Cetazum^® is a third generation Cephalosporin which has broad spectrum bactericidal activity by  inhibiting mucopeptide synthesis in microorganism cell wall. Cetazum^®  is effective against gram negative organism e.g : Pseudomonas aeruginosa, Ps. pseudomallei and Enterobacteriaceae including  Citrobacter and Enterobacter spp, Eschericia coli, Klebsiella spp, indole positive and  indole negative Proteus, Providencia, Salmonella, Serratia, Shigella spp and Yersinia enterocolitica and others gram negative organism including  Haemophilus influenzae, Moraxella (Branhamella) catarrhalis and Neisseria spp and also active against gram positive organism e.g Staphyllococci and Streptococci, some anaerobic organism e.g:  Bacteroides fragilis dan Clostridium difficile.

Composition :

Each vial contains :

Ceftazidime pentahydrate 1.16 g equivalent to Ceftazidime anhydrous 1.0 g

Indications :

Treatment of severe infections caused by organism sensitive to  Ceftazidime e.g : lower respiration tract infections, especially pneumoniae associated with fibrocystic, urinary tract, skin and tissue infections, bone and joint infections, peritonitis and gastro-intestinal tract infections, septicaemia and meningitis.

Dosage :

Adult : 1- 6 g/day i.v. administration be accomplished slowly (3 - 5 minutes) in divided dose on every 8 or 12 hours. Most infections, are given 1g every 8 hours or 2 g every 12 hours. In urinary tract infections and many less serious infections 500 mg or 1 g every 12 hours is usually adequate. In very severe infections, especially in immunocompromised patient, 2 g every 8 or 12 hours or 3 g every 12 hours should be administered. In fibrocystic adults who have pseudomonal lung infections, high doses of 100-150 mg/kg Body weight/day in 3 divided doses. Doses up to 9 g/day should be given to adults with normal renal function. A single dose more than 1 g/day should be given by i.v. administration.

Children : 30 - 100 mg/kg body weight/day in 2-3 divided doses. In severe infections, 150 mg/kg body weight/day (maximum 6 g/day) in 3 divided doses. Neonates and children < 2 months, 25-60 mg/kg body weight/day in 2 divided doses.

Patient with impaired renal function : Maintenance doses depend on Creatinine clearance :

In patient with severe infections, the unit given on the table maybe increased by 50%, in such patients that Cetazum^®   serum levels should not exceed 40 mg/ml.
In patient with peritonial dialysis an initial loading dose of 1 g or 500 mg 24 hourly may given. Cetazum^®  can be added to dialysis solutions, 125-250 mg of   Cetazum^®  usually for 2 l dialysis solutions.
In patients with haemodialysis, maintenance doses should be repeated following each haemodialysis periode.

IM Injection : Add 3 ml of water for injection, in vial of Cetazum^®, shake to obtain clear solution.

IV Injection : Add 10 ml of water for injection, in vial of Cetazum^®, shake to obtain clear solution.

Contraindication :

Patient with known hypersensitivity to Cephalosphorin.

Precautions and Warnings :

• Patient with known hypersensitivity to Cephalosporin and patient with impaired renal function.
• Patient with a history of gastrointestinal disease especially colitis.
• Long term therapy may result in the over growth of nonsusceptible microorganism (e.g.Candida/Enterococci).
• Caution for use in pregnant and nursing women.

1

2

3

4

5

6

7

8