Compound sulfadiazine tablets

This product is a compound preparation of sulfadiazine (SD) and trimethoprim (TMP). The combination of the two has a synergistic antibacterial effect. It has good antibacterial activity against 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 addition, it also has antimicrobial activity against Chlamydia trachomatis, Nocardia asteroides, Plasmodium and Toxoplasma in vitro. In recent years, bacterial resistance to this product is widespread, especially bacteria such as Shigella in the Enterobacteriaceae family, so it is rarely used clinically. The mechanism of action of this product is that sulfonamides act on dihydrofolate synthase, interfering with the first step of folic acid synthesis, while trimethoprim acts on the second step of folic acid anabolism, selectively inhibiting the action of dihydrofolate reductase. Therefore, the combination of the two can double-block the folic acid metabolism of bacteria, have a synergistic antibacterial effect, and reduce the number of drug-resistant strains compared with single-drug use.

This product is a compound preparation. Each tablet contains the following active ingredients: 0.4g sulfadiazine and 50mg trimethoprim.

1. Urinary tract infection caused by susceptible strains of Escherichia coli, Klebsiella, Enterobacter, Proteus mirabilis, Proteus vulgaris and Morganella. 2. Acute otitis media caused by Streptococcus pneumoniae or Haemophilus influenzae. 3. Acute exacerbation of chronic bronchitis in adults caused by Streptococcus pneumoniae or Haemophilus influenzae.

The usual dosage for adults is 2 tablets at a time, twice a day. The usual dosage for children is SD 20-30 mg/kg and TMP 4-6 mg/kg orally according to body weight, once every 12 hours for infants over 2 months and weighing less than 40 kg; the dosage for children weighing more than 40 kg is the same as the usual dosage for adults.

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

1. 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 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, and methotrexate. 4. Combination with bone marrow suppressive drugs may enhance the adverse reactions of such drugs to the hematopoietic system. Such as leukopenia and thrombocytopenia, if there is an indication to use the two drugs together, possible toxic reactions should be closely observed. 5. Long-term combination with contraceptives (estrogens) can 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. The risk of crystalluria increases. 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 The TMP in this product can inhibit the metabolism of warfarin and enhance its anticoagulant effect. 14 The 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 latter's bactericidal effect.

Keep away from light and store in sealed container.

Compound

Gansu Changee Bio-Pharmaceutical Co., Ltd.

• Founded in:

  2005-08-05

• Address:

  Tianshui Erpu Industrial Demonstration Zone

• Tax NO.:

  916205007734444550

• Registered Funds:

  229.09 million yuan

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