Clindamycin Phosphate for Injection

1 Pharmacological action: Clindamycin phosphate is a chemically synthesized clindamycin derivative. It has 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 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. 2 Toxicological studies: (1) Genotoxicity: The results of the Ames Salmonella reverse mutation test and the rat micronucleus test were both negative. (2) Reproductive toxicity: Rats were given this product orally at a dose of 300 mg/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 600 mg/kg orally or 250 mg/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. (3) Carcinogenicity: No long-term carcinogenic potential studies have been conducted on animals.

The main ingredient of this product is clindamycin phosphate

The following infectious diseases caused by Gram-positive bacteria: 1. Tonsillitis, suppurative otitis media, sinusitis, etc.; 2. Acute bronchitis, acute exacerbation of chronic bronchitis, lung abscess and bronchiectasis combined with infection, etc.; 3. Skin and soft tissue infections: furuncle, carbuncle, abscess, cellulitis, trauma, burns and postoperative infection, etc.; 4. Urinary tract infections: acute urethritis, acute pyelonephritis, prostatitis, etc.; 5. Others: osteomyelitis, sepsis, peritonitis and oral infection, etc. Various infectious diseases caused by anaerobic bacteria: 1. Empyema,

This product can be administered by intravenous drip or intramuscular injection, and the dosage is the same. 1. For adults, the dosage for intravenous drip is as follows: Moderate infection: 0.6-1.2g per day, divided into 2, 3, 4 doses, once every 12, 8, and 6 hours. Severe infection: 1.2-2.7g per day, divided into 2, 3, 4 doses, once every 12, 8, and 6 hours, or as directed by a doctor. 2. For children, the dosage for intravenous drip is as follows: Moderate infection: 15-25mg/kg per day, divided into 3 or 4 doses, once every 8 or 6 hours. Severe infection: 25-40mg/kg per day, divided into 3 or 4 doses, once every 8 or 6 hours. Or as directed by a doctor. For intramuscular injection, this product needs to be prepared with normal saline to a clear liquid of 50mg/ml-150mg/ml (or add 5ml of normal saline to each bottle to dissolve) and used immediately. For intravenous infusion, 0.6 g of this product should be diluted with 100-200 ml of normal saline or 5% glucose solution to a concentration of less than 6 mg/ml, and then infused intravenously for 30 minutes.

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 phosphatase, mild elevation of serum transaminase and jaundice. 6. A very small number of patients may develop pseudomembranous colitis.

It is contraindicated for patients with a history of allergy to clindamycin or lincomycin, pregnant women, and children under 4 years old.

Precautions during pregnancy and lactation: Use with caution in pregnant women.

1. This product can enhance the effect of neuromuscular blockers, and the two should be avoided as much as possible. 2. This product can enhance the neuromuscular blockade of inhaled anesthetics, leading to skeletal muscle weakness and respiratory depression or paralysis (apnea). Caution should be taken when using it together during or after surgery. Treatment with anticholinesterase drugs or calcium salts is expected to be effective. 3. Clindamycin phosphate has a neuromuscular blocking effect. When used in combination with antimyasthenic drugs, the latter's effect on skeletal muscle will be weakened. In order to control the symptoms of myasthenia, the dose of antimyasthenic drugs should be adjusted during the combined treatment. 4. When used with antiperistaltic antidiarrheal drugs, clindamycin phosphate may cause pseudomembranous colitis with severe watery diarrhea during the treatment course or even several weeks after the treatment course. Because it can delay the elimination of colonic endotoxins, thereby causing prolonged and aggravated diarrhea, it should not be used with antiperistaltic antidiarrheal drugs. 5 Chloramphenicol or erythromycin can compete with clindamycin phosphate at the target site, or inhibit the latter's binding to the bacterial ribosome 50s subunit, so clindamycin phosphate should not be used in combination with chloramphenicol or erythromycin. 6 When used in combination with opioid analgesics, the respiratory depressant effect of clindamycin phosphate and the central respiratory depressant effect of opioids may lead to prolonged respiratory depression or paralysis (apnea) due to cumulative phenomena, so patients must be closely observed or monitored. 7 Clindamycin phosphate is contraindicated when used with neomycin and kanamycin for intravenous drip in the same bottle. 8 It is forbidden to be used with ampicillin, phenytoin sodium, barbiturate hydrochloride, aminophylline, calcium gluconate and magnesium sulfate.

Keep in a dark, airtight container in a cool place (not exceeding 20℃).

0.9g (calculated as clindamycin)

Southwest Pharmaceutical Co., Ltd.

• Founded in:

  2015-01-08

• Address:

  No. 21 Tianxing Bridge, Shapingba District, Chongqing

• Tax NO.:

  915000003316906249

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  490.146298 million yuan

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