Compound Sulfamethoxazole Tablets for Acute Otitis Media in Children Over 2 Years Old Caused by Streptococcus Pneumoniae or Haemophilus Influenzae

• Transport Package: Carton
• Specification: 20x15x15cm
• Trademark: FUL
• Origin: China
• Model NO.: CF044-1
• Production Capacity: 100000/Month

Product Description

[Drug name] General name: Cotrimoxazole Tablets

Product name: Compound sulfamethoxazole tablets

Compound Sulfamethoxazole Tablets

Chinese pinyin: CompoundSulfamethoxazoleTablets

[Ingredients] Each tablet of this product should contain 0.360-0.440g sulfamethoxazole (C10H11N3O3S) and 72.0-88.0mg trimethoprim (C14H18N4O3)

Properties This product is white tablet.

[Indications] This product is a white tablet. In recent years, many common clinical pathogenic bacteria often show drug resistance to this product, so the treatment of bacterial infection should refer to the drug sensitivity results, the main indications of this product are the following infections caused by sensitive strains: 1. Urine tract infections caused by sensitive strains of Escherichia coli, Klebsiella, Enterobacteria, Proteus singular, Proteus common, and Morhizobacteria. 2. Acute otitis media in children over 2 years old caused by Streptococcus pneumoniae or Haemophilus influenzae. Acute onset of chronic bronchitis in adults caused by Streptococcus pneumoniae or Haemophilus influenzae. 4. Intrinal infection and Shigella infection caused by susceptible strains of Shigella flexneri or Shigella songii. 5. For the treatment of pneumocystis carinii pneumonia, this strain is the first choice. 6. For the prevention of pneumocystis carinii pneumonia, it is advisable to have at least one episode of pneumocystis carinii

[Usage and Dosage] 1. For adult bacterial infections, trimethoprim 160mg once and sulfamethoxazole 800mg once, once every 12 hours. For the treatment of pneumocystis carinii pneumonia, trimethopridine 3.75-5mg /kg and sulfamethoxazole 18.75-25mg /kg were given once every 6 hours. Prophylaxis for adults: Trimethoprim 160mg and sulfamethoxazole 800mg twice a day, followed by the same dose once a day or 3 times a week. 2. The usual dosage for children is prohibited for infants less than 2 months. For the treatment of bacterial infection, infants over 2 months old weighing less than 40kg were given SMZ 20 ~ 30mg/kg and TMP 4 ~ 6mg/kg orally once per body weight, once every 12 hours; The dose for children with body weight ≥40kg is the same as the usual dose for adults. To treat parasitic infections such as pneumocystis carinii pneumonia, oral administration of SMZ 18.75-25mg /kg and TMP 3.75-5mg /kg once per body weight, once every 6 hours. Chronic bronchitis acute attack of treatment at least 10 to 14 days; The course of treatment for urinary tract infection was 7 ~ 10 days. The course of bacterial dysentery was 5 to 7 days. The treatment course of acute otitis media in children was 10 days. The course of treatment for Pneumocystis carinii pneumonia is 14 to 21 days.

[Adverse Reactions] 1. Allergic reactions are relatively common, which can be manifested as drug eruption. In severe cases, erythema multiforme exudative, dermatitis exfoliative and epidermolytic atrophic dermatitis bullous may occur. Also have performance for photosensitive reaction, drug heat, joint and muscle pain, fever and other serum disease like reaction. Occasionally anaphylactic shock. 2. Neutropenia or deficiency, thrombocytopenia and aplastic anemia. Patients may present with sore throat, fever, pallor, and bleeding tendencies. Hemolytic anemia and hemoglobinuria. This is more common in newborns and children than in adults after sulfonamides are used in patients with glucose-6-phosphate dehydrogenase deficiency. Hyperbilirubinemia and neonatal nuclear jaundice. Because this product and bilirubin competition protein binding site, can cause free bilirubin increase. Neonatal liver function is not perfect, the treatment of bilirubin is poor, it is easy to produce high bilirubinemia and neonatal jaundice, occasionally can produce nuclear jaundice. 5. Liver damage. Jaundice, liver dysfunction and acute liver necrosis may occur in severe cases. 6. Kidney damage. Crystalline urine, hematuria and tubular urine may occur. Severe adverse effects of interstitial nephritis or tubular necrosis were occasionally observed. 7. Nausea, vomiting, stomach deficiency, diarrhea, headache, fatigue, etc., the general symptoms are mild. Occasionally, patients develop C. difficile enteritis, at which point medication should be discontinued. 8. Goitre enlargement and hypofunction occur occasionally. 9. Toxic reactions of the central nervous system may occasionally occur and manifest as delirium, disorientation, hallucinations, euphoria, or depression. 10. Occasionally aseptic meningitis may occur, with headache, stiff neck, nausea and other manifestations. Although the 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, bullae epidermolytic atrophic dermatitis, fulminant hepatic necrosis, granulocytosis, aplastic anemia and other blood system abnormalities. AIDS patients with the above adverse reactions are more common than non-AIDS patients.

