Tazicef Dosage

Dosage: 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.

The guidelines for dosage of Tazicef (ceftazidime for injection, USP) are listed in Table 3. The following dosage schedule is recommended.

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 dosage. The recommended dosage is presented in Table 4.

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:

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 may be 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 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.

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: Tazicef 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 (see PRECAUTIONS).

Note: Tazicef in ADD-Vantage® vials is not intended for direct IV or IM injection.

Intramuscular Administration: For IM administration, Tazicef should be reconstituted with Sterile Water for Injection. Refer to Table 5.

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.

For direct intermittent IV administration, reconstitute Tazicef as directed in Table 5 with Sterile Water for Injection. Slowly inject directly into the vein over a period of 3 to 5 minutes or give through the tubing of an administration set while the patient is also receiving one of the compatible IV fluids (see COMPATIBILITY AND STABILITY).

For IV infusion, reconstitute the 1- or 2-gram piggyback vial with 100 mL of Sodium Chloride Injection or one of the compatible IV fluids listed under the COMPATIBILITY AND STABILITY section. Alternatively, reconstitute the 1-gram or 2-gram vial and add an appropriate quantity of the resulting solution to an IV container with one of the compatible IV fluids.

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.

TAZICEF INJECTION IN ADD-VANTAGE® VIALS

Note: Tazicef (ceftazidime for injection, USP) in the ADD-Vantage® vial is intended to be administered as a single-dose intravenous infusion with the ADD-Vantage® flexible diluent container.

Tazicef in single-dose ADD-Vantage® vials should be prepared as directed (see RECONSTITUTION, for ADD-Vantage® Vials) with either 0.9% Sodium Chloride Injection in the 50 mL or 100 mL flexible diluent containers, 0.45% Sodium Chloride Injection in the 50 mL container or 5% Dextrose Injection in the 50 mL or 100 mL containers.

RECONSTITUTION

Single-Dose Vials:

For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. The vacuum may assist entry of the diluent. SHAKE WELL.

Withdraw the total volume of solution into the syringe (the pressure in the vial may aid withdrawal). The withdrawn solution may contain some bubbles of carbon dioxide.

Note: As with the administration of all parenteral products, accumulated gases should be expressed from the syringe immediately before injection of Tazicef.

These solutions of Tazicef are stable for 24 hours at room temperature or 7 days if refrigerated (5°C). Slight yellowing does not affect potency.

For IV infusion, dilute reconstituted solution in 50 to 100 mL of one of the parenteral fluids listed under COMPATIBILITY AND STABILITY.

“Piggyback” Vials:

For IV infusion, reconstitute with 10 mL of Sodium Chloride Injection according to the following table. The vacuum may assist entry of the diluent. SHAKE WELL.

Insert a gas relief needle through the vial closure to relieve the internal pressure. With the gas relief needle in position, add the remaining 90 mL of Sodium Chloride Injection. Remove the gas relief needle and syringe needle; shake the vial and set up for infusion in the normal way.

Note: To preserve product sterility, it is important that a gas relief needle is not inserted through the vial closure before the product has dissolved.

These solutions of Tazicef (ceftazidime for injection, USP) are stable for 24 hours at room temperature or 7 days if refrigerated (5°C). Slight yellowing does not affect potency.

ADD-Vantage® Vials: ADD-Vantage® vials of Tazicef (ceftazidime for injection, USP) are to be reconstituted only with 0.9% Sodium Chloride Injection or 5% Dextrose Injection in the 50 mL or 100 mL flexible diluent containers, or with 0.45% Sodium Chloride Injection in the 50 mL container.

DIRECTIONS FOR USE OF TAZICEF® (CEFTAZIDIME FOR INJECTION, USP) IN ADD-VANTAGE® VIALS

To Open Diluent Container:

Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

To Assemble Vial and Flexible Diluent Container:

(Use Aseptic Technique)

1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

    a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1), then pull straight up to remove the cap. (SEE FIGURE 2.)

Note: Do not access vial with syringe.

     b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.)

2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go.

    Note: Once vial is sealed, do not attempt to remove. (SEE FIGURE 4.)

3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

4. Label appropriately.

To Reconstitute the Drug:

1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

2. With the other hand, push the drug vial down into the container, telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.)

3. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

4. Mix container contents thoroughly and use within the specified time.

Preparation for Administration:

(Use Aseptic Technique)

     1.    Confirm the activation and admixture of vial contents.

     2.    Check for leaks by squeezing container firmly. If leaks are found discard unit as sterility may be impaired.

     3.    Close flow control clamp of administration set.

     4.    Remove cover from outlet port at bottom of container.

     5.    Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. Note: See full directions on administration set carton.

     6.    Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.

     7.    Squeeze and release drip chamber to establish proper fluid level in chamber.

     8.    Open flow control clamp and clear air from set. Close clamp.

     9.    Attach set to venipuncture device. If device is not in-dwelling, prime and make venipuncture.

   10.    Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

COMPATIBILITY AND STABILITY

Intramuscular: 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 Sterile Water for Injection that are frozen immediately after reconstitution in the original container are stable for 3 months when stored at -20°C. 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).

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. Solutions in Sterile Water for Injection in the original container or 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. 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. Do not force thaw by immersion in water baths or by microwave irradiation. 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 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.

ADD-Vantage® Vials: Ordinarily, ADD-Vantage® vials should be reconstituted only when it is certain that the patient is ready to receive the drug. However, Tazicef in ADD-Vantage® vials is stable for 24 hours at room temperature when reconstituted as directed (see RECONSTITUTION, ADD-Vantage® Vials, and DIRECTIONS FOR USE OF TAZICEF® INJECTION IN ADD-VANTAGE® VIALS).

Note: Parenteral drug products should be inspected visually for particulate matter prior to administration whenever solution and container permit.

As with other cephalosporins, Tazicef powder, as well as solutions, tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.