Compound sulfamethoxazole granules for children

1. Pharmacology This product is a sulfonamide antibacterial drug, a compound preparation of sulfamethoxazole (SMZ) and trimethoprim (TMP). It has good antibacterial effects on non-enzyme-producing Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Klebsiella, Salmonella, Proteus, Morganella, Shigella and other Enterobacteriaceae, Neisseria gonorrhoeae, Neisseria meningitidis, and Haemophilus influenzae. In particular, the antibacterial effect on Escherichia coli, Haemophilus influenzae, and Staphylococcus aureus is significantly enhanced compared with SMZ alone. In addition, it also has good antimicrobial activity against Chlamydia trachomatis, Nocardia asteroides, protozoa, and Toxoplasma in vitro. The mechanism of action of this product is: SMZ acts on the action of dihydrofolate reductase, and the combination of the two can double-block the folic acid metabolism of bacteria. The synergistic antibacterial effect of this product is enhanced compared with a single drug, and the number of drug-resistant strains is reduced. However, in recent years, bacterial resistance to this drug has also been on the rise.

Compound preparation. Each bag contains 100 mg of sulfamethoxazole and 20 mg of trimethoprim, and the auxiliary material is white sugar.

This product is white or off-white granules with sweet taste.

Used for respiratory tract, intestinal and urinary tract infections in children.

Oral administration. 3 months to 1 year old: 1/3-1/2 bag at a time; 1-5 years old: 1 bag at a time; 5-8 years old: 1.5-2 bags at a time. Once a day or as directed by a doctor. Take with warm water.

1. Allergic reactions are 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, drug fever, joint and muscle pain, and fever. Anaphylactic shock is occasionally seen. 2. Neutropenia or deficiency, thrombocytopenia, and aplastic anemia. Patients may present with sore throat, fever, pallor, and bleeding tendency. 3. Hemolytic anemia and hemoglobinuria. This is easy to occur in patients who lack glucose-6-phosphate dehydrogenase after using sulfonamides, and is more common in newborns and children than in adults. 4. Hyperbilirubinemia and neonatal kernicterus. Because this product competes with bilirubin for protein binding sites, it can cause an increase in free bilirubin. Neonates have imperfect liver function and poor bilirubin processing, so they are more likely to develop hyperbilirubinemia and neonatal jaundice, and kernicterus may occasionally occur. 5. Liver damage. Jaundice and liver dysfunction may occur, and in severe cases, acute liver necrosis may occur. 6. Kidney damage. Crystalluria, hematuria, and tubular urine may occur; occasionally, patients may experience serious adverse reactions such as interstitial nephritis or tubular necrosis. 7. Nausea and vomiting, decreased appetite, diarrhea, headache, fatigue, etc., generally mild symptoms. Occasionally, patients develop Clostridium difficile enteritis, and the drug must be discontinued at this time. 8. Occasionally, thyroid enlargement and hypofunction occur. 9. Central nervous system adverse reactions may occasionally occur, manifested as mental confusion, disorientation, hallucinations, euphoria or depression. 10. Occasionally, aseptic meningitis may occur, with symptoms such as headache, stiff neck, and nausea. Although serious adverse reactions caused by this product are rare, they often involve various organs and can be fatal, such as exudative erythema multiforme, exfoliative dermatitis, epidermolysis bullosa atrophic dermatitis, fulminant liver necrosis, agranulocytosis, aplastic anemia and other blood system abnormalities. The above adverse reactions are more common in AIDS patients than in non-AIDS patients.

1. Patients who are allergic to SMZ and TMP are contraindicated. 2. Since this product blocks the metabolism of folic acid and aggravates the folate deficiency in patients with megaloblastic anemia, it is contraindicated for patients with this disease. 3. Infants under 3 months old are contraindicated. 4. Patients with severe liver and kidney damage are contraindicated.

Precautions for children: This product is contraindicated for infants under 2 months old. Precautions for pregnancy and lactation: This product is contraindicated for pregnant and lactating women. Precautions for the elderly: Not yet clear.

1. The combined use of urine alkalinizing drugs can increase the solubility of this product in alkaline urine and increase excretion. 2. It cannot be used in combination with para-aminobenzoic acid, which can replace this product for bacterial uptake, and the two are antagonistic. 3. When the following drugs are used together with this product, this product can replace the protein binding sites of these drugs, or inhibit their metabolism, resulting in prolonged drug action time or adverse reactions. Therefore, when these drugs are used at the same time as this product, or when used after the application of this product, their dosages need to be adjusted. Such drugs include oral anticoagulants, oral hypoglycemic drugs, methotrexate, phenytoin sodium and thiopental sodium. 4. The combined use with bone marrow suppressive drugs may enhance the adverse reactions of such drugs to the hematopoietic system. Such as leukopenia and thrombocytopenia, etc. If there is an indication for combined use, possible adverse reactions should be closely observed. 5. When used in combination with thrombolytic drugs, their potential toxic effects may be increased. 6. When used in combination with hepatotoxic drugs, the incidence of hepatotoxicity may increase. Liver function should be monitored for such patients, especially those who have been taking the drug for a long time and have a history of liver disease. 7. When used in combination with photosensitizing drugs, photosensitization may be additive. 8. Patients receiving this product have an increased need for vitamin K. 9. It is advisable to use it in combination with methenamine, because methenamine can decompose in acidic urine to produce formaldehyde, which can form insoluble precipitates with this product, increasing the risk of crystalluria. 10. This product can replace the plasma protein binding site of phenylbutazone, and when the two are used together, it can enhance the effect of phenylbutazone. 11. When sulfinpyrazone is used in combination with this product, it can reduce the secretion of the latter from the renal tubules. The prolonged increase in its blood concentration is prone to toxic reactions. Therefore, the dose of this product may need to be adjusted during or after the use of sulfinpyrazone. When the course of sulfinpyrazone treatment is long, the blood concentration of this product should be monitored to help adjust the dose and ensure safe medication. 12. TMP in this product can inhibit the metabolism of warfarin and enhance its anticoagulant effect. 13. The combination of TMP in this product and cyclosporine can increase nephrotoxicity. 14. When rifampicin is used in combination with this product, the clearance of TMP in this product can be significantly increased and the blood elimination half-life can be shortened. 15. It is not suitable to be used in combination with anti-tumor drugs, 2,4-diaminopyrimidine drugs, or between courses of treatment with other folic acid donation anti-drugs, because it may cause bone marrow aplasia or megaloblastic anemia. 16. It is not suitable to be used in combination with dapsone, because the blood concentration of dapsone and TMP in this product can be increased when they are used in combination. The increase in dapsone concentration increases and aggravates adverse reactions, especially the occurrence of methemoglobinemia. 17. Avoid using it in combination with penicillins, because this product may interfere with the bactericidal effect of penicillins.

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Compound

24 months

Shanxi Sanjin Pharmaceutical Co., Ltd.

• Founded in:

  1999-01-28

• Address:

  No. 1001, Middle Section of Tongge Street, Xiaohe Industrial Park, Shanxi Transformation and Comprehensive Reform Demonstration Zone

• Tax NO.:

  91140100713652658Q

• Registered Funds:

  66 million yuan

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