Download CefTAZidime Basics

CefTAZidime
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Description
Formulation Details
[Pfizer Inc] (1 g)
Formulation Details
[Pfizer Inc] (2 g)
Formulation Details
[Pfizer Inc] (500 mg)
Formulation Details
[Pfizer Inc] (6 g)
Formulation Details
Fortaz® [Covis Pharmaceuticals] (500 mg)
Formulation Details
Fortaz® [Covis Pharmaceuticals] (1 g)
Formulation Details
Fortaz® [Covis Pharmaceuticals] (2 g)
Formulation Details
Fortaz® [Covis Pharmaceuticals] (6 g)
Formulation Details
Fortaz® [Covis Pharmaceuticals] (1 g)
Formulation Details
Fortaz® [Covis Pharmaceuticals] (2 g)
Formulation Details
Fortaz® [Covis Pharmaceuticals] (1 g)
Formulation Details
Fortaz® [Covis Pharmaceuticals] (2 g)
Formulation Details
Tazicef® [Hospira] (1 g)
Formulation Details
Tazicef® [Hospira] (1 g)
Formulation Details
Tazicef® [Hospira] (2 g)
Formulation Details
Tazicef® [Hospira] (6 g)
Formulation Details
Tazicef® [Hospira] (1 g)
Formulation Details
Tazicef® [Hospira] (2 g)
Formulation Details
[Sandoz Inc] (1 g)
Formulation Details
[Sandoz Inc] (2 g)
Formulation Details
[Sandoz Inc] (6 g)
Formulation Details
[Baxter Healthcare] (1 g)
Formulation Details
[Baxter Healthcare] (2 g)
Formulation Details
[Baxter Healthcare] (6 g)
Formulation Details
[Sagent Pharmaceuticals Inc] (1 g)
Formulation Details
[Sagent Pharmaceuticals Inc] (2 g)
Formulation Details
[Sagent Pharmaceuticals Inc] (6 g)
U.S. Brand Names
Fortaz; Fortaz in D5W; Tazicef
Canadian Brand Names
Ceftazidime For Injection; Fortaz®
Medication Safety Issues
Sound-alike/look-alike issues:
CefTAZidime may be confused with ceFAZolin, cefepime, cefoTEtan, cefOXitin, cefTRIAXone
Ceptaz® may be confused with Septra®
Tazicef® may be confused with Tazidime®
International issues:
Ceftim [Portugual] and Ceftime [Thailand] brand names for ceftazidime may be confused with Ceftin brand name for cefuroxime [U.S.,
Canada]; Cefiton brand name for cefixime [Portugal]
Generic Available (U.S.)
May be product dependent
Therapeutic Category
Antibiotic, Cephalosporin (Third Generation)
Clinical Pharmacology
Mechanism of Action
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final
transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to
ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Pharmacokinetics (Adult data unless noted)
Distribution: Widely throughout the body including bone, bile, skin, CSF (higher concentrations achieved when meninges are inflamed),
endometrium, heart, pleural and lymphatic fluids
Protein binding: 17%
Half-life elimination: 1-2 hours, prolonged with renal impairment; Neonates <23 days: 2.2-4.7 hours
Time to peak, serum: I.M.: ~1 hour
Excretion: Urine (80% to 90% as unchanged drug)
Indications & Usage
Use
Treatment of documented susceptible Pseudomonas aeruginosa infection and infections due to other susceptible aerobic gram-negative
organisms; empiric therapy of a febrile, granulocytopenic patient
Use: Unlabeled/Investigational
Bacterial endophthalmitis
Contraindications
Hypersensitivity to ceftazidime, any component of the formulation, or other cephalosporins
Warnings/Precautions
Concerns related to adverse effects:
• Elevated INR: May be associated with increased INR, especially in nutritionally-deficient patients, prolonged treatment, hepatic or
renal disease.
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis,
angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and
pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels, particularly in the presence of renal
impairment, may increase risk of seizures.
Pregnancy & Lactation
Pregnancy Risk Factor
B
Pregnancy Implications
Teratogenic effects were not observed in animal reproduction studies. Ceftazidime crosses the placenta and reaches the cord serum and
amniotic fluid. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins. Maternal peak
serum concentration is unchanged in the first trimester. After the first trimester, serum concentrations decrease by approximately 50% of
those in nonpregnant patients. Renal clearance is increased during pregnancy.
