Tazidime (Ceftazidime)

TAZIDIME®

Lilly

Ceftazidime

Antibiotic

Action and Clinical

In vitro studies indicate that the bactericidal action of ceftazidime results from inhibition of bacterial cell wall synthesis.

Indications And Clinical Uses :

For the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:

Pneumonia caused by P. aeruginosa, H. influenzae (including ampicillin-resistant strains), Klebsiella species, Enterobacter species, P. mirabilis, E. coli, Serratia species, S. pneumoniae and S. aureus (methicillin-susceptible strains).

Skin and skin-structure infections caused by P. aeruginosa, Klebsiella species, E. coli, P. mirabilis, Enterobacter species, S. aureus (methicillin-susceptible strains) and S. pyogenes.

Urinary tract infections caused by P. aeruginosa, Enterobacter species, Proteus species (indole-positive and negative), Klebsiella species and E. coli.

Bacteremia/Septicemia caused by P. aeruginosa, Klebsiella species, E. coli, Serratia species, S. pneumoniae, S. aureus (methicillin-susceptible strains) and S. epidermidis.

Bone infections caused by P. aeruginosa, P. mirabilis, Enterobacter species, and S. aureus (methicillin-susceptible strains).

Peritonitis caused by E. coli, Klebsiella species, Peptostreptococcus species and Bacteroides species (most strains of B. fragilis are resistant).

Specimens for bacteriologic cultures should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to ceftazidime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

Due to the nature of the underlying conditions which usually predispose patients to Pseudomonas infections of the lower respiratory and urinary tracts, a good clinical response accompanied by bacterial eradication may not be achieved despite evidence of in vitro sensitivity.

Contra-Indications:

Patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibiotics.

Warnings in Clinical States: Before therapy with ceftazidime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to ceftazidime, cephalosporins, penicillins or other drugs. Ceftazidime should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. This product should be given with caution to patients with type I hypersensitivity reactions to penicillin. If an allergic reaction to ceftazidime occurs, discontinue treatment with the drug. Serious acute hypersensitivity reactions may require epinephrine and other emergency measures.

Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including ceftazidime. Therefore, it is important to consider its diagnosis in patients administered ceftazidime who develop diarrhea. Such colitis may range in severity from mild to life-threatening.

Treatment with broad-spectrum antibiotics including ceftazidime may alter the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by C. difficile is one primary cause of antibiotic-associated colitis.

Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, management should include sigmoidoscopy, appropriate bacteriologic studies and fluid, electrolyte and protein supplementation. When the colitis does not improve after the administration of ceftazidime has been discontinued, or when it is severe, consideration should be given to the administration of oral vancomycin or other suitable therapy.

Precautions: Ceftazidime dosage should be reduced in patients with impaired renal function (see Dosage). High and prolonged serum antibiotic concentrations can occur from normal dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. The total daily dosage should be reduced when ceftazidime is administered to such patients to avoid the clinical consequences, e.g., seizures due to elevated levels of antibiotics (see Dosage). Continued dosage should be determined by degree of renal impairment, severity of infection and susceptibility of the causative organism.

As with other antibiotics, prolonged use of ceftazidime may result in the overgrowth of non-susceptible organisms including species originally sensitive to the drug. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken. Resistance has developed during therapy with ceftazidime by S. aureus, Enterobacteriaceae, Acinetobacter species and Pseudomonas species.

Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics or potent diuretics, such as furosemide. Although transient elevations of BUN and serum creatinine have been observed in clinical studies, there is no evidence that ceftazidime, when administered alone, is significantly nephrotoxic.

Pregnancy: The safety of ceftazidime in the treatment of infections during pregnancy has not been established. If the administration to pregnant patients is considered necessary, its use requires that the potential benefits be weighed against the possible hazards to the fetus.

Lactation: Ceftazidime is excreted in human milk in low concentrations (3.8 to 5.2 mg/mL). Caution should be exercised when ceftazidime is administered to a nursing woman.

Neonates: Safety in infants 1 month of age or younger has not been established.

Geriatrics: The elimination of ceftazidime may be reduced due to impairment of renal function.

Laboratory Test Changes: A false-positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solution or with Clinitest tablets but not with Tes-Tape (Glucose Enzymatic Test Strip, USP).

