SOTAGAMA table. 160 mg. 50 tablets
SOTAGAMA table. 160 mg. 50 tablets
Areas of application
Symptomatic tachycardiac ventricular heart rhythm disturbances (increased heart rate in heart chambers).
symptomatic and requiring treatment tachycardiac supraventricular heart rhythm disturbances (such as abnormal heart rhythms that occur with rapid heart rate and come from departments of supraventricular heart)
Prevention of recurrence of atrial fibrillation (irregular heartbeats chronic due to illness enhanced excitability of the atria) after electroconvulsive therapy
Prevention of attacks of atrial fibrillation (irregular heartbeats that begin with paroxysmal onset and result from intense morbid excitability of the atria).
When you must not be taken Sotagamma 160? Sotagamma 160 should not be taken if:
pronounced failure of the heart muscle (heart failure class IV NYHA; uncompensated heart failure)
acute heart attack
severe disturbances in impulse conduction between the atria and the cardiac chambers of the heart (AV-block II-nd and III-Grade)
sino-atrial block (heart block impaired conduction of the sinus node to the heart ventricle)
sick sinus syndrome (heart rhythm disturbances as a result of impaired sinus node), which may occur for example, sinus bradycardia (slow heart rate of <60 bpm), bradycardia-tachycardia syndrome (heart rate , changing from fast to slow and back), sino-atrial block (heart block conduction from the sinus node to the heart ventricle) or sinus arrest (stopping impulse formation in the sinus node)
resting heart rate below 50 beats per minute before treatment (bradycardia <50 bpm)
pre-existing QT prolongation
reduced levels of potassium (hypokalemia)
very low blood pressure (hypotension)
late stages of peripheral circulatory disturbance
severe respiratory illnesses caused by their narrowing (obstruction)
increased acidity of the blood caused by metabolism (metabolic acidosis)
Known hypersensitivity to sulfonamides and sotalol
In patients with psoriasis personal or family history of application of drugs that block beta-receptors (eg Sotagamma 160), should be done only after careful assessment of the benefit-risk.
Sotalolat has the ability to block beta-receptors may increase sensitivity to allergens and the severity of acute generalized allergic reactions (anaphylaxis).
In patients with severe hypersensitivity reactions in patients medical history and treatment to reduce, respectively, suppress the body's response (desensitization treatment) have an increased risk of a more severe anaphylactic reactions. Therefore, these patients require a very strict assessment of the evidence.
Intravenous administration of calcium channel blockers of the verapamil and diltiazem type is contraindicated in patients who are treated with Sotagamma 160 (except in emergencies).
What you need to know during pregnancy and lactation?
If you are pregnant or breast-feeding tell your doctor.
In pregnancy, especially during the first three months, Sotagamma 160 can be used only when strictly necessary and then evaluate the benefit - possible risk, because so far there is no adequate experience in pregnant women. Due to the possible occurrence of side effects (bradycardia and hypotension) in the newborn, treatment should be discontinued 48 to 72 hours before the time of birth. After birth, the child should also be monitored for a period of vreme.Sotalol hydrochloride passes into breast milk. If during treatment the patient nurse, the child should be monitored for possible drug effects.
What can be observed in children and adults?
For the purposes of Sotagamma 160 in children is not enough danni.Pri treatment of older patients should be considered as impaired renal function (see "Dosage").
Precautions and warnings for the application
What precautions should be taken into account?
Patients after myocardial infarction or those with impaired ventricular function are particularly vulnerable to breaches enhancement of the cardiac rhythm (proarrhythmia). They need very close supervision when assigned treatment with anti-arrhythmic medication.
The use of sotalol hydrochloride (intravenous) can only be done in a hospital setting. There is constant monitoring of breathing, blood pressure, heart rate and EKG.Lechenieto should be discontinued gradually in patients with ischemic heart disease or long implementation because its sharp break can lead to worsening of clinical medicine in a kartina.Naznachavaneto patients with hormone-producing adrenal tumor (pheochromocytoma) induces both blocking and alpha receptors.
During treatment with 160 Sotagamma can lead to hypoglycemia. Some signs of low blood sugar (especially tachycardia) can be obfuscated in therapy Sotagamma 160. This should be considered especially in diabetic patients with highly variable blood glucose and patients received applying strict diets (fasting, starvation).
What should I observe when driving, operating machinery, and safe at work without support?
