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Drug Interactions between brexanolone and sertraline

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

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Interactions between your drugs

Major

sertraline brexanolone

Applies to: sertraline and brexanolone

MONITOR CLOSELY: Coadministration with central nervous system (CNS) depressants (e.g., alcohol, benzodiazepines, opioids) or antidepressants may enhance the sedative effects of brexanolone and increase the likelihood or severity of sedation-related adverse reactions. Patients treated with brexanolone are at risk of excessive sedation or sudden loss of consciousness during administration. In clinical studies, 5% of patients receiving brexanolone infusion experienced sedation and somnolence that required dose interruption, compared to 0% of patients receiving placebo. Some patients also reported to have loss of consciousness or altered state of consciousness during the brexanolone infusion (4% vs. 0%). All patients recovered from loss or altered state of consciousness after dose interruption, with full recovery time ranging from 15 to 60 minutes. There was no clear association between loss or alteration of consciousness and pattern or timing of dose. Not all patients who experienced a loss or alteration of consciousness reported sedation or somnolence before the episode.

MANAGEMENT: Caution is advised during concomitant use of brexanolone with CNS depressants, antidepressants, or other agents that cause sedation. Patients should be closely monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. During the brexanolone infusion, monitor for sedative effects every 2 hours during planned, non-sleep periods, and immediately stop the infusion if there are signs or symptoms of excessive sedation. After symptoms resolve, the infusion may be resumed at the same or lower dose as clinically appropriate. If pulse oximetry reveals hypoxia, immediately stop the infusion and do not resume infusion following resolution of the hypoxia. Patients should be cautioned against driving, operating machinery, or engaging in potentially hazardous activities requiring mental alertness and motor coordination until sedative effects of brexanolone and other concomitant medications have dissipated. Patients must be accompanied during interactions with their child(ren) while receiving brexanolone because of the potential for excessive sedation and sudden loss of consciousness.

References (1)
  1. (2019) "Product Information. Zulresso (brexanolone)." Sage Therapeutics, Inc.

Drug and food interactions

Moderate

sertraline food

Applies to: sertraline

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of sertraline. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills. In addition, limited clinical data suggest that consumption of grapefruit juice during treatment with sertraline may result in increased plasma concentrations of sertraline. The proposed mechanism is inhibition of CYP450 3A4-mediated metabolism by certain compounds present in grapefruit. An in-vitro study demonstrated that grapefruit juice dose-dependently inhibits the conversion of sertraline to its metabolite, desmethylsertraline. In a study with eight Japanese subjects, mean plasma levels of sertraline increased by approximately 100% and maximum plasma concentrations increased by 66% after the ingestion of three 250 mL glasses of grapefruit juice per day for 5 days and administration of a single dose of sertraline 75 mg on the sixth day. In another small study with 5 patients, mean sertraline trough levels increased by 47% after taking sertraline for at least 6 weeks, then taking sertraline with 240 mL grapefruit juice daily for 1 week. The clinical significance is unknown; however, pharmacokinetic alterations associated with interactions involving grapefruit juice are often subject to a high degree of interpatient variability. The possibility of significant interaction in some patients should be considered.

MANAGEMENT: Patients receiving sertraline should be 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 sertraline affects them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities. Some authorities recommend that consumption of grapefruit juice should be avoided during sertraline therapy.

References (4)
  1. (2001) "Product Information. Zoloft (sertraline)." Roerig Division
  2. Lee AJ, Chan WK, Harralson AF, Buffum J, Bui BCC (1999) "The effects of grapefruit juice on sertraline metabolism: An in vitro and in vivo study." Clin Ther, 21, p. 1890-9
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Ueda N, Yoshimura R, Umene-Nakano W, et al. (2009) "Grapefruit juice alters plasma sertraline levels after single ingestion of sertraline in healthy volunteers." World J Biol Psychiatry, 10(4 Pt 3), p. 832-5

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.

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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.

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