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Thiamphenicol enteric-coated tablets

Product description
Approval date: November 09, 2007
 
Date of revision: September 30, 2010
 
          November 30, 2015
 
Thiamphenicol enteric-coated tablets
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
Common name: Thiamphenicol enteric-coated tablets
English name: Thiamphenicol Enteric-coated Tablets
Chinese Pinyin: Jiafengmeisu Changrongpian
 
[Ingredients] The main ingredient of this product is: Thiamphenicol. Its chemical name is: [R-(R*,R*)]N-[1-(hydroxymethyl)-2-hydroxy-2-[4-(methylsulfonyl)phenyl]ethyl]-2 , 2-dichloroacetamide.
 
Molecular formula: C12H15Cl2NO5S
 
Molecular weight: 356.23
 
【Properties】 This product is an enteric film-coated tablet, which is white after removing the coating.
 
[Indications] For infections such as respiratory tract, urinary tract, and intestinal tract caused by sensitive bacteria such as influenza bacillus, Escherichia coli, and Salmonella.
[Specification] 0.25g
 
[Usage and dosage] Oral. Adults 0.25 ~ 0.5g (1 ~ 2 tablets), 3 to 4 times a day, the dose of severe infections doubled; children by weight 25 ~ 50mg / Kg a day, divided into 4 times.
 
【Adverse reactions】
1. Digestive tract reactions such as abdominal pain, diarrhea, nausea, and vomiting may occur, and the incidence rate is below 10%.
2. Occasionally, allergic reactions such as rash.
3. No "grey-infant syndrome" has been found in premature infants and newborns. Only a few cases reported transient skin and pale complexion.
4. This product can cause toxicity of the hematopoietic system, mainly manifested as reversible inhibition of erythropoiesis, leukopenia and thrombocytopenia; rare with aplastic anemia.
 
5. Central nervous system reactions are mainly manifested by headache, lethargy, dizziness and peripheral neuritis. Long-term treatment with thiamphenicol in patients with neurological diseases can cause symptoms such as tactile sensation, sensory pain and hyperalgesia. The foot symptoms are more severe than the hands, and can be improved after stopping the drug, but not fully recovered.
 
[Contraindications] Disabled for allergic to any component of this product.
 
【Precautions】
1. Patients should regularly check the surrounding blood in the course of treatment. Long-term treatment should regularly check the number of reticulocytes and detect the occurrence of adverse reactions in the blood system.
2. After administration of renal insufficiency, thiamphenicol excretion is reduced, and there is a tendency to accumulate in the body, which should be used with caution and reduced.
 
3. Patients with hematopoietic dysfunction should be used with caution.
 
4. If you have any adverse events and/or adverse reactions during the use of this product, please consult your doctor.
 
5. Please let your doctor know if you are using other medicines at the same time.
 
6. Please keep out of reach of children.
 
[Pregnant women and lactating women]
Women should be avoided during pregnancy, especially in late pregnancy or childbirth. Lactation should be suspended during lactation.
 
[Children's medication]
Because the liver enzyme system is not mature, the function of renal excretion is poor, and the drug is slower than renal excretion. Therefore, this product is suitable for neonates, which may lead to excessive blood concentration and toxicity (grey infant syndrome). Newborns should be avoided.
 
[Geriatric medication] is not clear.
 
【medicine interactions】
 
1. Antiepileptic drugs (hydantoin). Because this product can inhibit the activity of hepatocyte microsomal enzymes, lead to the reduction of the metabolism of such drugs, or replace the serum protein binding sites of such drugs, can enhance the effect of drugs or increase toxicity, so when used in conjunction with this product or The dosage of such drugs must be adjusted for subsequent application.
 
2. When combined with a hypoglycemic agent (such as tolbutamide), the protein binding site is replaced, which can enhance its hypoglycemic effect, so the dosage of the drug needs to be adjusted. The nonionic binding characteristics of glipizide and glibenclamide make it less affected than other oral hypoglycemic agents, but caution should be exercised when used together.
3. Long-term oral contraceptives containing estrogen, such as taking this product at the same time, can reduce the reliability of contraception and increase the bleeding outside menstruation.
4. Since the product may have the action of a vitamin B6 antagonist or increase the renal excretion of the latter, resulting in the occurrence of anemia or peripheral neuritis, the need for the former is increased when the vitamin B6 is combined with the product.
5. Chloramphenicol can antagonize the hematopoiesis of vitamin B12, so it is not advisable to use them together.
6. When combined with certain myelosuppressive drugs, it can enhance myelosuppressive effects. Antitumor drugs, colchicine, hydroxybutazone, phenylbutazone and penicillamine are all such drugs. Simultaneous radiotherapy can also enhance myelosuppressive effects, and the dose of myelosuppressant or radiation therapy must be adjusted.
7. If this product is used before or during surgery, it can reduce the clearance of the induced anesthetic afentanil and prolong its action time due to its inhibitory effect on liver enzymes.
8. When phenobarbital and rifampicin liver drug enzyme inducer are used together with this product, the metabolism of the product can be enhanced, and the blood concentration of thiamphenicol is lowered.
9. Lincomycin can replace or prevent the binding of this product to the 50S subunit of bacterial ribosome, and the two can be used together for antagonism, so it is not suitable for joint application.
 
[Drug overdose] is not clear.
 
【Pharmacology and Toxicology】
 
This product is a similar substance of chloramphenicol. Its antibacterial spectrum and antibacterial effect are similar to those of chloramphenicol. It has a broad-spectrum antimicrobial effect in vitro, including aerobic Gram-negative bacteria and Gram-positive bacteria, anaerobic bacteria, and ricketts. Genus, spirochete and chlamydia. Bactericidal effects on the following bacteria: influenza bacillus, Streptococcus pneumoniae and Neisseria meningitidis. Only bacteriostatic effect on the following bacteria: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Group B Streptococcus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Salmonella typhi, Paratyphoid Anaerobic bacteria such as bacteria, Shigella, and Bacteroides fragilis. This product does not bind to glucuronic acid in the liver, so it has higher activity in vivo. This product is completely cross-resistant to chloramphenicol.
 
This product is a bacteriostatic agent. It can diffuse into bacterial cells and reversibly bind to the 50S subunit of bacterial ribosomes, hindering the growth of peptide chains (possibly due to inhibition of transpeptidase), thus inhibiting the formation of peptide chains, thereby preventing proteins Synthesis. In addition, this product also has a strong immunosuppressive effect.
 
【Pharmacokinetics】
 
After oral administration, the product was quickly and completely absorbed. After oral administration of 0.4 g, the plasma concentration peak time (Tmax) was 2 hours, and the peak plasma concentration (Cmax) was 4 mg/L. The protein binding rate was 10%. After absorption, the tissue is widely distributed in the body, and the content in the kidney, spleen, liver, lung and other organs is more. The blood elimination half-life (t1/2β) was 1.5 hours. This product is mainly excreted from the kidney by the original drug, and is discharged from the urine for 70% to 90% in 24 hours. Some of it is excreted from the bile, and the concentration in the bile can be several times of the blood concentration. Thiamphenicol is not metabolized in the body, so the blood concentration is not affected when liver function is abnormal.
 
[Storage] shading, sealing, and storing in a dry place (10 ~ 30 ° C).
 
[Packing] Aluminum-plastic packaging, 6 pieces per box; 12 pieces per box.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 edition of the second and the State Food and Drug Administration standard YBH03632007
[Approval No.] National Drug Standard H20073858
【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: 0750-2789348 2783621
 
400-8899-328 (National Service Phone)
 
    Fax number: 0750-2789348
 
Website: http://www.pdpharm.com
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