Aminophylline sustained-release tablets

This product is a complex salt of theophylline and ethylenediamine. Its pharmacological effect mainly comes from theophylline, and ethylenediamine increases its water solubility. This product has a direct relaxant effect on respiratory smooth muscle. Its mechanism of action is relatively complex. In the past, it was believed that it was caused by inhibiting phosphodiesterase and increasing the intracellular cAMP content. Recent experiments have shown that the bronchodilator effect of theophylline is partly due to the release of endogenous adrenaline and norepinephrine. In addition, theophylline is a purine receptor blocker that can counteract the contractile effect of adenine and other substances on the respiratory tract. Theophylline can enhance the contraction of the diaphragm, especially when the diaphragm contraction is weak, so it is beneficial to improve respiratory function.

The content of anhydrous theophylline (C7H8N4O2) in this product should be 74.0% to 84.0% of the labeled amount of aminophylline, and the content of ethylenediamine (C2H8N2) should not be less than 11.25% of the labeled amount of aminophylline.

This product is a white or slightly yellow film-coated tablet.

It is suitable for relieving wheezing symptoms of bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, etc.; it can also be used for asthma caused by cardiogenic pulmonary edema.

1 The usual oral dose for adults is 0.1g (1 tablet) to 0.2g (2 tablets) at a time, 0.3g (3 tablets) to 0.6g (6 tablets) a day; the maximum dose is 0.5g at a time, 1g a day. 2 The usual oral dose for children is 3-5mg/kg per time according to body weight, 3 times a day.

The toxicity of theophylline often occurs when the serum concentration is 15-20mu;g/ml, especially at the beginning of treatment. Common symptoms in the early stage include nausea, vomiting, irritability, insomnia, etc. When the serum concentration exceeds 20mu;g/ml, tachycardia and arrhythmia may occur. When the theophylline content in the serum exceeds 40mu;g/ml, symptoms such as fever, dehydration, and convulsions may occur. In severe cases, respiratory and cardiac arrest may occur, leading to death.

Patients who are allergic to this product, active peptic ulcers and uncontrolled convulsive diseases are contraindicated

Precautions for children: The plasma clearance rate of newborns may be reduced and the serum concentration may increase, so it should be used with caution. Precautions for pregnancy and lactation: This product can pass through the placental barrier and can also be secreted into breast milk and excreted with breast milk. It should be used with caution by pregnant women, parturients and lactating women. Precautions for the elderly: The plasma clearance rate of the elderly is reduced and the potential toxicity is increased. It should be used with caution in patients over 55 years old.

1. Diltiazem and verapamil can interfere with the metabolism of theophylline in the liver. When used in combination with this product, the blood concentration and toxicity of this product will be increased. 2. Cimetidine can reduce the liver clearance rate of this product. When used in combination, it can increase the serum concentration and (or) toxicity of theophylline. 3. Certain antibacterial drugs, such as erythromycin, roxithromycin, clarithromycin of macrolides, enoxacin, ciprofloxacin, ofloxacin, levofloxacin, clindamycin, lincomycin of fluoroquinolones, etc., can reduce the clearance rate of theophylline and increase its blood concentration, especially erythromycin and enoxacin. When theophylline is used in combination with the above drugs, the dosage should be appropriately reduced. 4. Phenobarbital, phenytoin, and rifampicin can induce liver enzymes and accelerate the liver clearance rate of theophylline; theophylline also interferes with the absorption of phenytoin. The plasma concentrations of both are reduced. The dosage should be adjusted when used in combination. 5. When used in combination with lithium salts, the renal excretion of lithium can be increased. Affect the effect of lithium salts. 6. When used in combination with mexiletine, the clearance of theophylline can be reduced, the concentration of theophylline in plasma can be increased, and the dosage needs to be adjusted. 7. When used in combination with caffeine or other xanthine drugs, their effects and toxicity can be increased.

Keep away from light and store in sealed container.

0.1g

24 months

Changchun Norman Bethune Pharmaceutical Co., Ltd.

• Founded in:

  1985-12-06

• Address:

  No. 358, Chuangxin Road, High-tech Industrial Development Zone, Changchun City, Jilin Province

• Tax NO.:

  91220101123997525C

• Registered Funds:

  64.4778 million yuan

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