DAROB 80 mg. 20 tablets

Ingredients:
1 tablet contains: 80 mg sotalol hydrochloride.
Other ingredients:
highly disperse silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, corn starch, sodium carboxymethyl starch.
Indications:
Symptomatic and requiring treatment tachycardiac supraventricular cardiac arrhythmias such. AV- nodal tachycardia, supraventricular tachycardia in WPW - syndrome or paroxysmal atrial fibrillation. Tezhkostepenni symptomatic ventricular tachycardia heart rhythm disorders.
Contraindications:
Darob 80 mg should not be administered to: expressed heart failure (heart failure IV. Degree in NYHA), shock, impaired the conduct of excitement from the atria to the cameras (AV block II. And III. Level), impaired the conduct of excitement between the sinus node and atrium (BSA block) syndrome sick sinus strongly slow heartbeat (bradycardia <50 beats / min.) prior extension of the QT interval, low blood pressure, late-stage disorders in the peripheral blood supply obstructive pulmonary diseases (eg. asthma), increased blood atsiditet known hypersensitivity to sulfonamides and sotalol, glottis edema, severe allergic rhinitis, intravenous calcium channel blockers verapamil and diltiazem type (exception: intensive medicine).
Caution should be exercised in: diabetic patients with highly variable blood glucose values and absolute diet, patients with producing hormones tumor of the adrenal gland (a desirable pre-treatment with alpha-receptor blockers), patients with impaired renal function (see Dosage) .
Patients with myocardial infarction and left ventricular dysfunction are particularly susceptible to gain rhythm disorders. Through its beta-receptor blocking properties, sotalol can increase sensitivity to allergens and the severity of anaphylactic reactions. It is therefore recommended strict compliance with the indications in patients with severe hypersensitivity reactions in the previous history and in patients desenzibilizirashta therapy. In patients with psoriasis in an individual or family history, administration of drugs with betaretseptorno blocking action should be done only after careful consideration of the benefit - risk.
Use during pregnancy and lactation:
Sotalol crosses the placenta and reaches significant concentrations in cord blood. Sotalol should be used during pregnancy, especially during the first three months, after careful consideration of the benefit - risk, because so far there is not enough data on its use in pregnancy.
Due to the possibility of having a slow heartbeat, low blood pressure, lower blood sugar and respiratory depression in the neonate, therapy Darob 80 mg should be discontinued 48-72 hours before the estimated date of childbirth. If this is not possible, 48-72 hours after birth, newborns should be monitored carefully. Sotalol passes into breast milk, where it reaches operating concentrations. Although adopted stern actively amount probably not a danger to the child, infants should be monitored on beta-blocking effects.
Undesirable effects:
When therapy with sotalol sometimes occur fatigue, vertigo, dizziness, headache, abnormal sensitivity as numbness and tingling, and a sense of cooling of the extremities. It is possible to reach and to strengthen violations in the peripheral blood flow, limiting lacrimation, lowering blood sugar, depressive moods, dry mouth, muscle cramps, respectively. muscle weakness, and disturbances in potency. Signs of low blood sugar (especially rapid pulse) can be masked. This should be taken into account particularly in strict fasting and in diabetics with highly variable blood glucose. Patients should have regular monitoring of blood sugar.
When therapy with sotalol rarely seen visual disturbances, and inflammation of the cornea and conjunctiva.
In patients with life-threatening heart rhythm disturbances or limited left ventricular function of the heart can lead to proarrhythmic effects that lead to severe impairment of cardiac function. Isolated reports of syncope.
Special instructions for use
Through its blood pressure lowering effect, this medication can reduce the ability to respond so as to affect the ability to drive and use machines. This is especially true for start of treatment and when changing the preparation, as well as its interaction with alcohol.
Recommendations:
Wearing contact lenses should take into account the coming into effect of sotalol decrease in tear production.
Interactions with other drugs:
The co-administration of 80 mg Darob and calcium antagonists (verapamil and diltiazem by type) must be taken due to the increased effect on sinusoviya- and AV- unit. During therapy with Darob 80 mg should be avoided intravenous calcium antagonists (verapamil and diltiazem by type), (exception: intensive medicine).
In combination therapy with anti-arrhythmic agents of Class I to avoid these substances, which may extend QRS - complex (especially hinidinopodobni substances), as it can lead to excessive extension of the QT- interval facilitated with the danger of occurrence of ventricular arrhythmias. For the same reason should be avoided and concomitant use of other antiarrhythmics class III, due to possible too extreme QT-prolongation. When concomitant administration of nifedipine (and other dihydropyridine derivatives), can lead to a more pronounced fall in blood pressure; You can think and enhanced suppression of sinus node.
With concomitant use of sotalol and noradrenaline or MAO inhibitors, and after abrupt discontinuation of concomitant treatment with clonidine, blood pressure can sharply increase. With the concomitant use of sotalol and tricyclic antidepressants, barbiturates, narcotics and phenothiazines, as well as hypotensive agents, diuretics and vasodilators, may lead to a more pronounced blood pressure lowering.
