Fedratinib Hydrochloride and Mirtazapine
Determining the interaction of Fedratinib Hydrochloride and Mirtazapine and the possibility of their joint administration.
In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.
Consumer:Consumer information for this interaction is not currently available.MONITOR: Coadministration of mirtazapine with drugs that inhibit one or more of its metabolic pathways may result in increased plasma concentrations of mirtazapine. In vitro data from human liver microsomes indicate that CYP450 2D6 and 1A2 are involved in the formation of the 8-hydroxy metabolite, while CYP450 3A4 is primarily responsible for the formation of the N-desmethyl and N-oxide metabolites. When cimetidine, a weak inhibitor of CYP450 1A2, 2D6 and 3A4, was given at 800 mg twice daily for 14 days to twelve healthy male subjects in combination with mirtazapine 30 mg once daily on days 6 to 12, mean steady-state mirtazapine peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 22% and 54%, respectively. Mirtazapine had no effect on the pharmacokinetics of cimetidine. In another study with 24 healthy male Caucasian subjects, administration of the potent CYP450 3A4 inhibitor ketoconazole at 200 mg twice daily for 6.5 days increased Cmax and AUC of a single 30 mg dose of mirtazapine by approximately 40% and 50%, respectively. A case report described increases in serum mirtazapine concentrations of three- to fourfold in two patients following the addition of fluvoxamine, a potent CYP450 1A2 and weak CYP450 2D6/3A4 inhibitor. One patient reported feeling more anxious with the combination. MANAGEMENT: The possibility of prolonged and/or increased pharmacologic effects of mirtazapine should be considered during coadministration of drugs that inhibit CYP450 1A2, 2D6 and/or 3A4. Therapeutic response to mirtazapine should be monitored more closely following initiation, discontinuation, or dosing change of CYP450 inhibitors, and the mirtazapine dosage adjusted as necessary. References Sitsen JM, Maris FA, Timmer CJ "Concomitant use of mirtazapine and cimetidine: a drug-drug interaction study in healthy male subjects." Eur J Clin Pharmacol 56 (2000): 389-94 "Product Information. Remeron (mirtazapine)." Organon, West Orange, NJ. Okubo M, Murayama N, Miura J, Chiba Y, Yamazaki H "Effects of cytochrome P450 2D6 and 3A5 genotypes and possible coadministered medicines on the metabolic clearance of antidepressant mirtazapine in Japanese patients." Biochem Pharmacol 93 (2015): 104-9 Stormer E, von Moltke LL, Shader RI, Greenblatt DJ "Metabolism of the antidepressant mirtazapine in vitro: contribution of cytochromes P-450 1A2, 2D6, and 3A4" Drug Metab Dispos 28 (2000): 1168-75 View all 4 references
Professional:MONITOR: Coadministration of mirtazapine with drugs that inhibit one or more of its metabolic pathways may result in increased plasma concentrations of mirtazapine. In vitro data from human liver microsomes indicate that CYP450 2D6 and 1A2 are involved in the formation of the 8-hydroxy metabolite, while CYP450 3A4 is primarily responsible for the formation of the N-desmethyl and N-oxide metabolites. When cimetidine, a weak inhibitor of CYP450 1A2, 2D6 and 3A4, was given at 800 mg twice daily for 14 days to twelve healthy male subjects in combination with mirtazapine 30 mg once daily on days 6 to 12, mean steady-state mirtazapine peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 22% and 54%, respectively. Mirtazapine had no effect on the pharmacokinetics of cimetidine. In another study with 24 healthy male Caucasian subjects, administration of the potent CYP450 3A4 inhibitor ketoconazole at 200 mg twice daily for 6.5 days increased Cmax and AUC of a single 30 mg dose of mirtazapine by approximately 40% and 50%, respectively. A case report described increases in serum mirtazapine concentrations of three- to fourfold in two patients following the addition of fluvoxamine, a potent CYP450 1A2 and weak CYP450 2D6/3A4 inhibitor. One patient reported feeling more anxious with the combination.
MANAGEMENT: The possibility of prolonged and/or increased pharmacologic effects of mirtazapine should be considered during coadministration of drugs that inhibit CYP450 1A2, 2D6 and/or 3A4. Therapeutic response to mirtazapine should be monitored more closely following initiation, discontinuation, or dosing change of CYP450 inhibitors, and the mirtazapine dosage adjusted as necessary.
- Sitsen JM, Maris FA, Timmer CJ "Concomitant use of mirtazapine and cimetidine: a drug-drug interaction study in healthy male subjects." Eur J Clin Pharmacol 56 (2000): 389-94
- "Product Information. Remeron (mirtazapine)." Organon, West Orange, NJ.
- Okubo M, Murayama N, Miura J, Chiba Y, Yamazaki H "Effects of cytochrome P450 2D6 and 3A5 genotypes and possible coadministered medicines on the metabolic clearance of antidepressant mirtazapine in Japanese patients." Biochem Pharmacol 93 (2015): 104-9
- Stormer E, von Moltke LL, Shader RI, Greenblatt DJ "Metabolism of the antidepressant mirtazapine in vitro: contribution of cytochromes P-450 1A2, 2D6, and 3A4" Drug Metab Dispos 28 (2000): 1168-75
Generic Name: fedratinib
Brand name: Inrebic
Synonyms: Fedratinib
Generic Name: mirtazapine
Brand name: Remeron, Remeron SolTab
Synonyms: n.a.
In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.
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