Children's compound sulfamethoxazole tablets

SMZ and TMP in this product are completely absorbed from the gastrointestinal tract after oral administration, and both can absorb more than 90% of the administered dose, and the peak blood drug concentration (Cmax) is reached 1 to 4 hours after taking the drug. After taking TMP 160mg and SMZ 800mg twice a day, the steady-state blood drug concentration is reached after 3 days, TMP is 1.72mg/L, and the plasma free concentration and total concentration of SMZ are 57.4mg/L and 68.0mg/L respectively. Both SMZ and TMP are mainly filtered from the glomerulus and secreted from the renal tubules, and the urine drug concentration is significantly higher than the blood drug concentration. After a single oral dose, 84.5% of the total SMZ is excreted in the urine within 0 to 72 hours, of which 30% is free sulfonamide including metabolites; TMP is excreted in the form of free drugs 66.8%. The excretion process of SMZ and TMP does not affect each other. The blood elimination half-life (t1/2b) of SMZ and TMP is 10 hours and 8-10 hours respectively. In patients with impaired renal function, the half-life is prolonged and the dosage needs to be adjusted. After absorption, both can be widely distributed in body tissues and fluids such as sputum, middle ear fluid, and vaginal secretions. They can also penetrate the blood-cerebrospinal fluid barrier to reach therapeutic concentrations. They can also cross the blood-placental barrier, enter the fetal blood circulation, and be secreted into breast milk.

This product is a compound preparation, each tablet contains the active ingredients 0.4g of sulfamethoxazole and 0.08g of trimethoprim.

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 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 disease or HIV-infected adults can use it, whose CD4 lymphocyte count is ≤200/mm3 or less than 20% of the total lymphocyte count. 7. Traveler's diarrhea caused by enterotoxigenic Escherichia coli (ETEC).

The usual dosage for children is contraindicated for infants under 2 months old. For the treatment of bacterial infections, infants and young children over 2 months old and weighing less than 40 kg should take SMZ 20-30 mg/kg and TMP 4-6 mg/kg orally once every 12 hours, according to their body weight; the dosage for children weighing more than 40 kg is the same as the usual dosage for adults. For the treatment of parasitic infections such as Pneumocystis carinii pneumonia, take SMZ 18.75-25 mg/kg and TMP 3.75-5 mg/kg orally once every 6 hours, according to their body weight, for a course of 14 to 21 days. The course of treatment for acute attacks of chronic bronchitis is at least 10 to 14 days; the course of treatment for urinary tract infections is 7 to 10 days; the course of treatment for bacillary dysentery is 5 to 7 days; the course of treatment for acute otitis media in children is 10 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 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, methotrexate, phenytoin sodium and thiopental sodium. 4. Combination 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 the use of 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.