Shandong Xier Kangtai


Full Prescribing Info
Each vial contains: Ceftazidime 1 gram.
*Equivalent to anhydrous Ceftazidime.
Ceftazidime (TAZIVEX) is a third-generation cephalosporin antibiotic with an extended spectrum of activity against Gram-negative bacteria, especially Pseudomonas spp. It is given by injection in the treatment of pseudomonal infections.
Pharmacology: Pharmacokinetics: Absorption: Ceftazidime is administered by injection as the sodium salt or in solution with arginine. Mean plasma concentrations of 17 and 39 μg per mL have been reported approximately one hour after intramuscular administration of 0.5 and 1 gram Ceftazidime respectively. Five minutes after intravenous bolus injections of 0.5, 1 and 2 g of Ceftazidime, mean plasma concentrations of 45, 90 and 170 μg per mL respectively, have been reported. The plasma half-life of Ceftazidime is about 2 hours, but this is prolonged in patients with renal failures and neonates. Clearance may be enhanced in patients with cystic fibrosis. It is about 10 to 17% bound to plasma proteins.
Distribution: Ceftazidime is widely distributed in body tissues and fluids, therapeutic concentration is achieved in the cerebrospinal fluid when the meninges are inflamed. It crosses the placenta and is excreted in the breast milk.
Elimination: Ceftazidime is passively excreted in bile, although only small proportion is eliminated by this route. It is mainly excreted by the kidneys, almost exclusively by glomerular filtration; about 80 to 90% of dose is recovered unchanged in the urine within 24 hours.
Ceftazidime is used in the treatment of susceptible infections, especially those due to Pseudomonas spp. They include infections of biliary tract, urinary tract, cystic fibrosis (respiratory tract infections), pneumonia, ENT, endophthalmitis, meningitis, septicaemia, skin and soft tissue infections (including burns, ecthyma gangrenosum and ulceration) and infections in immunocompromised patients.
Antimicrobial Action: Ceftazidime has a bactericidal action and broad spectrum of activity similar to cefotaxime, but increased activity against Pseudomonas spp. It is less active against staphylococci. Unlike Cefotaxime, it has no active metabolite.
Ceftazidime is highly stable to hydrolysis by most beta-lactamases. It is active in vitro against many gram negative bacteria including Pseudomonas aeruginosa and Enterobacteriaceae including Citrobacter and Enterobacter spp., Escherichia coli, Klebsiella spp., both indole-positive and indole-negative Proteus, Providencia, Salmonella, Serratia, and Shigella spp., and Yersinia enterocolitica. Other susceptible Gram positive bacteria include Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, and Neisseria spp. Among Gram-positive bacteria it is active against some staphylococci and Listeria monocytogenes and generally resistant. Ceftazidime is active against some anaerobes, although most strains of Bacteroides fragilis and Clostridium difficile are resistant.
Minimum inhibitory concentrations (MICs) of 6 μg or less per mL have been taken to indicate susceptibility to ceftazidime and MICs of 32 μg or more per mL, resistance. A MICs of about 4 μg per mL has been reported for Ps. Aeruginosa.
Resistance: As with Cefotaxime, resistance may develop during treatment due to depression of chromosomally-mediated beta-lactamases. It has been noted particularly in Pseudomonas spp. and in Enterobacteriaceae including Enterobacter and Klebsiella spp.
Dosage/Direction for Use
Ceftazidime is available as the pentahydrate but it is formulated with sodium carbonate, to form the sodium salt solution, or with arginine. Dosage is expressed in terms of anhydrous ceftazidime. It is administered by deep intramuscular injection or slow intravenous injection over 3 to 5 minutes, or intravenous infusion over up to 30 minutes. The usual dose for adults range from 1 to 6 g daily in divided doses at every 8 to 12 hours. The higher doses are used in severe infections especially in immunocompromised patients. In adults with cystic fibrosis who have pseudomonal lung infections, high doses of 100 to 150 mg per kg body weight daily in 3 divided doses are used, up to 9 g daily has been given to adults with normal renal function. Single dose of more than 1 g should be given intravenously.
Children are usually given Ceftazidime 30 to 100 mg per kg daily in 2 to 3 divided doses, but in severely ill children up to 150 mg per kg daily to a maximum of 6 g daily may be given in 3 divided doses. Neonates and infants up to 2 months old have been given 25 to 60 mg per kg daily in 2 divided doses.
In the elderly the dose should generally not exceed 3 g daily. In patients with impaired renal function the dosage of Ceftazidime may need to be reduced. Following a loading dose of 1 g, maintenance doses are based on creatinine clearance. Suggested maintenance doses are: creatinine clearance 31 to 50 mL per minute, 1 g every 12 hours; creatinine clearance 16 to 30 mL per minute, 1 gram every 24 hours; creatinine clearance 16 to 6 mL per minute, 0.5 g every 24 hours; creatinine clearance less than 5 mL per minute, 0.5 g every 48 hours. In severe infections, these doses may need to be increased by 50%. In these patients, ceftazidime through serum concentration should not exceed 40 μg per mL. In patients undergoing peritoneal dialysis a loading dose of 1 g may be given followed by 500 mg every 24 hours; Ceftazidime sodium may also be added to the dialysis fluid. In patients on hemodialysis, the appropriate maintenance dose of ceftazidime should be repeated after each dialysis period.
For surgical injection prophylaxis in patients undergoing prostatic surgery, a dose of 1 g may be given at induction of anesthesia and repeated if necessary when the catheter is removed. Ceftazidime can be used in association with aminoglycosides, another beta-lactam antibiotic such as piperacillin, or vancomycin in patients with severe neutropenia, or if infection with Bacteroides fragilis is suspected, in association with an antibiotic such as clindamycin or metronidazole. The drugs should generally be administered separately, or as prescribed by a physician.
Special Precautions
In case of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of Ceftazidime from the body.
Adverse Reactions
Ceftazidime is generally well tolerated. Adverse effects are similar to those for all cephalosporins, including hypersensitivity reactions. Like cefotaxime, ceftazidime has the potential for colonization and superinfection with resistant organisms. The risk of superinfection with, for example, Staphylococcus aureus may be higher than with cefotaxime, since ceftazidime is less active against staphylococci.
Drug Interactions
The activity of Ceftazidime against Pseudomonas aeruginosa and some Enterobacteriaceae may be enhanced by aminoglycosides. Nephrotoxicity and ototoxicity has been reported following concomitant administration of cephalosporins with aminoglycosides antibiotics or potent diuretics such as furosemide. These were not noted when ceftazidime is given alone. Antagonism has been reported in vitro between ceftazidime and chloramphenicol.
Caution For Usage
Direction for Reconstitution: *With 10 mL diluent reconstitution. Add 3 mL for IM and 10 mL for IV of Sterile Water for injection.
Store at temperatures not exceeding 30°C. Protect from light. The freshly reconstituted solution is recommended.
MIMS Class
ATC Classification
J01DD02 - ceftazidime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Tazivex powd for inj 1 g
10 × 1's (P775/vial)
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