1. It is contraindication for people allergic to SMZ and TMP; 2. This product is contraband in patients with megaloblastic anemia because it prevents the metabolism of folate and aggravates the deficiency of folate. 3. Pregnant women and lactating women are prohibited from using this product. 4. This product is contraindicated for infants under 2 months old. 5. People with severe liver and kidney function damage should not use this product.

1. It is forbidden for people allergic to SMZ and TMP; 2. This product is contraband in patients with megaloblastic anemia because it prevents the metabolism of folate and aggravates the deficiency of folate. 3. Pregnant women and lactating women are prohibited from using this product. 4. This product is contraindicated for infants under 2 months old. 5. People with severe liver and kidney function damage should not use this product.

[Special population medication] Children:

Because this product can compete with bilirubin in the binding site of plasma protein, and neonatal acetyl transferase system is not fully developed, sulfonamide free blood concentration increased, so that increased the risk of nuclear jaundice, so the application of this kind of drug in neonates and infants under 2 months is contraindicated. Children in the growth period, liver and kidney function is not perfect, the dosage should be reduced.



Precautions during pregnancy and lactation:

1. This product can pass through the blood placenta barrier to the fetus body, animal experiments have been found to have teratogenic effect. Studies in humans lack sufficient data and should be avoided by pregnant women. 2. This product can be secreted from the milk, the concentration in the milk can reach about 50% ~ 100% of the maternal blood drug concentration, the drug may have an effect on the baby. This product in the glucose -6- phosphate dehydrogenase deficiency in the newborn application may lead to hemolytic anemia. For the above reasons, lactating women should not use this product.

 

Precautions for the elderly:

Elder patients are more likely to have serious adverse reactions when using this product, such as severe skin rash and other skin allergic reactions and blood system abnormalities such as myelosuppression, leucopenia and thrombocytopenia, which are more likely to occur when using diuretics at the same time. Therefore, it should be avoided in elderly patients, and the decision should be made after weighing the advantages and disadvantages when there are definite indications.

[Drug interaction] 1. The combination of uretic alkalinizing drugs can increase the solubility of this product in alkaline urine and increase excretion. 2. Can not be used with p-aminobenzoic acid, p-aminobenzoic acid can be taken in place of this product by bacteria, the two antagonize each other. 3. When the following drugs are used together with this drug, this drug may replace the protein binding site of these drugs or inhibit their metabolism, resulting in prolonged action or toxic reactions. Therefore, the dosage of these drugs should be adjusted when they are used together with or after the application of this drug. These include oral anticoagulants, oral hypoglycemic agents, methotrexate, phenytoin sodium, and thiopental sodium. 4. Combined use with myelosuppressive drugs may enhance adverse reactions of such drugs to the hematopoietic system. For example, leukopenia, thrombocytopenia, etc., if there are indications that two drugs need to be used together, the possible toxic reactions should be closely observed. 5. Combined with birth control pills (estrogen type) for a long time can reduce the reliability of contraception and increase the chance of bleeding during menstruation. 6. When used in combination with thrombolytic drugs, their potential toxic effects may be increased. 7. When combined with hepatotoxic drugs, it may increase the incidence of hepatotoxicity. Liver function should be monitored in such patients, especially those who have been on medication for a long time and have a history of liver disease. 8. When combined with photosensitive drugs, the addition of photosensitive effects may occur. 9. Patients receiving this product have an increased need for vitamin K. 10. It is not suitable to use with Ulotropine, because Ulotropine can be decomposed in acidic urine to produce formaldehyde, which can form insoluble precipitate with this product. This increases the risk of crystallizing urine. 11. This product can replace the plasma protein binding site of butazone. When used together, the effect of butazone can be enhanced. 12. When used in combination with this product, it can reduce the secretion of the latter from the renal tubules, and the persistent increase of its blood concentration is prone to toxic reactions. Therefore, it may be necessary to adjust the dosage of this product during or after the application of this product. When the course of sulfonyrone is longer, the blood concentration of this product should be monitored to help adjust the dose and ensure safe use of the drug. 13. TMP in this product can inhibit the metabolism of warfarin and enhance its anticoagulant effect. 14. TMP in this product can increase renal toxicity when used in combination with cyclosporine. 15. Rifampicin can obviously increase the clearance of TMP and shorten the half-life of serum when used in combination with this product. 16. It should not be used in combination with antitumor agents, 2, 4-diaminopyrimidines, or between courses of other folate antagonists because of the potential for poor bone marrow regeneration or megaloblastic anemia. 17. Dapsone is not suitable to be used in combination with the TMP in this product because the blood concentration of both dapsone and the TMP in this product can be increased, and the increase of dapsone concentration will increase and aggravate adverse reactions, especially the occurrence of methemoglobinemia. 18. Avoid combination with penicillin drugs, as this product may interfere with the bactericidal action of such drugs.

