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Drug Interactions between mirtazapine and mitotane

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

mitotane mirtazapine

Applies to: mitotane and mirtazapine

MONITOR: Coadministration with inducers of CYP450 3A4 may decrease the plasma concentrations of mirtazapine, which is partially metabolized by the isoenzyme. In healthy study subjects, administration of mirtazapine (30 mg once daily) with the potent CYP450 3A4 inducer carbamazepine (400 mg twice daily) decreased mean steady-state mirtazapine peak plasma concentration (Cmax) and systemic exposure (AUC) by approximately 40% and 60%, respectively, compared to administration with placebo. In another study consisting of patients with unipolar depression receiving mirtazapine 45 mg daily, the addition of carbamazepine reportedly decreased mirtazapine plasma concentrations by approximately 47% after 3 weeks. Likewise, when mirtazapine 30 mg once daily was given with phenytoin 200 mg once daily in healthy, nonsmoking male volunteers, steady-state mirtazapine Cmax and AUC decreased by 33% and 47%, respectively, compared to mirtazapine given alone. Mirtazapine had no significant effect on the pharmacokinetics of either carbamazepine or phenytoin.

MANAGEMENT: The possibility of diminished therapeutic response to mirtazapine should be considered during coadministration with CYP450 3A4 inducers, particularly potent ones like carbamazepine, enzalutamide, lumacaftor, mitotane, phenobarbital, phenytoin, rifampin, and St. John's wort. Pharmacologic response to mirtazapine should be monitored more closely whenever a CYP450 3A4 inducer is added to or withdrawn from therapy, and the dosage adjusted as necessary.

References (4)
  1. (2001) "Product Information. Remeron (mirtazapine)." Organon
  2. Timmer CJ, Sitsen JMA, Delbressine LP (2000) "Clinical pharmacokinetics of mirtazapine." Clin Pharmacokinet, 38, p. 461-74
  3. Spaans E, Van Den Heuvel MW, Schnabel PG, et al. (2002) "Concomitant use of mirtazapine and phenytoin: a drug-drug interaction study in healthy male subjects." Eur J Clin Pharmacol, 58, p. 423-9
  4. Sitsen JM, Maris FA, Timmer CJ (2001) "Drug-drug interaction studies with mirtazapine and carbamazepine in healthy male subjects." Eur J Drug Metab Pharmacokinet, 26, p. 109-21

Drug and food interactions

Moderate

mitotane food

Applies to: mitotane

ADJUST DOSING INTERVAL: Fat-rich food enhances the absorption of mitotane. One study evaluated blood levels of mitotane (o,p'-DDD) after subjects ingested a single dose of 2 g administered using various delivery vehicles (e.g., tablets, granules, milk, chocolate or oil emulsion). Mitotane plasma levels were significantly higher for milk, chocolate, and oil emulsion when compared to those who received tablets or granules alone. In the same study, mitotane levels were evaluated in subjects following long-term treatment (total dose of 200 g over 30 to 60 days) in tablet, oil emulsion, or milk formulations. Significantly higher mean plasma levels were recorded in subjects who received mitotane as an oil emulsion or mixed in milk, when compared to tablets alone. Additionally, the recovery of o,p'-DDD from the feces was about 5 times higher in subjects who received tablets alone, suggesting absorption was reduced when compared to subjects who received mitotane mixed with a fat-rich vehicle (e.g., oil emulsion or milk).

GENERALLY AVOID: Concomitant use of mitotane with central nervous system (CNS) depressants, including alcohol, may potentiate adverse effects such as somnolence and sedation.

MANAGEMENT: According to product labeling, mitotane tablets should be taken during meals containing fat-rich food (e.g., milk, chocolate, or oil) and with a full glass of water. Patients should be advised to avoid or limit consumption of alcohol and to avoid activities requiring mental alertness such as driving or operating hazardous machinery until they know how the medication affects them.

References (4)
  1. (2023) "Product Information. Lysodren (mitotane)." HRA Pharma America
  2. (2023) "Product Information. Lysodren (mitotane)." Medunik Canada
  3. (2023) "Product Information. Lysodren (mitotane)." HRA Pharma UK & Ireland Ltd
  4. Moolenaar AJ, van Slooten H, van Seters AP, Smeenk D (2023) Blood levels of o,p-DDD following administration in various vehicles after a single dose and during long-term treatment https://link.springer.com/article/10.1007/BF00258213
Moderate

mirtazapine food

Applies to: mirtazapine

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol. Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

References (4)
  1. Warrington SJ, Ankier SI, Turner P (1986) "Evaluation of possible interactions between ethanol and trazodone or amitriptyline." Neuropsychobiology, 15, p. 31-7
  2. Gilman AG, eds., Nies AS, Rall TW, Taylor P (1990) "Goodman and Gilman's the Pharmacological Basis of Therapeutics." New York, NY: Pergamon Press Inc.
  3. (2012) "Product Information. Fycompa (perampanel)." Eisai Inc
  4. (2015) "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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