Product Overview
[Drug Name]
Generic Name: Sulfasalazine Enteric-Coated Tablets
Trade Name: Changchangning Sulfasalazine Enteric-Coated Tablets 0.25g x 100 Tablets
[Main Ingredient]
Sulfasalazine; its chemical name is 5-p-(2-pyridylaminosulfonyl)phenyl]azo salicylic acid.
[Indications/Main Functions]
Mainly used for inflammatory bowel disease, namely Crohn's disease and ulcerative colitis.
[Specifications]
0.25g x 100 tablets
[Dosage and Administration]
Oral. Adult Usual Dosage: Initial dose: 2-3g per day, divided into 3-4 oral doses. If no significant discomfort is noted, the dose can be gradually increased to 4-6g per day. After bowel symptoms resolve, the dose can be gradually reduced to a maintenance dose of 1.5-2g per day. For children, the initial dose is 40-60mg/kg per day, divided into 3-6 oral doses. After the condition resolves, the maintenance dose is 30mg/kg per day, divided into 3-4 oral doses.
[Adverse Reactions]
Serum sulfapyridine and its metabolite concentrations (20-40 μg/ml) are associated with toxicity. Toxicity is observed at concentrations exceeding 50 μg/ml, so the dose should be reduced to avoid toxic reactions. 1. Allergic reactions are common and may manifest as drug rashes. Severe cases may include exudative erythema multiforme, exfoliative dermatitis, and epidermolysis bullosa atrophic dermatitis. Serum sickness-like reactions may also occur, including photosensitivity, drug fever, joint and muscle pain, and fever. 2. Neutropenia or neutropenia, thrombocytopenia, and aplastic anemia. Patients may experience sore throat, fever, pallor, and a bleeding tendency. 3. Hemolytic anemia and hemoglobinuria. These are more common in patients with glucose-6-phosphate dehydrogenase deficiency and are more common in neonates and children than in adults. 4. Hyperbilirubinemia and neonatal kernicterus. This increases free bilirubin levels due to competition with bilirubin for protein binding sites. Neonates are more susceptible to hyperbilirubinemia and neonatal jaundice due to their imperfect liver function. Kernicterus may occasionally occur. 5. Liver damage: Jaundice, decreased liver function, and, in severe cases, acute hepatic necrosis may occur. 6. Kidney damage: Crystalluria, hematuria, and cystic urine may occur. Occasionally, patients may experience serious adverse reactions such as interstitial nephritis or renal tubular necrosis. 7. Nausea, vomiting, decreased appetite, diarrhea, headache, and fatigue. These symptoms are generally mild and do not affect continued medication. Occasionally, patients may develop Clostridium difficile enteritis, requiring discontinuation of medication. 8. Thyroid enlargement and hypofunction may occasionally occur. 9. Central nervous system toxicity may occasionally occur, manifesting as confusion, disorientation, hallucinations, euphoria, or depression. If these occur, the drug must be discontinued immediately. 10. Rarely, pancreatitis, male sperm deficiency, or infertility may occur.
[Contraindications]
This product is contraindicated in patients allergic to sulfonamides, pregnant or breastfeeding women, and children under 2 years old.
Drug Interactions
1. Concomitant use with urinary alkalinizing agents may increase the solubility of sulfonamides in alkaline urine, leading to increased excretion. 2. Para-aminobenzoic acid can displace sulfonamides for bacterial uptake, antagonizing the antibacterial effects of sulfonamides. Therefore, the two drugs should not be used together. 3. When the following drugs are used together with sulfonamides, the latter may displace the protein binding sites of these drugs or inhibit their metabolism, resulting in prolonged drug action or toxicity. Therefore, the dosage of these drugs should be adjusted when used together with sulfonamides or after sulfonamides. These drugs include oral anticoagulants, oral hypoglycemic agents, methotrexate, phenytoin sodium, and thiopental sodium. 4. Myelosuppressive drugs may enhance the adverse effects of sulfonamides on the hematopoietic system when used together with these drugs. If combined use of these two classes of drugs is indicated, close observation for possible toxic reactions should be conducted. 5. Contraceptive pills (hormones), when used in combination with sulfonamides for a long time, may 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 combination of hepatotoxic drugs and sulfonamides may cause an increase in the incidence of hepatotoxicity. Liver function should be monitored for such patients, especially those who have been taking the medicine for a long time and have a history of liver disease. 8. The combination of photosensitizing drugs and sulfonamides may cause additive photosensitivity. 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 an insoluble precipitate 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. Sulfinpyrazone ( Concomitant use of sulfinpyrazone with sulfonamides can reduce renal tubular secretion of sulfonamides, leading to elevated and prolonged blood concentrations and potentially toxic effects. Therefore, the sulfonamide dosage may need to be adjusted during or after sulfinpyrazone treatment. During prolonged sulfinpyrazone treatment, monitoring sulfonamide blood concentrations is recommended to facilitate dosage adjustments and ensure safe use. 13. Concomitant use with digitalis or folic acid can reduce absorption and blood concentrations, necessitating constant monitoring of the effects and efficacy of digitalis. 14. Concomitant use with probenecid can reduce renal tubular sulfonamide excretion, leading to elevated blood concentrations and prolonged effects, potentially leading to toxicity. 15. Concomitant use with neomycin can inhibit intestinal flora, affecting the intestinal breakdown of this drug and reducing its effectiveness.
[Precautions]
1. Glucose-6-phosphate dehydrogenase deficiency , hepatic insufficiency, renal insufficiency, porphyria, thrombocytopenia, granulocytopenia, porphyria, intestinal or urinary tract obstruction. 2. Drink plenty of water during the use of this product to maintain a high urine flow to prevent the occurrence of crystalluria, and take drugs to alkalinize urine if necessary. This product is prone to kidney damage in patients with dehydration, shock and the elderly, so it should be used with caution or avoided. 3. Use with caution in patients who are allergic to furosemide, sulfones, thiazide diuretics, sulfonylureas, carbonic anhydrase inhibitors and other sulfonamides. 4. During treatment, attention should be paid to the following examinations: (1) Complete blood test, which is especially important for patients receiving a longer course of treatment. (2) Proctoscopy and sigmoidoscopy to observe the effect of the medication and adjust the dose. (3) Regular urine tests during treatment (urinalysis every 2 to 3 days) to detect crystalluria that may occur during long-term or high-dose treatment. (4 Liver and kidney function tests, 5. In case of gastrointestinal irritation, in addition to emphasizing taking the medication after meals, it can be divided into smaller doses and taken several times, even hourly, to alleviate symptoms. 6. The dosage can be adjusted at any time based on the patient's response and tolerance. Some patients may utilize intermittent therapy (two weeks on, one week off). 7. If diarrhea symptoms do not improve, the dosage may be increased. 8. The nighttime interval between doses should not exceed eight hours. 9. The dosage should be reduced in patients with renal impairment.
[Use in Elderly Patients]
Senior patients are more likely to experience serious adverse reactions when using sulfonamides. Severe rash, bone marrow suppression, and thrombocytopenia are common serious adverse reactions in the elderly. Therefore, use of sulfonamides should be avoided in elderly patients. When indicated, the decision should be made after weighing the risks and benefits.
[Overdose]
Adverse reactions or toxic reactions increase when the daily dosage reaches or exceeds 4g or the serum drug concentration exceeds 50μg/mL.
