Carvedilol Sandoz, tablets 6,25mg 30 pcs

Carvedilol has vasodilatory, antianginal, antiarrhythmic effects.

Blocks alpha1-, beta1- and beta2-adrenoreceptors.

Does not have sympathomimetic activity of its own, has membrane-stabilizing properties.

Carvedilol has an antioxidant effect, eliminating free oxygen radicals.

Indications

Arterial hypertension (monotherapy or in combination with other antihypertensive drugs), stable angina pectoris.

Active ingredient

Composition

1 tablet contains 6.25 mg carvedilol.

How to take, the dosage

Carvedilol is taken orally, after meals, with a small amount of liquid. The dose is chosen individually. Arterial hypertension: the recommended dose for the first 7-14 days is 12.5 mg/day in the morning after breakfast or divided into 2 doses of 6.25 mg, then 25 mg/day once in the morning or divided into 2 doses of 12.5 mg.

After 14 days, the dose may be increased again.a Stable angina pectoris: The initial dose is 12.5 mg 2 times daily, after 7-14 days, under a physician’s supervision, the dose may be increased to 25 mg 2 times daily. In 14 days in case of insufficient effectiveness and good tolerability of the drug the dose can be increased.

The total daily dose should not exceed 100 mg (50 mg 2 times a day), over 70 years old – 50 mg/day (25 mg 2 times a day).

If the next dose is missed, Carvedilol should be taken as soon as possible; however, if the next dose is approaching, only that dose is taken, without doubling. If withdrawal of Carvedilol Obolensky is necessary, the dose should be reduced gradually over 1-2 weeks.

Interaction

Catecholamine depleting agents (reserpine, MAO inhibitors) may cause severe bradycardia and arterial hypotension. Concomitant administration of ACE inhibitors, thiazide diuretics, vasodilators, prescribed simultaneously with carvedilol may lead to a sharp drop in BP.

It enhances the effect of insulin and sulfonylurea derivatives (while masking or weakening the severity of symptoms of hypoglycemia, reducing the breakdown of liver glycogen to glucose).

When concomitantly administered with insulin or oral hypoglycemic agents, blood glucose levels should be monitored. CYP2D6 isoenzyme inhibitors (quinidine, fluoxetine, propafenone) may increase the concentration of R(+)-enantiomer of Carvedilol.

Co-administration with antiarrhythmic agents (especially class I) and BMCCs (verapamil, diltiazem) may provoke severe arterial hypotension and heart failure. Intravenous administration of these drugs together with taking carvedilol is contraindicated.

Elevates digoxin concentrations, which requires monitoring of digoxin concentrations since concomitant administration with cardiac glycosides may lead to AV blockade.

General anesthetics increase negative inotropic and hypotensive effects. Phenobarbital and rifampicin accelerate metabolism and decrease plasma concentration of carvedilol. Microsomal oxidation inhibitors (cimetidine), diuretics and ACE inhibitors increase the concentration and increase the hypotensive effect of carvedilol. Carvedilol delays the metabolism of cyclosporine.

Special Instructions

If the heart rate decreases to 55 bpm, the drug should be discontinued. In allergic persons or those undergoing desensitization, administration of Carvedilol may increase allergic sensitivity. Persons who wear contact lenses should be warned that the drug reduces tear production.

When completing treatment with Carvedilol Sandoz concomitantly with clonidine, the dosage of clonidine should first be gradually reduced and then clonidine and then carvedilol should be withdrawn first. If it is necessary to use Carvedilol Sandoz during lactation, breastfeeding should be stopped.

During treatment, alcohol intake should be excluded. In case of progression of circulatory insufficiency during treatment it is recommended to increase the dose of diuretics, in case of renal insufficiency the dose should be corrected taking into account the parameters of functional state of kidneys.

If surgical intervention with general anesthesia is necessary, the anesthesiologist should be warned about previous therapy with carvedilol. It should be noted that the drug may mask symptoms of thyrotoxicosis and hypoglycemia, therefore, regular monitoring of blood glucose levels and dosage adjustment if necessary are recommended.

Contraindications

Hypersensitivity, chronic obstructive pulmonary disease, severe hepatic insufficiency, marked bradycardia, sinus node weakness syndrome, grade II and III AV block (except for patients with pacemaker), decompensated heart failure, pulmonary hypertension or cardiogenic shock, hypotension, pregnancy, breast-feeding, age under 18 years (safety and effectiveness in those under 18 years old has not been established).

Side effects

In the recommended doses, Carvedilol is well tolerated, but in some cases, side effects may occur.

Digestive system disorders: nausea, dry mouth, abdominal pain, diarrhea or constipation, vomiting, increased liver transaminase activity.

Nervous system disorders: headache, dizziness, fatigue, loss of consciousness, muscle weakness (usually at the beginning of treatment), sleep disorders, depression, paresthesias.

Sensory organs: decrease in lacrimation.

Urinary system disorders: renal dysfunction, edema, urinary disorders.

Hematopoietic disorders: leukopenia, thrombocytopenia.

Allergic reactions: urticaria, itching, rash, appearance and/or exacerbation of psoriasis, sneezing, nasal congestion, bronchospasm, shortness of breath (in predisposed patients), very rare – anaphylactoid reaction.

Systemic diseases: bradycardia, orthostatic hypotension, angina pectoris, AV blockade, progression of circulatory failure (cold extremities), progression of heart failure, worsening of intermittent claudication and Raynaud’s syndrome.

Endocrine disorders: weight gain.

Others: pain in extremities, flu-like symptoms.

As with other drugs that block alpha-adrenoreceptors, latent diabetes mellitus may appear or increase its symptoms.

Overdose

Symptoms: marked BP decrease (BP 80 mmHg or lower), marked bradycardia (less than 50 bpm), respiratory disorders (bronchospasm, etc.), chronic circulatory failure, cardiogenic shock, cardiac arrest.

Treatment: within the first two hours induce vomiting and gastric lavage. Overdose requires intensive treatment, control of vital functions is necessary. The patient should be in a position with elevated legs, i.e. in Trendelenburg position. Beta-blocking antidotes are orciprenaline or isoprenaline 0.5-1 mg IV and/or glucagon at a dose of 1-5 mg (maximum dose 10 mg).

Severe hypotension is treated with parenteral fluid administration and repeated adrenaline administration at a dose of 5-10 mg (or its intravenous infusion at a rate of 5 mcg/min). In case of excessive bradycardia, administer IV atropine at a dose of 0.5-2 mg. To maintain cardiac activity: glucagon is administered rapidly (within 30 s) by IV, followed by a continuous infusion at a rate of 2-5 mg/h. If peripheral vasodilator action prevails (warm limbs, in addition to significant arterial hypotension), norepinephrine should be administered 5-10 mcg as an IV infusion – 5 mcg/min.

Beta-adrenomimetics (as an aerosol or intravenously) or aminophylline intravenously are prescribed to relieve bronchospasm. If seizures develop, slow administration of diazepam or clonazepam is recommended.

In severe cases of intoxication when symptoms of shock dominate, treatment should continue until the patient is stabilized, taking into account the T1/2 of carvedilol, which is 6-10 h.

Similarities