Brand names: Fortaz, Tazicef
Drug class: Third Generation Cephalosporins
Chemical name: [6R-[6α,7β(Z)]]-1-[[7-[[(2-Amino-4-thiazolyl) [(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl] pyridinium hydroxide, inner salt, pentahydrate
CAS number: 78436-06-2

Medically reviewed by Drugs.com on Sep 30, 2024. Written by ASHP.

Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.

Uses for Ceftazidime

Bone and Joint Infections

Treatment of bone and joint infections caused by susceptible Staphylococcus aureus (methicillin-susceptible [oxacillin-susceptible] strains only) Klebsiella, or Pseudomonas aeruginosa.

Intra-abdominal and Gynecologic Infections

Treatment of gynecologic infections (including endometritis, pelvic cellulitis, other infections of the female genital tract) caused by susceptible Escherichia coli.

Treatment of intra-abdominal infections (including peritonitis) caused by susceptible S. aureus (oxacillin-susceptible strains only), E. coli, or Klebsiella.

Treatment of polymicrobial intra-abdominal infections caused by susceptible aerobic and anaerobic bacteria and Bacteroides. Consider that many strains of B. fragilis are resistant; generally should not be used alone in serious intra-abdominal infections when this organism may be involved.

For initial empiric treatment of high-risk or severe community-acquired extrabiliary intra-abdominal infections in adults, IDSA recommends either monotherapy with a carbapenem (doripenem, imipenem, meropenem) or the fixed combination of piperacillin and tazobactam, or a combination regimen that includes either a cephalosporin (cefepime, ceftazidime) or fluoroquinolone (ciprofloxacin, levofloxacin) in conjunction with metronidazole.

Meningitis and Other CNS Infections

Treatment of meningitis caused by susceptible H. influenzae, Neisseria meningitidis, Ps. aeruginosa, or Streptococcus pneumoniae in adults or children.

Ceftazidime in conjunction with an aminoglycoside considered a regimen of choice for treatment of meningitis caused by susceptible P. aeruginosa or susceptible Enterobacteriaceae^{† [off-label]} (e.g., E. coli, P. mirabilis, Enterobacter, S. marcescens).

Cefotaxime or ceftriaxone generally preferred when a third generation cephalosporin is indicated for treatment of meningitis caused by H. influenzae, N. meningitidis, or S. pneumoniae.

Respiratory Tract Infections

Treatment of respiratory tract infections (including pneumonia) caused by susceptible S. aureus (methicillin-susceptible [oxacillin-susceptible] strains only), S. pneumoniae, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus mirabilis, Pseudomonas (including Ps. aeruginosa), or Serratia.

For treatment of community-acquired pneumonia (CAP) caused by Ps. aeruginosa, ATS and IDSA recommend a combination regimen that includes an antipseudomonal β-lactam (cefepime, ceftazidime, aztreonam, imipenem, meropenem, piperacillin, ticarcillin) given in conjunction with ciprofloxacin, levofloxacin, or an aminoglycoside.

Septicemia

Treatment of septicemia caused by susceptible S. aureus (methicillin-susceptible [oxacillin-susceptible] strains only), S. pneumoniae, Haemophilus influenzae, E. coli, Klebsiella, Ps. aeruginosa, or Serratia.

Select anti-infective for treatment of sepsis syndrome based on probable source of infection, causative organism, immune status of patient, and local patterns of bacterial resistance.

For initial treatment of life-threatening sepsis in adults, some clinicians suggest that a third or fourth generation cephalosporin (cefepime, cefotaxime, ceftriaxone, ceftazidime), the fixed combination of piperacillin and tazobactam, or a carbapenem (doripenem, imipenem, meropenem) be used in conjunction with vancomycin; some also suggest including an aminoglycoside or fluoroquinolone during initial few days of treatment.

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by susceptible S. aureus (oxacillin-susceptible strains only), S. pyogenes (group A β-hemolytic streptococci), Enterobacter, E. coli, Klebsiella, Proteus (including P. mirabilis), Ps. aeruginosa, or Serratia.

Urinary Tract Infections (UTIs)

Treatment of uncomplicated and complicated UTIs caused by susceptible Enterobacter, E. coli, Klebsiella, Proteus (including P. mirabilis), Ps. aeruginosa, or Serratia.

Burkholderia Infections

Treatment of septicemia or pulmonary infections caused by Burkholderia cepacia^{† [off-label]} (formerly Ps. cepacia); alone or in conjunction with an aminoglycoside. Co-trimoxazole considered drug of choice; ceftazidime, chloramphenicol, or imipenem are alternatives.

Treatment of melioidosis^{† [off-label]} caused by B. pseudomallei (formerly Ps. pseudomallei). Usually treated with initial parenteral regimen of ceftazidime, imipenem, or meropenem (some clinicians recommend co-trimoxazole also be included, especially if patient is septicemic) followed by prolonged maintenance with oral anti-infectives (e.g., co-trimoxazole with or without doxycycline). B. pseudomallei is difficult to eradicate (relapse of melioidosis is common).

Otitis Externa

Treatment of malignant otitis externa^{† [off-label]} caused by Ps. aeruginosa.

Acute bacterial otitis externa localized in the external auditory canal may be effectively treated using topical anti-infectives (e.g., otic preparations of ciprofloxacin or ofloxacin), but malignant otitis externa is an invasive, potentially life-threatening infection (especially in immunocompromised patients such as those with diabetes mellitus or HIV infection) and requires prompt diagnosis and long-term treatment with parenteral anti-infectives (e.g., ceftazidime and/or ciprofloxacin).

Pseudomonas aeruginosa Infections

Generally considered a drug of choice for treatment of infections caused by Ps. aeruginosa, including acute exacerbations of bronchopulmonary Ps. aeruginosa infections in children and adults with cystic fibrosis.

In severe infections, especially in immunocompromised patients, concomitant use of ceftazidime and an aminoglycoside (e.g., amikacin, gentamicin, tobramycin) is recommended. Consider that ceftazidime-resistant strains of Ps. aeruginosa can emerge during therapy and superinfection with resistant strains has occurred.

Anti-infective therapy in patients with cystic fibrosis may result in clinical improvement and Ps. aeruginosa may be temporarily cleared from the sputum, but a bacteriologic cure is rarely obtained and should not be expected.

Vibrio Infections

Treatment of infections caused by Vibrio vulnificus^{† [off-label]}.

Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime) is recommended. Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.

Empiric Therapy in Febrile Neutropenic Patients

Has been used alone or in conjunction with an aminoglycoside for empiric treatment of presumed bacterial infections in febrile neutropenic adults or children^†.

IDSA states that ceftazidime is no longer a reliable agent for empiric monotherapy in febrile neutropenic patients because of decreasing potency against gram-negative bacteria and poor activity against many gram-positive bacteria (e.g., streptococci).

Consult published protocols for the treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of the initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients. Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also is advised.

Perioperative Prophylaxis

Has been used for perioperative prophylaxis^† in patients undergoing vaginal hysterectomy, biliary or intra-abdominal surgery, or transurethral resection of the prostate.

First or second generation cephalosporins (cefazolin, cefotetan, cefoxitin, cefuroxime) generally preferred when a cephalosporin used for perioperative prophylaxis. Third generation cephalosporins (cefotaxime, ceftriaxone, ceftazidime) and fourth generation cephalosporins (cefepime) not usually recommended for perioperative prophylaxis since they are expensive, some are less active against staphylococci than first or second generation cephalosporins, they have spectrums of activity wider than necessary for organisms encountered in elective surgery, and their use for prophylaxis may promote emergence of resistant organisms.

Ceftazidime Dosage and Administration

Administration

Administer by intermittent IV injection or infusion or by deep IM injection. Also has been administered by continuous IV infusion^†.

Has been administered intraperitoneally in dialysis solutions. Should not be administered by intra-arterial injection since necrosis can occur.

IV route preferred for treatment of septicemia, meningitis, peritonitis, or other severe or life-threatening infections and in patients with lowered resistance resulting from malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

The commercially available frozen ceftazidime injection in dextrose should be used only for IV infusion.

For solution and drug compatibility information, see Compatibility under Stability.

IV Injection

Reconstitution

For intermittent IV injection, reconstitute vials containing 500 mg, 1 g, or 2 g with 5.3 mL, 10, or 10 mL, respectively, of sterile water for injection to provide solutions containing approximately 100, 100, or 170 mg/mL, respectively.

Shake vial after adding the diluent; carbon dioxide is released as drug dissolves and the solution will become clear within 1–2 minutes. When withdrawing a dose from reconstituted vials, consider that the solution may contain some carbon dioxide bubbles which should be expelled from the syringe before injection.

Rate of Administration

Inject appropriate dose of reconstituted solution into a vein over a period of 3–5 minutes or slowly into the tubing of a compatible IV solution.

IV Infusion

Reconstitution and Dilution

Reconstitute vials of containing 1 or 2 g of ceftazidime with 100 mL of sterile water for injection or compatible IV solution. Shake the vial after adding the diluent; carbon dioxide is released as the drug dissolves and the solution will become clear within 1–2 minutes. The appropriate dose of the drug should then be added to a compatible IV solution.

Reconstitute pharmacy bulk packages according to the manufacturer’s directions and then further dilute in a compatible IV infusion solution prior to administration.

ADD-Vantage or TwistVialvials labeled as containing 1 or 2 g of ceftazidime should be reconstituted according to the manufacturer’s directions.

Reconstitute (activate) commercially available Duplex drug delivery system containing 1 or 2 g of ceftazidime and 50 mL of 5% dextrose injection in separate chambers according to the manufacturer's directions. If refrigerated after reconstitution (see Storage under Stability), allow solution to reach room temperature prior to administration.

Thaw commercially available premixed injection (frozen) at room temperature (25°C) or under refrigeration (5°C); do not thaw by immersion in a water bath or by exposure to microwave radiation. A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature. Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found. Do not use in series connections with other plastic containers; such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from secondary container is complete.

Rate of Administration

Intermittent IV infusions generally have been infused over 15–30 minutes in adults, neonates, and children.

If a Y-type administration set is used, the other solution flowing through the tubing should be discontinued while ceftazidime is being infused.

IM Injection

IM injections should be made deeply into a large muscle mass, such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh.

Reconstitution

IM injections are prepared by adding 1.5 or 3 mL of sterile or bacteriostatic water for injection or 0.5 or 1% lidocaine hydrochloride injection to vials containing 500 mg or 1 g of ceftazidime, respectively, to provide solutions containing approximately 280 mg/mL.

Shake the vial after adding the diluent; carbon dioxide is released as the drug dissolves and the solution will become clear within 1–2 minutes. When withdrawing a dose from reconstituted vials, consider that the solution may contain some carbon dioxide bubbles which should be expelled from the syringe before injection.

Intraperitoneal Instillation

Reconstitute with sterile water for injection as for IV infusion and then further dilute in a compatible peritoneal dialysis solution to provide a solution containing 250 mg of ceftazidime in each 2 L of dialysis solution.

Dosage

Available as ceftazidime pentahydrate and as ceftazidime sodium; dosage expressed as anhydrous ceftazidime.

Do not use ceftazidime available in Duplex containers in patients who require less than entire 1- or 2-g dose in the container.

Pediatric Patients

General Dosage for Neonates

IV

Neonates ≤4 weeks of age: Manufacturer recommends 30 mg/kg every 12 hours.

Neonates ≤7 days of age: AAP recommends 50 mg/kg every 12 hours, regardless of weight.

Neonates 8–28 days of age: AAP recommends 50 mg/kg every 8–12 hours in those weighing ≤2 kg and 50 mg/kg every 8 hours in those weighing >2 kg.

General Dosage for Infants and Children 1 Month to 12 Years of Age

IV

25–50 mg/kg every 8 hours. Use 50 mg/kg every 8 hours in immunocompromised children or children with cystic fibrosis.

Children beyond neonatal period: AAP recommends 90–150 mg/kg daily in 3 equally divided doses for the treatment of mild to moderate infections or 200–300 mg/kg daily in 3 equally divided doses for treatment of severe infections.

General Dosage for Children >12 Years of Age

IV

Use usual adult dosage. (See Adult Dosage under Dosage and Administration.)

Meningitis

IV

Some clinicians recommend 100–150 mg/kg daily in 2 or 3 equally divided doses for neonates ≤7 days of age and 150 mg/kg daily in 3 divided doses in older neonates and children.

Because of a high rate of relapse, treatment duration should be ≥3 weeks for meningitis caused by gram-negative bacilli. In neonates, some clinicians recommend that treatment be continued for 2 weeks beyond the first sterile CSF culture or at least 3 weeks, whichever is longer.

Burkholderia Infections†

Severe Melioidosis Caused by Burkholderia pseudomallei†

IV

Children ≥2 months of age: 60 mg/kg daily in 2 equally divided doses recommended by some clinicians for children <2 months of age or 100 mg/kg daily in 3 equally divided doses. Concomitant co-trimoxazole or doxycycline may be indicated in septicemic or other severe cases.

Continue initial parenteral regimen for at least 10–14 days and until there is clinical improvement. When appropriate, switch to oral maintenance regimen (e.g., oral co-trimoxazole with or without oral doxycycline) and continue for at least 3–6 months to prevent recrudence or relapse. More prolonged oral maintenance therapy (up to 12 months) may be necessary, depending on the response to therapy and severity of initial illness.

Empiric Therapy in Febrile Neutropenic Children†

IV

50 mg/kg (maximum 2 g) every 8 hours has been used in pediatric patients ≥2 years of age.

Adults

General Adult Dosage

Less Severe Infections

IV or IM

1 g every 8–12 hours.

Severe or Life-threatening Infections

IV

2 g every 8 hours, especially in immunocompromised patients.

Bone and Joint Infections

IV

2 g every 12 hours.

Intra-abdominal and Gynecologic Infections

Serious Infections

IV

2 g every 8 hours.

Meningitis

IV

2 g every 8 hours. Duration of treatment is ≥3 weeks for meningitis caused by susceptible gram-negative bacilli.

Respiratory Tract Infections

Uncomplicated Pneumonia

IV or IM

0.5–1 g every 8 hours.

Pseudomonas Lung Infections in Cystic Fibrosis Patients

IV

30–50 mg/kg every 8 hours (up to 6 g daily).

Clinical improvement may occur, but bacteriologic cures should not be expected in patients with chronic respiratory disease and cystic fibrosis.

Skin and Skin Structure Infections

Mild Infections

IV or IM

0.5–1 g every 8 hours.

Urinary Tract Infections (UTIs)

Uncomplicated Infections

IV or IM

250 mg every 12 hours.

Complicated Infections

IV or IM

500 mg every 8–12 hours.

Burkholderia Infections†

Severe Melioidosis Caused by Burkholderia pseudomallei†

IV

40 mg/kg every 8 hours recommended by US Army Medical Research Institute of Infectious Diseases (USAMRIID). Others recommend 2 g every 8 hours (up to 6 g daily) or 50 mg/kg (up to 2 g) every 6 hours. Concomitant co-trimoxazole or doxycycline may be indicated in septicemic or other severe cases.

Continue initial parenteral regimen for at least 10–14 days and until there is clinical improvement. When appropriate, switch to an oral maintenance regimen (e.g., oral co-trimoxazole with or without oral doxycycline) and continue for at least 3–6 months to prevent recrudence or relapse. More prolonged oral maintenance therapy (up to 12 months) may be necessary, depending on the response to therapy and severity of initial illness.

Empiric Therapy in Febrile Neutropenic Patients†

IV

100 mg/kg daily in 3 divided doses or 2 g every 8 hours either alone or in conjunction with an aminoglycoside (amikacin, gentamicin, tobramycin) has been used.

Prescribing Limits

Pediatric Patients

Maximum 6 g daily.

Adults

Maximum 6 g daily.

Special Populations

Hepatic Impairment

Dosage adjustments not required unless renal function also impaired.

Renal Impairment

Reduce dosage in patients with Cl_cr ≤50 mL/minute.

Manufacturers recommend that adults with Cl_cr ≤50 mL/minute receive an initial loading dose of 1 g and a maintenance dosage based on Cl_cr. (See Table.)

Patients with renal impairment and severe infections who would generally receive 6 g daily if renal function were normal: increase dosage in table by 50% or dosing interval may be increased appropriately.

Patients undergoing hemodialysis: given an initial loading dose of 1 g followed by 1 g after each hemodialysis period.

Patients undergoing intraperitoneal dialysis or CAPD: given an initial loading dose of 1 g followed by 500 mg every 24 hours.

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal function. (See Renal Impairment under Dosage and Administration.)

Cautions for Ceftazidime

Contraindications

• Known hypersensitivity to ceftazidime or other cephalosporins.

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy. Careful observation of the patient is essential. Institute appropriate therapy if superinfection occurs.

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including ceftazidime, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.

Consider CDAD if diarrhea develops and manage accordingly. Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.

Neurotoxicity

Possibility of seizures, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia if inappropriately high dosage used in patients with renal impairment. (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Hypersensitivity reactions, including anaphylaxis, reported with dextrose-containing solutions; usually reported in patients receiving high dextrose concentrations (i.e., 50% dextrose), but also reported when corn-derived dextrose solutions administered to patients with or without history of hypersensitivity to corn products.

If an allergic reaction occurs, discontinue and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen).

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Cautious use recommended in individuals hypersensitive to penicillins: avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.

General Precautions

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis. (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Prolonged PT

Possibility of prolonged PT.

Monitor PT in patients at risk, including those with renal or hepatic impairment, poor nutritional state, receiving prolonged therapy, or stabilized on anticoagulant therapy. Administer vitamin K when indicated.

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of ceftazidime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

Resistance in Gram-negative Bacteria

Resistance caused by inducible type I β-lactamases can develop in some gram-negative bacilli (e.g., Enterobacter, Pseudomonas, Serratia) during treatment, leading to clinical failure in some cases.

When treating infections caused by these bacteria, perform periodic in vitro susceptibility testing when clinically appropriate. If patient fails to respond to monotherapy, an aminoglycoside or similar agent should be considered.

Risk of Distal Necrosis

Possibility of distal necrosis after inadvertent intra-arterial administration.

Sodium Content

Vials, pharmacy bulk packages, and ADD-Vantage vials contain ceftazidime admixed with sodium carbonate to facilitate dissolution. These preparations contain approximately 54 mg (2.3 mEq) of sodium per g of ceftazidime.

Patients with Diabetes

Like other dextrose-containing solutions, use Duplex drug delivery system containing ceftazidime and dextrose injection with caution in patients with overt or known subclinical diabetes mellitus or in patients with carbohydrate intolerance for any reason.

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk in low concentrations; use with caution.

Pediatric Use

To avoid unintentional overdosage, do not use ceftazidime available in Duplex containers in pediatric patients who require less than entire 1- or 2-g dose in the container.

Geriatric Use

No overall differences in safety and efficacy in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.

Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function. Select dosage with caution and assess renal function periodically because of age-related decreases in renal function. (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not affected.

Renal Impairment

Possible decreased clearance and increased serum half-life.

Neurotoxicity reported in some patients with renal impairment who received dosage inappropriately high for their renal status. (See Neurotoxicity under Cautions.)

Dosage adjustments necessary in patients with Cl_cr ≤50 mL/minute. See Renal Impairment under Dosage and Administration.

Common Adverse Effects

GI effects, hypersensitivity reactions, local reactions at IV injection sites.

Drug Interactions

Specific Drugs and Laboratory Tests

Ceftazidime Pharmacokinetics

Absorption

Bioavailability

Not absorbed from GI tract; must be given parenterally.

Following IM administration, peak serum concentrations attained in approximately 1 hour. May be absorbed more slowly in women than in men following IM injection into the gluteus maximus or vastus lateralis. In women, peak serum concentrations may be lower following IM injection into the gluteus maximus than into the vastus lateralis.

In patients with end-stage chronic renal failure who receive a single dose of the drug via an intraperitoneal catheter, peak serum concentrations attained 2.75 hours after the dose.

Distribution

Extent

Widely distributed into body tissues and fluids including the gallbladder, bone, bile, skeletal muscle, prostatic tissue, endometrium, myometrium, heart, skin, adipose tissue, aqueous humor, and sputum, and pleural, peritoneal, synovial, ascitic, lymphatic, and blister fluids.

Generally diffuses into CSF following IV administration; CSF concentrations higher in patients with inflamed meninges than in those with uninflamed meninges.

Distributed into bile, but biliary concentrations following IM or IV administration may be lower than concurrent serum concentrations.

Crosses the placenta and is distributed into milk.

Plasma Protein Binding

5–24%.

Elimination

Metabolism

Not metabolized.

Elimination Route

Eliminated unchanged principally in urine by glomerular filtration.

80–90% of a dose eliminated in urine within 24 hours.

Half-life

Adults with normal renal and hepatic function: distribution half-life 0.1–0.6 hours and elimination half-life 1.4–2 hours.

Neonates: 2.2–4.7 hours.

Children 1–12 months of age: 2 hours.

Special Populations

Patients with impaired hepatic function: serum half-life only slightly prolonged.

Patients with impaired renal function: serum concentrations higher and serum half-life prolonged. Serum half-life ranges from 9.4–10.3 hours in those with Cl_cr 13–27 mL/minute and 11–35 hours in those with Cl_cr<10 mL/minute.

Stability

Storage

Parenteral

Powder for Injection or IV Infusion

Fortaz: 15–30° C; protect from light.

Fortaz: Reconstituted IV solutions containing 100, 170, or 200 mg/mL prepared using sterile water and IV solutions that have been further diluted to 1–40 mg/mL in a compatible IV solution are stable for 12 hours at room temperature or 3 days under refrigeration.

Fortaz: Reconstituted IM solutions containing 280 mg/mL prepared using sterile or bacteriostatic water or 0.5 or 1% lidocaine hydrochloride are stable for 12 hours at room temperature or 3 days under refrigeration.

Tazicef: 20–25°C; protect from light.

Tazicef: Reconstituted IV or IM solutions containing 95, 180, or 280 mg/mL prepared using sterile water are stable for 24 hours at room temperature or 7 days when refrigerated.

Powder for injection and solutions may darken; does not indicate loss of potency.

For Injection, for IV Infusion

Fortaz TwistVial vials: 15–30°C; protect from light. After reconstitution, stable for 12 hours at room temperature or 3 days under refrigeration.

Tazicef ADD-Vantage vials: 20–25°C; protect from light. After reconstitution, stable for 24 hours at room temperature.

Duplex drug delivery system containing ceftazidime and dextrose injection: 20–25°C (may be exposed to 15–30°C); protect from light. After reconstitution (activation), use within 12 hours if stored at room temperature or within 3 days if stored in refrigerator; do not freeze.

Injection (Frozen) for Infusion

-20° C or lower. Thawed solution stable for 8 hours at room temperature or 3 days under refrigeration.

Do not refreeze after thawing.

Compatibility

Parenteral

Solution Compatibility

Less stable in sodium bicarbonate injection than in other IV solutions; sodium bicarbonate not recommended as a diluent.

Drug Compatibility

Actions and Spectrum

• Based on spectrum of activity, classified as a third generation cephalosporin. Usually less active in vitro against susceptible staphylococci than first generation cephalosporins; has an expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins.

• Usually bactericidal.

• Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.

• Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.

• Spectrum of activity of ceftazidime resembles that of ceftizoxime, cefotaxime, and ceftriaxone. However, ceftazidime more active against Pseudomonas than most other currently available parenteral third generation cephalosporins and less active against anaerobes and gram-positive aerobic cocci than these drugs.

• Gram-positive aerobes: active in vitro and in clinical infections against S. aureus (including β-lactamase-producing strains), S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci), and S. agalactiae (group B streptococci). Oxacillin-resistant (methicillin-resistant) staphylococci and enterococci (e.g., Enterococcus faecalis) are resistant.

• Gram-negative aerobes: active in vitro and in clinical infections against Citrobacter (including C. freundii, C. diversus), Enterobacter (including E. aerogenes, E. cloacae), E. coli, H. influenzae (including ampicillin-resistant strains), Klebsiella (including K. pneumoniae), Neisseria meningitidis, Proteus mirabilis, P. vulgaris, Pseudomonas (including Ps. aeruginosa), and Serratia. Also active in vitro against Acinetobacter, H. parainfluenzae, Morganella morganii, N. gonorrhoeae, Providencia (including P. rettgeri), Salmonella, Shigella, and Yersinia enterocolitica.

• Anaerobes: active in vitro and in clinical infections against Bacteroides; many strains of B. fragilis are resistant. Also active in vitro against Clostridium (except C. difficile), Peptococcus, and Peptostreptococcus.

• Strains of staphylococci resistant to penicillinase-resistant penicillins (methicillin-resistant [oxacillin-resistant] staphylococci) should be considered resistant to ceftazidime, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.

Advice to Patients

• Advise patients that antibacterials (including ceftazidime) should only be used to treat bacterial infections; they do not treat viral infections (e.g., the common cold).

• Importance of completing full course of therapy, even if feeling better after a few days.

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ceftazidime or other antibacterials in the future.

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

• Importance of informing clinicians if an allergic reaction occurs.

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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