Sulfasalazine Enteric-coated Tablets

The mode of action of sulfasalazine and its metabolites 5-aminosalicylic acid and sulfadiazine is still unclear, but it may be related to the anti-inflammatory and immunomodulatory effects shown in animal and in vitro tests. Animal autoradiographic studies have shown that sulfasalazine (SSZ) can be affinity with connective tissue and is at relatively high levels in serous fluid, liver and intestinal wall. Clinical studies on rectal administration of sulfasalazine and its main metabolite 5-aminosalicylic acid and sulfadiazine to patients with ulcerative colitis have shown that 5-aminosalicylic acid may be the main therapeutic effect. It is not clear whether this product mainly produces anti-rheumatic effects through sulfasalazine or its main metabolites.

The main ingredient of this product is sulfasalazine. Its chemical name is: 5-[p-(2-pyridylaminesulfonyl)benzene]azosalicylic acid. Structural formula: Molecular formula: C18H14N4O5S Molecular weight: 398.39

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

1. Ulcerative colitis: Treatment of mild to moderate ulcerative colitis; can be used as an adjuvant therapy in severe ulcerative colitis. It can also be used for maintenance treatment of ulcerative colitis during remission. 2. Crohn’s disease: Treatment of active Crohn’s disease, especially those involving the colon. 3. Rheumatoid arthritis: Rheumatoid arthritis and juvenile rheumatoid arthritis (polyarticular type) that are not significantly responsive to salicylates or other nonsteroidal anti-inflammatory drugs.

Inflammatory bowel disease (mainly ulcerative colitis) adults: 3-4g per day, taken orally in divided doses. The interval between doses should not exceed 8 hours. To prevent gastrointestinal intolerance, start with a small dose of 1-2g (4-8 tablets) per day. If it exceeds 4g per day, be alert to increased toxicity. Severe attacks: 1-2g each time (4-8 tablets), 3-4 times a day. It can be used in combination with steroid drugs to form an intensive treatment plan. Mild and moderate attacks: 1g each time (4 tablets), 3-4 times a day. Remission period: It is recommended to give a maintenance dose to prevent symptoms from recurring, generally 2-3 times a day, 1g (4 tablets) each time. Children: Take 40-60mg per kilogram of body weight per day, divided into 3-6 doses. To prevent recurrence: Take 1g (4 tablets) per kilogram of body weight per day.

1. The most common adverse reactions are: nausea, anorexia, fever, erythema and itching, headache, palpitations. 2. The following adverse reactions are less common and may be related to the dose: Blood system reactions: red blood cell abnormalities (such as hemolytic anemia, macrocytosis), cyanosis Gastrointestinal reactions: stomach pain and abdominal pain Central nervous system reactions: dizziness, tinnitus Kidney reactions: proteinuria, hematuria, skin reactions: yellowing of the skin 3. The following reactions may not be related to the dose: Blood system reactions: bone marrow suppression such as accompanied by leukopenia, granulocytopenia, thrombocytopenia Gastrointestinal reactions: hepatitis, pancreatitis Central nervous system reactions: peripheral neuropathy, aseptic meningitis Skin reactions: rash, urticaria, erythema multiforme/S

This product is contraindicated in patients who are allergic to sulfonamides and salicylates, patients with intestinal obstruction or urinary tract obstruction, and patients with acute intermittent porphyria.

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 kernicterus. Therefore, this type of drug should be banned in newborns and children under 2 years old. Precautions for pregnancy and lactation: 1. Sulfonamides can cross the blood-placental barrier to the fetus, and animal experiments have found 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% to 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, and when there is an indication, the pros and cons should be weighed before making a decision.

1. When used in combination with urine alkalinizing drugs, the solubility of sulfonamides in alkaline urine can be enhanced, which increases 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, the 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 together with sulfonamides, their potential toxic effects may be increased. 7. When hepatotoxic drugs are used together with sulfonamides, the incidence of hepatotoxicity may increase. For such patients, especially those who have been taking the drugs for a long time and have a history of liver disease, liver function should be monitored. 8. When photosensitizing drugs are used together with sulfonamides, additive photosensitization may occur. 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. Therefore, 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 is prolonged, and it is easy to be poisoned. 15. When used in combination with neomycin, neomycin inhibits intestinal flora, affects the decomposition of this product in the intestine, and reduces its effect.

Keep away from light and store in sealed container.

0.25 g

Tentative 24 months

SPH Zhongxi Pharmaceutical Co., Ltd.

• Founded in:

  1989-10-18

• Address:

  No. 446, Waiqingsong Road, Jiading District, Shanghai

• Tax NO.:

  9131011413362209XY

• Registered Funds:

  148.2 million yuan

• Email:

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