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active substance: amiodarone; 1 tablet contains amiodarone hydrochloride 200 mg;
excipients: corn starch; lactose monohydrate; povidone (K 90); magnesium stearate; colloidal anhydrous silica; pregelatinized starch.
Recurrence prevention: ventricular tachycardia, which is life-threatening (treatment should be started in a hospital with constant monitoring of the patient); symptomatic ventricular tachycardia (documented), which leads to disability; supraventricular tachycardia (documented), which requires treatment, and in cases where other drugs do not show a therapeutic effect or are contraindicated; ventricular fibrillation.
– Hypersensitivity to the drug and iodine;
– Sinus bradycardia, sinoatrial block, except when connected to an artificial pacemaker (risk of sinus node stops);
– Atrioventricular block II-III degree block and bundle branch block (without pacemaker);
– Congenital or acquired QT interval prolongation;
– Severe heart failure;
– Severe hypotension, collapse, shock;
– Concomitant use of drugs capable to prolong the QT interval and cause the development of paroxysmal tachycardias, including polymorphic ventricular tachycardia type “pirouette” (torsade de pointes);
– Interstitial lung disease;
– Simultaneous reception of MAO inhibitors;
– Thyroid dysfunction (hypo- and hyperthyroidism);
– Hypokalaemia, hypomagnesaemia;
– During pregnancy and lactation.
Dosage & Administration
The drug should be taken only on prescription!
Rotarytmil taken orally before meals and drink plenty of water.
Treatment usually begins with 200 mg (1 tablet) 3 times daily for a week, reducing the dose to 200 mg 2 times a day for the next week.
It is necessary to apply the minimum effective dose according to the patient’s response to the drug. After a period of saturation dose can be reduced to 200 mg or 100 mg per day. Occasionally, patients may require higher maintenance doses. Maintenance dose should be regularly reviewed, especially if it exceeds 200 mg per day.
Too high a dose during maintenance therapy can cause side effects that are believed to be associated with high levels of amiodarone and its metabolites in body tissues.
As Rotaritmil has a very long half-life, it can take a day (200 mg can be taken in a day, and 100 mg taken daily is recommended). You can take a break in taking the drug for 2 days a week. Daily ingestion is determined individually.
As with all patients it is important to use the minimum effective dose. Elderly patients may exhibit increased sensitivity to the action of the appointment Rotarytmilu even normal doses. Particular attention should be paid to monitoring thyroid function.
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