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Zibec Powder for Inj

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Zibec

Manufacturer Info

Manufacturer

Zifam Pinnacle

Distributor

Pinnacle House

 

Contents

Ceftazidime pentahydrate.

 

Indications / Uses

Treatment of patients with infections caused by susceptible strains of the designated organisms in the following disease: Lower respiratory tract infections, including pneumonia caused by Pseudomonas aeruginosa and other Pseudomonas spp, Haemophilus influenzae, including ampicillin-resistant strains, Klebsiella spp, Enterobacter spp, Proteus mirabilis, Escherichia coli, Serratia spp, Citrobacter spp, Streptococcus pneumoniae and Staphylococcus aureus (methicillin-susceptible strains).
Skin and skin-structure infections caused by Pseudomonas aeruginosa, Klebsiella spp, Escherichia coli, Proteus spp, including Proteus mirabilis and indole-positive Proteus, Enterobacter spp, Serratia spp, Staphylococcus aureus (methicillin-susceptible strains) and Streptococcus pyogenes (group A β-hemoltic Streptococci).
Urinary tract infections both complicated, caused by Pseudomonas aeruginosa, Enterobacter spp, Proteus spp, including Proteus mirabilis and indole-positive Proteus, Klebsiella spp and Escherichia coli.
Bacterial septicemia caused by Pseudomonas aeruginosa, Klebsiella spp, Haemophilus influenzae, Escherichia coli, Serratia spp, Streptococcus pneumoniae and Staphylococcus aureus (methicillin-susceptible strains).
Bone and joint infections caused by Pseudomonas aeruginosa, Klebsiella spp, Enterobacter spp and Staphylococcus aureus (methicillin-susceptible strains).
Gynaecologic infections, including endometritis, pelvic cellulitis and other infections of the female genital tract caused by Escherichia coli.
Intra-abdominal infections, including peritonitis caused by Escherichia coli, Klebsiella spp and Staphylococcus aureus (methicillin-susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp (many strains of Bacteroides fragilis are resistant).
Central nervous system infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis. Ceftazidime has also been used successfully in a limited number of cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae.

 

Dosage / Direction for Use

Adults: Usual Dose: 1 g administered IV or IM every 8-12 hrs. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection and the condition and renal function of the patient.

Administration: Reconstitute the contents with sterile water for injection 10 mL for IV administration or sterile water for injection 3 mL for IM administration.

 

Overdosage

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability and coma. Patients who received an acute overdosage should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of ceftazidime from the body.

Contraindications

Hypersensitivity to ceftazidime or to any of the excipients of Zibec.

 

Special Precautions

Hypersensitivity to cephalosporins and/or penicillins should be looked before starting ceftazidime. If the former is known, ceftazidime should not be given. Ceftazidime should be given cautiously to penicillin-sensitive patients keeping ready emergency resuscitative measures.

 

Adverse Reactions

Ceftazidime for injection is generally well-tolerated. The common adverse effects reported are gastrointestinal disturbances, headache, dizziness, hypersensitivity reactions including skin rashes, urticaria, pruritus, interstitial nephritis, drug fever and very rarely anaphylaxis. Transient pain may be experienced at the site of IM injection and occassionally, thrombophlebitis may follow at the site of IV injection.
Click to View ADR Monitoring Form

Interactions

Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibiotics or potent diuretics eg, furosemide.
Interference with Laboratory Tests: The administration of ceftazidime may result in a false-positive reaction for glucose in the urine when using Benedict’s solution or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (eg, Clinistix) be used.

Preg Safety (US)

           

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Storage

Store in a dry place at temperature below 25°C. Protect from light.

Description

Each vial contains sterile mixture of ceftazidime (as pentahydrate) 1000 mg and sodium bicarbonate.
Ceftazidime for injection is a 3rd generation cephalosporin, to reduce the development of drug-resistant bacteria and maintain the effectiveness of Zibec. It is a blend of sterile ceftazidime pentahydrate and sterile sodium carbonate available in sterile crystalline from supplied in vials equivalent to 1 g. Solution of Zibec range in colour from light yellow to amber. The pH of the freshly prepared solution ranges from 5-8.

Mechanism of Action

Pharmacology: Pharmacodynamics: Ceftazidime is a cephalosporin antibiotic. All cephalosporins (β-lactam antibiotics) inhibit cell wall production and are selective inhibitors of peptidoglycan synthesis. The initial step in drug action consists of binding of Zibec to cell receptors, called penicillin-binding proteins. After a β-lactam antibiotic has bound to these receptors, the transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked. Bacterial lysis is the end result.
Pharmacokinetics: After IV administration of ceftazidime 1 g dose over 5 min to normal adult male volunteers, mean peak serum concentrations (Cmax) of 90 mcg/mL was achieved. After IV infusion of ceftazidime 1 g over 20-30 min to normal adult male volunteers, Cmax of 69 mcg/mL was achieved. The absorption and elimination of ceftazidime were directly proportional to the size of the dose. The half life (t½) following IV administration was approximately 1.9 hrs. Less than 10% of ceftazidime was protein bound. The degree of protein-binding was independent of concentration.
Following IM administration of ceftazidime 1 g dose to normal adult volunteers, the Cmax was 39 mcg/mL at approximately 1 hr. Serum concentrations remained >4 mcg/mL for 6 and 8 hrs after the IM administration of 1 g dose. The t½ of ceftazidime in these volunteers was approximately 2 hrs.
Approximately 80-90% of an IM or IV dose of ceftazidime is excreted unchanged by the kidneys over a 24-hr period. The elimination of ceftazidime by the kidneys resulted in high therapeutic concentration in the urine.
Microbiology: Ceftazidime is bactericidal in action, exerting its effect by inhibition of enzymes responsible for cell wall synthesis. A wide range of gram-negative is susceptible to ceftazidime in vitro, including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important β-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and consequently, is active against many strains resistant to ampicillin and other cephalosporins.
Ceftazidime has been shown to be active against the following organism both in vitro and in clinical infections.
Gram-Negative Aerobes: Citrobacter spp, including Citrobacter freundii and Citrobacter diversus, Enterobacter spp, including Enterobacter cloacae and Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae including ampicillin-resistant strains, Klebsiella spp (including Klebsiella pneumoniae), Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Pseudomonas spp (including Pseudomonas aeruginosa) and Serratia spp.
Gram-Positive Aerobes: Staphylococcus aureus, including penicillinase- and non-penicillinase producing strains, Staphylococcus agalactiae (group B streptococci), Streptococcus pneumoniae, Streptococcus pneumoniae and Streptococcus pyogens (group A β-hemolytic streptococci).
Anaerobes: Bacteroides spp (Note: many strains of Bacteroides fragilis are resistant).
Ceftazidime has been shown to be active in vitro against most strains of the following organisms. However, the clinical significance of these data is unknown: Acinetobacter spp, Clostridium spp (not including Clostridium difficile), Haemophilus parainfluenzae, Morganella morganii (formerly Proteus morganii), Neisseria gonorrhoeae, Peptococcus spp, Peptostreptococcus spp, Providencia spp (including Providencia rettgeri, formerly Proteus rettgeri), Salmonella spp, Shigella spp, Staphylococcus epidermis and Yersinia enterocolitica.

 

MIMS Class

Cephalosporins

ATC Classification

J01DD02 – ceftazidime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

 

Regulatory Classification

POM

 

Presentation / Packing

Powd for inj (vial) 1000 mg x 1’s.

   

 


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