Avezol Special Precautions





Full Prescribing Info
Special Precautions
In some patients, particularly those with serious underlying diseases such as AIDS and cancer, abnormalities in haematological, hepatic, renal and other biochemical function test results have been observed during treatment with Avezol but the clinical significance and relationship to treatment is uncertain.
Very rarely, patients who died with severe underlying disease and who had received multiple doses of Avezol had post-mortem findings which included hepatic necrosis. These patients were receiving multiple concomitant medications, some known to be potentially hepatotoxic, and/or had underlying diseases which could have caused the hepatic necrosis.
In cases of hepatotoxicity, no obvious relationship to total daily dose of Avezol, duration of therapy, sex or age of the patient has been observed; the abnormalities have usually been reversible on discontinuation of Avezol therapy.
As a causal relationship with Avezol cannot be excluded, patients who develope abnormal liver function tests during Avezol therapy should be monitored for the development of more serious hepatic injury. Avezol should be discontinued if clinical signs or symptoms consistent with liver disease develop during treatment with Avezol.
Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson Syndrome and toxic epidermal necrolysis, during treatment with fluconazole. AIDS patients are more prone to the development of severe cutaneous reactions to many drugs.
If a rash develops in a patient which is considered attributable to Avezol, further therapy with this agent is not recommended.
In rare cases, as with other azoles, anaphylaxis has been reported.
Some azoles, including fluconazole, have been associated wih prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsade de pointes in patients taking fluconazole. Although the association of Fluconazole and QT-prolongation has not been fully established, fluconazole should be used with caution in patients with potentially proarrythmic conditions such as: Congenital or documented acquired QT prolongation,
Cardiomyopathy, in particular when heart failure is present,
Sinus bradycardia,
Existing symptomatic arrythmias,
Concomitant medication not metabolized by CY34A but known to prolong QT interval,
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalaemia.
Effects on ability to drive and use machines: Experience with Avezol indicates that therapy is unlikely to impair a patient's ability to drive or use machinery.
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