Product Overview
[Drug Name]
Trade Name: Xieliting
Generic Name: Belladonna Sulfamethoxazole and Trimerhoprim Tablets
English Name: Belladonna Sulfamethoxazole and Trimerhoprim Tablets
[Indications]
This product is used for chronic bacillary dysentery caused by Shigella dysenteriae and enteritis caused by other sensitive pathogens.
[Main Ingredients]
Sulfamethoxazole 0.4g, trimethoprim 80mg, and Belladonna fluid extract 8mg.
[Properties]
This product is an off-white tablet.
[Specifications]
10 tablets
[Drug Interactions]
1. The use of urine alkalinizing agents may increase the solubility of this product in alkaline urine, leading to increased excretion. 2. Do not use with para-aminobenzoic acid, as para-aminobenzoic acid may replace this product in bacterial uptake, resulting in antagonistic interactions between the two. 3. When used concomitantly with the following drugs, this drug may displace their protein binding sites or inhibit their metabolism, resulting in prolonged drug action or toxic reactions. Therefore, dosage adjustments are required when these drugs are used concomitantly with this drug or after this drug. These drugs include oral anticoagulants, oral hypoglycemics, methotrexate, phenytoin sodium, and thiopental sodium. 4. Concomitant use with myelosuppressive drugs may enhance the adverse effects of these drugs on the hematopoietic system, such as leukopenia and thrombocytopenia. If concomitant use of these drugs is indicated, close observation for possible toxic reactions is advised. 5. Long-term concomitant use with contraceptives (estrogens) may reduce contraceptive reliability and increase the risk of extramenstrual bleeding. 6. Concomitant use with thrombolytic drugs may amplify their potential toxic effects. 7. Concomitant use with hepatotoxic drugs may increase the incidence of hepatotoxicity. Liver function should be monitored in patients with these conditions, especially those taking these drugs for extended periods and those with a history of liver disease. 8. Additive photosensitivity may occur when used in combination with photosensitizing drugs. 9. Patients receiving this drug have an increased requirement for vitamin K. 10. It should not be used in combination with methenamine, as methenamine decomposes in acidic urine to produce formaldehyde, which can form an insoluble precipitate with this drug, increasing the risk of crystalluria. 11. This drug can displace the plasma protein binding sites of phenylbutazone, and when used together, it can enhance the effects of phenylbutazone. 12. When sulfinpyrazone is used in combination with this drug, it can reduce the latter's secretion from the renal tubules. Prolonged elevation of its blood concentration can easily lead to toxic reactions. Therefore, the dose of this drug may need to be adjusted during or after sulfinpyrazone treatment. When sulfinpyrazone treatment is prolonged, blood concentrations of this drug should be monitored to facilitate dosage adjustments and ensure safe use. 13. The trimethylolpropane in this drug can inhibit the metabolism of warfarin, enhancing its anticoagulant properties. 14. The trimethylolpropane in this drug can increase nephrotoxicity when used in combination with cyclosporine. 15. Rifampicin combined with this product may significantly increase the clearance of TMP and shorten its serum half-life. 16. This product should not be used in combination with antineoplastic drugs or 2,4-diaminopyrimidines, nor between courses of treatment with other folic acid antagonists, as it may cause bone marrow aplasia or megaloblastic anemia. 17. This product should not be used in combination with dapsone, as the blood concentrations of both dapsone and the TMP in this product may increase. This increased dapsone concentration may increase and aggravate adverse reactions, especially methemoglobinemia. 18. Avoid co-administration with penicillins, as this product may interfere with the bactericidal activity of these drugs.
[Adverse Reactions]
1. Allergic reactions are common and may manifest as drug rashes. Severe cases may develop exudative erythema multiforme, exfoliative dermatitis, and epidermolysis bullosa atrophicus. Serum sickness-like reactions may also occur, including photosensitivity, drug fever, joint and muscle pain, and fever. Anaphylactic shock may occur occasionally. 2. Neutropenia or deficiency, thrombocytopenia, and aplastic anemia. Patients may present with sore throat, fever, pallor, and bleeding tendency. 3. Hemolytic anemia and hemoglobin. This is more likely to occur in patients with glucose-6-phosphate dehydrogenase deficiency after taking sulfonamides, and is more common in newborns and children than in adults. 4. Hyperbilirubinemia and neonatal jaundice. Because this product competes with bilirubin for protein binding sites, it can cause increased free bilirubin. Newborns have imperfect liver function and poor bilirubin processing, so they are more likely to develop hyperbilirubinemia and neonatal jaundice, and occasionally kernicterus may occur. 5. Liver damage. Jaundice and decreased liver function may occur, and in severe cases, acute liver necrosis may occur. 6. Kidney damage. Crystalluria, hematuria, and tubular urine may occur; occasionally, patients may develop serious adverse reactions such as interstitial nephritis or renal tubular necrosis. 7. Nausea, vomiting, decreased appetite, diarrhea, headache, fatigue, etc., generally mild symptoms. Occasionally, patients develop Clostridium difficile enteritis, in which case the drug should be discontinued. 8. Thyroid enlargement and hypofunction may occur occasionally. 9. Central nervous system toxicity may occasionally occur, manifesting as confusion, disorientation, hallucinations, euphoria, or depression. 10. Dry mouth, blurred vision, increased heart rate, skin flushing, and dizziness. Severe cases may include mydriasis, excitement, and irritability.
[Contraindications]
1. Contraindicated in patients with allergies to SMZ and TMP. 2. Contraindicated in patients with megaloblastic anemia. 3. Contraindicated in pregnant and lactating women. 4. Contraindicated in newborns and infants under 2 months of age. 5. Contraindicated in patients with severe hepatic or renal impairment. 6. Contraindicated in patients with glaucoma or elevated intraocular pressure. 7. Contraindicated in patients with tachycardia. 8. Contraindicated in patients with benign prostatic hyperplasia. 9. Contraindicated in patients with pyloric obstruction.
[Precautions]
1. Cross-allergic reactions. Patients allergic to one sulfonamide may also be allergic to other sulfonamides. 2. Liver damage. Jaundice, decreased liver function, and in severe cases, acute hepatic necrosis may occur. Therefore, patients with liver damage should avoid this drug. 3. Renal damage. Crystalluria, hematuria, and cystic urine may occur. Therefore, while taking this drug, drink plenty of fluids and maintain a high urine flow. If this drug is used for a long course or in high doses, in addition to drinking plenty of fluids, it is advisable to take sodium bicarbonate with this drug to prevent this adverse reaction. This drug is susceptible to renal damage in patients with dehydration, shock, or the elderly. Therefore, use with caution or avoid this drug. Patients with decreased renal function should not use this drug. 4. Patients allergic to furosemide, sulfones, thiazide diuretics, sulfonamides, and carbonic anhydrase inhibitors may also be allergic to sulfonamides. 5. Use with caution in patients with gastric and duodenal ulcers and heart failure.
[Storage]
Store in a dry, airtight container protected from light.
[Approval Number]
National Medicine Approval No. H23023427
[Manufacturer]
Harbin Pharmaceutical Group Pharmaceutical Factory No. 6
