Medoflucon

Medoflucon Special Precautions

fluconazole

Manufacturer:

Medochemie

Distributor:

Medochemie
Full Prescribing Info
Special Precautions
Some patients, especially those with serious underlying disease, such as AIDS or cancer, treated with fluconazole have been observed to have abnormalities of renal, hepatic, haematological and other biochemical function tests. Clinical significance and causality is uncertain.
In very rare cases, patients with severe underlying disease and treated with fluconazole, who died were found to have hepatic necrosis. All were on concomitant multiple medications, some of which were known to be hepatoxic, or had underlying disease that could have caused hepatic necrosis. As a causal relationship with fluconazole cannot be excluded, in patients with a significant rise in liver enzymes the risk benefit of continued fluconazole therapy should be evaluated.
Patients have, in rare cases, developed exfoliative cutaneous reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, during fluconazole therapy. Development of such severe cutaneous reactions is more likely in AIDS patients.
If rash develops during superficial fungal infection therapy that is attributable to fluconazole, therapy should be discontinued. If it develops in patients being treated for invasive/systemic infection, they should be monitored closely and therapy discontinued if bullous lesions or erythema multiforme develops.
In rare cases, as with other azole, anaphylaxis has been reported. Some azoles, including fluconazole, have been associated with QT prolongation and Torsades de Pointes. Use fluconazole preparation with caution in patients with these potentially pro-arrhythmic conditions.
There have been reports of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester.
Effects on Ability to Drive and Use Machines: "Medoflucon" is unlikely to have any effect on the ability to drive or use machinery.
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