Compound sulfamethoxazole granules

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, Haemophilus influenzae, especially the antibacterial effect on Escherichia coli, Haemophilus influenzae, Staphylococcus aureus is significantly enhanced compared with SMZ alone. In addition, it also has good antimicrobial activity against Chlamydia trachomatis, Nocardia asteroides, protozoa, Toxoplasma gondii, etc. in vitro. The mechanism of action of this product is: SMZ acts on dihydrofolate synthase, interfering with the first step of folic acid synthesis, TMP acts on the second step of folic acid anabolism, selectively inhibiting 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 stronger than that of a single drug, and the number of resistant strains to it is reduced. However, in recent years, the resistance of bacteria to this product has also shown an increasing trend. 2. Toxicological animal experiments have found that long-term and high-dose use of this product can cause bone marrow suppression, leukopenia, and thrombocytopenia.

This product is a compound preparation, its components are sulfamethoxazole and trimethoprim.

This product is white or off-white granules.

1. For the treatment of urinary tract infections caused by sensitive strains of Escherichia coli, Klebsiella, Enterobacter, Proteus mirabilis, Proteus vulgaris and Morganella; 2. For the treatment of acute otitis media in children over 2 years old caused by Streptococcus pneumoniae or Haemophilus influenzae; 3. For the treatment of acute exacerbation of chronic bronchitis in adults caused by Streptococcus pneumoniae or Haemophilus influenzae; 4. For the treatment of intestinal infections and Shigella infections caused by sensitive strains of Shigella flexneri or Shigella sonnei; 5. For the treatment of Pneumocystis carinii pneumonia, this product is the first choice; 6. For the prevention of Pneumocystis carinii pneumonia, existing Pneumocystis carinii can be used

Oral. Adults: For the treatment of bacterial infections, take 1 bag at a time, twice a day or as directed by a doctor. Children: For the treatment of bacterial infections, infants aged 2 months and under 40 kg should take sulfamethoxazole 20-30 mg/kg and trimethoprim 4-6 mg/kg once every 12 hours. Children weighing more than 40 kg should take the same dose as adults. For the treatment of parasitic infections such as Pneumocystis carinii pneumonia, take sulfamethoxazole 18.75-25 mg/kg and trimethoprim 3.75-5 mg/kg orally once. When used to treat infectious diseases once every 6 hours, the treatment should be based on the course of treatment for different diseases.

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 reactions, drug fever, joint and muscle pain, and fever. Anaphylactic shock is occasionally seen. 2. Patients with neutropenia or deficiency, thrombocytopenia, and aplastic anemia may present with sore throat, fever, pallor, and bleeding tendency. 3. Hemolytic anemia and hemoglobinuria. This is easy to occur in patients with glucose-6-phosphate dehydrogenase deficiency 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 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 experience serious adverse reactions such as interstitial nephritis or tubular necrosis. 7. Nausea, vomiting, decreased appetite, diarrhea, headache, fatigue, etc., generally mild symptoms. Occasionally, patients develop Clostridium difficile enteritis, at which point the drug needs to be discontinued. 8. Occasionally, thyroid enlargement and decreased function may occur. 9. Adverse reactions of the central nervous system may occasionally occur, manifested as mental confusion, disorientation, hallucinations, euphoria, or depression. 10. Aseptic meningitis may occasionally occur, with symptoms such as headache, stiff neck, and nausea. Although serious adverse reactions caused by this product are rare, they often affect various organs and can be fatal, such as exudative erythema multiforme, exfoliative dermatitis, epidermolysis bullosa atrophic dermatitis, fulminant hepatic 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. This product is contraindicated for use in children under 2 months old; 2. This product is contraindicated for use in patients who are allergic to SMZ and TMP; 3. This product is contraindicated for use in patients with megaloblastic anemia because it blocks the metabolism of folic acid and aggravates folate deficiency; 4. This product should be used with caution in pregnant women.

Precautions for children: This product is contraindicated for children under 2 months old. Precautions for pregnancy and lactation: Pregnant women should use with caution. Precautions for the elderly: Elderly patients have an increased chance of serious adverse reactions when using this product, such as severe skin allergic reactions such as rashes, bone marrow suppression, leukopenia, thrombocytopenia and other blood system abnormalities, which are more likely to occur when using diuretics at the same time. Therefore, elderly patients should avoid using this product, and when there is an indication, the decision should be made after weighing the pros and cons.

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 use 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. For example, 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 should not be used 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, the effect of phenylbutazone can be enhanced. 11. When sulfinpyrazone is used in combination with this product, the latter's secretion from the renal tubules can be reduced, and its blood concentration is prolonged and 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 and 2,4-diaminopyrimidine drugs, nor should it be used between courses of treatment with other folic acid antagonists, 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 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.

Keep away from light and store in sealed container.

Sulfadimethoxazole 0.8 g, trimethoprim 0.16 g

Tentative 24 months

Heilongjiang Fuhe Pharmaceutical Group Co., Ltd.

• Founded in:

  1994-12-28

• Address:

  No. 1166, Zhengyang Street, Zhaodong City, Suihua City, Heilongjiang Province

• Tax NO.:

  912312001313217015

• Registered Funds:

  78.54 million yuan

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