Clindamycin Phosphate Injection

Pharmacological action: Clindamycin phosphate is a chemically synthesized clindamycin derivative with no antibacterial activity in vitro. After entering the body, it is rapidly hydrolyzed into clindamycin to exert antibacterial activity. In vitro tests have shown that clindamycin is active against the following microorganisms: aerobic Gram-positive cocci: Staphylococcus aureus and Staphylococcus epidermidis (both including penicillinase-producing and non-penicillinase-producing strains), Streptococci (except Enterococcus faecalis), and Pneumococci. Anaerobic Gram-negative bacilli: Bacteroides (including Bacteroides fragilis and Bacteroides nigrofaciens) and Fusobacterium. Anaerobic Gram-positive non-spore-producing bacilli: Propionibacterium, Eubacterium, and Actinomyces. Anaerobic and microaerophilic Gram-positive bacilli: Peptococcus, microaerophilic Streptococcus, and Peptostreptococcus. Toxicological studies: Genotoxicity: The results of the Ames Salmonella reverse mutation test and the rat micronucleus test were both negative. Reproductive toxicity: Rats were given this product orally at a dose of 0.3g/kg, and no effect on the mating and fertility of the animals was observed. Rats and mice were given clindamycin at a dose of up to 0.6g/kg orally or 0.25mg/kg subcutaneously, and no teratogenic effect was observed. However, adequate and rigorous clinical studies have not been conducted on pregnant women, and animal reproductive studies cannot fully predict human responses. Carcinogenicity: No long-term carcinogenic potential studies have been conducted on animals.

The main ingredient of this product is clindamycin phosphate. Its chemical name is: (2S-trans)-6-(1-methyl-4-propyl-2-pyrrolidine carbonate amino)-1-thio-methyl-7-chloro-6,7,8-trideoxy-L-threo-alpha;-D-galactopyranoside-2-dihydrogen phosphate. Chemical structure: Molecular formula: C18H34ClN2O8PS Molecular weight: 504.97 Excipients are benzyl alcohol and water for injection.

This product is a colorless or almost colorless clear liquid.

1. This product is suitable for 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 with infection, etc. 3), skin and soft tissue infections: furuncle, carbuncle, abscess, cellulitis, trauma and postoperative infection, etc. 4), urinary system infection: acute urethritis, acute pyelonephritis, prostatitis, etc. 5), others: osteomyelitis, sepsis, peritonitis and oral infection, etc. 2. This product is suitable for various infectious diseases caused by anaerobic bacteria: 1), empyema, lung abscess, lung infection caused by anaerobic bacteria. 2), skin and soft tissue infection, sepsis. 3), intra-abdominal infection: peritonitis,

This product can be administered by intravenous drip or intramuscular injection. 1. For adults, the dosage is as follows: moderate infection: 0.6-1.2 g/day, which can be divided into 2 times (once every 12 hours), 3 times (once every 8 hours) or 4 times (once every 6 hours); severe infection: 1.2-2.4 g/day, which can be divided into 2 times (once every 12 hours), 3 times (once every 8 hours) or 4 times (once every 6 hours), or as directed by a doctor; 2. For children, the dosage is as follows: moderate infection: 15-25 mg/kg/day, which can be divided into 3 times (once every 8 hours) or 4 times (once every 6 hours); severe infection: 25-40 mg/kg/day, which can be divided into 3 times (once every 8 hours) or 4 times (once every 6 hours), or as directed by a doctor. For intravenous infusion, 0.6 g of this product should be diluted with 100 ml-200 ml of normal saline or 5% glucose solution to a concentration of ≤6 mg/ml. The infusion time for each 100 ml should be no less than 30 minutes.

1 Local reaction: After intramuscular injection, pain, nodules and aseptic abscesses may occasionally occur at the injection site. Long-term intravenous infusion should pay attention to the occurrence of phlebitis. 2 Gastrointestinal reactions: Nausea, vomiting, abdominal pain and diarrhea may occur occasionally. 1-2% of patients may experience pseudomembranous colitis. 3 Allergic reactions: A small number of patients may develop drug-induced rashes and occasionally exfoliative dermatitis. 4 There is basically no toxic reaction to the hematopoietic system, but it may occasionally cause neutropenia, eosinophilia, thrombocytopenia, etc., which are generally mild and transient. 5 Transient elevation of alkaline acidase and serum transaminase, jaundice, and abnormal renal function may occur.

This product has cross-resistance with lincomycin and clindamycin and is contraindicated in patients with a history of allergy to clindamycin or lincomycin.

Precautions for children: Use with caution in children under 4 years old. Precautions for pregnancy and lactation: No studies have been conducted on pregnant women, but no effects on the fetus have been seen in animal reproduction studies, and the therapeutic benefits of using this drug for pregnant women may outweigh its potential harms. Alternatively, this drug has not been tested on animals, and there have been no sufficiently rigorous controlled studies on pregnant women. Pregnant and lactating women should be careful when using this product. Precautions for the elderly:

This product is antagonistic to erythromycin and should not be used together.

Keep away from light and store in sealed container.

2 ml: 0.3 g (calculated as C18H33ClN205S)

Two years

Cisen Pharmaceutical Co., Ltd.

• Founded in:

  1998-11-06

• Address:

  Tongji Science and Technology Industrial Park, Jining High-tech Zone

• Tax NO.:

  91370800706117999P

• Registered Funds:

  452,754,129 yuan

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