Sulfasalazine Enteric-coated Tablets

This product is a sulfonamide antibiotic. 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

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

Mainly used for inflammatory bowel disease, namely Crohn's disease and ulcerative colitis

Oral. Common 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 is 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 mu; g/ml) is related to toxicity. It is toxic when the concentration exceeds 50 mu; g/ml, so the dose should be reduced to avoid toxic reactions. 1 Allergic reactions are more common and may manifest as drug eruptions. In severe cases, exudative erythema multiforme, exfoliative dermatitis, and bullous epidermolysis 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 are prone to occur after use, and are more common in newborns and children than in adults.

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

Precautions for children: Since sulfonamides can compete with bilirubin for binding sites on plasma proteins, and the acetyltransferase system of newborns is not fully developed, the free blood concentration of sulfonamides increases, which increases the risk of nuclear jaundice. Therefore, this type of drug should be banned in newborns and children under 2 years old. Precautions for pregnancy and lactation: 1. Sulfonamides can pass through the blood-viscera barrier to the fetus, and animal experiments have found that they have teratogenic effects. There is a lack of sufficient data in human studies, so pregnant women should not use them. 2. Sulfonamides can be secreted in breast milk, and the concentration in breast milk can reach about 50%-100% of the maternal blood concentration. The drug may affect infants; the use of sulfonamides in newborns with glucose-6-phosphate dehydrogenase deficiency may cause hemolytic anemia. Therefore, it should be banned for breastfeeding women. Precautions for the elderly: Elderly patients have an increased chance of serious adverse reactions when using sulfonamides. For example, severe rash, bone marrow suppression and thrombocytopenia are common serious adverse reactions in the elderly. Therefore, elderly patients should avoid using them. When there is a real 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 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. When bone marrow suppressive drugs are used in combination with sulfonamides, the adverse reactions of such drugs to the hematopoietic system may be enhanced. If there is an indication for the combination of the two types of drugs, possible toxic reactions should be closely observed. 5. Contraceptives (estrogens), long-term use with sulfonamides can reduce the reliability of contraception and increase the chance of extramenstrual bleeding. 6. When thrombolytic drugs are used in combination with sulfonamides, their potential toxic effects may be increased. 7. The combined use of hepatotoxic drugs and sulfonamides may increase the incidence of hepatotoxicity. Liver function should be monitored for such patients, especially those who have been taking the drugs for a long time and have a history of liver disease. 8. The combined use of photosensitizing drugs and sulfonamides may cause additive photosensitization. 9. Patients receiving sulfonamide treatment have an increased need for vitamin K. 10. Hexamethylenetetramine can decompose in acidic urine to produce formaldehyde, which can form insoluble precipitates with sulfonamides. This increases the risk of crystalluria, so the two drugs should not be used together. 11. Sulfonamides can replace the plasma protein binding site of phenylbutazone, and when the two are used together, the effect of phenylbutazone can be enhanced. 12. When sulfinpyrazone is used together with sulfonamides, the latter can reduce the latter's secretion from the renal tubules, and its blood concentration increases and lasts for a long time, thus producing toxicity. Therefore, the dose of sulfonamides may need to be adjusted during or after the use of sulfinpyrazone. When the course of sulfinpyrazone is long, the blood concentration of sulfonamides should be monitored to help adjust the dosage and ensure safe use. 13 When used in combination with digitalis or folic acid, the latter's absorption is reduced and the blood concentration is reduced, so the effect and efficacy of digitalis must be observed at any time. 14 When used in combination with probenecid, it will reduce the excretion of sulfonamides in the renal tubules, causing the blood concentration of sulfonamides to increase, the effect to be prolonged, and easy to poison. 15 When used in combination with neomycin, neomycin inhibits intestinal flora, affects the decomposition of this product in the intestine, and reduces its effect.

Shade from light, store in a sealed container

0.25g

Tentative 24 months

Zhejiang Qianjin Pharmaceutical Co., Ltd.

• Founded in:

  2005-03-31

• Address:

  No. 68, Xingmei Avenue, Provincial High-tech Industrial Park, Xinchang, Zhejiang Province

• Tax NO.:

  913306241430498567

• Registered Funds:

  39 million yuan

• Email:

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