oteseconazole fda label

Fluconazole is an inhibitor of CYP3A4, an isoenzyme responsible for the metabolism of rilpivirine. However, coadministration with another moderate CYP3A4 inhibitor in healthy volunteers did not significantly change amlodipine exposure. Methohexital: (Minor) Barbiturates induce hepatic CYP enzymes including 3A4, 2C19 and 2C9 and may reduce effective serum concentrations of fluconazole. For example, the combination of fluconazole and glyburide has resulted in significant increases in the AUCs (roughly 44% or more) and Cmax (roughly 20%) of glyburide in healthy volunteers; however, individual patients may have greater or lesser changes in these pharmacokinetic parameters. 6 mg/kg/dose PO once, then 3 to 6 mg/kg/dose PO once daily for 14 to 21 days. Data from a population pharmacokinetic study in neonates revealed that a dose of at least 12 mg/kg/day is necessary to achieve target exposure (AUC/MIC more than 50 for Candida species with a MIC less than 8 mcg/mL) in 90% of neonates less than 30 weeks gestational age and 80% of neonates 30 to 40 weeks gestational age. Clin Cancer Res. 2001 Sep;8(3):175-82. These effects could be more pronounced in patients also receiving a CYP2D6 inhibitor. Dasatinib: (Contraindicated) Coadministration of fluconazole and dasatinib is contraindicated due to the potential for QT prolongation. Mavacamten is a CYP2C19 and CYP3A substrate and fluconazole is a strong CYP2C19 inhibitor and a moderate CYP3A inhibitor. Hydrochlorothiazide may decrease the renal clearance of fluconazole. 2009 Dec;5(12):1529-42. doi: 10.1517/17425250903228834. The available data indicate that the decreases in some individual ethinyl estradiol AUC values with fluconazole treatment are likely due to random variation. PDR.net is to be used only as a reference aid. Phase Status Purpose Conditions Count; 4: Completed: Treatment: Caucasian Patients With EGFR Mutation Positive Advanced NSCLC: 1: 4: The option for single daily dosing of amlodipine is an attractive feature of this drug Label. Dosing was studied using 4 different PIRRT setting simulations over 8 to 10 hours/day in a Monte Carlo simulation study using population pharmacokinetic data. Sibutramine: (Moderate) The hepatic CYP450 3A4-mediated metabolism of sibutramine may be inhibited by fluconazole, leading to increased concentrations of sibutramine. There was a mean +/- SD increase in fluconazole AUC and Cmax of 45% +/- 31% and 43% +/- 31%, respectively. Ethotoin: (Major) Fluconazole can decrease the metabolism of phenytoin. Fluconazole has also been associated with QT prolongation and rare cases of TdP. [57437], 800 mg IV once, then 400 mg IV once daily in febrile, immunosuppressed patients as an alternative to an echinocandin or amphotericin B. Guaifenesin; Hydrocodone: (Moderate) Consider a reduced dose of hydrocodone with frequent monitoring for respiratory depression and sedation if concurrent use of fluconazole is necessary. In addition, fluconazole inhibits CYP2C19 and CYP3A4. Although this interaction has not been studied, predictions about the interaction can be made based on the metabolic pathways of fluconazole and boceprevir. Epub 2018 Sep 28. Theoretically, prochlorperazine may increase the risk of QT prolongation if coadministered with other drugs that have a risk of QT prolongation. [, Church J, Fletcher EJ, Abdel-Hamid K, MacDonald JF: Loperamide blocks high-voltage-activated calcium channels and N-methyl-D-aspartate-evoked responses in rat and mouse cultured hippocampal pyramidal neurons. Animal studies have shown an increased risk of maternal bleeding during pregnancy but no increase in fetal malformations or fetal or maternal deathsLabel. Tazemetostat is a CYP3A4 substrate and fluconazole is a moderate CYP3A4 inhibitor. 2004 Mar;141(6):915-24. The data supporting the risk of adverse effects associated with this combination is limited to retrospective observational studies and results have been inconsistent. The FDA-approved dosage is 6 to 12 mg/kg/dose PO once daily. Lidocaine: (Moderate) Concomitant use of systemic lidocaine and fluconazole may increase lidocaine plasma concentrations by decreasing lidocaine clearance and therefore prolonging the elimination half-life. Vinorelbine: (Moderate) Monitor for an earlier onset and/or increased severity of vinorelbine-related adverse reactions, including constipation and peripheral neuropathy, if coadministration with fluconazole is necessary. The risk or severity of hyperkalemia can be increased when Loperamide is combined with Aceclofenac. Gefitinib may decrease the excretion rate of Abemaciclib which could result in a higher serum level. Lidocaine is a CYP3A4 and CYP1A2 substrate; fluconazole inhibits CYP3A4. In non-clinical studies, a single dose of 12,000 mg/m2 (about 80 times the recommended clinical dose on a mg/m2 basis) was lethal to rats. Clonazepam: (Moderate) Monitor for increased