Ceptaz

CEPTAZ (ceftazidime) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:

1. 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).
2. 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).
3. Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Klebsiella spp.; and Escherichia coli.
4. Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae, and Staphylococcus aureus (methicillin-susceptible strains).
5. Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin-susceptible strains).
6. Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.
7. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin-susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp. (many strains of Bacteroides fragilis are resistant).
8. Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis. Ceftazidime has also been used successfully in a limited number of cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae.

Specimens for bacterial cultures should be obtained before therapy in order to isolate and identify causative organisms and to determine their susceptibility to ceftazidime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

CEPTAZ (ceftazidime) may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibiotics have been used.

CEPTAZ (ceftazidime) may also be used concomitantly with other antibiotics, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient (see Compatibility And Stability). When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibiotics should be followed. The dosage depends on the severity of the infection and the patient's condition.

The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. No disulfiramlike reactions were reported.

Local Effects, reported in fewer than 2% of patients, were phlebitis and inflammation at the site of injection (1 in 69 patients).

Hypersensitivity Reactions, reported in 2% of patients, were pruritus, rash, and fever. Immediate reactions, generally manifested by rash and/or pruritus, occurred in 1 in 285 patients. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have also been reported with cephalosporin antibiotics, including ceftazidime. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported very rarely.

Gastrointestinal Symptoms, reported in fewer than 2% of patients, were diarrhea (1 in 78), nausea (1 in 156), vomiting (1 in 500), and abdominal pain (1 in 416). The onset of pseudomembranous colitis symptoms may occur during or after treatment (see WARNINGS).

Central Nervous System Reactions (fewer than 1%) included headache, dizziness, and paresthesia. Seizures have been reported with several cephalosporins, including ceftazidime. In addition, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in renally impaired patients treated with unadjusted dosage regimens of ceftazidime (see PRECAUTIONS: General).

Less Frequent Adverse Events (fewer than 1%) were candidiasis (including oral thrush) and vaginitis.

Hematologic: Rare cases of hemolytic anemia have been reported.

Laboratory Test Changes noted during ceftazidime clinical trials were transient and included: eosinophilia (1 in 13), positive Coombs' test without hemolysis (1 in 23), thrombocytosis (1 in 45), and slight elevations in one or more of the hepatic enzymes, aspartate aminotransferase (AST, SGOT) (1 in 16), alanine aminotransferase (ALT, SGPT) (1 in 15), LDH (1 in 18), GGT (1 in 19), and alkaline phosphatase (1 in 23). As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen, and/or serum creatinine were observed occasionally. Transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia, and lymphocytosis were seen very rarely.

Postmarketing Experience With Ceptaz (ceftazidime) Products

In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with CEPTAZ (ceftazidime) and were reported spontaneously. For some of these events, data are insufficient to allow an estimate of incidence or to establish causation.

General: Anaphylaxis; allergic reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest); urticaria; pain at injection site.

Hepatobiliary Tract: Hyperbilirubinemia, jaundice.

Renal and Genitourinary: Renal impairment.

Cephalosporin-Class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with ceftazidime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Adverse Reactions: Colitis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage.

Altered Laboratory Tests: Prolonged prothrombin time, false-positive test for urinary glucose, pancytopenia.

BEFORE THERAPY WITH CEPTAZ (ceftazidime) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEPTAZ (ceftazidime) OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ceftazidime, 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 one primary cause of "antibiotic-associated colitis."

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. 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.

Elevated levels of ceftazidime in patients with renal insufficiency can lead to seizures, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia (see PRECAUTIONS).

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of ceftazidime from the body.

Ceftazidime is a prescription medication used to treat bacterial infections, including lung, skin, bone, joint, brain, stomach, blood, urinary tract, and gynecological infections. Ceftazidime belongs to a group of drugs called cephalosporin antibiotics, which work to stop the growth of bacteria in the body.

This medication is available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional.

Common side effects of ceftazidime include irritation at the site of injection, rash, nausea, diarrhea, and vomiting.

Ceptaz is part of the drug class:

• Third generation cephalosporins

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ceftazidime, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ceftazidime falls into category B. There are no well-done studies that have been done in humans with ceftazidime. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Ceftazidime injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Check with your doctor right away if you or your child have any of the following symptoms while receiving this medicine: confusion; loss of consciousness; jerking or twitching of the muscles; seizures; seeing, hearing, or feeling things that are not there; or severe sleepiness.

