Flucloxacillin Sodium for Injection

Pharmacology: Mechanism of action This product is a semi-synthetic penicillinase-resistant penicillin. Its mechanism of action is similar to that of penicillin G, which binds to penicillin-binding proteins (PBPs) on the bacterial cell membrane, inhibits the biosynthesis of the bacterial cell wall, causes the bacteria to swell, rupture and die, and thus exerts a bactericidal effect. This drug is a bactericidal drug during the reproductive period. The antibacterial characteristics of this drug are: good stability to penicillinase, strong bactericidal effect on penicillinase-resistant Staphylococcus aureus, but weaker than penicillin in antibacterial effect on penicillin-sensitive Staphylococci and various streptococci. Antibacterial spectrum This drug has good antibacterial activity against penicillinase-producing Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, gonococci, and meningococci. Enterococcus faecalis, methicillin-resistant Staphylococcus aureus, entero-negative bacilli, Pseudomonas aeruginosa, and anaerobic Bacteroides fragilis are resistant to this drug. Toxicology: Acute toxicity: The LD50 of flucloxacillin sodium for oral administration in mice is 3.88g/kg, and the LD50 of subcutaneous injection is 2.2g/kg. In the long-term toxicity test, rats were divided into groups to take 200, 500, and 2000mg/kg of flucloxacillin sodium orally, and 250mg/kg was injected subcutaneously, and dogs were given 200, 500, and 1000mg/kg orally, and 250mg/kg was injected subcutaneously for 25 weeks. Except for very mild irritation at the subcutaneous injection site, no adverse reactions were observed. Teratogenicity study: Pregnant rats and mice were divided into groups to take 200 and 500mg/kg of flucloxacillin sodium orally. Results: There were no adverse reactions in the mother rats and fetuses, but the high-dose group of rats (far greater than the therapeutic dose) had an increased incidence of early embryonic death and absorption of fetuses.

The main ingredient of this product is flucloxacillin sodium, and there is no auxiliary material. Chemical name: (2S,5R,6R)-3,3-dimethyl-6-[5-methyl-3-(2-chloro-6-fluorophenyl)-4-isoxazolecarboxamido]-7-oxo-4-thia-1-azabicyclo[3,2,0]heptane-2-carboxylic acid sodium salt monohydrate Chemical structure: Molecular formula: C19H16ClFN3NaO5S·H2O Molecular weight: 493.87

This product is white or off-white crystalline powder.

This product is mainly suitable for mild and moderate infections caused by penicillin-resistant Staphylococcus and pathogenic bacteria sensitive to this product, including: 1. Skin and soft tissue infections: such as abscesses, furuncle, carbuncle, cellulitis, wound infection, burns, skin transplant monitoring, skin ulcers, eczema, acne, surgical prevention, etc.; 2. Respiratory tract and otolaryngology infections: such as pneumonia, empyema, lung abscess, pharyngitis, tonsillitis, otitis media/externa, sinusitis; 3. Internal medicine infections: such as endocarditis, meningitis, acute gastroenteritis, etc.; 4. Gynecological infections: septic abortion, maternal infection, vaginitis, pelvic inflammatory disease, adnexitis, etc.; 5. Surgical infections: appendicitis, hand and foot infection, paronychia, cholecystitis, mastitis, etc.

Adults: Intramuscular injection: 250 mg each time, 4 times a day. Intravenous drip: 250 mg-1g each time, 4 times a day, dissolve in 100 ml-250 ml normal saline or glucose injection, and slowly drip intravenously (each drip lasts 30-60 minutes). Use up within 4 hours. Reference dosage for children: According to the instructions and literature of similar foreign products, children under 2 years old should be given 1/4 of the adult dose; children aged 2-10 years should be given 1/2 of the adult dose.

As with other penicillins, side effects are rare, and most reactions are mild and short-lived. 1. Allergic reactions As with other β-lactam antibiotics, allergic reactions have been reported. The more common allergic reactions are rashes. If any allergic reaction occurs, treatment should be discontinued. 2. Liver A small number of patients may experience a temporary increase in aminotransferase after medication, but this can be reversed when treatment is discontinued. There are also reports of acute hepatic cholestasis and jaundice. 3. Kidneys Occasionally, there are reports of acute interstitial nephritis. 4. Gastrointestinal tract A small number of patients may experience gastrointestinal symptoms such as nausea, vomiting, abdominal distension, diarrhea, and loss of appetite, and pseudomembranous colitis is occasionally seen. 5. Central nervous system disorders, such as convulsions, may be related to large-dose intravenous administration in patients with renal failure. 6. Hematological effects Neutropenia and thrombocytopenia may occur, but they can be reversed by interrupting treatment.

It is contraindicated in patients with a history of allergy to penicillins or a positive penicillin skin test.

Precautions for children: See "Dosage and Administration" for dosage for children. Precautions for pregnancy and lactation: Pregnancy: Animal experiments have shown that flucloxacillin has no teratogenic effect. Since the clinical use of this drug in 1970, limited cases used in pregnant women have not shown adverse effects. However, any use of drugs in pregnant women should be extremely cautious, so flucloxacillin should only be used in pregnant women when the potential advantages outweigh the potential risks. Breastfeeding: The bottom amount of flucloxacillin can be detected in breast milk. The possibility of allergic reactions in breastfeeding infants must be considered. Therefore, flucloxacillin should only be used in breastfeeding women when the potential advantages outweigh the potential risks. Precautions for the elderly: When renal function is severely impaired, the dosage should be appropriately reduced.

Drug-drug interactions 1. This drug can be used in combination with amikacin to enhance the antibacterial effect against Staphylococcus aureus. 2. Probenecid drugs can inhibit the excretion of flucloxacillin, increase the blood concentration and prolong the maintenance time. 3. The use of this drug with live typhoid vaccine can reduce the immune effect of live typhoid vaccine. The possible mechanism is that this drug has antibacterial activity against Salmonella typhi. 4. The use of this drug with methotrexate can reduce the area under the drug concentration-time curve (AUC) of methotrexate, but this result is only a statistically significant difference and has no clinical significance. Drug-food interactions Food can significantly delay the oral absorption of this drug and reduce the peak plasma concentration of the drug by 50%.

Seal and store in a cool and dark place (avoid light and not exceed 20℃).

Calculated as C19H17ClFN3O5S 1.0g

24 months

Shanxi Zhendong Taisheng Pharmaceutical Co., Ltd.

• Founded in:

  1993-07-05

• Address:

  The First Pharmaceutical Park, Economic and Technological Development Zone, Datong City, Shanxi Province

• Tax NO.:

  91140200602165291J

• Registered Funds:

  395 million yuan

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