Amiodarone Hydrochloride Tablets

This product belongs to Class III antiarrhythmic drugs. The main electrophysiological effect is to prolong the action potential and effective refractory period of various myocardial tissues, which is conducive to eliminating reentrant excitation. At the same time, it has mild non-competitive α and β adrenergic receptor blocking and mild Class I and IV antiarrhythmic properties. Reduce the automaticity of the sinus node. It has no effect on the resting membrane potential and action potential height. The inhibition of forward conduction of the atrioventricular bypass pathway is greater than the reverse. Due to excessive prolongation of repolarization, the electrocardiogram has QT interval prolongation and T wave changes after oral administration, which can slow down the heart rate by 15~20% and prolong the PR and Q-T intervals by about 10%. It has a direct dilation effect on the coronary arteries and peripheral blood vessels. It can affect thyroid hormone metabolism. The characteristics of this product are long half-life, so the number of medications is small, the therapeutic index is large, and the antiarrhythmic spectrum is wide.

Amiodarone hydrochloride.

This product is off-white tablets.

It is clinically applicable to ventricular and supraventricular tachycardia and premature beats, paroxysmal atrial flutter and fibrillation, preexcitation syndrome, etc. It can also be used for patients with arrhythmias accompanied by congestive heart failure and acute myocardial infarction. It can also be effective for refractory paroxysmal tachycardia that is ineffective with other β-receptor blockers. In addition, it is also used to treat chronic coronary artery insufficiency and angina pectoris.

Common oral dosage for adults: For the treatment of supraventricular arrhythmias, take 0.4-0.6g per day, divided into 2-3 times. After 1-2 weeks, change to 0.2-0.4g per day as needed. Some patients can reduce the dose to 0.2g, 5 days a week or a smaller dose for maintenance. For the treatment of severe ventricular arrhythmias, take 0.6-1.2g per day, divided into 3 times. After 1-2 weeks, gradually change to 0.2-0.4g per day as needed.

1) Cardiovascular: Compared with other antiarrhythmic drugs, it has fewer adverse cardiovascular reactions. ① Sinus bradycardia, sinus arrest or sinoatrial block, atropine cannot counteract this reaction; ② Atrioventricular block; ③ Occasionally, Q-T interval prolongation with torsades de pointes; mainly seen in hypokalemia and when used in combination with other QT-prolonging drugs. The above adverse reactions are mainly seen in long-term high-dose and accompanied by hypokalemia. In all the above situations, the drug should be discontinued and can be treated with pressor drugs, isoproterenol, sodium bicarbonate (or sodium lactate) or pacemaker; pay attention to correcting electrolyte disorders; direct current cardioversion can be used when torsades de pointes develops into ventricular fibrillation. Due to the long half-life of this product, the treatment of adverse reactions needs to last for 5 to 10 days. (2) Thyroid: ① Hyperthyroidism, which can occur during or after medication. In addition to exophthalmos, typical signs of hyperthyroidism may appear, and new arrhythmias may also occur. Laboratory tests show that both T3 and T4 are increased and TSH is decreased. The incidence rate is about 2%. It can completely disappear after stopping the drug for a few weeks to a few months. A few people need to be treated with antithyroid drugs, propranolol or adrenocortical hormones; ② Hypothyroidism, the incidence rate is 1% to 4%, which is more common in the elderly. Typical signs of hypothyroidism may appear, and the TSH test is elevated. It can disappear after stopping the drug for a few months, but myxedema may remain. If necessary, it can be treated with thyroxine. (3) Gastrointestinal tract: constipation, a few people have nausea, vomiting, and decreased appetite, which is obvious when the load is high. (4) Eyes: Those who have taken the drug for more than 3 months have yellow-brown pigmentation in the lower 1/3 of the cornea in the basal layer, which is related to the course of treatment and dosage. It occurs less frequently in children. This deposit may occasionally affect vision, but there is no permanent damage. A few people may have halos, and rarely stop taking the drug due to eye side effects. (5) Nervous system: rare, related to the dose and course of treatment, tremor, ataxia, proximal muscle weakness, extrapyramidal signs may occur, patients who take the drug for more than 1 year may have peripheral neuropathy, which gradually disappears after reducing or stopping the drug. (6) Skin: photosensitivity is related to the course of treatment and dose, slate blue pigmentation of the skin, which gradually disappears after a long time (1 to 2 years) after stopping the drug. Other allergic rashes disappear quickly after stopping the drug. (7) Liver: hepatitis or fatty infiltration, increased aminotransferase, related to the course of treatment and dose. (8) Lungs: adverse reactions to the lungs often occur in patients who take the drug for a long time and in large quantities (0.8 to 1.2 g per day). Mainly produce allergic pneumonia, interstitial lung or alveolar fibrosis pneumonia, alveolar and interstitial foamy macrophages and type 2 pneumocyte proliferation, fibrosis, and occlusion of small bronchial lumens. Clinical manifestations include shortness of breath, dry cough and chest pain, restrictive lung function changes, increased erythrocyte sedimentation rate and increased white blood cell count, which can be fatal in severe cases. The drug should be discontinued and treated with adrenocortical hormones. (9) Others: Hypocalcemia and increased serum creatinine may occur occasionally.

