Carvedilol-OBL pills 12.5mg, 30pcs

Composition

1 tablet contains:

Active ingredient:

carvedilol 12.5 mg;

excipients:

sugar (sucrose),

magnesium stearate,

potato starch,

hydroxypropylmethylcellulose (hypromellose),

crosscarmellose sodium salt (primellose),

aerosil (colloidal silicon dioxide),

calcium phosphate.

Pharmacological action

Carvedilol has a combined non-selective β1-β2 – and α1-blocking effect. The drug does not have its own sympathomimetic activity, it has membrane-stabilizing properties.

Due to the blockade of beta-adrenergic receptors of the heart, blood pressure, cardiac output and heart rate can decrease. Carvedilol suppresses the renin-angiotensin-aldosterone system by blocking the beta-adrenergic receptors of the kidneys, causing a decrease in plasma renin activity.

By blocking alpha-adrenergic receptors, the drug can cause peripheral vascular dilation, thereby reducing systemic vascular resistance.

The combination of beta-adrenergic blockade and vasodilation has the following effects: in patients with arterial hypertension – lowering blood pressure;

in patients with coronary heart disease-anti-ischemic and anti-anginal effects;

in patients with left ventricular dysfunction and circulatory insufficiency – favorably affects hemodynamic parameters, increases the ejection fraction of the left ventricle and reduces its size.

Indications

• Arterial hypertension (in monotherapy and in combination with diuretics);
• chronic heart failure (in combination therapy);
• IHD: stable angina pectoris.

Contraindications

• hypersensitivity to carvedilol or other components of the drug;
• acute and chronic heart failure (decompensation);
• severe hepatic insufficiency;
• AV-block II-III degree;
• bradycardia (less than 50 beats/min);
• SSSU;
• hypotension (systolic blood pressure less than 85 mm Hg. calendar);
• cardiogenic shock;
• COPD;
• childhood and adolescence to 18 years (efficacy and safety not established).

With caution: Prinzmetal angina, thyrotoxicosis, peripheral vascular occlusive diseases, pheochromocytoma, psoriasis, renal failure, grade I AV block, extensive surgery and general anesthesia, diabetes mellitus, hypoglycemia, depression, myasthenia gravis.

Side effects

From the immune system:  very rare – hypersensitivity.

From the hematopoietic system:  common-anemia; rare-thrombocytopenia; very rare-leukopenia.

Nervous system disorders:  very frequent – dizziness, headache; infrequent-pre-fainting, syncope, paresthesia.

From the side of the visual organ:  frequent – visual disturbances, reduced tear production (dry eyes), eye irritation.

From the cardiovascular system:  very frequent – heart failure in the period of increasing the dose, a marked decrease in blood pressure; frequent-bradycardia, edema, hypervolemia, fluid retention, orthostatic hypotension, peripheral circulatory disorders (cold extremities, peripheral vascular diseases, exacerbation of intermittent claudication syndrome and Raynaud’s syndrome); infrequent – AV block II-III degree, angina pectoris.

Respiratory system disorders:  common – shortness of breath, pulmonary edema, asthma in predisposed patients, bronchitis, pneumonia, upper respiratory tract infections; rare-nasal congestion.

From the digestive system:  frequent – nausea, diarrhea, vomiting, dyspepsia, abdominal pain; infrequent-constipation, dry mouth.

Liver and biliary tract disorders:  very rare – increased ALT, AST, and GGT activity.

Skin and subcutaneous tissue disorders:  infrequent-skin reactions (for example, allergic exanthema, dermatitis, urticaria, pruritus, psoriasis-like and lichen-like skin lesions, alopecia); very rare-erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Musculoskeletal disorders:  frequent-pain in the extremities.

From the urinary system:  frequent – urinary tract infections, impaired urination, renal failure and impaired renal function in patients with diffuse vasculitis and / or impaired renal function; very rare – urinary incontinence in women (reversible after discontinuation of the drug).

From the genitals and breast:  infrequent – erectile dysfunction.

From the side of metabolism and nutrition:  frequent – hypercholesterolemia, hyperglycemia or hypoglycemia in patients with diabetes mellitus.

Common disorders:  very frequent – asthenia, increased fatigue; frequent-weight gain.