May potentiate the cardiac depressant effects of sotalol and drugs, respectively. other antiarrhythmics. Neuromuscular blockade of Tubocurarine can be enhanced by betaretseptornoto blocking. Therefore, the anesthetist should be informed of therapy with 80 mg Darob.
The concomitant use of sotalol and reserpine, clonidine, alpha-methyldopa, guanfacine and cardiac glycosides, can lead to greater reductions in heart rate, respectively. delays in the implementation of excitement in the heart.
With concomitant use of sotalol and insulin or oral antidiabetic agents, particularly with concomitant physical exercise can lead to marked reductions in blood sugar and to mask its symptoms (sweating, rapid pulse, trembling). The concomitant use of diuretics should monitor the potassium level.
Avoid concomitant use of tricyclic antidepressants and sotalol due to easy unlock ventricular arrhythmias. The same is true for joint use with alcohol. Be approached with caution in concomitant use of sotalol and substances that prolong the QT interval, eg. haloperidol, astemizole and terfenadine antihistamines, parasimpatikolitika terodiline, and antimalarials halofantrine due to the risk of proarrhythmic effects unlocking of the type "Torsades de pointes".
Dosage:
• Adults:
Tablets should be taken with a little liquid, without chewing.
Sotalol should not be taken during meals (especially dairy), as this can reduce the absorption of the active ingredient sotalol hydrochloride. Increasing the dose may be made at the earliest after a two-or three-day period after the start of administration of the medicinal product. Patients experienced a myocardial infarction, or with severe cardiac failure should be monitored during the phase of dose increase at this antiarrhythmic medicine. Patients experienced a myocardial infarction and / or heart rhythm disorders, or who have used long medicinal product, the suspension of treatment should be gradual, since abrupt termination may have an adverse effect on the picture of the disease. The duration of treatment should be determined by your doctor.
Severe symptomatic ventricular tachycardia:
The initial dose is twice daily 80 mg sotalol hydrochloride (meet twice daily in a small tablet sotalol or 1/2 large sotalol tablet twice daily).
If the effect is not sufficient, the daily dose may be increased to three times daily 80 mg sotalol hydrochloride (corresponding to three times a day, a small tablet or sotalol 1/2 bolus sotalol three times daily) or BID 160 mg sotalol hydrochloride (meet twice daily in two small tablets of sotalol or 1 large sotalol tablet twice daily).
In the case of zhivotozastrashavashi arrhythmias and insufficient efficacy, the dose may be increased to 480 mg daily (correspond to six small tablets sotalol or large tablets of 3 sotalol), divided into two or three separate doses. In these cases, increasing the dosage can be taken only if the potential benefit is greater than the possible increased risk of serious adverse reactions (especially proarrhythmic action)
Symptomatic and requiring treatment supraventricular tachycardia:
The initial dose is twice daily 80 mg sotalol hydrochloride (meet twice daily in a small tablet sotalol or 1/2 large sotalol tablet twice daily). If the tolerance to the drug is good, but the effect is not sufficient, the dosage may be increased to a three times daily 80 mg sotalol (corresponding to three times a day, a small tablet or sotalol 1/2 bolus sotalol TID). This dosage should not be exceeded in patients with paroxysmal atrial fibrillation.
In patients with chronic atrial fibrillation and provided that the tolerance to the medication is good, but the effect is not sufficient, the upper daily dose may be increased by not more than 160 mg sotalol (corresponds to a total of two times daily two small tablets sotalol or 1 large sotalol tablet twice daily).
In patients with impaired renal function, there is a risk of accumulation of sotalol after repeated administration in their dose should be adjusted to renal clearance, while monitored heart rate (not less than 50 beats per minute) and clinical response .
In patients with severe renal insufficiency sotalol should be recommended only for intensified ECG control and monitoring of serum concentrations.
Recommended dosages in patients with reduced renal function
In patients with reduced creatinine clearance values between 10-30 ml / min (serum creatinine 2-5 mg / dL), the dose should be reduced by half. In patients with reduced creatinine clearance values below 10 ml / min (serum creatinine> 5 mg / dL), the dose should be reduced to one quarter.
Method and duration of use:
Tablets taken before meals with a little liquid. Treatment with 80 mg Darob is generally long. Her interruption or change in dosage should be done only on prescription.
Patients with life-threatening heart rhythm disorders in no case take unwarranted changes in dosage or discontinuation of treatment with 80 mg Darob. In difficult tolerable delay pulse or high blood pressure decrease, the daily dose should be reduced. This also applies in the event of respiratory complaints; in this case the drug should be discontinued.
You should avoid abrupt withdrawal of Darob 80 mg to prevent extreme prevalence of protivoregulatornite processes. In patients with coronary heart disease and / or rhythm disturbances, interruption of treatment should be done very carefully to avoid deterioration of the clinical picture.
Expiry date:
The drug can not use it after expiration date.
• The drug can be stored out of reach of children.
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