Ceftazidime

Visa No.: 893110241800

Product: Ceftazidime EG Enfants et Nourrissons 0,5g

API: Ceftazidime

Product Category: Antibiotics

Version approved leaflet: 424/QÐ-QLD_05/09/2016_155

INDICATIONS

Ceftazidime is indicated for use in very severe infections that have not responded to treatment with conventional antibiotics, in order to limit the development of antimicrobial resistance:

• Septicaemia.
• Meningitis.
• Complicated urinary tract infections.
• Lower respiratory tract infections, including infections in patients with cystic fibrosis.
• Bone and joint infections.
• Gynaecological infections.
• Intra-abdominal infections.
• Skin and soft tissue infections, including burn and wound infections.

In the above infections, when the causative organism is identified or suspected to be Pseudomonas or Staphylococcus (e.g. Pseudomonas meningitis, infections in neutropenic patients), ceftazidime should be used in combination with another appropriate antibiotic.
 

DOSAGE AND ADMINISTRATION

Dosage 
Adult: 

• Usual dosage: 1 g every 8 or 12 hours, administered by intravenous or intramuscular injection. Maximum dose: 6 g/day.
• Uncomplicated urinary tract infections: 250 mg every 12 hours, by intravenous or intramuscular injection.
• Complicated urinary tract infections: 500 mg every 8 or 12 hours, by intravenous or intramuscular injection.
• Uncomplicated pneumonia; skin and skin structure infections:  500 mg to 1 g every 8 hours, by intravenous or intramuscular injection.
• Bone and joint infections: 2 g intravenously every 12 hours.
• Severe gynaecological infections, intra-abdominal infections, or life-threatening infections
• (especially in immunocompromised patients): 2 g intravenously every 8 hours.
• Gram-negative bacterial meningitis: 2 g intravenously every 8 hours. Due to the high relapse rate, treatment of infections caused by Gram-negative bacteria in patients with meningitis should be continued for at least 3 weeks.
• Patients with cystic fibrosis and pulmonary infection caused by Pseudomonas with normal renal function: 30–50 mg/kg intravenously every 8 hours. Maximum dose: 6 g/day.
• Empirical treatment in febrile neutropenic patients: 2 g intravenously every 8 hours, administered as monotherapy or in combination with an aminoglycoside antibiotic.

Elderly patients, patients with renal impairment: Dosage should be adjusted according to the physician’s guidance. .
Paediatric and neonatal dosing: Children over 2 months of age: Usual dose: 30–100 mg/kg/day, pided into 2–3 doses (every 8 or 12 hours). In very severe infections, the dose may be increased up to 150 mg/kg/day (maximum 6 g/day), pided into 3 doses.
Neonates and infants under 2 months of age, usual dose: 25–60 mg/kg/day, pided into 2 doses, administered every 12 hours.
Meningitis in infants older than 8 days: Usual dose: 50 mg/kg every 12 hours.

Method of administration
Ceftazidime 0.5 g may be administered by: slow intravenous injection over 3–5 minutes, or deep intramuscular injection into a large muscle mass.

Instructions for reconstitution: 
Intramuscular injection: Reconstitute with 1.5 mL of water for injection or lidocaine hydrochloride solution 0.5% or 1% to obtain a solution with a concentration of approximately 280 mg/mL.
Intravenous injection: Reconstitute with 5 mL of water for injection, 0.9% sodium chloride, or 5% dextrose solution to obtain a solution with a concentration of approximately 100 mg/mL.

Stability of the reconstituted solution: Ceftazidime 0.5 g injection should preferably be used immediately after reconstitution. However, the reconstituted solution has been shown to be stable under the following conditions:

• Solutions with a concentration of 280 mg/mL: Stable for 18 hours at room temperature (25°C) or 7 days under refrigeration (2°C–8°C).
• Solutions with a concentration of 100 mg/mL: Stable for 24 hours at room temperature (25°C) or 7 days under refrigeration (2°C–8°C).

CONTRAINDICATIONS

• Hypersensitivity to cephalosporins.
• History of anaphylactic reactions to penicillins.
   

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children