DAROB 160 mg. 20 tablets

1 tablet contains: 160 mg sotalol hydrochloride.
Other ingredients: highly disperse silicon dioxide, hidroksipropiltselupoza, lactose monohydrate, magnesium stearate, corn starch, sodium carboxymethyl starch.

Evidence
Symptomatic and requiring treatment tachycardiac supraventricular cardiac arrhythmias such. AV- nodal tachycardia, supraventricular tachycardias in WPW- syndrome or paroxysmal atrial fibrillation. Tezhkostepenni symptomatic ventricular tachycardia heart rhythm disorders.

Contraindications
Darob 160 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 grade II and III), impaired the conduct of excitement between sinus node and atrial (SA- Block) syndrome sick sinus strongly slow heartbeat (bradycardia <50 beats / min.), extending the previous QT- range, low blood pressure, late-stage disorders in the peripheral blood supply , obstructive pulmonary diseases (eg. asthma), increased blood atsiditetna known hypersensitivity to sotalop and sulfonamide, gpotisa swelling, severe allergic rhinitis, intravenous calcium channel blockers verapamil and diptiazemov type (exception: intensive medicine).
Caution should be exercised in: diabetic patients with highly variable blood glucose values and absolute diet, patients with hormone-producing tumor of the adrenal gland (a desirable pre-treatment with alpha-receptor blockers), patients with impaired renal function (see Dosage) .
Patients with myocardial infarction or left ventricular dysfunction are particularly susceptible to amplification of rhythm disorders. Through its beta-receptor blocking properties us, sotalop may 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 patients desenzibipizirashta therapy.
In patients with psoriasis in an individual or family history, administration of drugs with betaretseptorna blocking action should be done only after careful consideration of the benefit-risk.


Use during pregnancy and lactation
Sotalop crosses the placenta and reaches significant concentrations in cord blood. Co-tallow 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 are available during pregnancy.
Due to the possibility of the occurrence of slow heartbeat; low blood pressure, lower blood sugar and respiratory depression in the neonate, treatment with 160 mg of Darob 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.


Adverse reactions
In therapy sotalop sometimes occur fatigue, vertigo, dizziness, headache, abnormal sensitivity as tingling and numbness and a sense of cooling of the extremities. It is possible to reach and to strengthen violations in the peripheral blood flow, limiting salzootdepyaneto, lowering blood sugar, depressive moods, dry mouth, muscle cramps, respectively. muscle weakness, and disturbances in potency. Signs of low blood sugar (especially high pulse) can be masked. This should be taken into account particularly in strict fasting and in diabetic patients with highly variable blood glucose. Patients should have regular monitoring of blood sugar.
In therapy sotalop 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. In single cases have been reported 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
When wearing contact lenses should take into account the coming into effect of sotalol reduction in salzootdepyaneto.


Interactions with other medicinal products
The co-administration of Darob, 160 mg and calcium antagonists (verapamil and diltiazem by type) must be taken due to the increased effect on sinus-node and AV-. During therapy with 160 mg of Darob® should be avoided intravenous calcium antagonists (verapamil and diltiazem by type), (exception: intensive medicine). In combination therapy with anti-arrhythmic agents of Class! to avoid these substances, which may extend QRS- complex (especially hinidinopodobni substances), as it can lead to excessive prolongation of QT interval with the risk of facilitating the 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 marked decrease in blood pressure; You can think and enhanced suppression of sinus node.
Concurrent use of sotalop and noradrenaline or MAO - inhibitors and after abrupt discontinuation of therapy with accompanying kponidin, blood pressure can sharply increase. The concomitant use of sotapol and tricyclic antidepressants, barbiturates, phenothiazines and drugs asashtohipotenzivni, diuretics and vasodilators can lead to a marked lowering of blood pressure.
May potentiate the cardiac depressant effects of sotalop and drugs, respectively. other antiarrhythmics. Neuromuscular blockade of Tubocurarine can be enhanced by betaretseptornoto blocking. Therefore, the anesthesiologist should be aware of Darob therapy with 160 mg.
The concomitant use of sotapol and reserpine, clonidine, alpha metipdopa, guanfacine and cardiac glycosides, can lead to greater reductions in heart rate, respectively. delays in the implementation of excitement in the heart.
Concurrent use of sotalop and insulin or oral antidiabetic agents, particularly with concomitant physical exercise can lead to attenuation of 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 sotapol because of the easy-kpyuchvane ventricular arrhythmias. The same is true for joint use with alcohol. Be approached with caution in concomitant use of sotapol and substances that prolong the QT interval, eg. haloperidol, astemizole and terfenadine antihistaminige, parasimpatikolitika terodipin, and protivomapariynoto means halofantrin because of the danger of not unlocked proa rhythmic effects such ..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 two or three months after the beginning of the acceptance of the product.
Patients experienced a myocardial infarction, or with severe cardiac failure should be monitored during the phase of dose increase in 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 two ggyti 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 sotalo! hydrochloride (meet three times a day in a small tablet Sotalol or 1/2 large Sotalol tablet three times a day) or twice daily 160 mg sotalol hydrochloride (meet twice daily in two small tablets Sotalol or 1 large Sotalol tablet twice daily). In cases of life-threatening arrhythmias and insufficient efficacy, the dose may be increased to 480 mg daily (correspond to six small tablets or Sotalol 3 Toleman tablets 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 side effects (especially proarrhythmic action).
• symptomatic and requiring treatment supraventricular tachycardia:
The initial dose is twice daily 80 rag sotalol hydrochloride (meet twice daily in a small tablet Sotalol or 1/2 large Sotalol tablet twice daily). If the tolerance of the drug is good, but the effect is not sufficient, the dosage may be increased to a three times daily 80 mg sotalol hydrochloride (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 drug is good, but the effect is not sufficient, the upper daily dose may be increased by not more than 160 mg sotalol hydrochloride (generally meet twice daily in two small tablets Sotalol or 1 large Sotalol tablet twice daily).
• For patients with impaired renal function, there is a risk of accumulation of SotaloJ Repeated dose, dose it must comply with their 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 in enhanced ECG monitoring and tracking of serum.
• Recommended dosages in patients with reduced renal function
Patients snamaleni a creatinine clearance between 10-30ml / mm (serum creatinine 2-5 mg / dl) the dose should be reduced by half. In patients with reduced creatinine clearance values below 10 ml / mm (serum creatinine> 5 mg / dl) the dose should be reduced to a quarter.


Method and duration of use
Tablets taken before meals with a little liquid.
Treatment with 160 mg Darob rule long. Her interruption or change in dosage should be done only on prescription.
Patients with life-threatening heart rhythm disturbances in any case should not willfully change in dosage or discontinuation of Darob 160 mg. In difficult tolerable delay pulse or severely low blood pressure, the daily dose should be reduced. This also applies in the event of respiratory complaints; in this case the drug should be discontinued. Should avoid abrupt withdrawal of Darob 160 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
Medicinal product not to use it after expiration date.
Medicinal product to be stored out of reach of children.