ZAKZIDIM 2000mg 

Ceftazidime

Vial 2000 mg

Ceftazidime (Zaczidim^® )

Description

Ceftazidime is a semisynthetic, broad -spectrum β–lactam antibiotic of third generation cephalosporin.

Clinical pharmacology

Ceftazidime is bactericidal in action, exerting its effect by inhibition of enzymes responsible for cell wall synthesis. Ceftazidime binds with high affinity to penicillin binding proteins (PBP) in bacterial cytoplasmic membrane and by acylation of membrane-bound transpeptidase enzymes, prevent cross-linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity. Also cell division and growth are inhibited and elongation of susceptible bacteria and lysis frequently occur. Rapidly dividing bacteria are those most susceptible to the action of Ceftazidime .

Antibacterial activity

Ceftazidime has a high degree of stability in the presence of beta-lactamases (penicillinases and cephalosporinases) and, therefore, have excellent activity against a wide spectrum of gram-negative bacteria, including penicillinase-producing strains of N.gonorrhoeae and most Enterobacteriaceae (Citrobacter, E.coli, Enterobacter, Klebsiella, Morganella, Proteus, Providencia, and Serratia species). Ceftazidime is not as active against gram-positive cocci as are the first and second generation cephalosporins.

Ceftazidime has the greatest activity of the third-generation cephalosporins against P.aeruginosa.

Pharmacokinetics

Oral absorption negligible

Presystemic metabolism -

Plasma half – life Range 1.8-2.2h

Volume of distribution 16.0 l

Plasma protein binding <10%

Indication

1- Lower respiratory tract infections.

2- Skin and skin-structure infections.

3- Urinary tract infections.

4- Bacterial septicemia.

5- Bone & joint infections.

6- Gynecologic infections.

7- Intra-abdominal infections.

8- Central nervous system infections.

9- Meningitis.

10- Pelvic female infections.

11- Pulmonary infections, in cystic fibrosis.

Contraindication

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

Precaution

· After an initial loading dose of l gram, adult with impaired renal function (including dialysis patients) may require a reduction in dose. Although patients with impaired hepatic function don’t require dose reduction.

· Long- term therapy with Ceftazidime may allow for the overgrowth of Candida albicans, resulting in oral candidiasis.

· Risk-benefit should be considered when history of bleeding disorders, gastrointestinal diseases, specially ulcerative colitis, regional enteritis, or antibiotic associated colitis exist. (Ceftazidime may cause pseudomembranous colitis).

· As with other antibiotics, prolong use of Ceftazidime may result in overgrowth of nonsusceptible organisms.

Pregnancy

Pregnancy category B.

There are no adequate and well – controlled studies in pregnant women. Therefore Ceftazidime should be used during pregnancy only if clearly needed.

Breast feeding

Ceftazidime is excreted in human milk in low concentrations. Caution should be exercised when it is administered to a nursing woman.

Dosage

The dosing and strengths of the dosage form available are expressed in terms of Ceftazidime base. (not the sodium salt).

Usual adult dose

· Bone and joint infections: intravenous, 2 grams (base) every 12 hours.

· Intra-abdominal infections or meningitis or female pelvic infections or septicemia: Intravenous 2 grams (base) every 8 hours.

· Uncomplicated pneumonia or skin and soft tissue infections: intramuscular or intravenous 500 mg to l gram (base) every 8 hours.

· Melioidosis: intravenous, 120 mg per kg of body weight per day administered every 8 hours.

· Pulmonary infections in cystic fibrosis, due to pseudomonas: intravenous 30 to 50 mg (base) per kg of body weight every 8 hours up to 6 gram per day.

· Complicated urinary tract infections: Intravenous or intramuscular, 500 mg (base) every 8 to 12 hours.

· Uncomplicated urinary tract infections: Intravenous or intramuscular, 250 mg (base) every 12 hours.

· For all other infections, severe to life-threatening, specially in immunocompromised patients: Intravenous 2 grams (base) every 8 hours.

Usual pediatric dose

· Meningitis

Infants and children 1 month to 12 years of age: intravenous, 50mg (base) per kg of body weight every 8 hours.

Neonates up to 1 month of age: intravenous, 25 to 50mg (base) per kg of body weight every 12 hours.

· For all other infections

Infants and children 1 month to 12 years of age: intravenous 30 to 50mg (base) per kg of body weight every 8 hours.

Neonates up to 4 weeks of age: intravenous, 30mg (base) per kg of body weight every 12 hours.

Usual pediatric prescribing limits

6 grams (base) per day

Usual geriatric dose

· Dosing is the same as adult dose.

Usual geriatric prescribing limits

1 gram per day for patients older than 75 years of age even if serum creatinine concentrations are normal.

Note: Treatment with Ceftazidime should be continued for 2 days after the sign and symptoms of infection have disappeared.

Administration

To prepare solution for intramuscular use,

· 1.5 mL of sterile water for injection or bactriostatic water for injection or 0.5% or 1% lidocaine hydrochloride injection, should be added to each 500mg vial or 3mL of above diluent should be added to each 1 gram vial.

· It should be injected deeply into a large muscle mass.

To prepare solution for intravenous use,

· 5 mL of sterile water for injection should be added to each 500 mg vial or 10 mL of above diluent should be added to each 1 or 2 gram vials.

· For direct intermittent intravenous use, resulting solution should be administered slowly over a 3 to 5 minutes period.

To prepare solution for intravenous infusion

· Constitute 1 or 2 gram vials with 100mL of 0.9% sodium chloride injection, 1/6 M sodium lactate injection, 5% dextrose injection, 5% dextrose and 0.225% sodium chloride injection, 5% dextrose and 0.45% sodium chloride injection, 5% dextrose and 0.9% sodium chloride injection, 10% dextrose injection, ringer’s injection USP, lactated ringer’s injection USP. After releasing the carbon dioxide produced, add 90mL of the above diluent and use it as an intravenous infusion.

Patient consultation

· Continue medicine for full time of treatment.

· If you missed a dose, take as soon as possible, don’t take if almost time for next dose and don’t double doses.

· Patient do not treat viral infections (e.g., the common cold)

· If there wasn’t improvement of symptoms within few days, check with your physician.

· Store the medicine properly.

Warning

· Before Ceftazidime administration, previous hypersensitivity reactions to cephalosporins or penicillins must be determined because of cross – hypersensitivity among β-lactams.

· The carbon dioxide gas will be produced at the time of solvation.

· Avoid injection if there are any particles still remained in the solution after complete solving.

· Inject immediately after preparation.

· Use of diluents containing benzyl alcohol is not recommended for preparation of medications for use in neonates. A fatal toxic syndrome consisting of metabolic acidosis, CNS depression, respiratory problems, renal failure, hypotension and possible seizures and intracranial hemorrhage has been associated with this use.

·