Ceftizoxime

What is Ceftizoxime?

• Ceftizoxime (Cefizox) is a sterile, semisynthetic, broad­spectrum, beta­lactamase resistant cephalosporin antibiotic for parenteral (IV, IM) administration.

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Ceftizoxime

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構造式 Ceftizoxime

What are the uses of this medicine?

Ceftizoxime (Cefizox) is used in the treatment of:

• Lower Respiratory Tract Infections
• Urinary Tract Infections
• Gonorrhea including uncomplicated cervical and urethral gonorrhea
• Pelvic Inflammatory Disease
• Intra­Abdominal Infections
• Septicemia
• Skin and Skin Structure Infections
• Bone and Joint Infections
• Meningitis

How does this medicine work?

• A semisynthetic, broad spectrum, beta lactamase resistant, third generation cephalosporin with antibacterial activity.
• Ceftizoxime binds to and inactivates penicillin binding proteins (pbps) located on the inner membrane of the bacterial cell wall.
• Pbps are enzymes involved in the terminal stages of assembling the bacterial cell wall and in reshaping the cell wall during growth and division. Inactivation of pbps interferes with the cross linkage of peptidoglycan chains necessary for bacterial cell wall strength and rigidity.
• This results in the weakening of the bacterial cell wall and causes cell lysis.

Ceftizoxime has been shown to be active against most strains of the following microorganisms: Aerobic Gram-Positive Microorganisms:

• Staphylococcus aureus (including penicillinase producing strains)
• Staphylococcus epidermidis (including penicillinase producing strains)
• Streptococcus agalactiae
• Streptococcus pneumoniae
• Streptococcus pyogenes

Aerobic Gram-Negative Microorganisms:

• Enterobacter spp.
• Escherichia coli
• Haemophilus influenzae (including ampicillin­resistant strains)
• Klebsiella pneumoniae
• Morganella morganii
• Neisseria gonorrhoeae
• Proteus mirabilis
• Proteus vulgaris
• Providencia rettgeri
• Pseudomonas aeruginosa
• Serratia marcescens

Anaerobic Microorganisms:

• Bacteroides spp.
• Peptococcus spp.
• Peptostreptococcus spp.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who have known allergy to the drug.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• other cephalosporins and aminoglycosides.

Is this medicine FDA approved?

• Yes, it was FDA approved.
• It was removed from the US Market in 2007.

How should this medicine be used?

Recommended dosage:

Adult dosage:

• The usual adult dosage is 1 or 2 grams of Cefizox (ceftizoxime for injection, USP) every 8 to 12 hours.
• Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organisms.
• Because of the serious nature of urinary tract infections due to P. aeruginosa and because many strains of Pseudomonas species are only moderately susceptible to Cefizox, higher dosage is recommended.
• A single, 1 gram IM dose is the usual dose for treatment of uncomplicated gonorrhea.
• The IV route may be preferable for patients with bacterial septicemia, localized parenchymal abscesses (such as intra­abdominal abscess), peritonitis, or other severe or life­threatening infections.
• In those with normal renal function, the IV dosage for such infections is 2 to 12 grams of Cefizox (ceftizoxime for injection, USP) daily. In conditions such as bacterial septicemia, 6 to 12 grams/day may be given initially by the IV route for several days, and the dosage may then be gradually reduced

Pediatric patients 6 months or older:

• 50 mg/kg every 6 to 8 hours.
• Dosage may be increased to a total daily dose of 200 mg/kg (not to exceed the maximum adult dose for serious infection).

Administration:

IM Administration:

• Reconstitute with Sterile Water for Injection.
• SHAKE WELL.
• Inject well within the body of a relatively large muscle.
• Aspiration is necessary to avoid inadvertent injection into a blood vessel.
• When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses.

IV Administration:

• Reconstitute with Sterile Water for Injection.
• SHAKE WELL.
• Direct (bolus) injection, slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids.
• Parenteral drug products should be inspected visually for particulate matter prior to administration.
• If particulate matter is evident in reconstituted fluids, then the drug solution should be discarded.
• Reconstituted solutions may range from yellow to amber without changes in potency.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As ceftizoxime for injection, USP

This medicine is available in fallowing brand namesː

• Cefizox

What side effects can this medication cause?

The most common side effects of this medicine include:

• Hypersensitivity:Rash, pruritus, fever.
• Hepatic:Transient elevation in AST (SGOT), ALT (SGPT), and alkaline phosphatase.
• Hematologic:Transient eosinophilia, thrombocytosis. Some individuals have developed a positive Coombs test.
• Local Injection site:Burning, cellulitis, phlebitis with IV administration, pain, induration, tenderness, paresthesia.

The less common side effects may include:

• Hypersensitivity: Numbness and anaphylaxis have been reported rarely.
• Hepatic: Elevation of bilirubin has been reported rarely.
• Renal: Transient elevations of BUN and creatinine have been occasionally observed with Cefizox.
• Hematologic: Anemia, including hemolytic anemia with occasional fatal outcome, leukopenia, neutropenia, and thrombocytopenia have been reported rarely.
• Urogenital: Vaginitis has occurred rarely.
• Gastrointestinal: Diarrhea; nausea and vomiting have been reported occasionally.

What special precautions should I follow?

• Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ceftizoxime, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
• Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic­associated” colitis. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
• As with all broad­spectrum antibiotics, Cefizox (ceftizoxime for injection, USP) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
• Cephalosporins may be associated with a fall in prothrombin activity.
• Prescribing Cefizox in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• Cefizox is excreted in human milk in low concentrations. Caution should be exercised when Cefizox is administered to a nursing woman.
• Patients should be counseled that antibacterial drugs including Cefizox should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• Skipping doses or not completing the full course of therapy may

(1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefizox or other antibacterial drugs in the future.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and well­controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human effects, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and efficacy in pediatric patients from birth to six months of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• ceftizoxime sodium

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured for:

• Fujisawa Healthcare, Inc.
• Deerfield, IL

What should I know about storage and disposal of this medication?

• Unreconstituted Cefizox should be protected from excessive light, and stored at controlled room temperature (59º­86ºF) in the original package until used.

• Dailymed label info on Ceftizoxime
• FDA Ceftizoxime

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