Cefoxitin Sodium for Injection

Applicable to the following infections caused by bacteria sensitive to this product:

Key words:

Classification:

Anti-infection class

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+86-579-82131973

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Graphic Details

Date of approval:2007Year03Month29Day

Date modified:2010Year10Month20Day

Instructions for Cefoxitin Sodium for Injection

Please read the instructions carefully and use under the guidance of a physician.

[Name of Drug]]

Common Name: Cefoxitin Sodium for Injection

English name：Cefoxitin Sodium for Injection

Chinese pinyin：Zhusheyong Toubaoxidingna

[Ingredients] The main ingredient of this product is cefoxitin sodium, chemical name:(6R,7S)）-3-Hydroxymethyl-7-methoxy-8-oxo-7-[2 (2-thienyl) acetamido]-5-thia-1-azabicyclo-[4.2.0] oct-2-ene-2-carboxylate, sodium salt.

Chemical structural formula:

Molecular formula: C₁₆H₁₆N₃NaO₇S₂

Molecular weight: 449.43

[character] this product is white to white powder.

[indications] applicable to the following infections caused by bacteria sensitive to this product:

· Upper and lower respiratory tract infections

· Urinary tract infections including uncomplicated gonorrhea

Peritonitis and other intra-abdominal and pelvic infections

· Sepsis (including typhoid fever)

· Gynecological infections

· Bone and joint soft tissue infections

· Endocarditis

Because this product is effective against anaerobic bacteria and beta-The enzyme is stable, so it is particularly suitable for aerobic and anaerobic mixed infections, as well as for beta-Infection caused by bacteria sensitive to this product.

"Specifications" by C₁₆H₁₇N₃O₇S₂Calculation (1）1.0g，（2）2.0g。

Usage and dosage]

Intramuscular injection, intravenous injection or intravenous drip, the usual dosage for adults is 1-2g/times, every 6-8Once an hour. Or adjust the dose according to the sensitivity and condition of pathogenic bacteria (see table below)

Type of infection	Total daily dose	Usage
simple infection (pneumonia, urinarySysteminfections, skin infections)	3-4g	Every 6-81g hoursIntramuscular or intravenous drip
moderate and severe infection	6-8g	Every 41g hoursor 6-8 hours 2g intravenous drip
High-dose antibiotic treatment required Infections (such as gas gangrene)	12g	Every 42g hoursor 6 hours 3g intravenous drip

Patients with renal insufficiency need to adjust the dose according to creatinine clearance rate, according to the following table:

renal function	creatinine clearance	Dose	Number of medication
Mild impairment	50-30ml/Points	1-2g	8-12once an hour
Moderate damage	29-10ml/Points	1-2g	12-24once an hour
Severe damage	9-5ml/Points	0.5-1.0g	12-24once an hour
renal failure	<5ml/Points	0.5-1.0g	24-48once an hour

This product is used for intramuscular injection, per gram soluble in 0.5%Lidocaine Hydrochloride 2ml; For intravenous injection, dissolve in 10ml of sterile water for injection per gram; For intravenous drip, 1~2g cefoxitin sodium is dissolved in 50ml or 100ml of normal saline or 5% or 10% glucose solution.

adverse reaction]

Adverse reactions were mild. The most common local reactions are thrombophlebitis after intravenous injection and local induration and tenderness after intramuscular injection. In addition, allergic reactions (rash, pruritus, eosinophilia, fever, dyspnea, etc.), hypotension, diarrhea, nausea, vomiting, leukopenia, thrombocytopenia, anemia, and ALT、ASTALP, LDH, BUN or serum Cr value increased.

[taboo] on this product and cephalosporin antibiotics allergy disabled.

[Note]]

1Penicillin allergy with caution.

2Renal impairment and gastrointestinal history (especially colitis) with caution.

3When the product is compatible with aminoglycoside antibiotics, it will increase renal toxicity.

