High Quality Antibiotic Product Cefoxitin for Injection 1g

• Transport Package: Carton
• Specification: 1 vial/box
• Trademark: CEFOXITIN
• Origin: China
• Model NO.: 1g
• HS Code: 3003401000
• Production Capacity: 500000 Per Year

Product Description

PRODUCT DESCRIPTION

White to off-white, granules, or powder, having a slight characteristic odor

 

FORMULATION

Each vial contains Cefoxitin sodium, USP ......… 1 g

equivalent to Cefoxitin.

 

STORAGE

Store at temperatures not exceeding 30°C. Protect from light.

 

After reconstitution with Sterile Water for Injection or 1% Lidocaine HCl, the solution of Cefoxitin Sodium For Injection maintains satisfactory potency for 24 hours at room temperature or for 7 days in




a refrigerator.

INDICATIONS

TREATMENT

Cefoxitin Sodium For Injection is indicated for the treatment of the following infections due to susceptible organisms:

    ·Peritonitis and other intra-abdominal and intrapelvic infections

    ·Gynecological infections

    ·Septicemia

    ·Endocarditis

    ·Urinary tract infection, including uncomplicated gonorrhea

    ·Respiratory tract infections

    ·Bone and joint infections

    ·Skin and soft tissue infections

Cefoxitin Sodium For Injection is a broad-spectrum bactericidal antibiotic indicated for the treatment of infections caused by susceptible strains of gram-positive and gram-negative pathogens both aerobic and anaerobic. Cefoxitin Sodium For Injection has been clinically effective not only in infections due to antibiotic sensitive organ isms, but also in infections due to organisms resistant to one or more of the following antibacterial agents: penicillin, ampicillin, carbenicillin, tetracyclines, erythromycin, chloramphenicol, other cephalosporins, kanamycin, gentamycin, tobramycin and sulfamethoxazole-trimethoprim. Many gram-negative pathogens are resistant to penicillins and cephalosporins through the action of the beta-lactamases which are produced by these pathogens.Cefoxitin Sodium For Injection is remarkably stable in the presence of these bacterial beta-lactamases, both penicillinases and cephalosporinases. Hence, the clinical efficacy of Cefoxitin Sodium For Injection extends to many infections caused by such pathogens, of which the following are of particular clinical importance: E. coli; Klebsiella; P. mirabilis; Proteus; indole positive (which include the organisms now called Morganella morganii and Proteus vulgaris); Serratia marcescens; Providencia (including Providencia rettgeri) and the anaerobic Bacteroides fragilis.

 

Cefoxitin Sodium For Injection is indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. The majority of these mixed infections are associated with contamination by fecal flora as well as flora originating from the vagina, skin and mouth. In these mixed infections, Bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, cephalosporins and virtually all penicillins. However, Bacteroides fragilis is usually susceptible to Cefoxitin Sodium For Injection.

 

Cefoxitin Sodium For Injection is indicated for adjunctive therapy in the surgical treatment of infections, including abscesses, infection complicating hollow viscous perforations, cutaneous infections and infections of serous surfaces, whether caused by aerobes, mixed aerobes and anaerobes, or anaerobes.

PHARMACOLOGY

Cefoxitin is a beta-lactam derived from the chemical modification of cephamycin C (a naturally occurring antibiotic substance produced by Streptomyces lactamdurans, a novel filamentous bacterium). Cefoxitin is a bactericidal broad-spectrum, semi-synthetic antibiotic for parenteral administration. This new class of beta-lactam antibiotics, the cephamycins, are characterized by a 7-alphamethoxy-beta-lactam. The methoxy group is responsible for the property of resistance to degradation by bacterial beta-lactamases (penicillinases and cephalosporinases).

 

Side chains, attached by chemical modification of the basic cephamycin nucleus, determine some of the specific antibacterial actions and other properties. Cefoxitin has a broad spectrum antibacterial activity against gram-positive and gram-negative pathogens, both aerobic and anaerobic. Cefoxitin inhibits bacterial cell wall synthesis and is bactericidal. The unique molecular structure of cefoxitin gives a particularly high degree of resistance to beta-lactamases, a major mechanism of bacterial resistance to penicillins and cephalosporins. A high percentage of gram-negative rods which are beta-lactamase producing and resistant to penicillins or other cephalosporins are susceptible to cefoxitin. In addition, a high percentage of penicillinase-producing, penicillin-resistant gram-positive and gram-negative cocci are susceptible to cefoxitin.

