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 alpha and beta adrenergic receptor blocking and mild Class I and IV antiarrhythmic properties. Reduce the autonomy 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 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.

Main ingredients: This product contains amiodarone hydrochloride.

This product is off-white tablets.

Oral administration is suitable for the prevention of life-threatening paroxysmal ventricular tachycardia and ventricular fibrillation. It can also be used for paroxysmal supraventricular tachycardia, paroxysmal atrial flutter, and atrial fibrillation that are ineffective with other drugs, including those with preexcitation syndrome and maintenance treatment after electrical cardioversion of persistent atrial fibrillation and atrial flutter. It can be used to control the ventricular rate during persistent atrial fibrillation and atrial flutter. It is generally not suitable for the treatment of atrial and ventricular premature beats unless there are clear indications.

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: It has fewer adverse cardiovascular reactions than other antiarrhythmic drugs. ① Sinus bradycardia, sinus arrest or sinoatrial block, atropine cannot counteract this reaction; ② Atrioventricular conduction block; ③ Occasionally Q-T interval prolongation with torsades de pointes; mainly seen in hypokalemia and combined use of other QT-prolonging drugs; ④ The above adverse reactions are mainly seen in long-term high doses and accompanied by hypokalemia. The above conditions should be discontinued and can be treated with pressors, isoproterenol, sodium bicarbonate (or sodium lactate) or pacemakers; 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 continue for 5 to 10 days. 2 Thyroid: ① Hyperthyroidism, which can occur during use

1. Patients with severe sinus node dysfunction are prohibited from using this product. 2. Patients with II or III degree atrioventricular block are prohibited from using this product. 3. Patients with syncope caused by bradycardia are prohibited from using this product. 4. Patients who are allergic to this product are prohibited from using this product.

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: Not yet clear. Precautions for the elderly: Not yet clear.

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 torsades de pointes, so special care should be taken. From the start of the addition of this product, the original antiarrhythmic drug should be reduced by 30% to 50% in dose 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 types 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 Chinese medicine 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 in a light-proof and airtight container.

0.2g

24 months

Hainan Pharmaceutical Factory Co., Ltd. Pharmaceutical Factory No.1

• Founded in:

  2002-06-11

• Address:

  East of the northern section of Jinggang Street, High-tech Zone

• Tax NO.:

  91410500740720089R

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