 30 pcs

• Arterial hypertension (in monotherapy and in combination with diuretics)
• Cronic heart failure (in combination therapy)
• Ischemic heart disease: stable angina.

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Indications

Arterial hypertension (in monotherapy and combination with diuretics)
Chronic heart failure (as part of combination therapy)
Coronary heart disease: stable angina.

Special instructions

Therapy should be carried out over a long period of time and should not be stopped abruptly, especially in patients with coronary heart disease, as this can lead to a worsening of the underlying disease. If necessary, the dose reduction should be gradual over 1-2 weeks.

At the beginning of therapy with carvedilol or when the dose of the drug is increased in patients, especially elderly patients, an excessive decrease in blood pressure may be observed, mainly when standing up. A dose adjustment of the drug is necessary. In patients with chronic heart failure, when selecting a dose, an increase in symptoms of heart failure and the appearance of edema is possible. In this case, the dose of carvedilol should not be increased; it is recommended to prescribe large doses of diuretics until the patient’s condition is stabilized.

Continuous monitoring of the electrocardiogram and blood pressure is recommended while prescribing carvedilol and slow calcium channel blockers, phenylalkylamine derivatives (verapamil) and benzodiazepine (diltiazem), as well as with class I antiarrhythmic drugs.

It is recommended to monitor renal function in patients with chronic renal failure, arterial hypotension and chronic heart failure.

In case of surgery using general anesthesia, the anesthesiologist should be warned about previous therapy with carvedilol.

Carvedilol does not affect the concentration of glucose in the blood and does not cause changes in the glucose tolerance test in patients with non-insulin-dependent diabetes mellitus.

Avoid drinking ethanol during treatment.

Patients with pheochromocytoma should be prescribed alpha-blockers before starting therapy.

Patients wearing contact lenses should be aware that the drug may cause a decrease in tear production.

It is not recommended to drive a car at the beginning of therapy and when increasing the dose of carvedilol. You should refrain from other activities that require high concentration of attention and rapid psychomotor reactions.

Active ingredient

Carvedilol

Composition

1 tablet contains:

active ingredient:

carvedilol 25 mg,

excipients:

microcrystalline cellulose,

lactose (milk sugar),

crospovidone (plasdon XL 10),

sodium stearyl fumarate.

Pregnancy

There have been no controlled studies of the use of carvedilol in pregnant women, so prescribing the drug to this category of patients is possible only in cases where the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding is not recommended during treatment with carvedilol.

Contraindications

Hypersensitivity to carvedilol or other components of the drug,
acute and decompensated chronic heart failure,
requiring intravenous administration of inotropic agents,
severe liver failure,
atrioventricular block stage II-III,
severe bradycardia (less than 50 beats/min),
sick sinus syndrome,
arterial hypotension (systolic blood pressure less than 85 mm Hg),
cardiogenic shock,
bronchial asthma,
chronic obstructive pulmonary disease,
age under 18 years (efficacy and safety have not been established).

With caution
Bronchospastic syndrome, chronic bronchitis, pulmonary emphysema, Prinzmetal angina, thyrotoxicosis, occlusive diseases of peripheral vessels, pheochromocytoma, psoriasis, renal failure, first degree atrioventricular block, extensive surgical interventions and general anesthesia, diabetes mellitus, hypoglycemia, depression, myasthenia gravis.

Side Effects

From the central nervous system: headache, dizziness, syncope, muscle weakness (usually at the beginning of treatment), sleep disturbance, depression, paresthesia.

From the cardiovascular system: bradycardia, orthostatic hypotension, angina pectoris, atrioventricular block, rarely “intermittent” claudication, disorder

peripheral circulation, progression of heart failure.

From the gastrointestinal tract: dry mouth, nausea, abdominal pain, diarrhea or constipation, vomiting, increased activity of liver transaminases.

From the hematopoietic organs: thrombocytopenia, leukopenia.

From the urinary system: severe renal dysfunction, edema.

Allergic reactions: allergic skin reactions (exanthema, urticaria, itching, rashes), exacerbation of psoriatic rashes, sneezing, nasal congestion, bronchospasm, shortness of breath (in predisposed patients).

Other: flu-like syndrome, pain in the extremities, decreased lacrimation, weight gain.

Interaction

Carvedilol may potentiate the effect of other concomitantly taken antihypertensive drugs or drugs that have a hypotensive effect (nitrates).

When carvedilol and diltiazem are used together, cardiac conduction disturbances and hemodynamic disturbances may develop.
When carvedilol and digoxin are taken simultaneously, the concentration of the latter increases and the atrioventricular conduction time may increase.

Carvedilol may potentiate the effect of insulin and oral hypoglycemic agents, and the symptoms of hypoglycemia (especially tachycardia) may be masked; therefore, regular monitoring of blood sugar levels is recommended in patients with diabetes mellitus.

Inhibitors of microsomal oxidation (cimetidine) enhance, and inducers (phenobarbital, rifampicin) weaken the hypotensive effect of carvedilol.

Drugs that reduce the content of catecholamines (reserpine, monoamine oxidase inhibitors) increase the risk of developing arterial hypotension and severe bradycardia.

With simultaneous use of cyclosporine, the concentration of the latter increases (adjustment of the daily dose of cyclosporine is recommended).
Concomitant administration of clonidine may potentiate the antihypertensive and heart rate-lowering effects of carvedilol.
General anesthetics enhance the negative inotropic and hypotensive effect of carvedilol.

Overdose

Symptoms:

decreased blood pressure (accompanied by dizziness or fainting), bradycardia. Shortness of breath may occur due to bronchospasm and vomiting. In severe cases, cardiogenic shock, respiratory failure, confusion, and conduction disturbances are possible.

Treatment:

it is necessary to monitor and correct vital signs, if necessary, in the intensive care unit. Treatment is symptomatic. It is advisable to use intravenously m-anticholinergic agents (atropine), adrenergic agonists (epinephrine, norepinephrine).

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25° C.

Shelf life

2 years.

Manufacturer

Vertex, Russia