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Ceftazidime Pentahydrate

Generic Medicine
Indications

Ceftazidime injection is indicated for the treatment of infections caused by susceptible organisms in the following conditions:

Lower Respiratory Tract Infections: Including pneumonia caused by Pseudomonas aeruginosa, other Pseudomonas species, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Enterobacter spp., Proteus mirabilis, Escherichia coli, Serratia spp., Citrobacter spp., Streptococcus pneumoniae, and methicillin-susceptible Staphylococcus aureus.

Skin and Skin Structure Infections: Caused by Pseudomonas aeruginosa, Klebsiella spp., Escherichia coli, Proteus spp. (including P. mirabilis and indole-positive strains), Enterobacter spp., Serratia spp., methicillin-susceptible Staphylococcus aureus, and Streptococcus pyogenes.

Urinary Tract Infections: Both complicated and uncomplicated infections caused by Pseudomonas aeruginosa, Enterobacter spp., Proteus spp., Klebsiella spp., and Escherichia coli.

Bacterial Septicemia: Caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae, and methicillin-susceptible Staphylococcus aureus.

Bone and Joint Infections: Caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and methicillin-susceptible Staphylococcus aureus.

Gynecologic 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., methicillin-susceptible Staphylococcus aureus, and polymicrobial infections involving aerobic and anaerobic organisms such as Bacteroides spp.

Central Nervous System Infections: Including meningitis caused by Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa, and Streptococcus pneumoniae.

Pharmacology

Ceftazidime is a semisynthetic, broad-spectrum β-lactam antibiotic intended for parenteral use. It exerts bactericidal action by inhibiting enzymes responsible for bacterial cell wall synthesis. It is active against a wide range of Gram-negative organisms, including strains resistant to gentamicin and other aminoglycosides. Ceftazidime also shows activity against certain Gram-positive bacteria and remains stable against many clinically significant β-lactamases, including both plasmid-mediated and chromosomal enzymes. As a result, it retains activity against many organisms resistant to ampicillin and other cephalosporins.

Dosage Administration

The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. 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.

Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity & type of infections and the age, weight & renal function of the patient.

Adults: The adult dosage range for ceftazidime is 1 to 6 gm per day 8 or 12 hourly (IM/IV) in the majority of infections, 1 gm 8 hourly or 2 gm 12 hourly should be given.

  • In urinary tract infections and many less serious infections: 500 mg or 1 gm 12 hourly is usually adequate.
  • In severe infections, especially immunocompromised patients, including those with neutropenia: 2 gm 8 or 12 hourly should be administered. When used as a prophylactic agent in prostatic surgery 1 gm should be given at the induction of anaesthesia. A second dose should be considered at the time of catheter removal.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

  • Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

Neonates and Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day as two divided doses.

Administration

Ceftazidime may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh. Intra-arterial administration should be avoided. For IV/IM administration, Ceftazidime should be reconstituted with the supplied Sterile Water for Injection.

Contraindications

Ceftazidime is contraindicated in patients with known hypersensitivity to ceftazidime or to other cephalosporin antibiotics.

Side Effects

The most commonly reported adverse effects include local reactions at the injection site, as well as allergic and gastrointestinal reactions. Hypersensitivity reactions may present as pruritus, rash, and fever; angioedema and anaphylaxis are rare. Gastrointestinal symptoms include diarrhea, nausea, vomiting, and abdominal pain. Central nervous system effects such as headache, dizziness, and paresthesia may also occur.

Pregnancy & Lactation

Pregnancy: Adequate and well-controlled studies in pregnant women are lacking. Since animal studies may not always predict human response, ceftazidime should be used during pregnancy only if clearly necessary.

Lactation: Ceftazidime is excreted in human milk in low concentrations. As many drugs are excreted in breast milk and safety in nursing infants has not been fully established, a decision should be made whether to discontinue breastfeeding or discontinue the drug, considering its importance to the mother.

Precautions & Warnings

The total daily dose should be reduced in patients with renal impairment. Caution is advised in patients with a history of gastrointestinal disease, particularly colitis.

Special Populations

Impaired Renal Function: Ceftazidime is primarily excreted by the kidneys via glomerular filtration. In patients with reduced renal function (GFR <50 mL/min), dosage adjustment is necessary to prevent accumulation. In suspected renal insufficiency, an initial loading dose of 1 g may be given, followed by maintenance doses based on estimated GFR.

Dosage in Peritoneal Dialysis: Ceftazidime may be administered during peritoneal dialysis or continuous ambulatory peritoneal dialysis (CAPD). It can also be added to dialysis fluid (typically 125–250 mg per 2 L).

Impaired Hepatic Function: No dosage adjustment is required in patients with hepatic impairment.

Overdose Effects

Overdose is more likely in patients with renal failure. Reported symptoms include seizures, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients should be closely monitored and managed with supportive treatment.

Therapeutic Class

Third generation Cephalosporins

Storage Conditions

Store below 25°C, protected from light and moisture. Reconstituted solutions remain stable for up to 24 hours when stored at 2°–8°C.

Common Questions

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