Mesalazine Enteric-coated Tablets

Pharmacological action Mesalazine is the main active ingredient of sulfasalazine, which is used to treat ulcerative colitis. Under the action of bacteria in the colon, sulfasalazine is converted into sulfapyridine and mesalazine in equal molecular numbers. The mechanism of action of mesalazine (and sulfasalazine) is still unclear, and it may mainly produce its efficacy through local rather than systemic action. In patients with chronic inflammatory bowel disease, the production of arachidonic acid (AA) metabolites in the local mucosa can be increased through the cyclooxygenase pathway (producing prostaglandins) and the lipoxygenase pathway (producing leukotrienes (LTs) and hydroxyeicosatetraenoic acid (HETEs)), and mesalazine may reduce its local inflammation by inhibiting the production of cyclooxygenase and prostaglandins (PG) in the colon. Toxicological studies Genetic toxicity: The results of the Ames test, sister chromosome exchange induction (SCE) test, Chinese hamster ovary cell in vitro chromosome aberration test, and mouse bone marrow multi-stained cell micronucleus test were all negative. Reproductive toxicity: Rats were given oral doses of up to 480 mg/kg/day, and no effects on male and female fertility and reproductive function were observed. Rats and rabbits were given doses of 480 mg/kg/day, and no teratogenicity and fetal toxicity caused by mesalazine were shown. However, there is no sufficient and strictly controlled clinical research data on pregnant women. Since animal reproduction studies usually do not always predict the effects of drugs on humans, this product can only be used in pregnant women when it is clearly needed. Low and higher concentrations of N-acetyl metabolites of mesalazine have been detected in human milk, and their clinical significance is unclear. Mesalazine should be administered to lactating women with caution. Carcinogenicity: Rats and mice were given mesalazine at doses of 480 mg/kg/day and 2000 mg/kg/day through food, which are 2.4 times and 5.1 times the maximum recommended maintenance dose for humans (mesalazine 1.6 g/day, calculated based on body surface area), respectively, and no carcinogenic effect was shown.

The main ingredient of this product is mesalazine. Its chemical name is 2-hydroxy-5-aminobenzoic acid. Its chemical structure is: Molecular formula: C7H7NO3 Molecular weight: 153.14

This product is a brown-red enteric-coated tablet. After removing the coating, the core of the tablet is light brown.

Suitable for the treatment of colon ulcers and colitis.

Oral administration: The general dosage for adults is 1-2 tablets/time, 3 times a day. For mild or moderate emergencies, the dosage can be increased to 12 tablets/day, or as directed by a doctor.

1. Similar to a small number of patients who cannot tolerate sulfasalazine, the main side effects are nausea, diarrhea, abdominal pain, gastric burning sensation, poor appetite, abdominal distension, back pain, constipation, irregular menstruation and headaches reported in some cases. 2. Those who have had colitis aggravated by taking sulfasalazine in the past should also consider this before using this product. 3. There have been rare reports of leukopenia, thrombocytopenia, neutropenia, pancreatitis, hepatitis, pericarditis, myocarditis, alveolitis, acute interstitial nephritis, nephrotic syndrome and renal failure, which disappeared after stopping the drug. 4. If signs of renal failure occur during treatment, the possibility of drug-induced renal poisoning should be considered. 5. No bone marrow suppression, decreased sperm count and suppressed motility were found when taking sulfasalazine.

Patients with a history of allergic reactions to salicylates are contraindicated; patients with severe renal impairment (glomerular filtration rate

Precautions for children: There is no research data for children, so it is not recommended for children. It is forbidden for children under two years old. Precautions for pregnancy and lactation: Pregnant women should use it with caution. The doctor should ensure that the effect of treatment is greater than the harm to the body. Lactating women should use it with caution. Precautions for the elderly: Use with caution, and the user's renal function must be normal.

Not yet clear

Keep in a dark place and sealed at a temperature below 25℃.

0.4 g

24 months

Hengcheng Pharmaceutical Group Huainan Co., Ltd.

• Founded in:

  1998-10-14

• Address:

  No. 1, Zhenxing Road, Economic and Technological Development Zone, Huainan City, Anhui Province

• Tax NO.:

  913404007110463982

• Registered Funds:

  66 million yuan

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