[Pharmacological Effects] This product is a sulfamethoxazole antibacterial drug, a compound preparation of sulfamethoxazole (SMZ) and trimethoprim (TMP). It has a good antibacterial effect on non-enzymolytic Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Klebsiella, Salmonella, Proteus, Morganella, Shigella and other Enterobacteriaceae bacteria, Neisseria meningitidis, and Haemophilus influenzae. In particular, the antibacterial effect of SMZ on Escherichia coli, Haemophilus influenzae and Staphylococcus aureus was significantly stronger than SMZ single drug. In addition, it also had good anti-microbial activity against Chlamydia trachomatis, Nucardia stellaris, protozoa and Toxoplasma gondii. The mechanism of the product is as follows :SMZ acts on dihydrofolate synthetase and interferes with the first step of folic acid synthesis, while TMP acts on the second step of folic acid synthesis and selectively inhibits the action of dihydrofolate reductase. The combination of the two can double block folic acid metabolism of bacteria. The synergistic antibacterial effect of this product is stronger than that of single drug, and the strain showing resistance to it is reduced. However in recent years the resistance of bacteria to this article also shows a trend of increase.

[storage] shading, sealed storage.

[Specification] Sulfamethoxazole 0.4g, Trimethoprim 80mg.

[Packing specification] 45 pieces/box.

[Validity] 24 months

[Approval Number] National medicine approval H23021891



FAQ
1.who are we?
We are based in Fujian, China, start from 2000,sell to North America(40.00%),Southeast Asia(25.00%),Western Europe(25.00%),Africa(10.00%).There are total about 50 people in our office.

2. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;

3.what can you buy from us?
Pharmaceutical production lines,Intermediates,APIs,Finished Drug Preparations & Vaccines.

4. why should you buy from us not from other suppliers?
We have our own manufacture factories and one professional sales team working for the clients all over the world.

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5. After-sales service 24 hours
6. Competitive advantage products
7. Our value information is "Quality is our culture"
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Our Service
a)  Free amples can be provided.
b) Guide customers through professional technology and teach them how to use our products after sale
c) Determine the lowest price of high-quality products
1. Skilled experience: Our company is a leading manufacturer of professional production in China pharmaceutical field for many years.
2. The highest quality: to ensure high quality, once any problems are found, the package will be re-shipped for you.
3. Safe transportation: by air express (FedEx, UPS, DHL, EMS). It is recommended that you choose the most professional freight forwarder.
4. Fast delivery: We have stock, so once payment is received, we can deliver quickly.
5. Quality service: We will provide you with enthusiastic after-sales service. If you have any questions, we will reply to youwithin 24 hours.
6. Competitive price: discounts will be obtained when making large orders.

Our Manufacture Factory
Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.

Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd business radiates to all levels, including direct supply cooperation with government departments and industry representatives, as well as establishing supply cooperation relationship with retail industry. We supply high quality, safe and effective medicines and medical equipment to governments, hospitals, clinics and licensed pharmacies in different countries with timely and effective services at reasonable prices.

At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the SINOPHARM authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.


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