Adverse Effects:

Local effects, reported in 2.8% of patients, were phlebitis, thrombophlebitis, pain and inflammation at the site of injection or infusion.

Hypersensitivity reactions, reported in 2.7% of patients, were pruritus, urticaria, rash and fever. Immediate reactions, generally manifested by rash and/or pruritus, occurred in 1 in 285 patients. Angioedema and anaphylaxis (0.2% of patients; bronchospasm and/or hypotension) have been reported very rarely.

Gastrointestinal symptoms, reported in <4% of patients, were diarrhea, colitis, nausea, vomiting, and abdominal pain. Pseudomembranous colitis has been reported (see Warnings).

CNS reactions (less than 1%) included headache, dizziness, and paresthesia. Seizures have been reported with several cephalosporins including ceftazidime (see Precautions).

Less frequent adverse events (<1%) were candidiasis (including oral thrush) and vaginitis.

Hepatic: <4% of patients experienced transient elevations of hepatic values, these included: AST, ALT, LDH and alkaline phosphatase.

Renal: transient elevations of blood urea, blood urea nitrogen and/or serum creatinine were noted in <1% of patients.

Hematopoietic effects were noted and included eosinophilia (3.4%), positive Coombs’ test without hemolysis (5.1%). Transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia, thrombocytosis and lymphocytosis were seen in <1% of patients.

Symptoms And Treatment Of Overdose :

OverdoseSymptoms: No case of overdosage has been reported to date with ceftazidime, no specific information on symptoms or treatment are available. It is reported that the administration of large doses of parenteral cephalosporins may cause dizziness, paresthesias and headaches. Seizures may occur following overdosage with some cephalosporins, particularly in patients with renal impairment in whom accumulation is likely to occur.

Laboratory abnormalities that may occur after an overdose include elevations in creatinine, BUN, liver enzymes and bilirubin, a positive Coombs’ test, thrombocytosis, thrombocytopenia, eosinophilia, leukopenia and prolongation of the prothrombin time.

Treatment: If seizures occur, the drug should be discontinued promptly and anticonvulsant therapy may be administered if clinically indicated. The patient’s airway should be protected and ventilation and perfusion supported. The patient’s vital signs, blood gases, serum electrolytes, etc. should be meticulously monitored and maintained, within acceptable limits.

In cases of severe overdosage, especially in a patient with renal failure, combined hemodialysis and hemoperfusion may be considered if response to more conservative therapy fails. However, no clinical data supporting such therapy of ceftazidime overdosage are available.

Dosage And Administration:

Dosage And Administration: Ceftazidime may be administered i.v. or i.m. after reconstitution. Dosage and route of administration should be determined by the severity of infection, susceptibility of the causative organisms and condition and renal function of the patient.

Adults: The usual recommended daily dose is 1 to 6 g in divided doses; 250 mg to 2 g every 8 to 12 hours.

In patients with severe infections who would normally receive 6 g of ceftazidime daily were it not for renal insufficiency, dose may be increased by 50% or the dosing frequency increased appropriately. Continued dosage should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism.

In patients undergoing hemodialysis, a loading dose of 0.5 to 1 g is recommended, followed by 0.5 to 1 g after each hemodialysis period. Ceftazidime can also be used in patients undergoing intraperitoneal dialysis (IPD) and continuous ambulatory peritoneal dialysis (CAPD). In such patients, a loading dose of 1 g may be given, followed by 500 mg every 24 hours. In addition to i.v. use, ceftazidime can be incorporated in the dialysis fluid at a concentration of 250 mg/2 L of dialysis fluid.

Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction provided renal function is not impaired.

Infants and Children:* The dosage schedule is recommended, although renal status and seriousness of infection must be considered.

Due to the nature of the underlying conditions which usually predispose patients to Pseudomonas infections of the lower respiratory and urinary tracts, a good clinical response accompanied by bacterial eradication may not be achieved despite evidence of in vitro sensitivity.

Administration: I.M.: Ceftazidime should be injected well within the body of a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh.

I.V.: The i.v. route is preferable for patients with septicemia, peritonitis or other severe or life-threatening infections.

Intermittent I.V. Administration: The reconstituted solution may be slowly injected into the vein over a period of 3 to 5 minutes or given through the tubing of an administration set. During the infusion of the solution containing ceftazidime, the administration of other solutions should be discontinued temporarily.