Before you or your child have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Applies to ceftazidime: injectable powder for injection, intravenous solution

Gastrointestinal

Discontinuation of ceftazidime (the active ingredient contained in Ceptaz) may be necessary in severe, prolonged cases of diarrhea. Pseudomembranous colitis has been reported and should be considered if the patient does not respond to discontinuation of ceftazidime.[Ref]

Gastrointestinal side effects reported in less than 2% of patients have included diarrhea, nausea, vomiting, abdominal pain, and pseudomembranous colitis. Oral candidiasis has been reported in less than 1% of patients. Clostridium difficile associated diarrhea has also been reported.[Ref]

Hypersensitivity

Mild hypersensitivity reactions, such as rash, pruritus, and fever, have been reported and may necessitate discontinuation of ceftazidime (the active ingredient contained in Ceptaz) A case of asthma induced by occupational exposure to ceftazidime has been reported.

A case of occupational contact dermatitis due to cephalosporin allergy has been reported in a nurse who prepared cephalosporin solutions for administration to patients. The dermatitis resolved after the nurse stopped preparing the solutions.

A patient with sensitization to aztreonam showed cross-reactivity to ceftazidime. Ceftazidime and aztreonam contain the same side chain, which may explain the cross-sensitivity.[Ref]

Hypersensitivity reactions including rash, pruritus, and fever have been reported (2%). Cross reactions may occur in penicillin-allergic or aztreonam-allergic patients. Rarely, angioedema and anaphylactic reactions have occurred. Allergic reactions including cardiopulmonary arrest have been reported during postmarketing experience. Cephalosporin class antibiotics have been associated with Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.[Ref]

Renal

Although increases in serum creatinine do not necessarily indicate renal toxicity, urinary alanine aminopeptidase (AAP) has been found to be significantly increased in some patients and may indicate renal tubular cell damage.[Ref]

Renal side effects have included transient increases in serum creatinine and BUN. Renal impairment has been reported during postmarketing experience. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.[Ref]

Nervous system

Ceftazidime-induced encephalopathy has been reported in an 80-year-old man with underlying renal dysfunction. This patient became incoherent and tremulous and had severe myoclonic jerking in all extremities. Therapy was discontinued and symptoms abated, but reappeared on rechallenge with a smaller dose. Symptoms again resolved with discontinuation of ceftazidime (the active ingredient contained in Ceptaz) therapy. Several other cases of ceftazidime-induced encephalopathy, and hallucinations have been reported. In most cases the patients had underlying renal dysfunction. Symptoms were similar and resolved with dose reduction or drug discontinuation.

Neurologic reactions may be more likely to occur in patients with underlying renal dysfunction. Close monitoring of neurologic status is recommended.[Ref]

Nervous system side effects reported in less than 1% of patients have included headache, dizziness, paresthesia, and seizures. Encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have occurred in patients with renal dysfunction who received unadjusted doses of ceftazidime.[Ref]

Dermatologic

Dermatologic side effects have included pemphigus erythematosus and urticaria.[Ref]

Local

Local side effects have included phlebitis and inflammation at the injection site.[Ref]

Hematologic

Other transient hematologic effects, such as thrombocytopenia, thrombocytosis, and leukopenia, have been observed less frequently.[Ref]

Hematologic side effects have included transient eosinophilia, positive Coombs test without hemolysis, thrombocytosis, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, and lymphocytosis. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, neutropenia, pancytopenia, and agranulocytosis.[Ref]

Hepatic

Hepatic side effects have included transient increases in AST, ALT, GGT, and alkaline phosphatase. These elevations generally resolve after discontinuation of therapy. Hyperbilirubinemia and jaundice have been reported during postmarketing experience. Cephalosporins as a class have been associated with hepatic dysfunction, including cholestasis.[Ref]

Genitourinary

Genitourinary side effects have included vaginitis and candidiasis. Cephalosporins as a class have been associated with false-positive tests for urine glucose.[Ref]

Other

Other side effects have included superinfection.[Ref]

Some side effects of Ceptaz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.