Details
Date of approval: January 29, 2007
Sulfonidine yellow tablets instructions
Please read the instructions carefully and use them under the guidance of a physician.
【Drug Name】
Common name: sulfonidine ice tablets
English name: Sulfmethoxazole, Trimethoprim, Boneol and Artificial Cow-bezoar Tablets
Chinese Pinyin: Huang Ding Bing Huang Pian
[Ingredients] This product is a compound preparation, the components are: each tablet contains sulfamethoxazole 300mg, trimethoprim 60mg, artificial bezoar 30mg, borneol 5mg.
【Properties】
This product is a light orange yellow piece.
[indications]
For tonsillitis, bronchitis, enteritis, dysentery, urinary tract infections, etc.
【Dosage】
oral.
1 to 2 tablets at a time, 2 times a day.
【Adverse reactions】
1. Adverse reactions of sulfamethoxazole
(1) allergic reactions are more common, can be manifested as drug eruption, severe exudative polymorphous erythema, exfoliative dermatitis and bullous epidermis loose atrophic dermatitis; also manifested as photosensitivity, drug fever, joints and muscles A serum-like reaction such as pain and fever.
(2) neutropenia or deficiency, thrombocytopenia, and aplastic anemia. Patients may present with sore throat, fever, paleness, and bleeding tendency. Therefore, when the systemic application of sulfa drugs should be regularly checked for peripheral blood, abnormal and timely withdrawal.
(3) hemolytic anemia and hemoglobinuria. Patients with glucose-6-phosphate dehydrogenase are prone to occur after sulfa drug use, and are more common in adults and children than adults.
(4) hyperbilirubinemia and neonatal jaundice. Since sulfa drugs compete with bilirubin for protein binding sites, free bilirubin can be increased. Neonatal liver function is imperfect, poor treatment of bilirubin, it is more likely to occur hyperbilirubinemia and neonatal jaundice, and even nuclear jaundice can occur.
(5) Liver damage. May cause jaundice, liver dysfunction, severe acute liver necrosis can occur. Therefore, patients with liver damage should avoid the systemic application of sulfa drugs.
(6) Kidney damage. Crystalline urine, hematuria, and tubular urine can occur. If the application of this product is long, the dosage should be the same as taking sodium bicarbonate and drinking more water to prevent this adverse reaction. During the treatment, the urine routine is checked at least 2 to 3 times a week. If crystal urine or hematuria is found, sodium bicarbonate is given and a large amount of water is consumed until the crystal urine and hematuria disappear. Loss of water, shock and elderly patients with this product is prone to kidney damage, should be used with caution or avoid the application of this product. This product should not be used in patients with renal dysfunction. Occasionally, patients have serious adverse reactions of interstitial nephritis or tubular necrosis.
(7) nausea, vomiting, decreased appetite, diarrhea, headache, fatigue, etc., the general symptoms are mild, does not affect the continued use of drugs. Occasionally, patients develop C. difficile enteritis, and withdrawal is required at this time.
(8) Goiter and dysfunction occur occasionally.
(9) Central nervous system toxic reactions can occur, manifested as mental confusion, disorientation, hallucinations, euphoria or depression. Once it appears, it needs to be stopped immediately.
Serious adverse reactions caused by sulfa drugs are rare, but can be fatal, such as exudative polymorphous erythema, exfoliative dermatitis, bullous epidermis atrophic dermatitis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia Wait for the blood system to be abnormal. Treatment should be closely observed, and should be discontinued immediately when the early signs of rash or other reactions appear. The above-mentioned adverse reactions of AIDS patients are more common than those of non-AIDS patients.
2. Adverse reactions of trimethoprim
(1) Due to the interference of this product on folic acid metabolism, adverse reactions of the blood system may occur, and leukopenia, thrombocytopenia or methemoglobinemia may occur. Generally, white blood cells and thrombocytopenia are mild, and timely withdrawal may be expected to be resumed, and folic acid preparation may also be added.
(2) Allergic reactions, itching, rash, and even exudative polymorphous erythema.
(3) gastrointestinal reactions such as nausea, vomiting, diarrhea, and mild symptoms.
(4) Occasionally, aseptic meningitis can occur, with headache, neck stiffness, and nausea.
Compound sulfamethoxazole can cause anaphylactic shock. Older people are more likely to have severe skin allergic reactions and abnormal blood system when using this product, and those who use diuretics are more likely to occur.
[taboo]
Infants under 1.2 months are prohibited.
2. Severe renal impairment is prohibited.
3. Disabled for those who are allergic to sulfa drugs.
4. Patients with megaloblastic anemia are banned.
【Precautions】
1. Sulfamethoxazole
(1) Cross-allergic reactions. Patients who are allergic to a sulfa drug may also be allergic to other sulfa drugs.
(2) Patients who are allergic to furosemide, sulfone, thiazide diuretics, sulfonylureas, carbonic anhydrase inhibitors may also be allergic to sulfa drugs.
(3) Sulfonamide drugs can cross the blood placenta barrier to the fetus, and the effects of such drugs on the fetus are still lacking in human studies. In animal experiments, sulfamethoxazole was found to have teratogenic effects, mainly as cleft palate. However, there is a lack of sufficient information in human studies, but it may be more beneficial than harm when used in humans. However, in the perinatal period, sulfa drugs may cause neonatal jaundice, so it is not suitable for application.
(4) The sulfa drug can be secreted from the milk. The concentration in the milk can reach 50% to 100% of the maternal blood concentration. The drug may affect the baby. The use of sulfa drugs in neonates deficient in glucose-6-phosphate dehydrogenase has the potential to cause hemolytic anemia. For the above reasons, lactating women should not use this product.
(5) In children, sulfa drugs are used as adjuvants for pyrimethamine to treat congenital toxoplasmosis. The use of such drugs in neonates and infants under 2 months is contraindicated. Since sulfa drugs compete with bilirubin for binding sites on plasma proteins, and the neonatal acetyltransferase system is not well developed, the concentration of sulfamethoxine is increased, which increases the risk of nuclear jaundice.
(6) In the elderly, elderly patients have an increased chance of developing serious adverse reactions with sulfa drugs. Such as severe rash, myelosuppression and thrombocytopenia are common in severe adverse reactions in the elderly. Therefore, elderly patients should avoid the application, and it is necessary to weigh the pros and cons after the indication.
(7) The following conditions should be used with caution: Lack of glucose-6-phosphate dehydrogenase, liver damage, blood porphyria, and renal dysfunction.
(8) Drink more water during the application of sulfa drugs, maintain high urine flow, to prevent the occurrence of crystallized urine, and if necessary, take medicine to alkalinize urine.
(9) Pay attention to the examination during treatment:
1 whole blood examination is especially important for patients who receive a longer course of treatment;
2 regular urine examination during treatment (1 urine every 2 to 3 days) to find crystal urine that may occur during long course or high dose treatment;
3 liver and kidney function tests.
2. Trimethoprim
(1) This product can cross the blood placenta barrier, although the application of this drug has not been confirmed to have teratogenic effects in humans, but because TMP has teratogenic effects on rats and rabbits, its mechanism of action is to interfere with folate metabolism, in fetal circulation and The drug concentration in amniotic fluid is close to the maternal blood concentration, so this product must be weighed against the pros and cons during pregnancy to decide whether to use the drug.
(2) This product can be secreted into milk, its concentration is high, and the drug may interfere with the folate metabolism of breast-fed infants. Therefore, although the problem has not been confirmed in humans, the application of this product to the lactating mother must be weighed against the pros and cons. Whether to take medicine.
(3) This product should not be used in premature infants and newborns.
(4) The following conditions should be used with caution: liver function damage, megaloblastic anemia due to folic acid deficiency or other blood system diseases, renal damage.
(5) Peripheral blood test should be performed regularly during the course of medication. Folic acid deficiency is prone to occur in patients with long course of treatment, large doses, old age, malnutrition and taking anti-epilepsy. For example, white blood cells or platelets in peripheral blood have been significantly reduced. Discontinue this product.
[Pregnant women and lactating women]
Sulfonamides can cross the blood placental barrier to the fetus, and the effects of such drugs on the fetus are lacking in research in humans. In animal experiments, this product has been found to have teratogenic effects, and in the perinatal period, sulfa drugs may cause neonatal jaundice, so this product must be weighed against the pros and cons during pregnancy to determine whether to take the drug.
This product can be secreted into the milk, its concentration is high, the drug may have an impact on the baby. The use of sulfa drugs in neonates deficient in glucose-6-phosphate dehydrogenase has the potential to cause hemolytic anemia. For the above reasons, lactating women should not use this product.
[Child medication] See adverse reactions, contraindications, precautions.
[Geriatric Use]
Older patients have an increased chance of developing serious adverse reactions with sulfa drugs. Such as severe rash, myelosuppression and thrombocytopenia are common in severe adverse reactions in the elderly. Therefore, elderly patients should avoid the application, and it is necessary to weigh the pros and cons after the indication.
【medicine interactions】
1. Sulfamethoxazole
(1) Simultaneous application of urinary alkali chemicals can enhance the solubility of sulfa drugs in alkaline urine and increase excretion.
(2) p-aminobenzoic acid can be taken up by bacteria instead of sulfonamide, thus antagonizing the bacteriostatic action of sulfa drugs, and the two should not be used together.
(3) When the following drugs are used together with sulfa drugs, the latter can replace the protein binding sites of these drugs, or inhibit their metabolism, so that the drug action time is prolonged or toxicity occurs, so when these drugs are applied simultaneously with sulfa drugs, or in the application of sulfonamides The dose should be adjusted after use. Such drugs include oral anticoagulants, oral hypoglycemic agents, methotrexate, phenytoin, and thiopental.
(4) Simultaneous application of myelosuppressive drugs and sulfa drugs may enhance the adverse reactions of such drugs to the hematopoietic system. If there are two types of drugs to be used together, the toxic reactions that may occur should be closely observed.
(5) contraceptives (orally containing estrogens), while prolonged application of sulfa drugs can lead to reduced reliability of contraception and increase the chance of menstrual bleeding.
(6) When a thrombolytic drug is used together with a sulfa drug, it may increase its potential toxic effects.
(7) The simultaneous application of hepatotoxic drugs and sulfa drugs may cause an increase in the incidence of hepatotoxicity. Liver function should be monitored in such patients, especially those who have been taking longer medications and have a history of liver disease.
(8) The simultaneous application of light-sensitive drugs and sulfa drugs may result in the addition of light sensitivity.
(9) The need for vitamin K is increased in those receiving sulfa drugs.
2. Trimethoprim
(1) When the bone marrow inhibitor is used together with this product, the chance of leukopenia and thrombocytopenia increases.
(2) The concentration of dapsone and the same product can be increased, and the increase of the concentration of dapsone can increase and increase the adverse reactions, especially the occurrence of methemoglobinemia.
(3) This product should not be used simultaneously with anti-tumor drugs, 2,4-diaminopyrimidine drugs, and should not be applied between the treatments with other folic acid antagonists because of poor bone marrow regeneration or giant red blood cells. The possibility of anemia.
(4) The simultaneous application of rifampicin and this product can significantly increase the clearance of the latter and shorten the serum half-life.
(5) It can increase nephrotoxicity when used together with cyclosporin.
(6) This product can interfere with intrahepatic metabolism of phenytoin, increase the half-life (t1/2) of phenytoin by 50%, and reduce its clearance rate by 30%.
(7) Procainamide, in combination with trimethoprim, can reduce renal clearance in the former, resulting in an increase in the blood concentration of the drug and its metabolite, NAPA.
(8) Warfarin, trimethoprim can inhibit the metabolism of the drug and enhance its anticoagulant effect.
[Drug overdose] is not clear.
【Pharmacology and Toxicology】
Sulfamethoxazole (SMZ) and trimethoprim (TMP) have synergistic bacteriostatic or bactericidal effects because sulfa drugs act on dihydrofolate synthetase, interfering with the first step of synthesizing folic acid, while trimethoprim acts on folic acid The second step of anabolism selectively inhibits dihydrofolate reductase, so the combination of the two can double block the bacterial folate metabolism. The synergistic antibacterial effect of the two is enhanced compared with the single drug application, and the resistant strain is reduced.
【Pharmacokinetics】
The SMZ and TMP in this product are completely absorbed from the gastrointestinal tract after oral administration, and can absorb more than 90% of the administered amount. The peak plasma concentration (Cmax) was reached 1 to 4 hours after administration. TMP 160 mg and SMZ 800 mg were administered twice a day. After 3 days, the stable plasma concentration was reached. TMP was 1.72 mg/L. The plasma free concentration and total concentration of SMZ were 57.4 mg/L and 68.0 mg/L, respectively. Both SMZ and TMP were mainly secreted from glomerular filtration and renal tubules, and the concentration of urine was significantly higher than the plasma concentration. 84.5% of the total amount of SMZ was excreted from the urine within 0-72 hours after oral administration in a single dose, of which 30% were metabolites and free sulfonamides; TMP was discharged 66.8% in free form. The excretion process of both SMZ and TMP does not affect each other. The blood elimination half-life (t1/2β) of SMZ and TMP was 10 hours and 8-10 hours, respectively. In patients with renal dysfunction, the half-life was prolonged and the dose was adjusted. Both can be widely distributed into whole body tissues and body fluids such as sputum, middle ear fluid, and vaginal secretion after absorption. It can penetrate the blood-cerebrospinal fluid barrier to reach therapeutic concentrations. It can also cross the blood placental barrier, enter the fetal blood circulation and can be secreted into the milk.
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
[Packing] Aluminum-plastic packaging, 7 pieces per box; 14 pieces per box; 24 pieces per box.
[Validity Period] tentatively 24 months
[Executive Standards] Local Standards for Chemicals Rise National Standards Volume 8 WS-10001-(HD-0778)-2002
[Approval No.] National Drug Standard H44024482
【manufacturer】
Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal code: 529331
Phone number: (0750) 2787017
Fax number: (0750) 2787017
Website: http://www.pdpharm.com
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