Sulfadiazine Tablets

This product is a medium-acting sulfonamide. It has antibacterial effects on non-enzyme-producing Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Klebsiella, Salmonella, Shigella and other Enterobacteriaceae, gonococci, meningococci, Haemophilus influenzae. In addition, it also has antimicrobial activity against Chlamydia trachomatis, Nocardia asteroides, Plasmodium and Toxoplasma in vitro. The antibacterial activity of this product is the same as that of sulfamethoxazole. However, in recent years, bacterial resistance to this product has increased, especially Streptococcus, Neisseria and Enterobacteriaceae. Sulfonamides are broad-spectrum antibacterial agents. This product is similar in structure to para-aminobenzoic acid (PABA), and can compete with PABA on dihydrofolate synthase in bacteria, thereby preventing PABA from being used as a raw material to synthesize folic acid required by bacteria, and reducing the amount of metabolically active tetrahydrofolate, which is an essential substance for bacteria to synthesize purine, thymidine and deoxyribonucleic acid (DNA), thereby inhibiting the growth and reproduction of bacteria.

Sulfadiazine

This product is white or slightly yellow tablets; the color gradually darkens when exposed to light.

Sulfonamides are broad-spectrum antibacterial drugs, but because many common clinical pathogens are resistant to this class of drugs, they are only used for infections caused by sensitive bacteria and other sensitive pathogenic microorganisms. The indications of sulfadiazine (excluding the compound preparations of this class of drugs and trimethoprim) are: 1. Treatment and prevention of epidemic cerebrospinal meningitis caused by sensitive meningococci. 2. Combined with trimethoprim, it can treat otitis media and skin and soft tissue infections caused by Haemophilus influenzae, Streptococcus pneumoniae and other streptococci that are sensitive to it. 3. Astrocyte Nocardia. 4. An auxiliary drug for the treatment of chloroquine-resistant malignant malaria. 5. It is a second-choice drug for the treatment of cervicitis and urethritis caused by Chlamydia trachomatis. 6. It is a second-choice drug for the treatment of neonatal inclusion conjunctivitis caused by Chlamydia trachomatis.

1. For the treatment of general infections, the usual oral dose for adults is 1g once, twice a day, and the first dose is doubled. The usual oral dose for infants and children over 2 months old is 25-30mg/kg per body weight, twice a day, and the first dose is doubled (the total amount does not exceed 2g). 2. For the prevention of epidemic cerebrospinal meningitis, the usual oral dose for adults is 1g once, twice a day, and the course of treatment is 2 days. The usual oral dose for infants and children over 2 months old is 0.5g per day, and the course of treatment is 2-3 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 reactions, drug fever, joint and muscle pain, and fever. 2. Neutropenia or deficiency, thrombocytopenia, and aplastic anemia. Patients may present with sore throat, fever, pallor, and bleeding tendency. 3. Hemolytic anemia and hemoglobinuria. Patients who lack glucose 6-phosphate dehydrogenase are prone to this after taking sulfonamides, and are more common in newborns and children than in adults. 4. Hyperbilirubinemia and neonatal kernicterus. Sulfonamides compete with bilirubin for protein binding sites. Free bilirubin may increase. Neonates have imperfect liver function, so hyperbilirubinemia and neonatal jaundice are more likely to occur, 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 develop serious adverse reactions such as interstitial nephritis or tubular necrosis. 7. Nausea, vomiting, decreased appetite, diarrhea, headache, fatigue, etc., generally mild symptoms, do not affect continued medication. Occasionally, patients develop Clostridium difficile enteritis, and the drug should be discontinued at this time. .8. Occasionally, thyroid enlargement and hypofunction occur. 9. Central nervous system toxicity may occasionally occur, manifested as mental confusion, disorientation, hallucinations, euphoria or depression. Once it occurs, the drug should be discontinued immediately. Although serious adverse reactions caused by this product are rare, they can be fatal, such as exudative erythema multiforme, exfoliative dermatitis, bullous epidermolysis atrophic dermatitis, fulminant liver necrosis, agranulocytosis, aplastic anemia and other blood system abnormalities. Close observation should be made during treatment, and the drug should be discontinued immediately when rash or other early signs of reaction appear.

1. It is contraindicated for those who are allergic to sulfonamide drugs. 2. It is contraindicated for pregnant women and breastfeeding women. 3. It is contraindicated for infants under 2 months old. 4. It is contraindicated for those with poor liver and kidney function.

Precautions for children: Since sulfonamides 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 sulfonamides increases, which increases the risk of kernicterus. Therefore, this type of drug is contraindicated in newborns and infants under 2 months old. 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 for human studies, so 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% to 100% of the maternal blood drug concentration. The drug may have an impact on infants. The use of this product in newborns with glucose-6-phosphate dehydrogenase deficiency may cause hemolytic anemia. In view of the above reasons, this product should not be used by breastfeeding women. Precautions for the elderly: Elderly patients have an increased chance of serious adverse reactions when using this product. Severe rash, bone marrow suppression and thrombocytopenia are common serious adverse reactions in the elderly. Therefore, elderly patients should avoid using it, and when there is a real 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 with para-aminobenzoic acid, which can replace this product for bacterial uptake, and the two are antagonistic to each other. It is also not suitable to be used with local anesthetics containing para-aminobenzoyl such as procaine, benzocaine, tetracaine, etc. 3. When used with oral anticoagulants, oral hypoglycemic drugs, methotrexate, phenytoin sodium and thiopental sodium, the above drugs need to adjust the dosage, because this product can replace the protein binding site of these drugs, or inhibit their metabolism, resulting in prolonged drug action time or toxicity. 4. When used with bone marrow suppressive drugs, the potential toxic side effects of such drugs may be enhanced. If there is an indication to use two types of drugs together, the possible toxic reactions should be closely observed. 5. Long-term use with contraceptives (oral estrogen-containing ones) can reduce the reliability of contraception and increase the chance of extramenstrual bleeding. 6. When used with thrombolytic drugs, their potential toxic effects may be increased. 7. When used in combination with hepatotoxic drugs, the incidence of hepatotoxicity may increase. Such patients, especially those who have been taking the drug for a long time and have a history of liver disease, should be closely monitored. 8. When used in combination with photosensitizing drugs, additive photosensitivity may occur. 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, increasing the risk of crystalluria. 11. This product can replace the plasma protein binding site of phenylbutazone, and the combination of the two can increase the effect of phenylbutazone. 12. Because this product may interfere with the bactericidal effect of penicillins, it is best to avoid using it at the same time with such drugs. 13. When sulfinpyrazone is used in combination with this product, it can reduce the secretion of this product from the renal tubules, resulting in an increase in blood drug concentration and persistent or toxicity. Therefore, the dose of this product may need to be adjusted during or after the use of sulfinpyrazone.

Keep away from light and store in sealed container.

0.5g

24 months

Jinling Pharmaceutical Co., Ltd. Nanjing Jinling Pharmaceutical Factory

• Founded in:

  1996-09-16

• Address:

  No. 58, Xingang Avenue, Nanjing Economic and Technological Development Zone

• Tax NO.:

  9132019270413930XB

• Registered Funds:

  -

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