 

PHARMACOKINETICS

Cefoxitin is widely distributed in the body tissues and fluids including ascetic, pleural and synovial fluid. The drug diffuses poorly into cerebrospinal fluid following IM or IV administration, even when the meninges are inflamed. It crosses the placenta, and fetal serum concentrations may be equal to maternal serum concentrations. Small amounts of the drug are distributed into breast milk. Relatively high concentrations are achieved in bile.

 

The serum half-life of Cefoxitin Sodium For Injection is 0.7 - 1.1 hours in adults with normal renal function. However, serum concentrations of the drug are higher and the serum half-life is longer in patients with renal impairment. Approximately 2% or less of a dose of Cefoxitin Sodium For Injection is metabolized to descarbamyl Cefoxitin Sodium For Injection which is microbiologically inactive. This drug is rapidly excreted in urine by both glomerular filtration and tubular secretion. In adults with normal renal function, approximately 85% of a single IM or IV dose of cefoxitin is excreted unchanged in the urine within 6 hours. Cefoxitin Sodium For Injection is removed by hemodialysis, but not by peritoneal dialysis

 

 

PROPHYLAXIS

Cefoxitin Sodium For Injection is indicated for the prevention of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated, potentially contaminated, or where the occurrence of post-operative infection could be especially serious.

 

DOSAGE AND ADMINISTRATION

Cefoxitin Sodium For Injection may be administered intravenously or intramuscularly. Dosage and route of administration should be determined by severity of infections, susceptibility of the causative organism and condition of the patient. Therapy should be started while awaiting the results of susceptibility testing.


PREPARATION OF SOLUTION

For intravenous use, 1 g should be constituted with at least 10 mL of Sterile Water for Injection, and 2 g with 10 or 20 mL. 1 g or 2 g of cefoxitin sodium for infusion may be constituted with 50 or 100 mL of 0.9% Sodium Chloride Injection, 5% or 10% Dextrose Injection, or any of the compatible solutions listed below.

 

ADMINISTRATION

INTRAVENOUS ADMINISTRATION

The intravenous route is preferable for patients with bacteremia, bacterial septicaemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions such as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

 

For intermittent intravenous administration, a solution containing 1 g or 2 g in 10 mL of Sterile Water for Injection can be injected over a period of 3 to 5 minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions.

 

However, during infusion of the solution containing cefoxitin sodium, it is advisable to temporarily discontinue administration of any other solutions at the same site.

 

For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin sodium may be added to an intravenous bottle containing 5% Dextrose Injection, 0.9% Sodium Chloride Solution, 5% Dextrose and 0.9%  Sodium Chloride Solution or 5% Dextrose Injection with 0.02% sodium bicarbonate solution. Butterfly or scalp vein type needles are preferred for this type of infusion.

 

INTRAMUSCULAR ADMINISTRATION ONLY

Reconstitute Cefoxitin Sodium For Injection 1 g with 2 mL Sterile Water for Injection, or 0.5% or 1 % lidocaine HCl (without epinephrine) solution. Cefoxitin Sodium For Injection is given by deep injection into a large muscle mass.

 

Avoid injection into a blood vessel. Note: Some patients may be hypersensitive to lidocaine.

 

CONTRAINDICATIONS

Cefoxitin Sodium For Injection is contraindicated in persons who have shown hypersensitivity to cefoxitin. In the absence of clinical experience, Cefoxitin Sodium For Injection should not be administered in patients who have shown hypersensitivity to cephalosporins.

WARNINGS FOR NEONATES

Solutions containing preservatives should not be used for injection or for flushing catheters in treating neonates. Benzyl alcohol as preservative in Bacteriostatic Water for Injection and Bacteriostatic Sodium Chloride Injection has been associated with toxicity in neonates.data are unavailable on the toxicity of other preservatives in this age group. Therefore, any diluent used with Cefoxitin Sodium For Injection in the treatment of neonates should be free of any preservative.

 

 

AVAILABILITY

Cefoxitin Sodium For Injection 1g Sterile Powder for Injection IV x 1 vial

 

CAUTION

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription