Clindamycin Hydrochloride and Sodium Chloride Injection

Pharmacological action: In vitro tests have shown that clindamycin is active against the following microorganisms: aerobic Gram-positive cocci: Staphylococcus aureus and Staphylococcus epidermidis (both penicillinase-producing and non-penicillinase-producing strains), Streptococci (except Enterococcus faecalis), and Pneumococci. Anaerobic Gram-negative rods: Bacteroides (including Bacteroides fragilis and melanin-producing Bacteroides) and Fusobacterium. Anaerobic Gram-positive non-spore-producing rods: Propionibacterium, Eubacterium, and Actinomyces. Anaerobic and microaerophilic Gram-positive rods: Peptococcus, microaerophilic Streptococcus, and Peptostreptococcus. Toxicological studies: Genotoxicity: The results of the Ames Salmonella reverse mutation test and the rat micronucleus test were negative. Reproductive toxicity: The oral administration of this product to rats at a dose of 300 mg/kg did not affect the mating and fertility of the animals. Rats and mice were given clindamycin at doses up to 600 mg/kg orally or 250 mg/kg subcutaneously, and no teratogenic effects were observed. However, adequate and rigorous clinical studies have not been conducted in pregnant women, and animal reproductive studies cannot fully predict human responses. Carcinogenicity: Long-term carcinogenic potential studies have not been conducted in animals.

The main ingredient of this product is clindamycin hydrochloride, and its chemical name is 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-7(S)-chloro-6,7,8-trideoxy-L-threo-α-D-galactoctinopyranoside hydrochloride. The chemical structure is: Molecular formula: C18H33ClN2O5S·HCl Molecular weight: 461.44 Auxiliary materials: sodium chloride

This product is a colorless or almost colorless clear liquid.

1. For the treatment of the following infectious diseases caused by Gram-positive bacteria: (1) tonsillitis, suppurative otitis media, sinusitis, etc.; (2) acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia, lung abscess and bronchiectasis combined infection, etc.; (3) skin and soft tissue infections: furuncle, carbuncle, abscess, fossa inflammation, trauma and postoperative infection, etc.; (4) urinary tract infections: acute urethritis, acute pyelonephritis, prostatitis, etc.; (5) others: osteomyelitis, sepsis, peritonitis and oral infection, etc.; 2. For the treatment of various infectious diseases caused by anaerobic bacteria: (1) empyema, lung abscess, anaerobic lung disease; (2) skin and soft tissue infections, sepsis; (3) intra-abdominal infections: peritonitis, intra-abdominal abscess; (4) female pelvic and genital infections: endometritis, non-gonococcal fallopian tube and ovarian abscess, pelvic fossa inflammation and post-gynecological surgery infection, etc.

This product is administered by intravenous drip, and each drip time is not less than 30 minutes. 1. For adults, the dosage is as follows: Moderate infection: 0.6-1.2 g/day, divided into 2, 3, or 4 doses, once every 12, 8, or 6 hours; Severe infection: 1.2-2.7 g/day, divided into 2, 3, or 4 doses, once every 12, 8, or 6 hours, or as directed by a doctor. 2. For children, the dosage is as follows: Moderate infection: 15-25 mg/kg/day, divided into 3 or 4 doses, once every 8 or 6 hours; Severe infection: 25-40 mg/kg/day, divided into 3 or 4 doses, once every 8 or 6 hours. Or as directed by a doctor.

1. Local reaction: Mild pain may occur occasionally at the injection site. During long-term intravenous infusion, attention should be paid to the occurrence of phlebitis. 2. Gastrointestinal reaction: Nausea, vomiting, abdominal pain and diarrhea may occur occasionally. 3. Allergic reaction: A small number of patients may develop drug-induced rash. 4. There is basically no toxic reaction to the hematopoietic system. It may occasionally cause neutropenia, eosinophilia, thrombocytopenia, etc., which are generally mild and transient. 5. A small number of patients may experience transient alkaline phosphate, mild increase in serum transaminase and jaundice. 6. A very small number of patients may develop pseudomembranous colitis.

Patients with a history of allergy to clindamycin or lincomycin are contraindicated.

Precautions for children: When children (newborns to 16 years old) use this product, they should pay attention to organ system function monitoring. Precautions for pregnancy and lactation: 1. There is no detailed research data at present, and a clear judgment cannot be made. Therefore, pregnant women should pay attention to the pros and cons of using this product. If this drug is really needed, it should be used. 2. It has been reported that when 150 mg of clindamycin is taken orally or 600 mg of clindamycin phosphate is intravenously infused, the amount of drug in breast milk ranges from 0.7 to 3.8 mcg/ml. Because clindamycin may cause adverse reactions in newborns, breastfeeding women must stop using this product. Precautions for the elderly: 1. Pharmacokinetic studies of clindamycin have shown that there is no significant difference in pharmacokinetics between young patients with normal liver and kidney function and elderly patients after oral or intravenous injection of clindamycin. 2. Clinical studies of clindamycin have not yet included a sufficient number of patients aged 65 and above, and it is currently difficult to determine whether their clinical responses are significantly different from those of young patients. However, clinical experience suggests that antibiotic-related colon and diarrhea (caused by Clostridium difficile) occur more frequently in the elderly (>60 years old) and are more severe. Therefore, when elderly patients use this product, they should be carefully observed or monitored for diarrhea.

1. Clindamycin has a neuromuscular blocking effect and may enhance the effect of other neuromuscular blockers. Therefore, clindamycin should be used with caution in patients taking these drugs. 2. It has been confirmed that the antagonism between clindamycin and erythromycin has clinical significance, and the two drugs should not be used at the same time. 3. This product may be incompatible with ampicillin, phenytoin sodium, mabital hydrochloride, aminophylline, calcium gluconate and magnesium sulfate.

Store in a cool place (not exceeding 20°C).

100ml: Clindamycin 0.3g and sodium chloride 0.9g

24 months

Fujian Tianquan Pharmaceutical Co., Ltd.

• Founded in:

  1996-09-03

• Address:

  No. 28, Lianzhuang North Road, Xinluo District, Longyan City, Fujian Province

• Tax NO.:

  91350800157879471K

• Registered Funds:

  67.56 million yuan

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