Description overdue on 09/15/2014
- Latin name: SotaHEXAL
- ATC code: C07AA07
- Active substance: Sotalol (Sotalol)
- Manufacturer: Salyutas Pharma GmbH, Germany
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Instructions for use Sotageksala (method and dosage)
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Synonyms
- Babies
- With alcohol
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
One tablet contains 80 mg or 160 mg sotalol hydrochloride as the active substance.
Additional ingredients:
- corn starch;
- magnesium stearate;
- giproloza;
- lactose monohydrate;
- colloidal silicon dioxide;
- carboxymethylstarch sodium.
Product form
The tablets are round, white, convex, one side embossed with the inscription «SOT» and a line on the other side. One package - 20, 50 or 100 tablets.
Pharmacological action
Antiarrhythmic effect.
Pharmacodynamics and pharmacokinetics
Sotageksal the active substance sotalol It is beta1-adrenergic blocker , and of beta 2-adrenoblocker It does not show their own sympathomimetic activity and membrane stabilizing. Like the other things drugs from the group beta-adrenoblokatorov, sotalol oppresses the secretion of Renin How at loading, so and in resting position.
Beta-adrenoceptor blocking effect manifests Sotageksala decrease heart rate and decrease CAS limited, causing decreased myocardial oxygen demand and the load on the heart muscle.
Antiarrhythmic effects associated with blocking β-adrenoceptor , And with extrapolation-building work of infarction . The main effect of the drug is to increase the duration of the effective refractory period in the ways of the pulse.
When oral bioavailability reaches more than 90%.
The plasma Cmax observed for 2, 5-4 hours.
Absorption of the active substance in food intake is reduced by approximately 20%.
When receiving a daily dose ranging from 40 mg to 640 mg cotalola content in the plasma is proportional to the dose received.
Css observed after 2-3 days.
It binds to plasma proteins and has poor penetrating the BBB. In cerebrospinal fluid concentration of the drug it makes only 10% from its content in the plasma.
Do not metabolized.
In unaltered from 80% to 90% of the received dose is excreted in the urine, the remainder in the faeces.
T1 / 2 from 10 to 20 hours.
Indications
Indications for use of the drug are Sotageksal chronic disease of heart rate, as well as violations wearing symptomatic:
- ventricular tachycardia;
- paroxysmal atrial fibrillation;
- supraventricular tachycardia , Including the syndrome WPW;
- ventricular premature beats.
Contraindications
- Individual sensitivity to the Sotageksala;
- AV-block (2nd and 3rd degree);
- heart failure;
- sinoatrial block;
- bronchial asthma;
- cardiogenic shock;
- tachycardia type "pirouette";
- sinus bradycardia (with heart rate less than 55 beats per minute);
- sick sinus syndrome;
- cardiomegaly (no symptoms of heart failure);
- bradycardia;
- Prinzmetal angina;
- chronic obstructive pulmonary disease;
- hypotension (systolic blood pressure less than 90 mm Hg, particularly in myocardial infarction);
- syndrome of extended interval QT;
- occlusive peripheral vascular disease (aggravated intermittent claudication, gangrene or pain at rest);
- sharp myocardial infarction;
- metabolic acidosis;
- heavy allergic rhinitis;
- diabetes Complicated ketoacidosis;
- Simultaneous therapy is conducted with the use of MAO inhibitors;
- period breast-feeding ;
- age 18 years.
Medicine Sotageksal administered with extreme caution in reference to allergic reactions history, and during desensitizing therapy, because of the ability of the drug to suppress the sensitivity to allergens.
Side effects
Side effects of the drug Sotageksal divided on the basis of its effect on the organs and systems of the human body.
Cardiovascular system:
- shortness of breath;
- bradycardia;
- chest pain;
- AV-block;
- heart palpitations;
- swelling;
- strengthening of symptomatology heart failure;
- fainting;
- lowering blood pressure;
- arrhythmogenic effect;
- sometimes - strengthening of of attacks of angina.
Digestive system:
- dry mouth;
- nausea;
- diarrhea;
- vomiting;
- flatulence or constipation;
- stomach ache.
Central nervous system:
- headache;
- fatigue;
- dizziness;
- state of depression;
- mood changes;
- feeling of alarm;
- tremor;
- sleep disorders;
- asthenia;
- paresthesias in the extremities;
- Depression.
Senses:
- inflammation of the conjunctiva and cornea of the eye;
- blurred vision;
- reduction of tearing;
- hearing loss;
- dysgeusia.
Side effects from the organs of vision should be considered when the patient's use of contact lenses.
Endocrine system:
- sometimes it was observed hypoglycemia (mainly in patients suffering diabetes or adhering to a strict diet).
Respiratory system:
- available bronchospasm (especially in case of violation ventilation).
Urogenital:
- rarely - reduced potency.
Skin:
- redness;
- itching;
- rash;
- psoriazoformny dermatosis;
- hives;
- alopecia.
Others:
- muscle weakness;
- fever;
- cold extremities;
- convulsions.
Laboratory findings:
- overestimated results at carrying out of photometric analysis of urine on metanephrine.
Instructions for use Sotageksala (method and dosage)
The drug is taken orally, swallowing the tablet whole and with water. Desirable taking the drug for 1-2 hours before a meal, as a meal reduces the absorption of the drug Sotageksal .
Application Instruction recommends selection of individual drug dose for each patient, depending on the reaction, and the severity of the disease.
Typically, the initial daily dose is 80 mg Sotageksala. If unsatisfactory therapeutic effect may gradually increase the initial dose to 240-320 mg per day, divided into 2-3 doses. The therapeutic effect is achieved in most patients when taking the daily dose of from 160 mg to 320 mg, divided into 2 doses.