Dizziness, fainting, headache and asthenia are usually mild and occur more frequently at the beginning of therapy with Carvedilol Zentiva.

When using the drug in patients with chronic heart failure and low blood pressure (systolic blood pressure

The presence of beta-blocking properties in the drug does not exclude the possibility of manifestation of latent diabetes mellitus, decompensation of existing diabetes mellitus, or suppression of the contrinsular system.

Interaction

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

When carvedilol and diltiazem are used together, cardiac conduction disorders and hemodynamic disorders may develop. With simultaneous use of carvedilol and digoxin, the concentration of the latter increases and the time of atrioventricular conduction may increase.

Carvedilol can potentiate the effects of insulin and oral hypoglycemic agents, while the symptoms of hypoglycemia (especially tachycardia) can be masked, so regular monitoring of blood sugar levels is recommended in diabetic patients.

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

Drugs that reduce the content of catecholamines (reserpine, monoaminooxidase inhibitors)increase the risk of hypotension and severe bradycardia.

Concomitant use of cyclosporine increases the concentration of the latter (correction of the daily dose of cyclosporine is recommended).

Concomitant use of clonidine may potentiate the antihypertensive and heart rate-reducing effects of carvedilol. General anesthetics enhance the negative inotropic and hypotensive effects of carvedilol.

How to take, course of use and dosage

Inside, regardless of food intake.

Arterial hypertension

The initial dose is 6.25-12.5 mg once a day for the first two days of treatment. Then 25 mg once a day. If the antihypertensive effect is insufficient, the dose can be increased 2-fold after 2 weeks of therapy. The maximum recommended daily dose of the drug is 50 mg once a day (possibly divided into 2 doses).

Coronary heart disease

The initial dose is 12.5 mg twice daily for the first two days of treatment. Then 25 mg 2 times a day. If the antianginal effect is insufficient, the dose can be increased 2-fold after 2 weeks of therapy. The maximum recommended daily dose of the drug is 100 mg per day, divided into 2 doses.

Chronic heart failure

The dose is selected individually, under the careful supervision of a doctor. The recommended starting dose is 3.125 mg twice daily for 2 weeks. With good tolerability, the dose is increased at intervals of at least 2 weeks to 6.25 mg 2 times a day, then to 12.5 mg 2 times a day, then to 25 mg 2 times a day. The dose should be increased to the maximum, which is well tolerated by patients. In patients with a body weight of less than 85 kg, the target dose is 50 mg per day; in patients with a body weight of more than 85 kg, the target dose is 75-100 mg per day.

Overdose

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

Treatment: it is necessary to monitor and correct vital signs, if necessary – in the intensive care unit. Treatment is symptomatic. Intravenous use of m-holinoblokatorov (atropine), adrenomimetics (epinephrine, norepinephrine) is advisable.

Special instructions

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

At the beginning of therapy with Carvedilol-OBL or with an increase in the dose of the drug, patients, especially the elderly, may experience an excessive decrease in blood pressure, mainly when standing up. It is necessary to adjust the dose of the drug. In patients with chronic heart failure, when selecting the dose, it is possible to increase the symptoms of heart failure, the appearance of edema. At the same time, the dose of Carvedilol-OBL should not be increased; it is recommended to prescribe high doses of diuretics until the patient’s condition stabilizes.

Continuous monitoring of ECG and blood pressure is recommended with simultaneous use of Carvedilol-OBL and slow calcium channel blockers, phenylalkylamine derivatives (verapamil) and benzothiazepine (diltiazem), as well as with Class I antiarrhythmics.

It is recommended to monitor renal function in patients with chronic renal failure, arterial hypotension and chronic heart failure. In the case of surgical intervention using general anesthesia, the anesthesiologist should be warned about previous therapy with Carvedilol-OBL.

Carvedilol-OBL 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.

During the treatment period, the use of ethanol should be avoided.

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

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

Influence on the ability to drive motor vehicles and manage mechanisms

It is not recommended to drive a car at the beginning of therapy and when increasing the dose of Carvedilol-OBL. You should refrain from other activities related to the need for high concentration of attention and rapid psychomotor reactions.

Form of production

Tablets

Active ingredient

Carvedilol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets