Instructions

【Ingredients】This product is a compound preparation containing 0.4 g of the active ingredient sulfamethoxazole and 80 mg of trimethoprim. 
【Description】 This product is a white film. 
【Indications】 In recent years, many clinical common pathogens often show resistance to this product. Therefore, the treatment of bacterial infection requires reference to drug susceptibility results. The main indications of this product are the following infections caused by sensitive strains: 
1. Escherichia coli Urinary tract infections caused by Bacillus, Klebsiella, Enterobacter, Proteus mirabilis, Proteus vulgaris and Mogans sensitive strains. 
2. Acute otitis media in children over 2 years old caused by Streptococcus pneumoniae or Haemophilus influenzae. 
3. Acute exacerbation of adult chronic bronchitis caused by Streptococcus pneumoniae or Haemophilus influenzae. 
4. Intestinal infection and Shigella infection caused by the sensitive strain of Shigella or Shigella. 
5. Treatment of Pneumocystis carinii pneumonia, this product is preferred. 
6. Prevention of Pneumocystis carinii pneumonia, may be used in patients with at least one episode of Pneumocystis carinii, or HIV adult infection, CD4 lymphocyte count ≤ 200 / mm3 or less than the total number of lymphocytes 20%. 
7. Tourists with diarrhea caused by enterotoxin-producing Escherichia coli (ETEC). 
【Strength】Sulfamethoxazole 0.4g, trimethoprim 80mg. 
【Usage and Dosage】
1. Commonly used in adults: treatment of bacterial infections, once trimethoprim 160mg and sulfamethoxazole 800mg, taken once every 12 hours. Treatment of Pneumocystis carinii pneumonia once trimethoprim 3.75 ~ 5mg / kg, sulfamethoxazole 18.75 ~ 25mg / g, taken once every 6 hours. Adult preventive medication: initial trimethoprim 160mg and sulfamethoxazole 800mg, 2 times a day, followed by the same dose once a day, or 3 times a week. 
2. Commonly used in children: infants under 2 months are prohibited. For the treatment of bacterial infection, infants and young children weighing less than 40 kg for 2 months or more should be orally administered SMZ20~30mg/kg and TMP4~6mg/kg once every 12 hours; the dose of ≥40kg is the same as that of adults. Treatment of parasitic infections such as Pneumocystis carinii pneumonia, oral administration of SMZ18.75~25mg/kg and TMP3.75~5mg/kg once every 6 hours. The course of acute exacerbation of chronic bronchitis is at least 10-14 days: the course of urinary tract infection is 7-10 days; the course of bacterial dysentery is 5-7 days; the course of acute otitis media in children is 10 days: Pneumocystis carinii pneumonia the treatment is from 14 to 21 days. 
【Adverse Reaction】 
1. Allergic reactions are more common, which can be manifested as drug eruptions. In severe cases, exudative polymorphous erythema, exfoliative dermatitis and bullous epidermis release atrophic dermatitis can also occur; there are also photosensitivity reactions, drug fever, Serum-like reactions such as joint and muscle pain and fever. Occasionally anaphylactic shock. 
2. Neutropenia or deficiency, thrombocytopenia, and aplastic anemia. Patients may present with propensity for sore throat, fever, paleness, and blood stasis. 
3. Hemolytic anemia and hemoglobinuria. This is prone to occur in patients who are deficient in glucose-6-phosphate dehydrogenase after administration of sulfa drugs, and is more common in newborns and pediatrics than in adults. 
4. Hyperbilirubinemia and neonatal jaundice. Since this product competes with bilirubin for protein binding sites, it can cause an increase in free bilirubin. 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, jaundice, liver dysfunction can occur, and severe liver necrosis can occur in severe cases. 
6. Kidney damage, crystallized urine, hematuria and tubular urine can occur; occasionally patients with serious adverse reactions of interstitial nephritis or tubular necrosis. 
7. Nausea, vomiting, decreased appetite, diarrhea, headache, fatigue, etc., the general symptoms are mild. Occasionally, patients develop C. difficile enteritis, and withdrawal is required at this time. 
8. Goiter and hypofunction occasionally occur. 
9. Central nervous system toxicity can occur, manifested as mental confusion, disorientation, hallucinations, euphoria or depression. 
10. Occasionally, aseptic meningitis can occur, with headache, neck stiffness, and nausea. Although the serious adverse reactions caused by this product are rare, they often involve various organs and can be fatal, such as exudative polymorphous erythema, exfoliative dermatitis, bullous epidermis loose atrophic dermatitis, fulminant hepatic necrosis, agranulocytosis Abnormal blood system such as aplastic anemia. The above-mentioned adverse reactions of AIDS patients are more common than those of non-AIDS patients. 
【Contraindications】 
1. Disable allergic to SMZ and TMP. 
2. Because this product prevents the metabolism of folic acid and aggravates the deficiency of folate in patients with megaloblastic anemia, the patient is banned. 
3. Pregnant women and lactating women ban this product. 
4. Infants less than 2 months are prohibited from using this product. 
5. This product is contraindicated in patients with severe liver and kidney dysfunction.
【Precautions】 
1.Because it is not easy to remove bacteria, the following diseases should not be used for treatment or prevention: 
①Prevention or long-term treatment of otitis media. Group 
②A hemolytic streptococcus tonsils and pharyngitis. 
2. Cross-allergic reactions. Patients who are allergic to a sulfa drug may also be allergic to other sulfa drugs. 
3. Liver damage, jaundice, liver function decline, severe liver necrosis can occur, so patients with liver damage should avoid application. 
4. Kidney damage, crystallized urine, hematuria and tubular urine can occur, so you should drink more water during this product to maintain high urine flow. If the application is long and the dose is large, in addition to drinking more water, it should be taken with carbonic acid. Sodium hydrogen to prevent this adverse reaction. 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. 
5. Patients who are allergic to furosemide, sulfone, thiazide diuretics, sulfonylureas, and carbonic anhydrase inhibitors may also be allergic to sulfa drugs. 
6. The following conditions should be used with caution: Lack of glucose-6-phosphate dehydrogenase, blood porphyria, folate deficiency blood system disease, dehydration, AIDS, shock and elderly patients. 
7. During the medication, it is necessary to check: 
①whole blood examination is especially important for patients with long course of treatment, large doses, old age, malnutrition and anti-epileptic drugs. 
② During the treatment, regular urine tests should be performed (Check urine routine once every 2-3 days) to find crystallized urine that may occur during long-term or high-dose treatment. 
③liver and kidney function tests.
8. severe infections should be measured blood concentration, for most patients with infectious diseases free sulfa concentration of 50 ~ 150μg / m (severe infection 120 ~ 150μg / m) can be effective. The total sulfa blood concentration should not exceed 200 μg / ml, if more than this concentration, the incidence of adverse reactions increased. 
9. Do not arbitrarily increase the dose, increase the number of medications or extend the course of treatment to prevent accumulation of poisoning. 
10. Because this product can inhibit the growth of E. coli and interfere with the synthesis of B vitamins in the intestine, if you use this product for more than one week, you should also give vitamin B to prevent its deficiency. 
11. If folic acid deficiency is caused by taking this product, folic acid preparation can be taken at the same time. The latter does not interfere with the antibacterial activity of TMP, because the bacteria cannot utilize the synthesized folic acid. If there is signs of myelosuppression, the product should be discontinued, and intramuscular injection of folic acid 3~6mg should be given once a day for 2 days or as needed until the hematopoietic function returns to normal. For long-term and excessive use of this product, give high doses of folic acid and extend the course of treatment. 
【Pregnant women and lactating women】
1. This product can cross the blood placenta barrier to the fetus, animal experiments found teratogenic effects. There is insufficient information in human studies, and pregnant women should avoid application. 
2. This product can be secreted from the milk. The concentration in the milk can reach 50%~100% of the maternal blood concentration. The drug may affect the baby. This product is used in neonates deficient in glucose-6-phosphate dehydrogenase to cause hemolytic anemia. For the above reasons, lactating women should not use this product. 
【Children's medication】Because this product can compete with bilirubin for binding sites on plasma proteins, and the neonatal acetyltransferase system is not well developed, the concentration of sulfamethoxine is increased, resulting in the risk of nuclear jaundice. The use of such drugs in neonates and infants under 2 months is contraindicated. The child is in the stage of growth and development, the liver and kidney function is still not perfect, and the dosage should be reduced. 
【Geriatric patients】The elderly patients have increased chances of serious adverse reactions when using this product: such as skin anaphylaxis such as severe rash and abnormal blood system such as myelosuppression, leukopenia and thrombocytopenia, and the use of diuretics is more likely to occur. Therefore, elderly patients should avoid using it, and it is decided after weighing the pros and cons. 
【Drug Interactions】 
1. The combination of urinary alkali chemicals can increase the solubility of the product in alkaline urine and increase the excretion. 
2. Can not be combined with p-aminobenzoic acid, p-aminobenzoic acid can be taken up by bacteria instead of this product, and the two antagonize 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, so that the drug action time is prolonged or toxic reactions occur, so when these drugs are applied simultaneously with this product, or in the application The dosage should be adjusted after use. Such drugs include oral anticoagulants, oral hypoglycemic agents, methotrexate, phenytoin, and thiopental. 
4. Combination with myelosuppressive drugs may be reluctant to adversely affect the hematopoietic system. Such as white blood cells, thrombocytopenia, etc., if there are two indications for the same use, the possible toxicity should be closely observed. 
