Fortaz

Fortaz Manufacturers

• Cardinal Health
  

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  Fortaz | Cardinal Health

  

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  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 FORTAZ are listed in Table 3. The following dosage schedule is recommended.

  Table 3. Recommended Dosage Schedule Dose Frequency Adults Usual recommended dosage 1 gram IV or IM q8-12hr Uncomplicated urinary tract infections 250 mg IV or IM q12hr Bone and joint infections 2 grams IV q12hr Complicated urinary tract infections 500 mg IV or IM q8-12hr Uncomplicated pneumonia; mild skin and skin-structure infections 500 mg-1 gram IV or IM q8hr Serious gynecologic and intra-abdominal infections 2 grams IV q8hr Meningitis 2 grams IV q8hr Very severe life-threatening infections, especially in immunocompromised patients 2 grams IV q8hr Lung infections caused by Pseudomonas spp. in patients with cystic fibrosis with normal renal function* 30-50 mg/kg IV to a maximum of 6 grams per day q8hr Neonates (0-4 weeks) 30 mg/kg IV q12hr

  Infants and children

  (1 month-12 years) 30-50 mg/kg IV to a maximum of 6 grams per day† q8hr

  *  Although clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis.

  †  The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis.

  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 FORTAZ may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 4.

  Table 4. Recommended Maintenance Dosages of FORTAZ in Renal Insufficiency 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. Creatinine Clearance (mL/min)

  Recommended Unit Dose

  of FORTAZ Frequency of Dosing 50-31 1 gram q12hr 30-16 1 gram q24hr 15-6 500 mg q24hr <5 500 mg q48hr

  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:

  Males: Creatinine clearance (mL/min) = Weight (kg) x (40 - age)

  72 x serum creatinine (mg/dL)

  Females: 0.85 x male value

  In patients with severe infections who would normally receive 6 grams of FORTAZ 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.

  FORTAZ can also be used in patients undergoing intraperitoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of FORTAZ may be given, followed by 500 mg every 24 hours. In addition to IV use, FORTAZ can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid.

  Note: Generally FORTAZ 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

  FORTAZ 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).

  Intramuscular Administration

  For IM administration, FORTAZ should be constituted with one of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride 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, constitute FORTAZ 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, constitute the 500-mg, 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 listed under the COMPATIBILITY AND STABILITY section.

  Intermittent IV 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.

  ADD-Vantage vials are to be constituted only with 50 or 100 mL of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 0.45% Sodium Chloride Injection in Abbott ADD-Vantage flexible diluent containers (see Instructions for Constitution). ADD-Vantage vials that have been joined to Abbott ADD-Vantage diluent containers and activated to dissolve the drug are stable for 12 hours at room temperature or for 3 days under refrigeration. Joined vials that have not been activated may be used within a 14-day period; this period corresponds to that for use of Abbott ADD-Vantage containers following removal of the outer packaging (overwrap).

  Freezing solutions of FORTAZ in the ADD-Vantage system is not recommended.

  Table 5. Preparation of Solutions of FORTAZ Size

  Amount of Diluent to be Added

  (mL)

  Approximate Available Volume

  (mL)

  Approximate Ceftazidime Concentration

  (mg/mL) Intramuscular 500-mg vial 1.5 1.8 280 1-gram vial 3.0 3.6 280 Intravenous 500-mg vial 5.3 5.7* 100 1-gram vial 10.0 10.8† 100 2-gram vial 10.0 11.5‡ 170 Pharmacy bulk package 6-gram vial 26 30 200

  *  To obtain a dose of 500 mg, withdraw 5.0 mL from the vial following reconstitution.

  †  To obtain a dose of 1 g, withdraw 10.0 mL from the vial following reconstitution.

  ‡  To obtain a dose of 2 g, withdraw 11.5 mL from the vial following reconstitution.

  All vials of FORTAZ as supplied are under reduced pressure. When FORTAZ is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use please follow the recommended techniques of constitution described on the detachable Instructions for Constitution section of this insert.

  Solutions of FORTAZ, 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 FORTAZ and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

  Directions for Use of FORTAZ Frozen in Galaxy® Plastic Containers

  FORTAZ supplied as a frozen, sterile, iso-osmotic, nonpyrogenic solution in plastic containers is to be administered after thawing either as a continuous or intermittent IV infusion. The thawed solution is stable for 8 hours at room temperature or for 3 days if stored under refrigeration. Do not refreeze.

  Thaw container at room temperature (25°C) or under refrigeration (5°C). Do not force thaw by immersion in water baths or by microwave irradiation. 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. Mix after solution has reached room temperature. Check for minute leaks by squeezing bag firmly. Discard bag if leaks are found as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.

  Use sterile equipment.

  Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Administration Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

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• Covis Pharmaceuticals, Inc.
  

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  Fortaz | Covis Pharmaceuticals, Inc.

  

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  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 FORTAZ are listed in Table 5. The following dosage schedule is recommended.