(1) Patients with severe sinus node dysfunction should not use this product. (2) Patients with Ⅱ or Ⅲ degree atrioventricular block should not use this product. (3) Patients with syncope caused by bradycardia should not use this product. (4) Patients with pulmonary interstitial fibrosis caused by various reasons should not use this product. (5) Patients who are allergic to this product should not use this product.

Precautions for children: The safety and effectiveness of amiodarone in children are still unclear. Precautions for pregnancy and lactation: This product can enter the fetus through the placenta. Rat experiments have confirmed that amiodarone has toxic effects on the fetus. Clinically, there are reports that pregnant women taking amiodarone can cause congenital goiter, hyperthyroidism and hypothyroidism in the fetus. The original drug and metabolites in the blood of newborns are 25% of the maternal blood concentration. It is known that iodine can also pass through the placenta, so pregnant women should weigh the pros and cons when using it. This product and its metabolites can be secreted in breast milk, so those who take this product should not breastfeed. Precautions for the elderly: Elderly people who take amiodarone orally need to closely monitor electrocardiograms and lung function.

(1) Increase the anticoagulant effect of warfarin, which can last from 4 to 6 days after the addition of this product to several weeks or months after discontinuation of the drug. When used in combination, the prothrombin time should be closely monitored and the dose of the anticoagulant should be adjusted. (2) Enhance the effects of other antiarrhythmic drugs on the heart. This product can increase the concentrations of quinidine, procainamide, flecainide and phenytoin in plasma. Combination with Class Ia drugs can aggravate the prolongation of the Q-T interval and, in rare cases, can cause torsade de pointes, so special caution should be used. From the start of the addition of this product, the original antiarrhythmic drug should be reduced in dose by 30% to 50% and gradually discontinued. If it must be used in combination, the recommended dose is usually reduced by half. (3) Combination with beta-receptor blockers or calcium channel blockers can aggravate sinus bradycardia, sinus arrest and atrioventricular block. If this occurs, the dose of this product or the first two classes of drugs should be reduced. (4) Increases serum digoxin concentration and may also increase the concentration of other digitalis preparations to toxic levels. When starting to use this product, digitalis drugs should be discontinued or reduced by 50%. If used in combination, the serum concentration of these drugs should be carefully monitored. This product has the effect of enhancing the inhibitory effect of digitalis drugs on the sinoatrial node and atrioventricular node. (5) When used in combination with potassium-excreting diuretics, it can increase arrhythmias caused by hypokalemia. (6) Increases the effect of sunlight-sensitive drugs. (7) Can inhibit the thyroid uptake of [123I], [133I] and [99mTc].

Keep away from light and store in sealed container.

0.2g

24 months

Sanofi (Hangzhou) Pharmaceuticals Co., Ltd.

• Founded in:

  1995-11-30

• Address:

  No. 325, Jiangling Road, Binjiang District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100609136127P

• Registered Funds:

  $28.8 million

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