Co-sulfamethoxazole Tablets

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, gonococci, 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 been increasing.

Each tablet of this product should contain 0.360-0.440g of sulfamethoxazole (C10H11N3O3S) and 72.0-88.0mg of trimethoprim (C14H18N4O3).

This product is white tablets.

This product is a white tablet. In recent years, many common clinical pathogens often show resistance to this product, so the treatment of bacterial infections needs to refer to the drug sensitivity results. The main indications of this product are the following infections caused by sensitive strains: 1. Urinary tract infections caused by sensitive strains of Escherichia coli, Klebsiella, Enterobacter, Proteus mirabilis, Proteus vulgaris and Morganella. 2. Acute otitis media in children over 2 years old caused by Streptococcus pneumoniae or Haemophilus influenzae. 3. Acute exacerbation of chronic bronchitis in adults caused by Streptococcus pneumoniae or Haemophilus influenzae. 4. Intestinal infections and Shigella infections caused by sensitive strains of Shigella flexneri or Shigella sonnei. 5. This product is the first choice for the treatment of Pneumocystis carinii pneumonia. 6. For the prevention of Pneumocystis carinii pneumonia, patients with a history of at least one attack of Pneumocystis carinii can be used.

1. Common dosage for adults: 160 mg of trimethoprim and 800 mg of sulfamethoxazole for bacterial infection, taken once every 12 hours. For the treatment of Pneumocystis carinii pneumonia, 3.75-5 mg/kg of trimethoprim and 18.75-25 mg/kg of sulfamethoxazole are taken once every 6 hours. Preventive medication for adults: initially give 160 mg of trimethoprim and 800 mg of sulfamethoxazole twice a day, then take the same dose once a day, or 3 times a week. 2. Common dosage for children: It is forbidden for infants under 2 months old. For the treatment of bacterial infection, infants over 2 months old and weighing less than 40 kg are given SMZ 20-30 mg/kg and TMP 4-6 mg/kg orally according to body weight, once every 12 hours; the dosage for children weighing ≥40 kg is the same as the common dosage for adults. For the treatment of parasitic infections such as Pneumocystis carinii pneumonia, SMZ 18.75-25 mg/kg and TMP 3.75-5 mg/kg are taken orally once every 6 hours according to body weight. The course of treatment for acute exacerbation of chronic bronchitis is at least 10-14 days; the course of treatment for urinary tract infection is 7-10 days; the course of treatment for bacillary dysentery is 5-7 days; the course of treatment for acute otitis media in children is 10 days; the course of treatment for Pneumocystis carinii pneumonia is 14-21 days.

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. Occasionally, anaphylactic shock is 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 taking 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. Newborns have imperfect liver function and poor bilirubin processing, so they are more likely to develop hyperbilirubinemia and neonatal jaundice, and occasionally kernicterus. 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, vomiting, decreased appetite, diarrhea, headache, fatigue, etc., generally mild symptoms. Occasionally, patients may develop Clostridium difficile enteritis, and the drug should be discontinued at this time. 8. Occasionally, thyroid enlargement and hypofunction may occur. 9. Central nervous system toxicity 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 prohibited from using this product. 2. Since this product blocks the metabolism of folic acid and aggravates the folate deficiency in patients with megaloblastic anemia, patients with this disease are prohibited from using this product. 3. Pregnant and lactating women are prohibited from using this product. 4. Infants under 2 months old are prohibited from using this product. 5. Patients with severe liver and kidney damage are prohibited from using this product.

Precautions for children: Since this product 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 sulfonamide increases, which increases the risk of kernicterus. Therefore, the use of this type of drug in newborns and infants under 2 months old is contraindicated. Children are in the growth and development period, and their liver and kidney functions are not yet perfect, so the dosage should be reduced as appropriate. Precautions for pregnancy and lactation: 1. This product can cross the blood-placental barrier to the fetus, and animal experiments have found that it has teratogenic effects. There is a lack of sufficient data in human studies, and pregnant women should avoid using it. 2. This product can be secreted in breast milk, and the concentration in breast milk can reach about 50%-100% of the maternal blood drug concentration. The drug may affect the baby. The use of this product in newborns with glucose-6-phosphate dehydrogenase deficiency may lead to hemolytic anemia. In view of the above reasons, this product should not be used by lactating women. Elderly patients are more likely to experience serious adverse reactions when using this product: such as severe skin allergic reactions such as rash, and blood system abnormalities such as bone marrow suppression, leukopenia and thrombocytopenia. It is more likely to occur when using diuretics at the same time. Therefore, elderly patients should avoid using this product. If 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 to each other. 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 toxic 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. For example, leukopenia and thrombocytopenia, etc. If there is an indication for the combined use of the two drugs, the possible toxic reactions should be closely observed. 5. Long-term combined use with contraceptives (estrogens) may reduce the reliability of contraception and increase the chance of extramenstrual bleeding. 6. When used in combination with thrombolytic drugs, their potential toxic effects may be increased. 7. 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. 8. When used in combination with photosensitive drugs, photosensitization may be additive. 9. Patients receiving this product have an increased need for vitamin K. 10. 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. This increases the risk of crystalluria. 11. 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. 12. When sulfinpyrazone is used in combination with this product, the latter's secretion from the renal tubules can be reduced. 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 application 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. 13. TMP in this product can inhibit the metabolism of warfarin and enhance its anticoagulant effect. 14. TMP in this product can increase nephrotoxicity when used in combination with cyclosporine. 15. When rifampicin is used in combination with this product, the clearance of TMP in this product can be significantly increased and the serum half-life can be shortened. 16. 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. 17. It is not suitable to be used in combination with dapsone, because the blood concentration of both 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. 18. Avoid using it in combination with penicillins, because this product may interfere with the bactericidal effect of such drugs.

Keep away from light and store in sealed container.

Sulfadimethoxazole 0.4 g and trimethoprim 80 mg

24 months

Zhejiang Huayuan Pharmaceutical Co., Ltd.

• Founded in:

  2001-08-03

• Address:

  Huayuan Industrial Zone, Nanma Town, Dongyang City, Zhejiang Province

• Tax NO.:

  91330783730924109A

• Registered Funds:

  150 million yuan

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