Chloramphenicol Injection

This product has a broad-spectrum antimicrobial effect in vitro, including aerobic Gram-negative and Gram-positive bacteria, anaerobes, Rickettsia, spirochetes and Chlamydia. It has bactericidal effects on the following bacteria: influenza bacillus, Streptococcus pneumoniae and Neisseria meningitidis. It only has antibacterial effects on the following bacteria: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, group B hemolytic Streptococcus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Salmonella typhi, Salmonella paratyphi, Shigella, Bacteroides fragilis and other anaerobic bacteria. The following bacteria are usually resistant to chloramphenicol: Pseudomonas aeruginosa, Acinetobacter, Enterobacter, Serratia marcescens, indole-positive Proteus, methicillin-resistant Staphylococcus and Enterococcus. This product is an antibacterial agent. Chloramphenicol is fat-soluble and enters bacterial cells by diffusion, and reversibly binds to the 50S subunit of the bacterial ribosome, which blocks the growth of the peptide chain (possibly due to the inhibition of the action of transpeptidase), thereby inhibiting the formation of peptide chains and preventing protein synthesis.

The main ingredient of this product is chloramphenicol, and its chemical name is D-threo-(-)-N-[α-(hydroxymethyl)-β-hydroxy-p-nitrophenylethyl]-2,2-dichloroacetamide.

This product is a colorless or slightly yellow clear liquid.

1. Typhoid and other Salmonella infections: It is the drug of choice for typhoid and paratyphoid caused by sensitive strains. This product is generally not suitable for gastroenteritis caused by Salmonella infection. It can still be used if the condition is serious and there is a possibility of septicemia. In adult typhoid and paratyphoid Salmonella infections, fluoroquinolones are the first choice (pregnant women and children should not use this type of drug). 2. This product can be used as one of the drugs for ampicillin-resistant Haemophilus influenzae type B meningitis or Streptococcus pneumoniae, Neisseria meningitidis meningitis, and sensitive Gram-negative bacillus meningitis in patients allergic to penicillin. 3. Brain abscesses, especially those caused by ear, are often mixed infections of aerobic and anaerobic bacteria. 4. Severe anaerobic infections, such as infections caused by Bacteroides fragilis, are especially suitable for those with lesions involving the central nervous system. It can be used in combination with aminoglycoside antibiotics to treat abdominal and pelvic infections to control the simultaneous presence of aerobic and anaerobic infections. 5. When there is no other low-toxic antibiotic alternative, it can be used to treat various serious infections caused by sensitive bacteria, such as sepsis and lung infections caused by Haemophilus influenzae, Salmonella and other Gram-negative bacteria, often in combination with aminoglycosides; 6. For Rickettsial infections, it can be used to treat Q fever, Rocky Mountain spotted fever, endemic typhus, etc.

Dilute and drip intravenously. Adults: 2-3g per day, divided into 2 doses; children: 25-50mg/kg per day, divided into 3-4 doses; newborns: no more than 25mg/kg per day, divided into 4 doses.

1. Toxic reaction to the hematopoietic system is the most serious adverse reaction of chloramphenicol. There are two different forms of manifestation: 1. Dose-related reversible bone marrow suppression, which is common in patients with blood drug concentrations exceeding 25 mg/L. The clinical manifestations are anemia, and may be accompanied by leukopenia and thrombocytopenia. 2. Bone marrow toxicity reactions that are not related to doses often manifest as severe, irreversible aplastic anemia. Patients with aplastic anemia may have a latent period of several weeks to several months, and it is not easy to detect early. Its clinical manifestations include bleeding tendency caused by thrombocytopenia, such as petechiae, ecchymoses, and epistaxis, as well as signs of infection caused by granulocytopenia, such as high fever, sore throat, jaundice, pallor, etc. The vast majority of aplastic anemia occurs after oral chloramphenicol. 2. Hemolytic anemia may occur in some patients with congenital glucose-6-phosphate dehydrogenase deficiency. 3. Gray baby syndrome, a typical case occurs when high doses of chloramphenicol are administered within 48 hours after birth. Gray baby syndrome may occur after 3-4 days of treatment, and the blood drug concentration may be as high as 40-200 mg/L. Clinical manifestations include abdominal distension, vomiting, progressive pallor, cyanosis, microcirculatory disorders, no temperature rise, and irregular breathing. It often occurs when premature infants or newborns use large doses of chloramphenicol (more than 25 mg/kg per day by body weight). Similar manifestations may also occur when adults or older children use larger doses (about 100 mg/kg per day by body weight). If the drug is stopped early, it can still be fully recovered. 4. Long-term treatment of this product can induce bleeding tendency, which may be related to bone marrow suppression, decreased intestinal flora leading to blocked vitamin K synthesis, and prolonged prothrombin time. 5. Peripheral neuritis and optic neuritis often occur during long-term treatment. If the drug is stopped early, it is often reversible. There are also cases of optic atrophy and blindness. 6. Allergic reactions are rare. Can cause various rashes, solar dermatitis, and angioneurotic edema. Generally mild, it can improve rapidly after stopping the drug. 7. Superinfection, can cause lung, gastrointestinal and urinary tract infections caused by Proteus, Pseudomonas aeruginosa, Staphylococcus aureus, fungi, etc. 8. Digestive tract reactions, may include diarrhea, nausea and vomiting.