Lactation
Enters breast milk/use caution (AAP rates “compatible”; AAP 2001 update pending)
Adverse Reactions
1% to 10%:
Gastrointestinal: Diarrhea (1%)
Local: Pain at injection site (1%)
Miscellaneous: Hypersensitivity reactions (2%)
<1%: Anaphylaxis, angioedema, asterixis, BUN increased, candidiasis, creatinine increased, dizziness, encephalopathy, eosinophilia,
erythema multiforme, fever, headache, hemolytic anemia, hyperbilirubinemia, jaundice, leukopenia, myoclonus, nausea, neuromuscular
excitability, paresthesia, phlebitis, pruritus, pseudomembranous colitis, rash, Stevens-Johnson syndrome, thrombocytosis, toxic epidermal
necrolysis, transaminases increased, vaginitis, vomiting
Reactions reported with other cephalosporins: Seizure, urticaria, serum-sickness reactions, renal dysfunction, interstitial nephritis, toxic
nephropathy, elevated BUN, elevated creatinine, cholestasis, aplastic anemia, hemolytic anemia, pancytopenia, agranulocytosis, colitis,
prolonged PT, hemorrhage, superinfection
Interactions
Drug Interactions: Metabolism/Transport Effects
None known.
Drug Interactions
Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product
for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider
therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected.
Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic
antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D:
Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Lab Test Interactions
Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), falsepositive serum or urine creatinine with Jaffé reaction
Dosing
Dosing: Adults
Bacterial arthritis (gram negative bacilli): I.V.: 1-2 g every 8 hours
Bone and joint infections: I.V.: 2 g every 12 hours
Cystic fibrosis, lung infection caused by Pseudomonasspp: I.V.: 30-50 mg/kg/dose every 8 hours (maximum: 6 g daily)
Endophthalmitis, bacterial (unlabeled use): Intravitreal: 2.25 mg/0.1 mL NS in combination with vancomycin
Intra-abdominal infection, severe (in combination with metronidazole): I.V.: 2 g every 8 hours for 4-7 days (provided source
controlled). Not recommended for hospital-acquired intra-abdominal infections (IAI) associated with multidrug-resistant gram negative
organisms or in mild-to-moderate community-acquired IAIs due to risk of toxicity and the development of resistant organisms
(Solomkin, 2010).
Melioidosis: I.V.: 40 mg/kg/dose every 8 hours for 10 days, followed by oral therapy with doxycycline or TMP/SMX
Otitis externa: I.V.: 2 g every 8 hours
Peritonitis (CAPD):
Anuric, intermittent: 1-1.5 g daily
Anuric, continuous (per liter exchange): Loading dose: 250 mg; maintenance dose: 125 mg
Pneumonia: I.V.:
Uncomplicated: 500 mg to 1 g every 8 hours
Complicated or severe: 2 g every 8 hours
Prosthetic joint infection,Pseudomonas aeruginosa(alternative to cefepime or meropenem): I.V.: 2 g every 8 hours for 4-6 weeks
(consider addition of an aminoglycoside) (Osmon, 2013)
Skin and soft tissue infections: I.V., I.M.: 500 mg to 1 g every 8 hours
Severe infections, including meningitis, complicated pneumonia, endophthalmitis, CNS infection, osteomyelitis, gynecological,
skin and soft tissue: I.V.: 2 g every 8 hours
Urinary tract infections: I.V., I.M.:
Uncomplicated: 250 mg every 12 hours
Complicated: 500 mg every 8-12 hours
Dosing: Elderly
I.M., I.V.: Dosage should be based on renal function with a dosing interval not more frequent then every 12 hours.
Dosing: Pediatric
Susceptible infections: I.V.:
Children 1 month to 12 years: 30-50 mg/kg/dose every 8 hours; maximum dose: 6 g/day (higher doses reserved for immunocompromised
patients, cystic fibrosis, or meningitis)
Children ≥12 years: Refer to adult dosing.
Dosing: Renal Impairment
Clcr 30-50 mL/minute: Administer every 12 hours
Clcr 10-30 mL/minute: Administer every 24 hours
Clcr <10 mL/minute: Administer every 48-72 hours
Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): Dialyzable (50% to 100%): 500 mg to 1 g every 24 hours
or 1-2 g every 48-72 hours (Heintz, 2009). Note: Dosing dependent on the assumption of 3 times per week, complete IHD sessions.
Peritoneal dialysis (PD): Loading dose of 1 g, followed by 500 mg every 24 hours
Continuous renal replacement therapy (CRRT) (Heintz, 2009; Trotman, 2005): Drug clearance is highly dependent on the method of renal
replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse
reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are
general recommendations only (based on dialysate flow/ultrafiltration rates of 1-2 L/hour and minimal residual renal function) and
should not supersede clinical judgment:
CVVH: Loading dose of 2 g followed by 1-2 g every 12 hours
CVVHD/CVVHDF: Loading dose of 2 g followed by either 1 g every 8 hours or 2 g every 12 hours. Note: Dosage of 1 g every 8 hours
results in similar steady-state concentrations as 2 g every 12 hours and is more cost effective. Dosage of 2 g every 8 hours
may be needed for gram-negative rods with MIC ≥4 mg/L (Heintz, 2009).
