Cefizox (Ceftizoxime)


SmithKline Beecham

Ceftizoxime Sodium


Action And Clinical Pharmacology: In vitro studies indicate that the bactericidal action of ceftizoxime results from inhibition of cell-wall synthesis in aerobic and anaerobic gram-positive and gram-negative organisms. In vitro, ceftizoxime shows a strong affinity for penicillin-binding proteins 1a, 1bs and 3 of E. coli.

Indications And Clinical Uses: In the treatment of the infections listed below when caused by susceptible strains of the designated microorganisms:

Lower Respiratory Tract Infections caused by Streptococcus species (including S. pneumoniae but excluding enterococci); Klebsiella species; P. mirabilis; E. coli; H. influenzae (including ampicillin-resistant strains); S. aureus (including penicillinase-producing but excluding methicillin-resistant strains); Serratia species and Enterobacter species.

Urinary Tract Infections caused by E. coli; S. epidermidis; P. aeruginosa; P. mirabilis; Klebsiella species; S. marcescens and Enterobacter species.

Due to the nature of the underlying conditions which usually predispose patients to Pseudomonas infections of the urinary tract, a good clinical response accompanied by bacterial eradication may not be achieved despite evidence of in vitro sensitivity.

Intra-abdominal Infections caused by E. coli; S. epidermidis; Streptococcus species (excluding enterococci); Klebsiella species; Bacteroides species (including B. fragilis); Peptococcus species and Peptostreptococcus species.

Septicemia caused by Streptococcus species (excluding enterococci but including S. pneumoniae); S. aureus (excluding methicillin-resistant strains); E. coli; Bacteroides species (including B. fragilis); Klebsiella species and S. marcescens.

Skin Structure Infections caused by S. aureus (excluding methicillin-resistant strains); S. epidermidis; E. coli; Klebsiella species, (including K. pneumoniae); Streptococcus species (excluding enterococci but including Group A b-hemolytic Streptococcus pyogenes); P. mirabilis; Serratia species; Enterobacter species; Bacteroides species (including B. fragilis); Peptococcus species, and Peptostreptococcus species.

Bone and Joint Infections caused by S. aureus (excluding methicillin-resistant strains); P. mirabilis; Peptococcus species and Peptostreptococcus species.

Specimens for bacteriologic culture should be obtained prior to therapy in order to identify the causative organisms and to determine their susceptibilities to ceftizoxime. Therapy with ceftizoxime may be initiated before results of the susceptibility studies are known. However, modification of the treatment may be required once these results become available.

Contra-Indications: In persons who have shown hypersensitivity to ceftizoxime or other members of the cephalosporin group of antibiotics.

Manufacturers’ Warnings In Clinical States: Before therapy with ceftizoxime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Ceftizoxime should be given cautiously to penicillin-sensitive patients. Antibiotics, including ceftizoxime, should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. If an allergic reaction to ceftizoxime occurs, its administration should be discontinued. Serious acute hypersensitivity reactions may require epinephrine and other emergency measures.

Pseudomembranous colitis has been reported with the use of ceftizoxime (and other antibiotics). Therefore it is important to consider this diagnosis in patients administered ceftizoxime and who develop diarrhea.

Treatment with broad-spectrum antibiotics alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate a toxin produced by C. difficile is one primary cause of antibiotic-associated colitis.

Mild cases of colitis may respond to drug discontinuation alone. Moderate to severe cases should be managed with fluid, electrolyte and protein supplementation as indicated. When the colitis is not relieved by drug discontinuation or when it is severe, consideration may be given to the administration of oral vancomycin or other suitable therapy. Other possible causes of colitis should also be considered.

Precautions: Transient elevations of BUN and serum creatinine have been observed in clinical studies. However, there is no other evidence that ceftizoxime has produced alterations in renal function. Renal status should be periodically evaluated, especially in seriously ill patients.

Prolonged use of ceftizoxime may result in the overgrowth of nonsusceptible organisms including species originally sensitive to the drug. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Ceftizoxime should be administered with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Impaired Renal Function: Since ceftizoxime is excreted primarily in the urine, patients with impaired renal function (i.e., creatinine clearance 1.32 mL/s or 79 mL/min) should be placed on a special dosage schedule recommended under Dosage. Normal dosages in these individuals are likely to produce excessive serum concentrations of ceftizoxime.

Drug Interactions: The concomitant administration of some cephalosporins and aminoglycosides has caused nephrotoxicity. The effect of administering ceftizoxime concomitantly with aminoglycosides is not known.

Pregnancy: The safety of ceftizoxime in pregnancy has not been established. Its use in pregnant women requires that the likely benefit from the drug be weighed against the possible risk to the mother and fetus. The pharmacokinetics in pregnant patients have not been investigated. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus caused by ceftizoxime. Animal reproduction studies, however, are not always predictive of human response.

Labor and Delivery: The safety and efficacy of ceftizoxime use during labor and delivery has not been investigated.

Lactation: Ceftizoxime is excreted in human milk in low concentrations (less than 4% of serum concentrations at 1 hour after dosing). The clinical significance of this is unknown; therefore caution should be exercised if ceftizoxime is to be administered to a nursing woman.

Infants and Children: The safety in infants less than 6 months of age has not been established. In children 6 months of age and older, treatment with ceftizoxime has been associated with transient elevated levels of eosinophils, AST, ALT, and CPK (creatine phosphokinase). The CPK elevation may be related to i.m. administration.

Geriatrics: The elimination of ceftizoxime may be reduced due to an age-dependent reduction in renal function.

Adverse Reactions: Ceftizoxime is generally well tolerated.