Continuous I.V. Infusion: Ceftazidime may also be administered over a longer period of time.

Note: If therapy with ceftazidime is carried out in combination with an aminoglycoside antibiotic, either, each of these antibiotics should be administered at different sites, or ceftazidime and aminoglycosides may be administered sequentially by intermittent i.v. infusion. After the administration of 1 of the 2 drugs, the tubing is carefully and thoroughly flushed with an approved solution for reconstitution and then the other drug solution is administered. An aminoglycoside should not be mixed with ceftazidime in the same container.

Reconstitution: I.M.: Solutions for Reconstitution: Sterile Water for Injection or, if required, Bacteriostatic Water for Injection, 0.5 to 1.0% Lidocaine Hydrochloride Injection.

Shake well until dissolved. The prepared solution may be further diluted to the desired volume with any of the solutions for i.v. infusion listed below.

Continuous I.V. Infusion: Reconstitute 1 or 2 g vials with 10 mL Sterile Water for Injection. The appropriate quantity of the reconstituted solution may be added to an i.v. bottle containing any of the solutions listed below.

Pharmacy Bulk Vial: The availability of the bulk pharmacy vial is restricted to hospitals with a recognized i.v. admixture program.

Tazidime for Injection does not contain any preservatives. The Pharmacy Bulk Vial is intended for multiple dispensing for i.v. use only, employing a single puncture.

Following reconstitution with Sterile Water for Injection, the solution should be dispensed and diluted for use within 8 hours. Any unused reconstituted solution should be discarded after 8 hours.

Solutions for I.V. Infusion: 0.9% Sodium Chloride Injection, M/6 Sodium Lactate Injection, Ringers Injection USP, Lactated Ringers Injection USP, 5% Dextrose Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 10% Dextrose Injection, Normosol-M in 5% Dextrose Injection.

When ceftazidime is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use, please follow the recommended techniques of reconstitution described below.

Solutions of ceftazidime, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction. However, if concurrent therapy with ceftazidime and an aminoglycoside is indicated, each of these antibiotics should be administered in different sites.

Instructions for Reconstitution: For 1 g i.m./i.v. and 2 g i.v. vials:

1. Inject the diluent and shake well to dissolve.

2. Carbon dioxide is released as the antibiotic dissolves, generating pressure within the vial. The solution will become clear within 1 to 2 minutes.

3. Invert the vial, and completely depress the syringe plunger prior to insertion.

4. Insert the needle through the vial stopper. Be sure the needle remains within the solution, and withdraw contents of the vial in the usual maner. Pressure in the vial may aid withdrawal.

5. The withdrawn solution may contain carbon dioxide bubbles which should be expelled from the syringe before injection.

For 6 g pharmacy bulk package:

1. When diluent is being added, the vial must be vented to prevent buildup of pressure due to release of carbon dioxide formed as the antibiotic dissolves. Use standard venting procedures outlined in the venting card for Tazidime.

2. Inject 26 mL of diluent to provide a solution containing approximately 1 g of ceftazidime activity per 5 mL. Inject 56 mL of diluent to provide a solution containing approximately 1 g of ceftazidime activity per 10 mL.

3. Dissolve the antibiotic by gently agitating the solution.

4. Allow sufficient time (1 to 2 minutes) for carbon dioxide to vent before dispensing solution.

5. After storage, relieve any additional pressure that may develop in the vial before dispensing.

Storage: Ceftazidime in the dry state should be stored at room temperature and protected from light.

Reconstituted solutions should be administered within 12 hours when stored at room temperature (not exceeding 25°C), and within 48 hours when refrigerated, from the time of reconstitution.

Incompatibility: Ceftazidime should not be added to blood products, protein hydrolysates or amino acids. It should not be mixed together with an aminoglycoside.

Availability And Storage:

Pharmacy Bulk Vial (No. 7241): Each vial of dry powder contains: ceftazidime 6 g and sodium carbonate 708 mg. Rubber-stoppered vials of 100 mL.

Vials: 1 g: Each vial of dry powder contains: ceftazidime 1 g and sodium carbonate 118 mg. Rubber-stoppered vials of 20 mL.

2 g : Each vial of dry powder contains: ceftazidime 2 g and sodium carbonate 236 mg. Rubber-stoppered vials of 50 mL.

TAZIDIME® Lilly Ceftazidime Antibiotic

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