Note: For patients receiving CVVHDF, some recommend giving a loading dose of 2 g followed by 3 g over 24 hours as a
continuous I.V. infusion to maintain concentrations ≥4 times the MIC for susceptible pathogens (Heintz, 2009).
Dosing: Hepatic Impairment
No dosage adjustment necessary.
Available Products
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous, as sodium [strength expressed as base]:
Fortaz in D5W: 1 g (50 mL); 2 g (50 mL)
Tazicef: 1 g/50 mL (50 mL)
Solution Reconstituted, Injection:
Fortaz: 500 mg (1 ea); 1 g (1 ea); 2 g (1 ea); 6 g (1 ea)
Tazicef: 1 g (1 ea); 2 g (1 ea); 6 g (1 ea)
Generic: 1 g (1 ea); 2 g (1 ea); 6 g (1 ea); 100 g (1 ea)
Solution Reconstituted, Injection [preservative free]:
Generic: 1 g (1 ea); 2 g (1 ea); 6 g (1 ea)
Solution Reconstituted, Intravenous:
Fortaz: 1 g (1 ea); 2 g (1 ea)
Tazicef: 1 g (1 ea); 2 g (1 ea)
Solution Reconstituted, Intravenous, as sodium [strength expressed as base]:
Generic: 1 g/50 mL (1 ea); 2 g/50 mL (1 ea)
Administration
Administration, I.M.
Inject deep I.M. into large mass muscle.
Administration, I.V.
Ceftazidime can be administered IVP over 3-5 minutes or I.V. intermittent infusion over 15-30 minutes.
Administration, I.V. Detail
Any carbon dioxide bubbles that may be present in the withdrawn solution should be expelled prior to injection. Administer around-the-clock
to promote less variation in peak and trough serum levels.
pH: 5-8 (Fortaz®); 5.0-7.5 (Tazicef®)
Storage & Compatibility
Storage
Fortaz®: Store dry vials at 15°C to 30°C (59°F to 86°F). Protect from light. Reconstituted solution and solution further diluted for I.V.
infusion are stable for 12 hours at room temperature, for 3 days when refrigerated, or for 12 weeks when frozen at -20°C (-4°F). After
freezing, thawed solution in SWFI for I.M. administration is stable for 3 hours at room temperature or for 3 days when refrigerated; thawed
solution in NS in a Viaflex® small volume container for I.V. administration is stable for 12 hours at room temperature or for 3 days when
refrigerated; and thawed solution in SWFI in the original container is stable for 8 hours at room temperature or for 3 days when refrigerated.
Premixed frozen solution: Store frozen at -20°C (-4°F). Thawed solution is stable for 8 hours at room temperature or for 3 days under
refrigeration; do not refreeze.
Fortaz®, Tazicef®: ADD-Vantage® vials: Following dilution, may be stored for up to 12 hours at room temperature or for 3 days under
refrigeration. Freezing solutions in the ADD-Vantage® system is not recommended. Joined vials that have not been activated may be used
within 14 days.
Tazicef® vials: Store dry vials at 20°C to 25°C (68°F to 77°F). Protect from light. Reconstituted vials and solution further diluted for I.V.
infusion are stable for 24 hours at room temperature, for 7 days when refrigerated, or for 12 weeks when frozen at -20°C (-4°F). When
thawed, solution is stable for 8 hours at room temperature and 4 days when refrigerated.
Reconstitution
I.M.: Using SWFI, bacteriostatic water, lidocaine 0.5%, or lidocaine 1%, reconstitute the 500 mg vials with 1.5 mL or the 1 g vials with 3 mL;
final concentration of ~280 mg/mL
I.V.: Using SWFI, reconstitute as follows (Note: After reconstitution, may dilute further with a compatible solution to administer via I.V.
infusion):
Fortaz®:
~100 mg/mL solution:
500 mg vial: 5.3 mL SWFI (withdraw 5 mL from the reconstituted vial to obtain a 500 mg dose)
1 g vial: 10 mL SWFI (withdraw 10 mL from the reconstituted vial to obtain a 1 g dose)
6 g vial: 56 mL SWFI (withdraw 10 mL from the reconstituted vial to obtain a 1 g dose)
~170 mg/mL solution: 2 g vial: 10 mL SWFI (withdraw 11.5 mL from the reconstituted vial to obtain a 2 g dose)
~200 mg/mL solution: 6 g vial: 26 mL SWFI (withdraw 5 mL from the reconstituted vial to obtain a 1 g dose)
Tazicef®:
~95 mg/mL solution: 1 g vial: 10 mL SWFI (withdraw 10.6 mL from the reconstituted vial to obtain a 1 g dose)
~180 mg/mL solution: 2 g vial: 10 mL SWFI (withdraw 11.2 mL from the reconstituted vial to obtain a 2 g dose)
Fortaz®, Tazicef®: ADD-Vantage® vials: Dilute in 50 or 100 mL of D5W, NS, or 0.45% sodium chloride in an ADD-Vantage® flexible diluent
container only.
