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CefTAZidime

Pronunciation

Pronunciation

(SEF tay zi deem)

Index Terms

  • Tazidime

Dosage Forms

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)

Generic: 1 g/50 mL (1 ea); 2 g/50 mL (1 ea)

Brand Names: U.S.

  • Fortaz
  • Fortaz in D5W
  • Tazicef

Pharmacologic Category

  • Antibiotic, Cephalosporin (Third Generation)

Pharmacology

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.

Distribution

Widely throughout the body including bone, bile, skin, CSF (higher concentrations achieved when meninges are inflamed), endometrium, heart, pleural and lymphatic fluids

Excretion

Urine (80% to 90% as unchanged drug)

Time to Peak

Serum: IM: ~1 hour

Half-Life Elimination

1 to 2 hours, prolonged with renal impairment

Protein Binding

<10%

Use: Labeled Indications

Bacterial septicemia: Treatment of septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae, and Staphylococcus aureus (methicillin-susceptible strains).

Bone and joint infections: Treatment of bone and joint infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin-susceptible strains).

CNS infections: Treatment of meningitis caused by Haemophilus influenzae and Neisseria meningitidis. Ceftazidime has also been used successfully in cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae.

Empiric therapy in the immunocompromised patient: Empiric treatment of infections in immunocompromised patients.

Gynecologic infections: Treatment of endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.

Intra-abdominal infections: Treatment of peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin-susceptible strains) and polymicrobial intra-abdominal infections caused by aerobic and anaerobic organisms and some Bacteroides spp. (many strains of Bacteroides fragilis are resistant).

Lower respiratory tract infections: Treatment of lower respiratory tract infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin-susceptible strains).

Skin and skin-structure infections: Treatment of skin and skin-structure infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp.; including Proteus mirabilis and indole-positive Proteus; Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin-susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci).

Urinary tract infections (UTI): Treatment of complicated and uncomplicated UTIs caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Klebsiella spp.; and Escherichia coli.

Use: Unlabeled

Bacterial endophthalmitis, melioidosis (Burkholderia pseudomallei) infection

Contraindications

Clinically significant hypersensitivity to ceftazidime, other cephalosporins, penicillins, other beta-lactam antibiotics, or any component of the formulation

Dosing: Adult

Bacterial arthritis (gram negative bacilli): IV: 1-2 g every 8 hours

Cystic fibrosis: IV:

Manufacturer’s labeling: 90 to 150 mg/kg/day every 8 hours (maximum: 6 g daily)

Alternative recommendations: Intermittent IV infusion: 200 to 400 mg/kg/day divided every 6 to 8 hours (maximum: 8 to 12 g daily); or by continuous IV infusion: 100 to 200 mg/kg/day (maximum: 12 g daily) (Zobell, 2013)

Empiric therapy in immunocompromised patients: IV: 2 g every 8 hours

Endophthalmitis, bacterial (off-label use): Intravitreal: 2 to 2.25 mg/0.1 mL NS in combination with vancomycin (Jackson, 2003; Roth, 1997)

Intra-abdominal infection, severe (in combination with metronidazole): IV: 2 g every 8 hours for 4 to 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 (off-label use): IV: Note: Switching to meropenem therapy is indicated if patient condition worsens (eg, organ failure, new infection focus development, repeat blood cultures remained positive). Oral eradication therapy is recommended after the intensive (acute) phase treatment is complete (Lipsitz, 2012).

Severe, acute phase: 50 mg/kg/dose every 8 hours (maximum dose: 2 g) or 2 g for one dose, followed by 6 g daily by continuous infusion for ≥10 days with or without TMP/SMX (Lipsitz, 2012).

Peritonitis (CAPD) (off-label route; Li, 2010): Intraperitoneal:

Intermittent: 1 to 1.5 g every 24 hours per exchange in the long dwell (≥6 hours)

Continuous (per liter exchange): Loading dose: 500 mg; maintenance dose: 125 mg. Note: If patient has residual renal function (eg, >100 mL/day urine output), empirically increase each dose by 25%.

Pneumonia:

Uncomplicated: IM, IV: 500 mg to 1 g every 8 hours

Hospital-acquired pneumonia (off-label dose): IV: 2 g every 8 hours (ATS/IDSA, 2005)

Prosthetic joint infection, Pseudomonas aeruginosa (alternative to cefepime or meropenem): IV: 2 g every 8 hours for 4 to 6 weeks (consider addition of an aminoglycoside) (Osmon, 2013)

Skin and soft tissue infections: IV, IM: 500 mg to 1 g every 8 hours

Severe infections, including meningitis, CNS infection, osteomyelitis, gynecological: IV: 2 g every 8 hours

Urinary tract infections: IV, IM:

Uncomplicated: 250 mg every 12 hours

Complicated: 500 mg every 8 to 12 hours

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Susceptible infections: IV:

Children 1 month to 12 years: 30 to 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.

Indication-specific dosing:

Cystic fibrosis: Infants, Children, and Adolescents: IV:

Manufacturer’s labeling: 150 mg/kg/day divided every 8 hours (maximum: 6 g daily)

Alternative recommendations: 200 to 300 mg/kg/day divided every 8 hours (maximum: 6 g daily) (Red Book [AAP], 2012)

Melioidosis (off-label use): IV: Note: Switching to meropenem therapy is indicated if patient condition worsens (eg, organ failure, new infection focus development, repeat blood cultures remained positive). Oral eradication therapy is recommended after the intensive (acute) phase treatment is complete (Lipsitz, 2012).

Severe, acute phase: Infants >3 months, Children, and Adolescents: 50 mg/kg/dose every 8 hours (maximum dose: 2 g) or 2 g for one dose, followed by 6 g daily by continuous infusion for ≥10 days with or without TMP/SMX (Lipsitz, 2012). Note: Depending on infection severity, the dose for patients ≥3 months can be ≤40 mg/kg (maximum dose: 2 g) (Lipsitz, 2012).

Dosing: Renal Impairment

Note: If the dose recommended in the dosing section is lower than that recommended for patients with renal insufficiency as outlined below, the lower dose should be used. In severe infections, when the usual dose would be ceftazidime 6 g/day in patients without renal impairment, consider increasing the doses below by 50% or increase the dosing frequency. Further dosage adjustments should be determined by infection severity, susceptibility and patient response to therapy.

CrCl 31 to 50 mL/minute: 1 g every 12 hours

CrCl 16 to 30 mL/minute: 1 g every 24 hours

CrCl 6 to 15 mL/minute: 500 mg every 24 hours

CrCl <5 mL/minute: 500 mg every 48 hours

Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): Dialyzable (50% to 100%): 500 mg to 1 g every 24 hours or 1 to 2 g every 48 to 72 hours (Heintz, 2009). Note: Dosing dependent on the assumption of 3 times per week, complete IHD sessions.

Peritoneal dialysis (PD): IV:

Intermittent: Loading dose of 1 g, followed by 500 mg every 24 hours

Continuous: Loading dose of 1 g, followed by 500 mg every 24 hours. Note: an additional 125 mg per liter of exchange fluid may be added to the dialysate if clinically warranted.

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 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH: Loading dose of 2 g followed by 1 to 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 IV infusion to maintain concentrations ≥4 times the MIC for susceptible pathogens (Heintz, 2009).

Dosing: Hepatic Impairment

No dosage adjustment necessary.

Reconstitution

IM: 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

IV: Reconstitute intact vials as follows (Note: After reconstitution, may dilute further with a compatible solution to administer via IV infusion):

Fortaz, Tazicef:

~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)

Duplex container: Unlatch side tab, unfold, remove foil strip from drug chamber. Point set port in downward direction, fold container just below the diluent meniscus, and squeeze the diluent chamber until the seal between the diluent and drug powder opens. Agitate until dissolved.

Administration

Administer around-the-clock to promote less variation in peak and trough serum levels. Ceftazidime can be administered deep IM into large mass muscle, IVP over 3 to 5 minutes, or IV intermittent infusion over 15 to 30 minutes. Do not admix with aminoglycosides in same bottle/bag. Ceftazidime may be administered intravitreally as 2 to 2.25 mg/0.1 mL NS in combination with vancomycin (separate syringes) (Jackson, 2003; Roth, 1997).

Intraperitoneal administration may be used in conjunction with IV use for systemic infections if continuous peritoneal dialysis is used (added to the dialysate in each exchange). Intraperitoneal administration alone may also be used for the treatment of peritonitis and added to the dialysate in intermittent (added to the longest dwell time per day) or continuous (loading dose, followed by a maintenance dose per liter of exchange) peritoneal dialysis.

Dietary Considerations

Some products may contain sodium.

Compatibility

Stable in D5NS, D5W, D10W, LR, NS, Ringer's injection, sterile water for injection, in peritoneal dialysis solutions. Duplex container: Do not admix with other drugs.

Y-site administration: Incompatible with acetylcysteine, amiodarone, amphotericin B cholesteryl sulfate complex, amsacrine, azithromycin, caspofungin, dobutamine, doxorubicin liposome, erythromycin lactobionate, idarubicin, midazolam, pantoprazole, pemetrexed, pentamidine, phenytoin, warfarin.

Storage

Vials: Store intact vials at 20°C to 25°C (68°F to 77°F). Protect from light. Reconstituted solution and solution further diluted for IV infusion are stable for 24 weeks when immediately frozen at -20°C (-4°F). After freezing, thawed solution in NS in a Viaflex small volume container for IV administration is stable for 24 hours at room temperature or for 7 days when refrigerated. Do not refreeze the thawed solution. Ceftazidime solutions (concentrations 1 to 40 mg/mL) in NS, D5W, D5NS, LR, D10W, Ringer's injection, or SWFI are stable for 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) and for 7 days if refrigerated (4°C [39°F]). Consult detailed reference regarding stability of ceftazidime in other solutions.

Duplex container: Store unactivated containers at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Do not freeze. Unactivated duplex containers with foil strip removed from the drug chamber must be protected from light and used within 7 days at room temperature. Once activated, must be used within 12 hours if stored at room temperature or within 3 days if stored under refrigeration.

Premixed frozen solution: Store at -20°C (-4°F). Thawed solution is stable for 8 hours at room temperature or for 3 days under refrigeration; do not refreeze.

Drug Interactions

Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Chloramphenicol: May diminish the therapeutic effect of CefTAZidime. Management: Consider using a different combination of antimicrobials, especially if bactericidal activity is desired. If these agents are combined, monitor for reduced antimicrobial effectiveness and/or therapeutic failure. Consider therapy modification

Probenecid: May increase the serum concentration of Cephalosporins. 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. 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 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Test Interactions

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction

Adverse Reactions

1% to 10%:

Cardiovascular: Phlebitis (1%)

Endocrine & metabolic: Increased lactate dehydrogenase (6%), increased gamma-glutamyl transferase (5%)

Gastrointestinal: Diarrhea (1%)

Hematologic & oncologic: Eosinophilia (8%), positive direct Coombs test (4%; without hemolysis), thrombocythemia (2%)

Hepatic: Increased serum ALT (7%), increased serum AST (6%), increased serum alkaline phosphatase (4%)

Hypersensitivity: Hypersensitivity reactions (2%)

Local: Inflammation at injection site (1%), pain at injection site (1%)

<1% (Limited to important or life-threatening): Agranulocytosis, anaphylaxis, angioedema, asterixis, brain disease, candidiasis, Clostridium difficile associated diarrhea, erythema multiforme, hemolytic anemia, hyperbilirubinemia, increased lactate dehydrogenase, leukopenia, lymphocytosis, myoclonus, nausea, neuromuscular excitability, neutropenia, paresthesia, pseudomembranous colitis, renal disease (may be severe, including renal failure), renal insufficiency, seizure, skin rash, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, vaginitis

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.

• Neurotoxicity: High ceftazidime levels in patients with renal insufficiency can lead to seizures, encephalopathy, coma, asterixis, myoclonia, and neuromuscular excitability. Reduce total daily dosage.

• 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; dosage adjustment recommended.

• 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.

Monitoring Parameters

Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been 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.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea. Have patient report immediately to prescriber bruising, bleeding, injection site irritation, urinary retention, change in amount of urine passed, chills, pharyngitis, seizures, severe loss of strength and energy, vaginitis, or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).

• 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.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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