Mesalazine Enteric-coated Tablets

Pharmacological action The anti-inflammatory mechanism of mesalazine is not fully understood. In vitro studies have shown that mesalazine has a certain effect on the content of prostaglandins in the intestinal mucosa, has the function of scavenging reactive oxygen free radicals, and may have a certain inhibitory effect on lipoxygenase. This product is an enteric-coated tablet of mesalazine, which releases mesalazine in the intestine after oral administration. After reaching the intestine, mesalazine mainly acts locally on the intestinal mucosa and submucosal tissues. The bioavailability or plasma concentration of mesalazine has nothing to do with the therapeutic effect. Toxicological studies. In toxicological studies, it was found that repeated oral administration of mesalazine in large doses is nephrotoxic (renal papillary necrosis, proximal tubular epithelial damage or entire nephron damage). The clinical relevance of these findings is still unclear. Animal studies have not found that mesalazine has mutagenic, teratogenic, or carcinogenic effects.

Mesalazine.

This product is an enteric-coated tablet, which is off-white to slightly reddish in color after removing the coating.

1. For the treatment of ulcerative colitis: including treatment of acute attacks and maintenance treatment to prevent recurrence; 2. For the treatment of acute attacks of Crohn's disease.

Adults: According to the needs of individual clinical patients, the following daily doses are recommended: Crohn's disease: 2 to 6 tablets once, 3 times a day during acute attacks; total daily amount: 1.5g to 4.5g. Ulcerative colitis: 2 to 4 tablets once, 3 times a day during acute attacks; total daily amount: 1.5g to 3.0g. Maintenance period: 2 tablets once, 3 times a day; total daily amount: 1.5g. Conventional dosing method: Take 1 hour before breakfast, lunch, and dinner. The whole tablet must be swallowed with a large amount of liquid (do not chew it). In order to obtain the ideal therapeutic effect during acute attacks and maintenance treatment, it is recommended to take this product continuously and regularly. The course of treatment is determined by the doctor. Foreign countries recommend that the drug be taken for 8 to 12 weeks during the acute attack period of ulcerative colitis or Crohn's disease.

May cause mild stomach discomfort. Occasionally nausea, headache, dizziness, etc.

1. Those who are allergic to mesalazine, salicylic acid and its derivatives or any of the excipients in this product; 2. Those with renal dysfunction and severe liver dysfunction; 3. Patients with gastric or duodenal ulcers; 4. Those with a bleeding tendency (prone to bleeding).

Precautions for children: Due to the lack of experience in the use of children in the relevant age groups, it is temporarily recommended that children do not use this product. Precautions for pregnancy and lactation: Use in pregnant and lactating women: Pregnancy: Mesalazine can cross the placental barrier. Currently, there are limited clinical data on the use of this product by pregnant women, and no relevant epidemiological data. Pregnant women can only use this product when the expected clinical benefits outweigh the potential risks to the fetus. Animal studies of oral administration have shown that mesalazine has no direct or indirect adverse effects on pregnancy, embryo or fetal development. Lactation: Small amounts of mesalazine and N-acetyl-5-aminosalicylic acid can be secreted through breast milk. There is limited experience in the use of mesalazine by lactating women. It cannot be ruled out that it may cause allergic reactions such as diarrhea in infants. Lactating women should only use this product when the expected clinical benefits outweigh the potential risks to the infant. Precautions for the elderly: Elderly patients should reduce the dosage of mesalazine.

At present, no special drug interaction studies have been conducted on this product. It is speculated that interactions may occur when this product is used simultaneously with the following drugs: 1. Coumarin anticoagulants: may increase the inhibitory effect of coagulation (increase the risk of gastrointestinal bleeding). 2. Glucocorticoids: may increase gastric adverse reactions. 3. Sulfonylurea drugs: may increase the hypoglycemic effect. 4. Methotrexate: may increase the potential toxicity of methotrexate. 5. Probenecid or sulfinpyrazone: may reduce uric acid excretion. 6. Spironolactone or furosemide: may reduce diuretic effect. 7. Rifampicin: may reduce anti-tuberculosis effect. 8. Azathioprine or 6-mercaptopurine: may increase bone marrow suppression.

Keep away from light and store in a sealed container.

0.25 g

24 months

Heilongjiang Tianhong Pharmaceutical Co., Ltd.

• Founded in:

  2000-06-30

• Address:

  Beijing Road, Limin Economic and Technological Development Zone, Hulan District, Harbin City, Heilongjiang Province, and Siping Road, Limin Economic and Technological Development Zone

• Tax NO.:

  912301007236561505

• Registered Funds:

  100 million yuan

• Email:

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