I.V. Compatibility
Stable in D5NS, D5W, D10W, LR, NS, Ringer's injection, sterile water for injection, in peritoneal dialysis solutions
Y-site administration: Compatible: Acyclovir, allopurinol, amifostine, amikacin, anidulafungin, aztreonam, bivalirudin, ciprofloxacin,
daptomycin, dexmedetomidine, diltiazem, docetaxel, dopamine, enalaprilat, epinephrine, esmolol, etoposide phosphate, famotidine,
fenoldopam, filgrastim, fludarabine, foscarnet, furosemide, gallium nitrate, gemcitabine, gentamicin, granisetron, heparin, hetastarch in
lactate electrolyte injection (Hextend®), hydromorphone, insulin (regular), ketamine, labetalol, linezolid, melphalan, meperidine,
methylprednisolone sodium succinate, milrinone, morphine, ondansetron, paclitaxel, ranitidine, remifentanil, sufentanil, tacrolimus,
telavancin, teniposide, thiotepa, tigecycline, tobramycin, valproate sodium, vinorelbine, zidovudine. Incompatible: Acetylcysteine,
amiodarone, amphotericin B cholesteryl sulfate complex, amsacrine, azithromycin, caspofungin, dobutamine, doxorubicin liposome,
erythromycin lactobionate, idarubicin, midazolam, pantoprazole, pemetrexed, pentamidine, phenytoin, warfarin. Variable (consult detailed
reference): Aminopylline, cisatracurium, doxapram, drotrecogin alfa, fluconazole, nicardipine, propofol, sargramostim, theophylline,
vancomycin.
Compatibility in syringe: Compatible: Dimenhydrinate, hydromorphone. Incompatible: Pantoprazole.
Monitoring
Monitoring Parameters
Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Breast-Feeding Considerations
Very small amounts of ceftazidime are excreted in breast milk. The manufacturer recommends that caution be exercised when administering
ceftazidime to nursing women. Ceftazidime in not absorbed when given orally; therefore, any medication that is distributed to human milk
should not result in systemic concentrations in the nursing infant. Nondose-related effects could include modification of bowel flora.
Patient Education
Discuss specific use of drug and side effects with patient as it relates to treatment. Patient may experience nausea, diarrhea, or vaginal yeast
infection. Have patient report immediately to prescriber ecchymosis or rash. Educate patient about signs of a significant reaction (eg,
wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not
a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Dietary Implications
Some products may contain sodium.
View the Patient Handout: English | Spanish
Additional Information
With some organisms, resistance may develop during treatment (including Enterobacter spp and Serratia spp). Consider combination therapy
or periodic susceptibility testing for organisms with inducible resistance.
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Davies SP, Lacey LF, Kox WJ, et al, “Pharmacokinetics of Cefuroxime and Ceftazidime in Patients With Acute Renal Failure Treated by
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Lipsky BA, Berendt AR, Cornia PB, et al, "2012 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and
Treatment of Diabetic Foot Infections," Clin Infect Dis, 2012, 54(12):e132-73. [PMID: 22619242]
Klein NC and Cunha BA, “Third-Generation Cephalosporins,” Med Clin North Am, 1995, 79(4):705-19. [PMID: 7791418]
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26(4):583-4. [PMID: 6393862]
Osmon DR, Berbari EF, Berendt AR, et al, “Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guideline by the
Infectious Diseases Society of America,” Clin Infect Dis, 2013, 56(1):e1-25. [PMID: 23223583]
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Efficacy,” Drugs, 1995, 49(4):577-617. [PMID: 7789291]
“Results of the Endophthalmitis Vitrectomy Study. A Randomized Trial of Immediate Vitrectomy and of Intravenous Antibiotics for the
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Roth DB and Flynn HW Jr, “Antibiotic Selection in the Treatment of Endophthalmitis: The Significance of Drug Combinations and Synergy,”
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Sirgo MA and Norris S, “Ceftazidime in the Elderly: Appropriateness of Twice-Daily Dosing,” DICP Ann Pharmacother, 1991, 25(3):284-8.
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