This drug (and when used consistent with the prescription) may change as the reactions that affect their ability to participate actively in traffic, maintenance of machines or work without safe foothold.
This is true to a large extent at the beginning of treatment, increasing the dose of the drug and change, as well as interaction with alcohol.
What else should care?
Taking sotalol reduces slazootechenieto that can affect when wearing contact lenses.
What other drugs affect the action of Sotagamma 160?
Tell your doctor all the medicines priemate.Pri simultaneous oral administration of 160 Sotagamma and calcium channel blockers of the verapamil and diltiazem type can lead to a significant drop in blood pressure, bradycardia in heart rhythm disturbances and high-grade atrio-ventricular impaired impulse transmission resulting from the combined effect on sinus and AV (atrio-ventricular)-vazli.Protivopokazano is intravenous administration of calcium channel blockers of the verapamil and diltiazem type in patients treated with Sotagamma 160 (except in emergencies) . In combination with antiarrhythmic agents of Class I (especially hinidinopodobni substances) and other antiarrhythmics class III, there is a risk of significant prolongation of QT, associated with an increased risk of the occurrence of ventricular arrhythmias.
The simultaneous administration of calcium channel blockers nifedipinov type can lead to a greater decrease in blood pressure.
The simultaneous administration of noradrenaline and Sotagamma 160 or MAO inhibitors, and after abrupt discontinuation of concomitant administration of clonidine may significantly increase blood pressure.
Co-administration of Sotagamma 160 and tricyclic antidepressants, barbiturates, phenothiazine drugs and preparations, and antihpertonichni medications, diuretics and vasodilators can cause a large drop in blood pressure.
Sotagamma 160 reduces cuts to the heart muscle (negative inotropic effect). This effect may be enhanced by the application and the drugs and antiaritmitsi.Namalyavashtoto heart rate and impulse conduction actions Sotagamma 160 (negative chronotropic and dromotropic-) may increase with concomitant use of reserpine, clonidine, alpha-methyldopa, and guanfacin cardiac glycosides.
Neuromuscular blockade by tubocurarine may be increased due to the inhibition of beta-receptors.
Co-administration of 160 and Sotagamma insulin or oral antidiabetic agents (especially during exercise) can lead to decreased blood sugar (hypoglycemia) symptoms with phrasing.
Co-administration of diuretics, leading to increased excretion of potassium (eg, furosemide, hydrochlorothiazide) there is an increased risk of heart rhythm disruption due to hypokalemia.
Concomitant use of tricyclic antidepressants or alcohol Sotagamma 160 should be avoided because of the potential for the occurrence of ventricular arrhythmias (described isolated cases). Concurrent use of sotalol and medications that can prolong the QT-interval, such as tri-and tetracyclic antidepressants (imipramine, maprotolin), antihistamines (astemizole, terfenadine), macrolide antibiotics (erythromycin), probucol, haloperidol, halofantrine and terolidin, there is an increased risk of a proarrhythmic action (Torsade de pointes). Please note that these data apply to drugs whose administration has ended recently.
Which foods, spices and beverages you should avoid?
During treatment with 160 Sotagamma should not drink alcohol.
User dosage, method and duration of administration
The dosage and duration of treatment is determined by lekarya.Sledvashtite instructions apply only in cases that your doctor has prescribed Sotagamma 160 otherwise. Please adhere to the instructions for use, otherwise Sotagamma 160 may exert its therapeutic effect!
How much and how often you should take Sotagamma 160?
Tachycardiac symptomatic ventricular heart rhythm:
If the tablet of 80 mg sotalol is not sufficient, the dose may be increased to two patipo 160 mg (corresponding to half a tablet Sotagamma 160). Threatening arrhythmias in the dose may be increased to 480 mg / day (corresponding to three tablets Sotagamma 160 per day).
In this case, increasing the dose may be taken if the potential benefit is greater than the possible increased risk of severe adverse actions (especially proarrhythmic action).
In patients with paroxysmal atrial fibrillation should not exceed three times the dose of 80 mg daily.
In patients with chronic atrial fibrillation. where low doses are not sufficient effect, the dosage may be increased up to two times daily 160 mg (equivalent to 2 times daily tablet Sotagamma 160) with good tolerability.
Increasing the dose should be made at the earliest after 2-3 days.
How and when to take Sotagamma 160?
