Betacor 80 mg 30 tablets

Betacor 80 mg 30 tablets

Composition:
Active substance:
Sotalol hydrochloride 80 mg.
Excipients:
Lactose monohydrate, maize starch, povidone, magnesium stearate.
Description:
Betacor is a Class III antiarrhythmic drug and a non-selective beta-blocker.
It is intended for the treatment and prevention of serious cardiac rhythm disorders (arrhythmias).
The drug slows the conduction of nerve impulses in the heart, prolongs the recovery period of the heart muscle, and stabilizes its electrical activity.
Indications:
- Ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation).
- Supraventricular arrhythmias (including atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia).
- Prophylaxis of life-threatening ventricular arrhythmias.
Dosage and Administration:
Initial dose:
80 mg twice daily.
If necessary, the dose can be gradually increased to 320 mg per day.
Maximum dose:
480-640 mg/day (in divided doses) under strict medical supervision.
Dose adjustment is required for patients with renal impairment.
Not recommended for use in children.
Method of administration:
Tablets should be taken orally with water.
Contraindications:
- Hypersensitivity to sotalol or any other component of the drug.
- Bronchial asthma, severe chronic obstructive pulmonary disease (COPD).
- Sinus bradycardia (heart rate <50 beats per minute), sick sinus syndrome.
- Atrioventricular (AV) block of second or third degree in the absence of a pacemaker.
- Cardiogenic shock, uncontrolled heart failure.
- QT interval prolongation, hypokalemia (low potassium levels), hypomagnesemia (low magnesium levels).
Precautions:
- There is a risk of life-threatening "pirouette" type arrhythmia (torsades de pointes) associated with QT interval prolongation.
- ECG monitoring is required at the initiation of therapy and with each dose increase.
- Regular monitoring of electrolyte levels (potassium and magnesium) in the blood is necessary.
- Discontinuation of the drug should be gradual to avoid "rebound" exacerbation of arrhythmia and worsening of the condition.
- Use with caution in elderly patients, and in cases of renal impairment, diabetes mellitus, and thyrotoxicosis.
Side Effects:
- Very common (≥1/10): increased fatigue, dizziness, bradycardia (slow heart rate).
- Common (≥1/100 to <1/10): dyspnea, palpitations, nausea, vomiting, diarrhea.
- Uncommon (≥1/1000 to <1/100): torsades de pointes, syncope, hypotension (low blood pressure), bronchospasm.
- Rare (≥1/10,000 to <1/1000): skin rash, depression, confusion, hallucinations.
- Very rare (<1/10,000): agranulocytosis, thrombocytopenia.
Pregnancy and Lactation:
Pregnancy:
Use is contraindicated, except in absolutely necessary cases where the potential benefit to the mother outweighs the potential risk to the fetus. The decision must be made by a physician.
Lactation:
Sotalol is excreted in breast milk. Due to the risk to the child, breastfeeding is not recommended.
Storage Conditions:
Store at a temperature not exceeding 30°C, in a dry place protected from moisture.
Keep out of reach of children.
Package:
A carton box containing 3 blisters of 10 tablets total.
30 tablets per pack.