Fluconazole 10mg ml suspension - Diflucan Drug Imprint

Furthermore, it was shown in healthy volunteers that fluconazole delayed the elimination of fentanyl significantly. Elevated fentanyl concentration may lead to respiratory depression. Patients should be monitored closely for the potential risk of respiratory depression. Dosage adjustment of fentanyl may be necessary.

HMG CoA reductase inhibitors: If concomitant therapy is necessary, the patient should be observed for symptoms of myopathy and rhabdomyolysis and creatine kinase should be monitored. Moderate inhibitors of CYP3A4 such as fluconazole increase olaparib plasma concentrations; concomitant use is not recommended. If the combination cannot be avoided, limit the dose of olaparib to mg twice daily. Fluconazole significantly increases the concentration and AUC of ciclosporin.

During concomitant treatment with fluconazole mg daily and ciclosporin 2. This combination may be used by reducing the dose of ciclosporin depending on ciclosporin concentration. Although not studied in vivo or in vitro, fluconazole may increase serum concentrations of everolimus through inhibition of CYP3A4.

Fluconazole increases plasma concentrations of sirolimus presumably by inhibiting the metabolism of sirolimus via CYP3A4 and P-glycoprotein.

Fluconazole may increase the serum concentrations of orally administered tacrolimus up to 5 times due to inhibition of tacrolimus metabolism through CYP3A4 in the intestines. No significant pharmacokinetic changes have been observed when tacrolimus is given intravenously. Increased tacrolimus levels have been associated with nephrotoxicity. Dose of orally administered tacrolimus should be decreased depending on tacrolimus concentration.

Fluconazole inhibits the metabolism of losartan to its active metabolite E 74 which is responsible for most of the angiotensin II-receptor antagonism which occurs during treatment with losartan. Patients should have their blood pressure monitored continuously. Fluconazole may enhance the serum concentration of methadone. Dose adjustment of methadone may be necessary. Fluconazole inhibits the hepatic metabolism of phenytoin.

With coadministration, serum phenytoin concentration levels should be monitored in order to avoid phenytoin toxicity. There was a case report that a liver-transplanted patient treated with prednisone developed acute adrenal cortex insufficiency when a three month therapy with fluconazole was discontinued.

The discontinuation of fluconazole presumably caused an enhanced CYP3A4 activity which led to increased metabolism of prednisone. Patients on long-term treatment with fluconazole and prednisone should be carefully monitored for adrenal cortex insufficiency when fluconazole is discontinued. There have been reports of uveitis in patients to whom fluconazole and rifabutin were coadministered.

In combination therapy, symptoms of rifabutin toxicity should be taken into consideration. Dose adjustment of saquinavir may be necessary. Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas e.

Frequent monitoring of blood glucose and appropriate reduction of sulfonylurea dose is recommended during coadministration. Patients who are receiving high dose theophylline or who are otherwise at increased risk for theophylline toxicity should be observed for signs of theophylline toxicity while receiving fluconazole. Therapy should be modified if signs of toxicity develop. Although not studied, fluconazole may increase the plasma levels of the vinca alkaloids e. Based on a case-report in one patient receiving combination therapy with all-trans-retinoid acid an acid form of vitamin A and fluconazole, CNS related undesirable effects have developed in the form of pseudotumour cerebri, which disappeared after discontinuation of fluconazole treatment.

This combination may be used but the incidence of CNS related undesirable effects should be borne in mind. Coadministration of oral voriconazole mg Q12h for 1 day, then mg Q12h for 2.

Monitoring for voriconazole associated adverse events is recommended if voriconazole is used sequentially after fluconazole. Patients receiving this combination should be monitored for the development of zidovudine-related adverse reactions. Dose reduction of zidovudine may be considered.

An open-label, randomized, three-way crossover study in 18 healthy subjects assessed the effect of a single mg oral dose of azithromycin on the pharmacokinetics of a single mg oral dose of fluconazole as well as the effects of fluconazole on the pharmacokinetics of azithromycin.

There was no significant pharmacokinetic interaction between fluconazole and azithromycin. Two pharmacokinetic studies with a combined oral contraceptive have been performed using multiple doses of fluconazole. Thus, multiple dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive. Co-administration with ivacaftor, a cystic fibrosis transmembrane conductance regulator CFTR potentiator, increased ivacaftor exposure by 3-fold and hydroxymethyl-ivacaftor M1 exposure by 1.

A reduction of the ivacaftor dose to mg once daily is recommended for patients taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin. There have been reports of multiple congenital abnormalities including brachycephalia, ears dysplasia, giant anterior fontanelle, femoral bowing and radio-humeral synostosis in infants whose mothers were treated for at least three or more months with high doses mg daily of fluconazole for coccidioidomycosis.

The relationship between fluconazole use and these events is unclear. Studies in animals have shown reproductive toxicity see section 5. Fluconazole in standard doses and short-term treatments should not be used in pregnancy unless clearly necessary. Breast-feeding Fluconazole passes into breast milk to reach concentrations similar to those in plasma see section 5.

Breast-feeding may be maintained after a single dose of mg fluconazole. There have been reports of uveitis in patients to whom fluconazole and rifabutin were co-administered. Avoid concomitant administration of voriconazole and fluconazole. Fluconazole may increase the serum concentrations of orally administered tacrolimus up to 5 times due to inhibition of tacrolimus metabolism through CYP3A4 in the intestines. No significant pharmacokinetic changes have been observed when tacrolimus is given intravenously.

Increased tacrolimus levels have been associated with nephrotoxicity. Following oral administration of midazolam, fluconazole resulted in substantial increases in midazolam concentrations and psychomotor effects. This effect on midazolam appears to be more pronounced following oral administration of fluconazole than with fluconazole administered intravenously.

Systemic exposure to tofacitinib is increased when tofacitinib is co-administered with fluconazole, a combined moderate CYP3A4 and potent CYP2C19 inhibitor. Reduce the dose of tofacitinib when given concomitantly with fluconazole i. Dosage adjustments of triazolam may be necessary. Two pharmacokinetic studies with a combined oral contraceptive have been performed using multiple doses of fluconazole. Thus, multiple dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.

Although not studied in vitro or in vivo, concomitant administration of fluconazole with pimozide may result in inhibition of pimozide metabolism. Increased pimozide plasma concentrations can lead to QT prolongation and rare occurrences of torsades de pointes. Co-administration of fluconazole and pimozide is contraindicated. Although not studied in vitro or in vivo, concomitant administration of fluconazole with quinidine may result in inhibition of quinidine metabolism.

Use of quinidine has been associated with QT prolongation and rare occurrences of torsades de pointes. An effect of this magnitude should not necessitate a change in the fluconazole dose regimen in subjects receiving concomitant diuretics. Dosage adjustment of alfentanil may be necessary. Fluconazole increases the effect of amitriptyline and nortriptyline. Concurrent administration of fluconazole and amphotericin B in infected normal and immunosuppressed mice showed the following results: The clinical significance of results obtained in these studies is unknown.

An open-label, randomized, three-way cross-over study in 18 healthy subjects assessed the effect of a single mg oral dose of azithromycin on the pharmacokinetics of a single mg oral dose of fluconazole as well as the effects of fluconazole on the pharmacokinetics of azithromycin.

There was no significant pharmacokinetic interaction between fluconazole and azithromycin. There is a risk of developing carbamazepine toxicity. Certain calcium channel antagonists nifedipine, isradipine, amlodipine, verapamil, and felodipine are metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of the calcium channel antagonists.

Frequent monitoring for adverse events is recommended. Half of the celecoxib dose may be necessary when combined with fluconazole.

Combination therapy with cyclophosphamide and fluconazole results in an increase in serum bilirubin and serum creatinine. The combination may be used while taking increased consideration to the risk of increased serum bilirubin and serum creatinine. One fatal case of possible fentanyl fluconazole interaction was reported.

The author judged that the patient died from fentanyl intoxication. Furthermore, in a randomized crossover study with 12 healthy volunteers it was shown that fluconazole delayed the elimination of fentanyl significantly. Elevated fentanyl concentration may lead to respiratory depression. Fluconazole can increase halofantrine plasma concentration due to an inhibitory effect on CYP3A4. If concomitant therapy is necessary, the patient should be observed for symptoms of myopathy and rhabdomyolysis and creatinine kinase should be monitored.

Fluconazole inhibits the metabolism of losartan to its active metabolite E 74 which is responsible for most of the angiotensin II-receptor antagonism which occurs during treatment with losartan. Patients should have their blood pressure monitored continuously.

Fluconazole may enhance the serum concentration of methadone. Dosage adjustment of methadone may be necessary. Amiodarone Concomitant administration of fluconazole with amiodarone may increase QT prolongation.

Caution must be exercised if the concomitant use of fluconazole and amiodarone is necessary, notably with high-dose fluconazole mg. Amitriptyline, Nortriptyline Fluconazole increases the effect of amitriptyline and nortriptyline. Amphotericin B Concurrent administration of fluconazole and amphotericin B in infected normal and immunosuppressed mice showed the following results: The clinical significance of results obtained in these studies is unknown. Azithromycin An open-label, randomized, three-way crossover study in 18 healthy subjects assessed the effect of a single mg oral dose of azithromycin on the pharmacokinetics of a single mg oral dose of fluconazole as well as the effects of fluconazole on the pharmacokinetics of azithromycin.

There was no significant pharmacokinetic interaction between fluconazole and azithromycin. There is a risk of developing carbamazepine toxicity. Calcium Channel Blockers Certain calcium channel antagonists nifedipine , isradipine, amlodipine , verapamil , and felodipine are metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of the calcium channel antagonists. Frequent monitoring for adverse events is recommended.

Half of the celecoxib dose may be necessary when combined with fluconazole. Cyclophosphamide Combination therapy with cyclophosphamide and fluconazole results in an increase in serum bilirubin and serum creatinine. The combination may be used while taking increased consideration to the risk of increased serum bilirubin and serum creatinine. Fentanyl One fatal case of possible fentanyl fluconazole interaction was reported.

The author judged that the patient died from fentanyl intoxication. Furthermore, in a randomized crossover study with 12 healthy volunteers it was shown that fluconazole delayed the elimination of fentanyl significantly.

Elevated fentanyl concentration may lead to respiratory depression. Halofantrine Fluconazole can increase halofantrine plasma concentration due to an inhibitory effect on CYP3A4.

If concomitant therapy is necessary, the patient should be observed for symptoms of myopathy and rhabdomyolysis and creatinine kinase should be monitored. Losartan Fluconazole inhibits the metabolism of losartan to its active metabolite E 74 which is responsible for most of the angiotensin Il-receptor antagonism which occurs during treatment with losartan. Patients should have their blood pressure monitored continuously. Methadone Fluconazole may enhance the serum concentration of methadone.

Dosage adjustment of methadone may be necessary. Prednisone There was a case report that a liver-transplanted patient treated with prednisone developed acute adrenal cortex insufficiency when a three month therapy with fluconazole was discontinued.

The discontinuation of fluconazole presumably caused an enhanced CYP3A4 activity which led to increased metabolism of prednisone.

Patients on long-term treatment with fluconazole and prednisone should be carefully monitored for adrenal cortex insufficiency when fluconazole is discontinued. Dosage adjustment of saquinavir may be necessary.

Sirolimus Fluconazole increases plasma concentrations of sirolimus presumably by inhibiting the metabolism of sirolimus via CYP3A4 and P-glycoprotein. Vinca Alkaloids Although not studied, fluconazole may increase the plasma levels of the vinca alkaloids e. Vitamin A Based on a case report in one patient receiving combination therapy with all- trans- retinoid acid an acid form of vitamin A and fluconazole, CNS related undesirable effects have developed in the form of pseudotumour cerebri, which disappeared after discontinuation of fluconazole treatment.

This combination may be used but the incidence of CNS related undesirable effects should be borne in mind. Patients receiving this combination should be monitored for the development of zidovudine-related adverse reactions. Dosage reduction of zidovudine may be considered. DIFLUCAN has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions.

In cases of DIFLUCAN-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex, or age of the patient has been observed. Anaphylaxis In rare cases, anaphylaxis has been reported. Fatal outcomes have been reported in patients with serious underlying diseases. Patients with deep seated fungal infections who develop rashes during treatment with DIFLUCAN should be monitored closely and the drug discontinued if lesions progress.

Fluconazole should be discontinued in patients treated for superficial fungal infection who develop a rash that may be attributed to fluconazole. Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of mg.

These reported anomalies are similar to those seen in animal studies. During post-marketing surveillance, there have been rare cases of QT prolongation and torsade de pointes in patients taking fluconazole. Most of these reports involved seriously ill patients with multiple confounding risk factors, such as structural heart disease , electrolyte abnormalities, and concomitant medications that may have been contributory.

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