5. Prolonged use with contraceptives (estrogens) can lead to reduced reliability of contraception and increase the chance of bleeding outside menstruation. 
6. When combined with thrombolytic drugs, it may increase its potential toxic effects. 
7. When combined with hepatotoxic drugs, it 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. When combined with a photosensitizing drug, the addition of photosensitivity may occur.
9. The need for vitamin K is increased in patients receiving this product. 
10. It should not be combined with urotropine, because urotropine can be decomposed in acidic urine to produce formaldehyde, which can form insoluble precipitate with this product. Increases the risk of developing crystalline urine. 
11. This product can replace the plasma protein binding site of phenylbutazone, which can enhance the effect of phenylbutazone when used together. 
12. Sulfopyrone can reduce the secretion of the latter from the renal tubule when combined with this product, and its blood concentration is prolonged and prone to toxic reaction. Therefore, it may need to be adjusted during the application of sulfinpyrazone or after application of its treatment. Dosage. When the sulfopirone treatment is long, the blood concentration of the product should be monitored to help adjust the dosage and ensure safe medication. 
13. TMP in this product can inhibit the metabolism of warfarin and enhance its anticoagulant effect. 
14. TMP combined with cyclosporine in this product can increase nephrotoxicity. 
15. When rifampicin is combined with this product, it can obviously increase the TMP clearance and shorten the serum half-life in this product. 
16. It is not advisable to use it together with anti-tumor drugs, 2,4-diaminopyrimidine drugs, or between the treatments with other folic acid antagonists, because of the possibility of poor bone marrow regeneration or megaloblastic anemia. 
17. It should not be combined with dapsone, because the concentration of dapsone in combination with TMP in this product can be increased, and the increase in the concentration of dapsone increases and worsens the adverse reactions, especially methemoglobinemia. happened. 
18. Avoid use with penicillin drugs, as this product may interfere with the bactericidal effect of such drugs. 
【Drug overdose】The blood solubility of this product should not exceed 200μg/ml. Above this concentration, the incidence of adverse reactions is increased and the toxicity is enhanced. Excessive short-term use of this product may cause loss of appetite, abdominal pain, nausea, vomiting, dizziness, headache, lethargy, confusion, depression, fever, hematuria, crystallized urine, blood diseases, jaundice, bone marrow suppression. The general treatment is gastric lavage, vomiting or heavy drinking after stopping the drug; when the urine output is low and the renal function is normal, the treatment can be given. Blood, electrolytes, etc. should be detected during the treatment. If there is a more obvious adverse reaction of the blood system or jaundice, hemodialysis should be given. If the bone marrow is inhibited, the drug should be stopped first, and the folic acid 3-6 mg intramuscular injection should be given once a day for 3 days or until the hematopoietic function returns to normal. Long-term overdose of this product can cause bone marrow suppression, resulting in the reduction of platelets, white blood cells and megaloblastic anemia. In the case of myelosuppression, the patient should be treated with intramuscular injection of 5-15 mg of leucovorin per day until the hematopoietic function returns to normal.
【Pharmacology and Toxicology】 This product is a sulfa antibiotic. It is a combination of sulfamethoxazole (SMZ) and trimethoprim (TMP). It is a non-producing strain of Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae. , Escherichia coli, Klebsiella, Salmonella, Proteus, Morganella, Shigella and other Enterobacteriaceae bacteria, Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae have good The antibacterial effect, especially for Escherichia coli, Haemophilus influenzae, and Staphylococcus aureus, is significantly stronger than that of SMZ alone. In addition, it also has good antimicrobial activity against Chlamydia trachomatis, N. sphaeroides, Protozoa, Toxoplasma, and the like in vitro. The mechanism of action of this product is: SMZ acts on dihydrofolate synthetase, interferes with the first step of synthesizing folic acid, TMP acts on the second step of folate anabolism, and selectively inhibits the action of dihydrofolate reductase. The folate metabolism of bacteria is double blocked. The synergistic antibacterial effect of this product is stronger than that of single drug, and the drug resistant strain is reduced. However, in recent years, the resistance of bacteria to this product has also increased. 
【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 dose. The peak plasma concentration (Cmax) is reached 1 to 4 hours after taking the drug. TMP160mg and SMZ800mg were administered twice a day. After 3 days, the steady-state plasma concentration was reached. The 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. After a single oral administration, 84.5% of the total amount of SMZ was excreted from the urine within 0 to 72 hours, of which 30% was free sulfonamide including metabolites; TMP was leached 66.8% in the form of free drug. 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 and stored. 
【Package】Packed in medicinal plastic bottles, 100 tablets per bottle. 
【The shelf life】36 months 
【Executive Standard】Chinese Pharmacopoeia(2015) Volume Ⅱ.
【Approval No.】GYZZ H35020603 
【Manufacturer】Fujian Pacific Pharmaceutical Co., Ltd.