Tablets should be taken with some liquid without davchat.Sotagamma 160 should not be taken with meals as this can reduce the absorption of the active ingredient sotalol.
How long should you take Sotagamma 160?
The duration of treatment determined doctor.
After long oral administration of 160 Sotagamma therapy should be withdrawn gradually rather than abruptly.
Overdose and other errors in usage / implementation
What should I do if taken too much Sotagamma 160 (intentional or inadvertent overdose)?
In suspected overdose Sotagamma 160 immediately inform your doctor. He will decide, depending on the symptoms what should be done. In poisoning and / or in case of severe symptoms should immediately seek medical attention.
The clinical picture depends on the degree of intoxication and is primarily cardiovascular and central nervous symptoms such as fatigue, unconsciousness fundus, sometimes generalized convulsions,hypotension, bradycardia to asystole (ECG often seen replacement rate), but also atypical ventricular tachycardia (Torsade de pointes) and symptoms of cardiovascular shock.
What should you do if you have too little Sotagamma 160 or you forget a dose?
If you forget one or more doses, do not double the next dose intake and proceed with the treatment prescribed amount of medication. Reappearance of abnormal heart rhythms immediately contact your doctor.
What you need to follow if you interrupt or stop treatment prematurely?
Do not attempt any changes in dosage without consulting your doctor! In patients with ischemic heart disease or after long use of the drug, withdrawal should be gradual, as abrupt discontinuation may lead to worsening of the disease picture.
What side effects may occur with the use of 160 Sotagamma? Upon treatment with 160 Sotagamma Occasionally fatigue, dizziness, headache, confusion, hallucinations, often dreams, paresthesia (poor sensitivity) and a feeling of coldness.
Less common side effects were gastrointestinal symptoms (eg, nausea, vomiting, diarrhea), unlocking dyspnea in patients with obstructive respiratory disorders, skin reactions (redness, itching, exanthema), alopecia (hair loss), and violations of sanya.Osven This can lead to increased peripheral blood flow, depressive mood, muscle cramps and weakness respectively, in violation of potency.
Rare adverse hypotension, worsening heart failure (heart muscle weakness), bradycardia (very slow heart rate) and AV-conduction disorders (disorders of impulse conduction between the atria and ventricle). In rare cases of syncope (seizures, fainting). In some cases, it may lead to increased angina attacks pektoris.Proaritmichno action in the form of change or enhance violations heart rate, which can lead to serious disturbances of cardiac function with a possible consequence of cardiac arrest.
Arrhythmogenic effects may occur especially in patients with life-threatening heart rhythm disturbances and reduced left ventricular function.
Since Sotagamma QT-160 extended time can lead to the occurrence of ventricular tahiartimii (including Torsades de pointes) - mainly in overdose and as a result - as seen bradikardiya.Ryadko are dry mouth, conjunctivitis (inflammation of the lining of the eye) or reduce the formation of tears, in rare cases, visual disturbances, and keratoconjunctivitis.
During treatment with 160 Sotagamma can lead to hypoglycemia (a condition with low blood sugar). Signs of low blood sugar, particularly tachycardia (fast heart rate), can not be seen clearly in treatment Sotagamma 160. It can be expected especially in diabetics with many varying levels of blood sugar in patients on strict diets (fasting, starvation). Upon treatment with 160 Sotagamma can disrupt fat metabolism (increased total cholesterol and triglycerides , reduced HDL-cholesterol).
Drugs that block beta-receptors (eg Sotagamma 160) can occasionally trigger psoriasis to worsen the symptoms of the disease or cause such skin zabolyavaniya.Poradi properties of beta-blocker receptors, Sotagamma 160 may increase sensitivity to allergens and severity of acute allergic disorders (anaphylaxis). Therefore, in patients with severe hypersensitivity reactions in patients medical history and treatment to suppress the allergic response (desensibilizatsionno treatment) can lead to very severe allergic reactions.
If you observe adverse reactions to you, especially those that are not described in this usage information, please report them to your doctor or pharmacist.
Instructions and directions for the shelf life of the drug
Date indicating the expiry date printed on the carton and blister.
Do not use the medicine after this date!
How should I store Sotagamma 160?
No special storage conditions.
The drug should be kept out of reach of children!
1 tablet contains 160 mg sotalol hydrochloride
microcrystalline cellulose, magnesium stearate, highly dispersed silica