Adverse reactions : תופעות לוואי

Adverse Reactions
Clinical trial experience has shown that ceftazidime is generally well tolerated.
Data from large clinical trials (internal and published) were used to determine the frequency of very common to uncommon undesirable effects. The frequencies assigned to all other undesirable effects were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.
The following convention has been used for the classification of frequency: very common >1/10 common >1/100 and <1/10 uncommon >1/1,000 and <1/100


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 rare >1/10,000 and <1/1,000 very rare <1/10,000.
Infections and infestations
Uncommon: Candidiasis (including vaginitis and oral thrush).

Blood and lymphatic system disorders
Common: Eosinophilia and thrombocytosis.
Uncommon: Leucopenia, neutropenia, and thrombocytopenia.
Very rare: Lymphocytosis, haemolytic anaemia, and agranulocytosis.

Immune system disorders
Very rare: Anaphylaxis (including bronchospasm and/or hypotension).
Nervous system disorders
Uncommon: Headache and dizziness.
Very rare: Paraesthesia.
There have been reports of neurological sequelae including tremor, myoclonia, convulsions, encephalopathy, and coma in patients with renal impairment in whom the dose of ceftazidime has not been appropriately reduced.

Vascular disorders
Common: Phlebitis or thrombophlebitis with i.v. administration.

Gastrointestinal disorders
Common: Diarrhoea.
Uncommon: Nausea, vomiting, abdominal pain, and colitis, antibacterial agent- associated diarrhoea and colitis
Very rare: Bad taste.
As with other cephalosporins, colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis.

Renal and urinary disorders
Uncommon: Transient elevations of blood urea, blood urea nitrogen and/or serum creatinine
Very rare: Interstitial nephritis, acute renal failure.

Hepatobiliary disorders
Common: Transient elevations in one or more of the hepatic enzymes, ALT (SGPT), AST (SOGT), LDH, GGT and alkaline phosphate.
Very rare: Jaundice.

Skin and subcutaneous tissue disorders
Common: Maculopapular or urticarial rash.
Uncommon: Pruritus.
Very rare: Angioedema, erythemia multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, DRESS (drug interaction with eosinophilia and systemic symptoms) *.
* There have been rare reports where DRESS has been associated with ceftazidime.

General disorders and administration site conditions
Common: Pain and/or inflammation after i.m. injection.
Uncommon: Fever.

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Investigations
Common: Positive Coombs test.
Uncommon: As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen and/or serum creatinine have been observed.
A positive Coombs test develops in about 5% of patients and may interfere with blood cross-matching.

Postmarketing experience
The following events have been observed during clinical practice in patients treated with 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.