  Table 5. Recommended Dosage Schedule * Although clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis. † The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis.

  Dose

  Frequency

  Adults

  Usual recommended dosage

  1 gram IV or IM

  q8-12hr

  Uncomplicated urinary tract infections

  250 mg IV or IM

  q12hr

  Bone and joint infections

  2 grams IV

  q12hr

  Complicated urinary tract infections

  500 mg IV or IM

  q8-12hr

  Uncomplicated pneumonia; mild skin and skin-structure infections

  500 mg-1 gram IV or IM

  q8hr

  Serious gynecologic and intra-abdominal infections

  2 grams IV

  q8hr

  Meningitis

  2 grams IV

  q8hr

  Very severe life-threatening infections, especially in immunocompromised patients

  2 grams IV

  q8hr

  Lung infections caused by Pseudomonas spp. in patients with cystic fibrosis with normal renal function*

  30-50 mg/kg IV to a maximum of 6 grams per day

  q8hr

  Neonates (0-4 weeks)

  30 mg/kg IV

  q12hr

  Infants and children

  (1 month-12 years)

  30-50 mg/kg IV to a maximum of 6 grams per day†

  q8hr

  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 FORTAZ may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 6.

  Table 6. Recommended Maintenance Dosages of FORTAZ in Renal Insufficiency

  NOTE: IF THE DOSE RECOMMENDED IN Table 5 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN Table 6, THE LOWER DOSE SHOULD BE USED.

  Creatinine Clearance (mL/min)

  Recommended Unit Dose

  of FORTAZ

  Frequency of Dosing

  50-31

  1 gram

  q12hr

  30-16

  1 gram

  q24hr

  15-6

  500 mg

  q24hr

  <5

  500 mg

  q48hr

  When only serum creatinine is available, the following formula (Cockcroft's equation)5 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) x (140 - age)

  72 x serum creatinine (mg/dL)

  Females: 0.85 x male value

  In patients with severe infections who would normally receive 6 grams of FORTAZ 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.

  FORTAZ can also be used in patients undergoing intraperitoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of FORTAZ may be given, followed by 500 mg every 24 hours. In addition to IV use, FORTAZ can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid.

  Note: Generally FORTAZ 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

  FORTAZ 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).

  Intramuscular Administration

  For IM administration, FORTAZ should be constituted with one of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection. Refer to Table 7.

  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, constitute FORTAZ as directed in Table 7 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, constitute the 500-mg, 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 listed under the COMPATIBILITY AND STABILITY section.

  Intermittent IV 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.

  TwistVialTM vials are to be constituted only with 50 or 100 mL of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 0.45% Sodium Chloride Injection in compatible flexible diluent containers (see Instructions for Constitution). TwistVialTM vials that have been joined to compatible diluent containers and activated to dissolve the drug are stable for 12 hours at room temperature or for 3 days under refrigeration. Joined vials that have not been activated may be used within a 14-day period; this period corresponds to that for use of compatible diluent containers following removal of the outer packaging (overwrap).

  Freezing solutions of FORTAZ is not recommended.

  Table 7. Preparation of Solutions of FORTAZ * To obtain a dose of 500 mg, withdraw 5.0 mL from the vial following reconstitution. † To obtain a dose of 1 g, withdraw 10.0 mL from the vial following reconstitution. ‡ To obtain a dose of 2 g, withdraw 11.5 mL from the vial following reconstitution.

  Size

  Amount of Diluent to be Added

  (mL)

  Approximate Available Volume

  (mL)

  Approximate Ceftazidime Concentration

  (mg/mL)

  Intramuscular

  500-mg vial

  1.5

  1.8

  280

  1-gram vial

  3.0

  3.6

  280

  Intravenous

  500-mg vial

  5.3

  5.7*

  100

  1-gram vial

  10.0

  10.8†

  100

  2-gram vial

  10.0

  11.5‡

  170

  Pharmacy bulk package

  6-gram vial

  26

  30

  200

  All vials of FORTAZ as supplied are under reduced pressure. When FORTAZ is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use please follow the recommended techniques of constitution described on the detachable Instructions for Constitution section of this insert.

  Solutions of FORTAZ, 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 FORTAZ and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

  Directions for Use of FORTAZ Frozen in Galaxy® Plastic Containers

  FORTAZ supplied as a frozen, sterile, iso-osmotic, nonpyrogenic solution in plastic containers is to be administered after thawing either as a continuous or intermittent IV infusion. The thawed solution is stable for 8 hours at room temperature or for 3 days if stored under refrigeration. Do not refreeze.

  Thaw container at room temperature (25°C) or under refrigeration (5°C). Do not force thaw by immersion in water baths or by microwave irradiation. 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. Mix after solution has reached room temperature. Check for minute leaks by squeezing bag firmly. Discard bag if leaks are found as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.

  Use sterile equipment.

  Caution

  Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Administration

  1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set.

  Close
  No Recall

  More Info