It is contraindicated for those who are allergic to this product.

Precautions for children: Since the liver enzyme system of newborns is not mature and the renal excretion function is poor, the drug is excreted from the kidneys more slowly than that of adults. Therefore, the use of chloramphenicol in newborns is likely to lead to excessive blood drug concentration and toxic reactions (gray baby syndrome). Therefore, this product should not be used in newborns. If there is an indication that this product must be used, it should be used under the condition of monitoring blood drug concentration if conditions permit. Precautions for pregnancy and lactation: Since chloramphenicol can pass through the placental barrier, it may cause toxic reactions to both premature infants and full-term newborns, resulting in "gray baby syndrome". Therefore, this product should not be used during pregnancy, especially in the late pregnancy or delivery period. This product is secreted from breast milk and may cause adverse reactions in breastfeeding infants, including severe bone marrow suppression reactions. Therefore, this product should not be used in breastfeeding women. Breastfeeding should be suspended when it must be used. Precautions for the elderly: Most of the tissues and organs of elderly patients are degenerated, their functions are reduced, and their autoimmune functions are also reduced. Chloramphenicol can cause serious adverse reactions, so elderly patients should use it with caution.

1. Antiepileptic drugs (hydantoins). Chloramphenicol can inhibit the activity of liver cell microsomal enzymes, resulting in reduced metabolism of such drugs, or chloramphenicol can replace the serum protein binding sites of such drugs, which can enhance the effect of the drugs or increase their toxicity. Therefore, when used with chloramphenicol or after it, the dosage of such drugs must be adjusted. 2. When used with hypoglycemic drugs (such as tolbutamide), the hypoglycemic effect can be enhanced due to the replacement of protein binding sites, so the dosage of such drugs needs to be adjusted. The non-ionic binding characteristics of glipizide and glyburide make them less affected than other hypoglycemic drugs, but caution is still required when used together. 3. Long-term use of contraceptives containing estrogen, such as chloramphenicol, can reduce the reliability of contraception and increase menstrual bleeding. 4. Since this product can have the effect of vitamin B6 antagonists or increase the renal excretion of the latter, it can lead to anemia or peripheral neuritis. Therefore, when vitamin B6 is used together with this product, the body's need for the former increases. 5 This product can antagonize the hematopoietic effect of vitamin B12, so the two should not be used together. 6 When used with certain bone marrow suppressive drugs, it can enhance the bone marrow suppressive effect, such as anti-tumor drugs, colchicine, hydroxyphenylbutazone, phenylbutazone and penicillamine. When radiotherapy is performed at the same time, the bone marrow suppressive effect can also be enhanced, and the dose of bone marrow suppressants or radiotherapy must be adjusted. 7 If used before or during surgery, due to the inhibitory effect of this product on liver enzymes, it can reduce the clearance of the induced anesthetic alfentanil and prolong its duration of action. 8 When liver enzyme inducers such as phenobarbital and rifampicin are used with this product, their metabolism can be enhanced, resulting in a decrease in blood drug concentrations. 9 Antagonistic effects may occur when used in combination with macrolide antibiotics such as lincomycin or erythromycin, so it is not suitable for combined use.

Keep away from light and store in a sealed container.

2ml:0.125g

12 months

Henan Tongyuan Pharmaceutical Co., Ltd.

• Founded in:

  2002-09-30

• Address:

  No. 254, Gongqu Road, Shihe District, Xinyang City

• Tax NO.:

  914115027425444372

• Registered Funds:

  80 million yuan

• Email:

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