Severe arrhythmias Threatening the life of the patient, the dose can be increased to the maximum - 480 mg, divided into 2 or 3 doses. The maximum dose can be administered only in extreme cases where the potential benefits of the drug outweighed by the risk of possible side effects (especially proaritmogennoe action).
Overdose
In case of accidental overdose, possibly lowering blood pressure, bronchospasm, bradycardia, hypoglycemia , Generalized seizures, ventricular tachycardia, unconsciousness .
In rare severe cases observed asystole and symptoms of cardiogenic shock.
Displaying gastric lavage , The appointment of adsorbents Holding hemodialysis, and symptomatic therapy, including the introduction of Atropine (Intravenously 1-2 times); Glucagon (as an infusion dose 0, 2 mg / kg body weight, followed by increasing doses up to 0, 5 mg / kg).
Cooperation
Concomitant use of drugs from the group Calcium channel blockers slow , eg Verapamil and Diltiazem It can lead to a lowering of blood pressure, because of the deterioration of contractility. You should avoid intravenous drugs of this group on the background of the therapy sotalol (exception make up cases of of urgent medical aid).
When combined reception Nifedipine and other derivatives of 1, 4-dihydropyridine observed lowering of blood pressure.
Appointment MAO inhibitors or H oradrenalina, as the abrupt withdrawal of treatment Clonidine may cause hypertension. Recommend to a gradual discontinuation of Clonidine a few days after the cancellation Sotageksala. Beta-blockers potentiate hypertension cancellation upon termination of therapy Clonidine In this regard, they should be lifted slowly.
Sharp low blood pressure may cause tricyclic antidepressants, phenothiazines, barbiturates, opioids and antihypertensive agents, vasodilators and diuretics.
Combined application Class IA antiarrhythmics (in peculiarities quinidine type: Procainamide, quinidine, disopyramide ) Or grade III ( Amiodarone ) Can lead to a marked prolongation of the interval QT. Drugs that prolong the interval QT, to use caution with drugs that prolong the interval. Among these drugs except Class I antiarrhythmic agents: tricyclic antidepressants, phenothiazines, astemizole, terfenadine and some quinolone antibiotics series.
Appointment inhalation anesthesia , including Tubocurarine during therapy drug of Sotageksal increases the risk of suppress myocardial function As well as the development of hypotension.
Simultaneous treatment and Sotageksalom Clonidine, reserpine, guanfacine, Alfa-methyldopa, and cardiac glycosides may cause bradycardia , And also slowdown of conducting pulse in the heart.
Application insulin or other oral hypoglycemic drugs especially during exercise, intensifies hypoglycemia and the severity of her symptoms ( tremors, rapid pulse, excessive sweating ). With diabetes dose should be adjusted hypoglycemic agents.
Kaliyvyvodyaschie diuretics ( Hydrochlorothiazide, Furosemide ) May give rise arrhythmias.
During the therapy with Sotageksal may require the use of large doses beta-adrenomimetikov ( Terbutaline, salbutamol, Isoprenaline ).
Terms of sale
Prescription.
Storage conditions
The temperature is not above 25 ° C.
Shelf life
5 years.
Cautions
Be particularly careful when taking Sotageksala patients diabetes history, with fluctuations of blood glucose and strict diets. Also, when psoriasis , Including family history, if renal impairment (correction mode), the elderly and pheochromocytoma (requires the simultaneous application of alpha-blockers ).
Therapy is conducted under the control the ECG, the HELL, the CARDIAC CONTRACTIONS RATE . In marked decrease in blood pressure or a decrease in heart rate should be adjusted daily dose Sotageksala.
Abolition of treatment with the drug should be slowly Sotageksal under the supervision of the attending physician.
Sotalol should not appoint hypomagnesemia or hypokalemia to stabilize the existing conditions that may increase the QT interval and increase the risk of arrhythmia type "pirouette".
It should monitor electrolyte balance and acid-base balance in patients with prolonged or severe diarrhea As well as in patients receiving therapy associated with reduction of concentration in the body of magnesium and / or potassium.
Sotalol at thyrotoxicosis It may mask some of its clinical manifestations (eg, tachycardia ). In this regard, abrupt withdrawal of therapy is contraindicated in patients with thyrotoxicosis Because of the possible increase in disease symptoms.
Analogs
Propranolol
Sotaleks
Anaprilin
If due to any reason the appointment can not be Sotageksal product, you can offer the following analogues:
- Whiskey;
- Inderal;
- Obzidan;
- Korgard 80 etc.
Synonyms
- Sotalol;
- Sotaleks.
Babies
Not appointed at the age of 18 years.
With alcohol
There should be no joint use of the drug Sotageksal and alcohol, as alcohol increases CNS depression.
During pregnancy and lactation
Appointment Sotageksala during pregnancy, especially during the first trimester, is possible only for health reasons.
In the case of treatment during pregnancy, receiving the drug should be discontinued for 48-72 hours before the alleged attack labor, because of the possible development of hypokalemia, hypotension, bradycardia and respiratory depression in the newborn.
If necessary, use Sotageksal during lactation should stop breastfeeding.
Reviews Sotageksale
With proper selection of doses, adherence and all the recommendations of the attending physician, the absence of absolute and relative contraindications reviews of Sotageksale mostly positive. Sometimes they describe different side effects which, if found should contact your doctor to correct the dose or replacement therapy.
Price Sotageksala where to buy
Price Sotageksala the domestic pharmaceutical market is approximately equal to:
- 80 mg tablet №20 - 90 rubles;
- 160 mg Tablets №20 - 140 rubles.
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