Ceftazidime and Dextrose

CEFTAZIDIME AND DEXTROSE- ceftazidime injection, solution
B. Braun Medical Inc.

1 INDICATIONS AND USAGE

1.1 Lower Respiratory Tract Infections

Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of lower respiratory tract infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae , including ampicillin-resistant isolates; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis ; Escherichia coli ; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae ; and Staphylococcus aureus (methicillin-susceptible isolates).

1.2 Skin and Skin-structure Infections

Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of 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 isolates); and Streptococcus pyogenes (group A beta-hemolytic streptococci).

1.3 Bacterial Septicemia

Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of bacterial septicemia caused by Pseudomonas aeruginosa , Klebsiella spp., Haemophilus influenzae , Escherichia coli , Serratia spp., Streptococcus pneumoniae , and Staphylococcus aureus (methicillin-susceptible isolates).

1.4 Bone and Joint Infections

Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of bone and joint infections caused by Pseudomonas aeruginosa , Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin-susceptible isolates).

1.5 Gynecologic Infections

Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of gynecologic infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.

1.6 Intra-abdominal Infections

Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of intra-abdominal infections, including peritonitis caused by Escherichia coli , Klebsiella spp., and Staphylococcus aureus (methicillin-susceptible isolates) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp. (many isolates of Bacteroides fragilis are resistant).

1.7 Central Nervous System Infections

Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of 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.

1.8 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftazidime for Injection and Dextrose Injection and other antibacterial drugs, Ceftazidime for Injection and Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Adult and Pediatric Patients (Who Require the Full Adult Dose)

Ceftazidime for Injection and Dextrose Injection in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. Ceftazidime for Injection and Dextrose Injection should be administered intravenously (IV) over approximately 30 minutes.

The guidelines for dosage of Ceftazidime for Injection and Dextrose Injection are listed in Table 1. The following dosage schedule is recommended.

Table 1: Recommended Dosage Schedule for Creatinine Clearance greater than 50 mL/min

Adults	Dose	Frequency
Bone and joint infections	2 grams IV	every 12hr
Uncomplicated pneumonia; mild skin and skin-structure infections	500 mg*–1 gram IV	every 8hr
Serious gynecologic and intra-abdominal infections	2 grams IV	every 8hr
Meningitis	2 grams IV	every 8hr
Very severe life-threatening infections, especially in immunocompromised patients	2 grams IV	every 8hr

* Use this formulation of ceftazidime only in patients who require the entire 1 or 2 gram dose and not any fraction thereof.

2.2 Pediatric Patients

Ceftazidime for Injection and Dextrose Injection in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftazidime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of ceftazidime [see Use in Specific Populations (8.4)]

2.3 Patients with Renal Impairment

Ceftazidime for Injection and Dextrose Injection in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftazidime. To prevent unintentional overdose, this product should not be used in patients with creatinine clearance less than or equal to 15 mL/min who require less than a 1 g dose of ceftazidime.

In patients with impaired renal function (creatinine clearance less than or equal to 50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime for Injection and Dextrose Injection may be given. An estimate of creatinine clearance should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 2.

Table 2: Recommended Maintenance Dosages of Ceftazidime for Injection and Dextrose Injection in Renal Insufficiency

Creatinine Clearance (mL/min)	Recommended Unit Dose of Ceftazidime for Injection and Dextrose Injection	Frequency of Dosing
50–31	1 gram	every 12hr
30–16	1 gram	every 24hr

NOTE: IF THE DOSE RECOMMENDED IN TABLE 1 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 2, THE LOWER DOSE SHOULD BE USED.

When only serum creatinine is available, the following formula (Cockcroft’s equation)¹ may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:

Males:	Creatinine Clearance (mL/min) =	Weight (kg) × (140-age)
		72 × serum creatinine (mg/dL)
Females:	0.85 × above value

In patients with severe infections who would normally receive 2 grams IV every 8hr of Ceftazidime for Injection and Dextrose Injection were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency may be increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism.

The creatinine clearance should be adjusted for body surface area or lean body mass, and the dosing frequency should be reduced in cases of renal insufficiency.

In patients undergoing hemodialysis, a loading dose of 1 gram is recommended, followed by 1 gram after each hemodialysis period.