Propafenone Hydrochloride Tablets

1This product belongs to the Ic class (i.e., directly acting on the cell membrane) antiarrhythmic drug. The experimental results of isolated animal myocardium indicate that 0.5-1ug/min can reduce the depolarization effect during contraction, thereby prolonging conduction, slightly prolonging the duration of action potential and the effective refractory period, and can increase the threshold potential of myocardial cells, significantly reducing the spontaneous excitability of the myocardium. It acts on both the atrium and ventricle (mainly affecting the Purkinje fibers, with a smaller effect on the myocardium), and also on the formation and conduction of excitement. Clinical data show that the therapeutic dose (300mg orally and 30mg intravenously) can reduce the irritability of the myocardium, the effect is long-lasting, PQ and QRS are increased, and the effective refractory period of the atrium and atrioventricular node is prolonged. It has an antagonistic effect on various types of experimental arrhythmias. The antiarrhythmic effect is related to its membrane stabilization and competitive blocking effect. It also has a weak calcium antagonist effect (100 times weaker than verapamil), a mild myocardial inhibitory effect, increases end-diastolic pressure, and reduces stroke volume, and its effects are proportional to the dose of the drug. It also has a mild antihypertensive and heart rate-reducing effect. 2 In vitro experiments have shown that propafenone can relax coronary artery and bronchial smooth muscle. 3 It has a local anesthetic effect similar to procaine. 4 Rats took 180-360 mg/kg/day (12-24 times the maximum recommended dose for adults) orally for six months and developed renal function abnormalities, with inflammatory and non-inflammatory reactions in the renal tubules and interstitium. Hepatic fatty degeneration can be found when rats are given 19 times the maximum recommended dose for adults for a long time.

The main component of this product and its chemical name is: 3-phenyl-1-[2-[3-(propylamino)-2-hydroxypropoxy]-phenyl]-1-propanone hydrochloride. Its structural formula is: Molecular formula: C21H27NO3HCl

This product is white or off-white tablets.

Used for paroxysmal ventricular tachycardia and supraventricular tachycardia (including those with preexcitation syndrome).

Oral: 100-200 mg per time, 3-4 times a day. Therapeutic dose: 300-900 mg per day, divided into 4-6 doses. Maintenance dose: 300-600 mg per day, divided into 2-4 doses. Due to its local anesthetic effect, it is advisable to swallow it with drinks or food after meals and do not chew it.

1. There are few adverse reactions, the main ones are dry mouth and numbness of tongue and lips, which may be due to its local anesthetic effect. In addition, early adverse reactions include headache, dizziness, and glare, followed by gastrointestinal disorders such as nausea, vomiting, and constipation. There are also symptoms of atrioventricular block. There are two reports of cholestatic liver damage after two weeks of continuous use, and the activity of each enzyme returned to normal 2 to 4 weeks after discontinuation of the drug. It is believed that this pathological change is an allergic reaction and individual factors. 2. No damage to the lungs, liver, and hematopoietic system was found during the trial. A few patients had mild reactions such as dry mouth, headache, dizziness, and gastrointestinal discomfort, which generally disappeared after discontinuation of the drug or reduction of the dosage. It has been reported that individual patients had atrioventricular conduction block, prolonged Q-T interval, mild prolongation of P-R interval, prolonged QRS time, etc.

It is contraindicated in patients with sinus node dysfunction without pacemaker protection, severe atrioventricular block, bilateral bundle branch block, severe congestive heart failure, cardiogenic shock, severe hypotension, and those who are allergic to the drug.

Precautions for children: The safety and effectiveness of this drug in children are not yet known. Precautions for pregnancy and lactation: Pregnant women should use it with caution. It is recommended that lactating women stop using it. Precautions for the elderly: There is no increase in age-related side effects when using this drug in elderly patients. However, elderly patients may experience a drop in blood pressure after taking the drug. In addition, elderly patients are prone to liver and kidney damage, so it should be used with caution. The effective drug dose for elderly patients is lower than normal.

Combination with quinidine can slow down the metabolic process. Combination with local anesthetics increases the occurrence of central nervous system side effects. It can increase serum digoxin concentration in a dose-dependent manner. Combination with propranolol and metoprolol can significantly increase their plasma concentration and elimination half-life, but has no effect on this product. Combination with warfarin can increase warfarin blood concentration and prothrombin time. Combination with cimetidine can increase the blood steady-state level of this product, but has no effect on its electrophysiological parameters.

Keep away from light and store in a sealed container.

50mg

36 months

Beijing Shuguang Pharm Co., Ltd.

• Founded in:

  1979-11-10

• Address:

  Building 1, No. 7, Lane 1, Xiyuanzi, Dongcheng District, Beijing

• Tax NO.:

  91110101101524129G

• Registered Funds:

  12.69 million yuan

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