CEFTIZOXIME SODIUM FOR INJECTION Pharmaceutical outsourcing project find (CRO) Contract Research Organization
You can contact this pharmacutical clinical contract research projects author: Steter Williamz
CEFTIZOXIME SODIUM FOR INJECTION Pharmaceutical outsourcing project find (CRO) Contract Research Organization
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Drugs (CRO) Contract Research Pharmaceutical outsourcing project description:
Drug Category: cephalosporin and carbapenem
Properties: This product is white or light yellow crystalline powder.
Pharmacokinetics: intramuscular injection of 0.5g or 1.0g of this product after the peak plasma concentration (Cmax) were 13.7mg / L and 39mg / L, at 1 hour after administration to reach. Intravenous injection of this product 2g or 3g, 5 minutes after the peak plasma concentration (Cmax) were 131.8mg / L and 221.1mg / L. Ceftizoxime is widely distributed in the body and body fluids in a variety of organizations, including pleural effusion, ascites, bile, gallbladder wall, cerebrospinal fluid (meninges with inflammation), prostatic fluid and bone tissues can reach therapeutic concentrations. Protein binding rate of 30%. This product is the blood elimination half-life (t1/2β) for 1.7 hours. In the body are not metabolized within 24 hours of delivery for more than 80% of the amount in order to prototype
Indications: lower respiratory tract infections caused by susceptible strains, urinary tract infections, abdominal infection, pelvic infection, septicemia, skin and soft tissue infections, bone and joint infections, Streptococcus pneumoniae or Haemophilus influenzae meningitis caused by gonorrhea and simple.
Pharmacology and toxicology: The product is a third-generation cephalosporin, a broad-spectrum antibacterial activity against a variety of Gram-positive bacteria and gram-negative bacteria produce a broad-spectrum (-lactamase (including penicillin and cephalosporins enzymes enzyme) stability. The product of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and other Enterobacteriaceae have a strong antibacterial effect, such as Pseudomonas aeruginosa and Acinetobacter sensitive to this product poor. ceftizoxime against Haemophilus influenzae and Neisseria gonorrhoeae have a good antibacterial effect. The product of Staphylococcus aureus and Staphylococcus epidermidis the role of the first and second generation cephalosporins for the worse, anti-A oxygen-resistant Staphylococcus aureus and Enterococcus are resistant to this product, all kinds of streptococci are highly sensitive to this product. Peptococcus, Peptostreptococcus, and some Bacteroides and other anaerobic bacteria Duocheng sensitive to this product, storm
Contraindications: For this product, and other cephalosporin allergies is disabled.
Note: 1. To be required before the FDA asked in detail about whether patients with earlier in this product, other cephalosporins, penicillins or other drugs allergy history, because the penicillins and cephalosporins and other β-lactam antibiotics between the has confirmed the existence of cross-allergic reactions. In patients allergic to penicillin antibiotics about 5% ~ 10% of pairs of cross-allergic reaction to cephalosporins occur. Therefore patients with a history penicillin allergy, there are indications should be the FDA must fully weigh under close observation after the caution. As in previous penicillin occurred in patients with shock, then the FDA should not re-elect. As should the FDA, when, in the event an allergic reaction, immediate stop
Pregnant and lactating women drugs: animal studies have not found this product on the reproductive capacity and fetal damage, but the safety of drugs during pregnancy is not clear, pregnant women only when there are clear indications of when the applications. This product can be secreted a small amount of milk in lactating women, breast-feeding should be suspended when the FDA.
Medication for children: 6 months of age children to the FDA's safety and effectiveness has not been established.
Medication in elderly patients: Elderly patients often accompanied by renal dysfunction, should appropriately reduce the dose or dose interval extension.
Drug Interactions: Although no drug interactions of this product with other reports, but there are other cephalosporin antibiotics, in combination with aminoglycoside nephrotoxicity when reported.
Usage and dosage: 1. Adults commonly used quantity: one 1 ~ 2g, every 8 to 12 hours a time; severe infection the dose may be increased to a 3 ~ 4g, every 8 hours one time. Treatment of non-complicated urinary tract infection, a 0.5g, every 12 hours one time.
2.6 months and 6 months or more the amount of infants and children used: according to the weight once 50mg/kg, every 6 to 8 hours a time.
3. Those with impaired renal function: patients with impaired renal function need to adjust the dose according to their degree of damage. Giving 0.5 ~ 1g of the first loading dose, the renal function in patients with mild injury (endogenous creatinine clearance rate Clcr to 50 ~ 79ml / min) used a dose of 0.5g, for every eight small
Adverse reactions: 1. Rash, itching, and allergic reactions such as drug fever, diarrhea, nausea, vomiting, loss of appetite and so on.
2. Alkaline phosphatase, elevated serum aminotransferase mild, transient serum bilirubin, blood urea nitrogen and creatinine increased and so on. 3. Anemia (including hemolytic anemia), neutropenia, increased eosinophils, or thrombocytopenia rare.
4. Occasionally headache, numbness, dizziness, vitamin K and vitamin B deficiency, allergic shock.
5. A very small number of patients with mucosal candidiasis may occur.
6. Burning sensation at the injection site, cellulitis, phlebitis (intravenous persons), pain, hardening and feeling abnormal.
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June 29th, 2010 at 09:30