Hypersensitivity: Incidence>1%;
Liver: Incidence>1%;
Blood: Incidence 1%: neutropenia, leukopenia, thrombocytopenia. Incidence>1%;
Renal: Incidence 1%: transient elevation of BUN and creatinine;
Local: Incidence>1%;
Genitourinary: Incidence1%: vaginitis;
Gastrointestinal: Incidence 1%: diarrhea, nausea, vomiting, pseudomembranous colitis.

No disulfiram-like reactions have been reported.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: No case of acute overdosage has been reported to date; consequently there is no specific information available on symptoms or treatment. In cases of suspected overdosage, supportive therapy should be instituted according to symptoms. Serum ceftizoxime levels can be reduced by hemodialysis.

Dosage And Administration: Ceftizoxime may be administered either i.m. or i.v. after reconstitution.

Dosage and route of administration should be determined by the condition of the patient, severity of the infection and susceptibility of the causative organism(s). The i.v. route may be preferable for patients with bacterial septicemia, or other severe or life-threatening infections.

The usual course of treatment should be 7 to 14 days, and should normally continue at least 48 hours after evidence of bacterial eradication has been obtained. For b-hemolytic streptococcal infections, a minimum of 10 days of treatment is recommended.

Adults: The recommended daily dosage is 1 to 12 g administered in equally divided doses every 8 to 12 hours.

Because of the serious nature of urinary tract infections due to P. aeruginosa and because many strains are only moderately susceptible to ceftizoxime, higher dosage may be appropriate when urinary tract infections are caused by these organisms. Other therapy should be instituted if the response is not prompt.

Adults with Impaired Renal Function: In patients in whom the creatinine clearance is 1.32 mL/s (79 mL/min) or less, the dosage must be reduced. Following an initial loading dose of 500 mg to 1.0 g i.m. or i.v., the maintenance dosing schedule presented in Table II should be followed in patients with reduced renal function.

I.M. Administration: The reconstituted solution of ceftizoxime should be injected well within the body of a relatively large muscle, such as the gluteus. When administering 2 g i.m. doses, the dose should be divided equally and then injected into different large muscle masses.

I.V. Administration: Injection (bolus): The reconstituted solution of ceftizoxime should be injected slowly over 3 to 5 minutes, directly or through the tubing system by which the patient is receiving another compatible i.v. solution. During administration of the solution containing ceftizoxime, it is desirable to temporarily discontinue administration of the other solution.

Intermittent or continuous infusion: The further diluted reconstituted solution of ceftizoxime should be administered over a 20 to 30 minute period.

Note: Ceftizoxime solutions should not be physically mixed with any other drug. There is a known incompatibility with aminoglycoside antibiotics. Therefore, they should not be physically mixed with ceftizoxime solutions nor administered at the same site.

Reconstitution: For I.M. Injection: Reconstitute with Sterile Water for Injection or Bacteriostatic Water for Injection (see Table IV).

For I.V. Infusion: Reconstitute as for i.v. injection. Further dilute the reconstituted solution to 50 to 100 mL with one of the Solutions for I.V. Infusion (see below).

Solutions for I.V. Infusion: Sodium Chloride Injection; 5% or 10% Dextrose Injection; 5% Dextrose and 0.9%, 0.45% or 0.2% Sodium Chloride Injection; Ringer’s Injection; Lactated Ringer’s Injection; 10% Invert Sugar in Sterile Water for Injection; 5% Sodium Bicarbonate in Sterile Water for Injection; 5% Dextrose in Lactated Ringer’s Injection only when reconstituted with 4% Sodium Bicarbonate Injection.

Extended Use of I.V. Admixtures: Although i.v. admixtures may often be physically and chemically stable for longer periods, due to microbiological considerations, they are usually recommended for use within 24 hours at room temperature or 48 hours when refrigerated (2 to 8°C).

Hospitals and institutions that have recognized admixture programs and use validated aseptic techniques for preparation of i.v. solutions may extend the storage times for ceftizoxime admixtures with 5% Dextrose Injection or 0.9% Sodium Chloride Injection in Viaflex bags in concentrations of 5 to 20 mg/mL to 14 days when stored under refrigeration at 2 to 8°C.

Manufacturers’ Warnings In Clinical States: As with all parenteral drug products, i.v. admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit. Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used.

Stability and Storage: Ceftizoxime powder for injection should be stored at room temperature (15 to 30°C). Reconstituted solutions intended for i.m. injection should be used within 16 hours when stored at room temperature or 48 hours when refrigerated (2 to 8°C). Reconstituted solutions intended for i.v. injection or solutions further diluted for i.v. infusion should be used within 24 hours when stored at room temperature or 48 hours when refrigerated (2 to 8°C) from the time of the initial reconstitution.

Solutions of ceftizoxime range from colorless to pale yellow, depending upon the diluent and volume used. The solution should be discarded if it becomes cloudy. The pH of freshly reconstituted solutions usually ranges from 6.0 to 8.0.

A solution of ceftizoxime 1 g in 13 mL Sterile Water for Injection is isotonic.

Incompatibility: Ceftizoxime should not be added to blood products, protein hydrolysates or amino acids. It should not be mixed together with an aminoglycoside.

Availability And Storage: Each vial of sterile powder contains: ceftizoxime sodium (expressed in terms of free acid). Sodium: approx. 60 mg/g (2.6 mEq sodium ion). Standard vials of 1 and 2 g. Store unreconstituted product at room temperature (15 to 30°C).

CEFIZOX® SmithKline Beecham Ceftizoxime Sodium Antibiotic

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