Thiodaron (amiodarone, thiazotic acid) tablets №30

Description

Thiodaron (amiodarone, thiazotic acid) tablets №30

Composition

active substances: 1 tablet contains amiodarone hydrochloride, in terms of 100% of the substance – 200 mg; morpholinium salt of thiazotic acid, in terms of 100% of the substance – 100 mg, which is equivalent to 66.5 mg of thiazotic acid.

Excipients: microcrystalline cellulose, croscarmellose sodium, potato starch, talc, polysorbate 80 (twin-80), calcium stearate.

Dosage form

Tablets.

Basic physical and chemical properties: tablets of white or white with a yellowish tinge, flat-cylindrical shape, with a bevel and a dash.

Pharmacotherapeutic group

Combined cardiac drugs.
ATX code C01E X.

Pharmacological properties

This is a combination medicine that is used for conditions accompanied by a violation of the heart rhythm.

Indications

Thiodaron tablets is prescribed:

• for the treatment of severe arrhythmias that do not respond to therapy with other drugs or when other pharmaceuticals cannot be prescribed;
• with tachyarrhythmias associated with WPW syndrome;
• with atrial fibrillation / flutter;
• with tachyarrhythmias of a paroxysmal nature, incl. ventricular fibrillation, atrioventricular, atrial, ventricular tachycardia, when other pharmaceuticals cannot be prescribed.

Contraindications

Thiodaron tablets is not used:

• with allergies to components, to iodine;
• with sinus bradycardia;
• with sick sinus syndrome;
• with sinoatrial blockade;
• with cardiogenic shock;
• with atrioventricular block II – III century. (without using a pacemaker);
• with hypokalemia;
• with arterial hypotension;
• with collapse;
• with hypothyroidism;
• with interstitial lung diseases;
• with thyrotoxicosis;
• with two-, three-beam blockades;
• with congenital / acquired lengthening of Q – T;
• with hypomagnesemia;
• with hypothyroidism / hyperthyroidism; when taking monoamine oxidase inhibitors;
• while taking medications that prolong Q – T;
• during pregnancy / lactation.

With caution Thiodaron is prescribed for bronchial asthma, AV-blockade of the 1st stage, chronic heart failure (III-IV FC), liver failure, as well as in old age.

Application during pregnancy and lactation

The use of Thiodaron is contraindicated during these periods.

Method of administration and dosage

Thiodaron tablets is administered orally with water before meals.
Standard loading dose:
in the hospital, an initial dose of 600-800 mg / day (for amiodarone) is used in several doses, maximum 1200 mg / day, until a total dose of 10,000 mg is reached (within 5-8 days);
on an outpatient basis, an initial dose of 600–800 mg / day is used until a total dose of 10,000 mg is reached (within 10–14 days).
The standard maintenance dose is 100–400 mg / day.

Overdose

Symptoms: paroxysmal tachycardia “pirouette”, decreased pressure, bradycardia, cardiac arrest, atrioventricular block, kidney / liver dysfunction.
Overdose treatment: the appointment of sorbents, gastric lavage, the appointment of cholestyramine, with tachycardia “pirouette” – the introduction of magnesium salts into the vein, with bradycardia – beta-adrenostimulants; cardiostimulation.

Side effects:

• Digestive disorders: pseudo-alcoholic hepatitis, dullness / loss of taste, heaviness in the stomach, nausea, loss of appetite, toxic hepatitis, cirrhosis, development of liver failure.
• Neurological disorders: pseudotumor of the brain, sleep disturbances, peripheral neuropathy, extrapyramidal symptoms, headache, myopathy, cerebellar ataxia.
• Cardiovascular disorders: moderate bradycardia, proarrhythmogenic effect (aggravation of existing arrhythmias, occurrence of new ones, cardiac arrest), SA / AV blockade, severe bradycardia.
• Respiratory disorders: interstitial / alveolar pneumonitis, pleurisy, pulmonary fibrosis, bronchospasm, bronchiolitis obliterans with pneumonia, pulmonary hemorrhage.
• Perceptual disorders: microdeposits in the epithelium of the cornea, optic neuritis, visual neuropathy.
• Skin changes: photosensitivity, alopecia, exfoliative dermatitis, rash, bluish / grayish skin pigmentation.
• Metabolic disorders: hyperthyroidism / hypothyroidism, impaired ADH secretion.
• Others: epididymitis, impotence, vasculitis, thrombocytopenia, hemolytic anemia, aplastic.