DOSAGE AND ADMINISTRATION
NOTE: This insert is for a Pharmacy Bulk Package and is intended for preparing IV admixtures only. Dosage recommendations for intramuscular or intravenous injection and intraperitoneal use are for informational purposes only.
Dosage: The usual adult dosage is 1 gram administered intravenously every 8 or 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.
The guidelines for dosage of Tazicef (ceftazidime for injection, USP) are listed in Table 3. The following dosage schedule is recommended.
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Table 3. Recommended Dosage Schedule
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Dose
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Frequency
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Adults
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Usual recommended dose
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1 gram IV
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q8 or 12h
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Uncomplicated urinary tract infections
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250 mg IV
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q12h
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Bone and joint infections
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2 grams IV
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q12h
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Complicated urinary tract infections
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500 mg IV
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q8 or 12h
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Uncomplicated pneumonia; mild skin and
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500 mg to 1 gram
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q8h
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skin structure infections
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IV
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Serious gynecological and
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2 grams IV
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q8h
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intra-abdominal infections
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Meningitis
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2 grams IV
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q8h
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Very severe life-threatening infections,
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2 grams IV
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q8h
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especially in immunocompromised patients
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Lung infections caused by Pseudomonas
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30 to 50 mg/kg IV
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q8h
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spp. in patients with cystic fibrosis
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to a maximum
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with normal renal function*
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of 6 grams/day
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Neonates (0− 4 weeks)
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30 mg/kg IV
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q12h
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Infants and children
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30 to 50 mg/kg IV
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q8h
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(1 month − 12 years)
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to a maximum
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of 6 grams/day†
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* Although clinical improvement has been shown, bacteriological cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis.
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† The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis.
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Impaired Hepatic Function : No adjustment in dosage is required for patients with hepatic dysfunction.
Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate [GFR]<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 may be given. An estimate of GFR should be made to determine the appropriate maintenance dose. The recommended dosage is presented in Table 4.
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Table 4. Recommended Maintenance Doses of Tazicef (ceftazidime for injection, USP) in Renal Insufficiency
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NOTE: IF THE DOSE RECOMMENDED IN TABLE 3 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 4, THE LOWER DOSE SHOULD BE USED.
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Creatinine
Clearance
(mL/min.)
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Recommended
Unit Dose of
Tazicef
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Frequency
of Dosing
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50 − 31
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1 gram
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q12h
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30 − 16
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1 gram
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q24h
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15 − 6
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500 mg
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q24h
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<5
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500 mg
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q48h
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When only serum creatinine is available, the following formula (Cockcroft’s equation)4 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:
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Males:
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Creatinine clearance (mL/min.) =
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[Weight (kg) x (140 - age)] / [72 x serum creatinine (mg/dL)]
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Females:
0.85 x male value
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In patients with severe infections who would normally receive 6 grams of Tazicef daily were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection and susceptibility of the causative organism.
In pediatric patients as for adults, the creatinine clearance should be adjusted for body surface area or lean body mass and the dosing frequency 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.
Tazicef (ceftazidime for injection, USP) can also be used in patients undergoing intra-peritoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of Tazicef may be given, followed by 500 mg every 24 hours. In addition to IV use, Tazicef can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 liters of dialysis fluid.
Note: Generally Tazicef should be continued for 2 days after the signs and symptoms of infection have disappeared, but in complicated infections longer therapy may be required.
Administration: See above NOTE concerning the proper use of Pharmacy Bulk Packages.
Intravenous Administration: The IV route is preferable for patients with bacterial septicemia, bacterial meningitis, peritonitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure or malignancy, particularly if shock is present or pending.
Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing ceftazidime it is desirable to discontinue the other solution.
All vials of Tazicef as supplied are under reduced pressure. When Tazicef is dissolved, carbon dioxide is released and a positive pressure develops. See RECONSTITUTION.
Solutions of Tazicef, 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 Tazicef and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.
RECONSTITUTION
Directions for Proper Use of Pharmacy Bulk Packages:
Note: The Pharmacy Bulk Package is for use in a pharmacy admixture service only. Using aseptic technique, the closure should be penetrated only 1 time after reconstitution using a sterile dispensing set which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. The withdrawal of container contents should be accomplished without delay. THE ENTIRE CONTENTS OF THE VIAL SHOULD BE DISPENSED WITHIN 4 HOURS OF INITIAL ENTRY.
A plastic bail attached to the Pharmacy Bulk Package provides a suitable hanging device while dispensing in the pharmacy.
Reconstitute with Sterile Water for Injection according to the following table.
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Table 5
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Diluent to
Be Added
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Approx. Avail.
Volume
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Approx. Avg.
Concentration
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26 mL
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30 mL
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1 gram/5 mL
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56 mL
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60 mL
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1 gram/10 mL
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The vacuum may assist entry of the diluent. SHAKE WELL.
Insert a gas relief needle through the vial closure to relieve the internal pressure. Remove the gas relief needle before extracting any solution.
COMPATIBILITY AND STABILITY
IMPORTANT: The following chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.
Intravenous: Tazicef (ceftazidime for injection, USP) when reconstituted as directed with Sterile Water for Injection, maintains satisfactory potency for 24 hours at room temperature or for 7 days under refrigeration (5°C). Solutions in 0.9% Sodium Chloride Injection in Viaflex® small volume containers that are frozen immediately after reconstitution are stable for 3 months when stored at -20°C. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Frozen solutions should only be thawed at room temperature. Do not force thaw by immersion in water baths or by microwave irradiation. For larger volumes where it may be necessary to warm the frozen product (to a maximum of 40°C), care should be taken to avoid heating after thawing is complete. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 8 hours at room temperature or for 4 days in a refrigerator (5°C).
Tazicef (ceftazidime for injection, USP) is compatible with the more commonly used IV infusion fluids. Solutions at concentrations between 1 mg/mL and 40 mg/mL in the following infusion fluids may be stored for up to 24 hours at room temperature or 7 days if refrigerated: 0.9% Sodium Chloride Injection; Ringer’s Injection USP; Lactated Ringer’s Injection USP; 5% Dextrose Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose Injection.
Tazicef is less stable in Sodium Bicarbonate Injection than in other IV fluids. It is not recommended as a diluent. Solutions of Tazicef in 5% Dextrose and 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers and volume control devices of common IV infusion sets.
Ceftazidime at a concentration of 20 mg/mL has been found physically compatible for 24 hours at room temperature or 7 days under refrigeration in Sterile Water for Injection when admixed with: cefazolin sodium 330 mg/mL; heparin 1000 units/mL; and cimetidine HCl 150 mg/mL.
Ceftazidime at a concentration of 20 mg/mL has been found physically compatible for 24 hours at room temperature or 7 days under refrigeration in 5% Dextrose Injection when admixed with potassium chloride 40 mEq/L.
Vancomycin solution exhibits a physical incompatibility when mixed with a number of drugs, including ceftazidime. The likelihood of precipitation with ceftazidime is dependent on the concentrations of vancomycin and ceftazidime present. It is therefore recommended, when both drugs are to be administered by intermittent IV infusion, that they be given separately, flushing the IV lines (with one of the compatible IV fluids) between the administration of these two agents.
Note: Parenteral drug products should be inspected visually for particulate matter prior to administration whenever solution and container permit.
As with other cephalosporins, Tazicef (ceftazidime for injection, USP) powder, as well as solutions, tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.
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