Sulfasalazine Enteric-coated Tablets

This product is a sulfonamide antibacterial drug. It is an oral sulfonamide that is not easily absorbed. The absorbed part is decomposed into 5-aminosalicylic acid and sulfapyridine under the action of intestinal microorganisms. After 5-aminosalicylic acid is complexed with the intestinal wall connective tissue, it stays in the intestinal wall tissue for a long time to play an antibacterial, anti-inflammatory and immunosuppressive role, such as reducing Escherichia coli and Clostridium, while inhibiting the synthesis of prostaglandins and other inflammatory mediators leukotrienes. Therefore, it is currently believed that the main component of this product that produces therapeutic effects on inflammatory bowel disease is 5-aminosalicylic acid. Sulfapyridine produced by the decomposition of this product shows a weak antibacterial effect on intestinal flora.

The main ingredient of this product is sulfasalazine; its chemical name is 5-[p-(2-pyridylaminesulfonyl)phenyl]azosalicylic acid.

This product is an enteric sugar-coated tablet, which is brown after removing the coating.

It is mainly used for inflammatory bowel diseases, namely Crohn's disease and ulcerative colitis.

Common oral dosage for adults: The initial dose is 2-3g per day, divided into 3-4 times orally. If there is no obvious discomfort, it can be gradually increased to 4-6g per day. After the symptoms of intestinal disease are relieved, the dose can be gradually reduced to the maintenance dose of 1.5-2g per day. The initial dose for children is 40-60mg/kg per day, divided into 3-6 times orally. After the condition is relieved, it is changed to a maintenance dose of 30mg/kg per day, divided into 3-4 times orally.

The concentration of serum sulfapyridine and its metabolites (20-40 μg/ml) is related to toxicity. It is toxic when the concentration exceeds 50 μg/ml, so the dose should be reduced to avoid toxic reactions. 1 Allergic reactions are more common and may manifest as drug rash. In severe cases, exudative erythema multiforme, exfoliative dermatitis, and epidermolysis bullosa atrophic dermatitis may occur; there are also serum sickness-like reactions such as photosensitivity reactions, drug fever, joint and muscle pain, and fever. 2 Neutropenia or deficiency, thrombocytopenia, and aplastic anemia. Patients may show sore throat, fever, pallor, and bleeding tendency. 3 Hemolytic anemia and hemoglobinuria. Patients with glucose-6-phosphate dehydrogenase deficiency should use

It is contraindicated for people who are allergic to sulfonamides, pregnant women, lactating women, and children under 2 years old.

Precautions for children: Children under 2 years old are prohibited to use. Precautions for pregnancy and lactation: Pregnant and lactating women are prohibited to use. Precautions for the elderly: Elderly patients have an increased chance of serious adverse reactions when using sulfonamides. Severe rash, bone marrow suppression and thrombocytopenia are common serious adverse reactions in the elderly. Therefore, elderly patients should avoid using it. If there is an indication, the decision should be made after weighing the pros and cons.

1. Combination with urine alkalinizing drugs can enhance the solubility of sulfonamides in alkaline urine and increase excretion. 2. Para-aminobenzoic acid can replace sulfonamides and be taken up by bacteria, antagonizing the antibacterial effect of sulfonamides. Therefore, the two should not be used together. 3. When the following drugs are used in combination with sulfonamides, the latter can replace the protein binding sites of these drugs, or inhibit their metabolism, resulting in prolonged drug action or toxicity. Therefore, when these drugs are used in combination with sulfonamides, or when used after the application of sulfonamides, their dosages need to be adjusted. Such drugs include oral anticoagulants, oral hypoglycemic drugs, methotrexate, phenytoin sodium, and thiopental sodium. 4. Myelosuppressive drugs, when used in combination with sulfonamides, may enhance the effects of such drugs on the hematopoietic system.

Keep away from light and store in sealed container.

0.25g

Tentative 24 months

ShanxiTongda Pharmaceutical Co., Ltd.

• Founded in:

  1997-05-30

• Address:

  The First Pharmaceutical Industrial Park, Datong Economic Development Zone

• Tax NO.:

  911402006020035321

• Registered Funds:

  50 million yuan

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