sedation and respiratory depression if clonazepam is coadministered with fluconazole; adjust the dose of clonazepam if necessary. Limited data are available regarding the safety of maprotiline in combination with other QT-prolonging drugs. [, Hare S, Smith SJ, Metifiot M, Jaxa-Chamiec A, Pommier Y, Hughes SH, Cherepanov P: Structural and functional analyses of the second-generation integrase strand transfer inhibitor dolutegravir (S/GSK1349572). Half this dose caused no mortality in mice. oteseconazole. Hosp Pharm. Clin Cancer Res. Meperidine; Promethazine: (Moderate) Concomitant use of promethazine and fluconazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Treat for at least 4 to 6 weeks with final duration depending on resolution of lesions. After administration, fosaprepitant is rapidly converted to aprepitant. Coadministration may result in elevated plasma concentrations of pazopanib, causing an increased risk for adverse events such as QT prolongation. 800 mg IV once, then 400 mg IV once daily. Afatinib may decrease the excretion rate of Prazosin which could result in a higher serum level. While there is evidence that fluconazole can inhibit the metabolism of ethinyl estradiol, there is no evidence that fluconazole is a net inducer of ethinyl estradiol metabolism. (Moderate) Fluconazole has been shown to inhibit the clearance of caffeine by 25 percent. For infected cardiac hardware, treat for at least 4 to 6 weeks after hardware removal. 1999 May;49(5):394-7. doi: 10.1055/s-0031-1300433. Pasireotide: (Moderate) Use caution when using pasireotide in combination with fluconazole as concurrent use may increase the risk of QT prolongation. Fluconazole has been associated with QT prolongation and rare cases of torsade de pointes (TdP). Mirtazapine: (Moderate) Concomitant use of fluconazole and mirtazapine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. eCollection 2016. Isavuconazole, the active moiety of isavuconazonium, is a sensitive substrate of the hepatic isoenzyme CYP3A4; fluconazole is an inhibitor of this enzyme. For BMT patients who are anticipated to have ANC less than 500 cells/mm3, begin therapy several days prior to the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises back above 1000 cells/mm3. In physiologically based pharmacokinetic (PBPK) simulations, the Cmax and AUC values of acalabrutinib were increased by 2- to almost 3-fold when acalabrutinib was coadministered with moderate CYP3A inhibitors. Epub 2003 Jun 24. Nevirapine is a CYP3A4 substrate and fluconazole is a moderate CYP3A4 inhibitor. 2000 Oct;14(5):523-8. Restart suppressive therapy if CD4 count is less than 100 cells/mm3. Coadministration of etravirine and fluconazole significantly increased etravirine exposures. Prazosin, also known as Minipress, is a drug used to treat hypertension. Because rosiglitazone is a substrate of CYP2C9, concomitant use with fluconazole may increase plasma concentrations of rosiglitazone. Rimegepant: (Major) Avoid a second dose of rimegepant within 48 hours if coadministered with fluconazole; concurrent use may increase rimegepant exposure. J Mol Med (Berl). Fluconazole has been associated with QT prolongation and rare cases of TdP. There is some debate about the optimal dosing frequency in neonates; however, some pharmacokinetic data and guidelines support every 24-hour dosing. [, Imming P, Sinning C, Meyer A: Drugs, their targets and the nature and number of drug targets. Concomitant use may increase the systemic exposure of ergot alkaloids and increase the risk for adverse reactions such as vasospasm which may lead to cerebral ischemia and ischemia of the extremities. Guidelines recommend fluconazole for immunocompetent patients with uncomplicated debilitating or symptomatic chronic cavitary pneumonia and extrapulmonary soft tissue disease. Elbasvir; Grazoprevir: (Moderate) Administering elbasvir; grazoprevir with fluconazole may cause the plasma concentrations of elbasvir and grazoprevir to increase; thereby increasing the potential for adverse effects (i.e., elevated ALT concentrations and hepatotoxicity). Drug created at June 13, 2005 13:24 / Updated at November 10, 2022 05:47. Loperamide is a long acting antidiarrheal used to control nonspecific diarrhea and chronic diarrhea caused by inflammatory bowel disease, or gastroenteritis. If a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor during cinacalcet therapy, the manufacturer recommends that dosage adjustment may be needed with close monitoring of PTH and serum calcium concentrations. If concomitant use is unavoidable, monitor electrocardiograms and correct electrolyte abnormalities. Consider intravascular catheter removal. 2010 Jan;54(1):254-8. doi: 10.1128/AAC.00842-09. 1996 Jan 4;295(1):69-73. Pazopanib: (Contraindicated) Due to the risk of life-threatening arrhythmias such as torsade de pointes (TdP), coadministration of fluconazole with drugs that both prolong the QT interval and are CYP3A4 substrates, like pazopanib, is contraindicated. Paricalcitol: (Moderate) Care should be taken when dosing paricalcitol with strong CYP3A4 inhibitors, such as fluconazole. Fluconazole is also recommended for coccidioidomycosis in hematopoietic stem cell transplant (HSCT), solid organ transplant, and patients receiving biologic response modifiers. [, Bylund DB: Heterogeneity of alpha-2 adrenergic receptors. Thioridazine is considered contraindicated for use along with fluconazole which, when combined with thioridazine, may prolong the QT interval and increase the risk of TdP, and/or cause orthostatic hypotension. 6 mg/kg/dose (Max: 200 mg/dose) PO once, then 3 to 6 mg/kg/dose (Max: 100 mg/dose) PO once daily for 7 to 14 days. [, Adams HR: Pharmacologic problems in circulation research: alpha adrenergic blocking drugs. Although there has been debate about the optimal dosing frequency in neonates, data and guidelines support every 24-hour dosing. Abemaciclib may decrease the excretion rate of Dolutegravir which could result in a higher serum level. Avoid life-threatening adverse drug events & improve clinical decision support. Esomeprazole: (Minor) Fluconazole may inhibit the CYP2C19 isoenzyme, leading to increased plasma levels of drugs that are substrates for the CYP2C19 isoenzyme, such as esomeprazole. A course of at least 14 days may decrease the likelihood of relapse. If you believe you are experiencing an interaction, contact a healthcare provider immediately. Coadministration of fluconazole 100 mg PO and hydrochlorothiazide 50 mg PO for 10 days in normal volunteers (n = 13) resulted in a significant increase in fluconazole AUC and Cmax compared to fluconazole given alone. In addition, the apparent cyclosporine clearance decreased by 45%. [28674] [32700] [53057], 400 to 800 mg IV once daily until resolution of all signs and symptoms and CSF and radiologic abnormalities. Hydrocodone; Ibuprofen: (Moderate) Consider a reduced dose of hydrocodone with frequent monitoring for respiratory depression and sedation if concurrent use of fluconazole is necessary. Epub 2009 Nov 2. Monitor blood pressure closely during concurrent use of these medications. Drug created at March 19, 2008 16:40 / Updated at November 10, 2022 05:47. Dosing should take into consideration patient-specific factors (e.g., intrinsic renal function), type of infection, the duration of renal replacement therapy, the effluent flow rate, and the replacement solution administered. In addition to increased systemic exposure, the maximum concentration and half-life of S-(+)-ibuprofen were all statistically significantly greater in the presence of fluconazole. Saquinavir: (Contraindicated) Although the manufacturer of fluconazole provides dose adjustment recommendations for saquinavir when the two drugs are coadministered, the manufacturer of saquinavir contraindicates this drug combination. Lidocaine; Epinephrine: (Moderate) Concomitant use of systemic lidocaine and fluconazole may increase lidocaine plasma concentrations by decreasing lidocaine clearance and therefore prolonging the elimination half-life. Fluconazole increased mitapivat overall and peak exposure by approximately 2.6-fold and 1.6-fold, respectively, after mitapivat 5, 20, or 50 mg twice daily. Direct actions of amlodipine on vascular smooth muscle result in reduced blood pressure 9. Midazolam: (Moderate) Midazolam is metabolized by hepatic isozyme CYP3A4. Fluconazole has been associated with QT prolongation and rare cases of torsade de pointes (TdP). Epub 2007 Jul 6. Norfloxacin: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering fluconazole with norfloxacin. Fluconazole can inhibit colchicine's metabolism via CYP3A4, resulting in increased colchicine exposure. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. Elderly patients show a reduced clearance of amlodipine with an AUC (area under the curve) increase of about 4060%, and a lower initial dose may be required Label. Easily compare up to 40 drugs with our drug interaction checker. 2012 Apr;21(4):523-30. doi: 10.1517/13543784.2012.661713. The risk or severity of hypoglycemia can be increased when Amlodipine is combined with Acarbose. 2002 Jan 1;30(1):412-5. Fluconazole tablets, administered concomitantly with oral contraceptives containing ethinyl estradiol have resulted in an overall mean increase in ethinyl estradiol compared to placebo. There was a mean +/- SD increase in fluconazole AUC and Cmax of 45% +/- 31% and 43% +/- 31%, respectively. Coadministration with a moderate CYP3A4 inhibitor in elderly hypertensive patients increased systemic exposure to amlodipine by 60%. Epub 2006 Feb 2. Although there has been debate about the optimal dosing frequency in neonates, data and guidelines support every 24-hour dosing for neonates.

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