Medication for pregnant and lactating women]Pregnant women and lactating women with caution.

children's medication]Premature, newborn with caution.

elderly medication]Use with caution in frail elderly patients.

drug interaction]1cefoxitin sodiumWhen combined with aminoglycoside antibiotics, there is a synergistic antibacterial effect, but when combined with increased nephrotoxicity.
　　2cefoxitin sodiumWhen combined with strong diuretics such as furosemide, it may increase nephrotoxicity.
　　3cefoxitin sodiumWhen combined with probenecid, it can delay the excretion of this product, improve the blood concentration of cefoxitin and prolong the half-life.
　　4cefoxitin sodiumIt can affect alcohol metabolism, increase the concentration of acetaldehyde in the blood, and cause disulfiram-like reactions (facial flushing, headache, dizziness, abdominal pain, stomach pain, nausea, vomiting, shortness of breath, increased heart rate, decreased blood pressure, drowsiness, hallucinations, etc.).

drug overdose]　Treatment of drug overdose: mainly symptomatic and supportive treatment.
　　（1) For acute allergy, commonly used medicationthings(Antihistamines, corticosteroids, epinephrine, or other vasopressor amines)Inhalation of oxygen and maintenance of airway patency, including tracheal intubation.
　　（2) For antibiotic-associated pseudomembranous colitis, moderate to severe, fluid, electrolyte, and protein supplementation may be required; oral metronidazole, lichen, cholestyramine, or vancomycin may also be required if necessary. However, for severe watery diarrhea, antidiarrheal drugs that reduce peristalsis should not be used.
　　（3) Anticonvulsants can be used if necessary.
　　（4) Hemodialysis helps to remove drugs from the serum.

pharmacology and toxicology]

cefoxitin sodium for injection via inhibitionCell wall synthesis and kill bacteria, and because of the structural characteristics of this product to the bacteria produced by the beta-lactamase has a high resistance, the following clinical common gram-positive, negative aerobic and anaerobic pathogens are highly sensitive to this product.

aerobic bacteria anaerobic bacteria

gram-positive cocci gram-positive cocci

-staphylococci (including coagulase-positive,-Enterococcus

negative and penicillinase-producing strains)-Streptococcus faecalis

-Agroup beta hemolytic streptococci-microaerophilic streptococcus

-Bgroup beta hemolytic streptococcus

-Streptococcus pneumoniaegram-positive bacilli

-D in other streptococciGroup Streptococcus-Clostridium perfringens

gram-negative cocci -Clostridium

-Neisseria gonorrhoeae (Neisseria)-true bacillus

-Neisseria meningitidis-Propionibacterium acnes

gram-negative bacilli gram-negative cocci

-E. coli-Vecronella

-Klebsiella pneumoniae

-Klebopsis There are also the following gram-negative bacteria

-Proteus mirabilis-Bacteroides fragilis

-Proteus (indole positive)-Bacteroides melanin

Proteus vulgis-Bacteroides (including penicillin-sensitive and

penicillin-resistant strains of Proteus morgans)

-Influenza (Haemophilus) bacillus-Fusobacterium

-Serratia mucilae

-Pruveden bacteria

-Salmonella and Shigella

The sensitivity of cefoxitin sodium for injection to the following bacteria depends on the strain to be tested for drug sensitivity.

-Nitrate-negative bacilli of the genus Acinetobacter-Alkalobacter faecalis

-Citrobacter-Enterobacteriaceae

Cefoxitin sodium for injection is resistant to most strains of Pseudomonas aeruginosa, Enterococcus, Bacillus cloacae, etc.

pharmacokinetics]

Normal volunteers intramuscular injection of 1g20-30.Minute blood concentration peaked at 24 μg/ml. After intravenous injection of 1g, the blood concentration reached a peak of 110 μg/ml in 5 minutes, and the blood concentration was less than 1 μg/ml after 4 hours. The half-life of this product is 41-59 minutes after intravenous injection and 64.8 minutes after intramuscular injection. 6 hours after about 85% of the drug to the prototype through the kidney excretion, intramuscular injection of this product 1g, urine drug concentration of up to 3000 g/ml or more.

This product is widely distributed in the body, after administration can quickly enter a variety of body fluids, including pleural effusion, ascites, bile, but the cerebrospinal fluid penetration rate is low, protein binding rate of 80.7.

Cefoxitin sodium for injection is mainly excreted from the kidney in prototype, and renal clearance rate includes glomerular filtration and tubular excretion.hours equivalent to 85% of the dose givenIt is excreted from the urine through the kidneys and has a plasma elimination half-life of 1 hour.

[Storage] airtight, in a cool dark place (protected from light and not more than 20℃) preservation.

[packing] Xilin bottle, 1Bottle/Box or 10Bottle/Box.

Period of Validity 24Months.

[Implementation standard] Chinese Pharmacopoeia 2010Year Edition II

[Approval No.] Chinese Medicine H20066968（1.0g), Chinese medicine standard word H20066969（2.0g）

production enterprise]

Company: Zhejiang Jianfeng Pharmaceutical Co., Ltd.

Production address:No.58, Gaofan Section, Baitang Lower Line, Wucheng District, Jinhua City, Zhejiang Province

Postal Code: 321016

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