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Drug Interactions between ganaxolone and Provigil

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

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Interactions between your drugs

Major

modafinil ganaxolone

Applies to: Provigil (modafinil) and ganaxolone

GENERALLY AVOID: Coadministration with potent or moderate inducers of CYP450 isoenzymes may significantly decrease the plasma concentrations of ganaxolone. According to the prescribing information, ganaxolone is metabolized by CYP450 3A4/5, 2B6, 2C19, and 2D6. In healthy study subjects, coadministration of ganaxolone with rifampin, a potent inducer of CYP450 2C19 and 3A4 and a moderate inducer of CYP450 2B6, decreased ganaxolone peak plasma concentration (Cmax) and systemic exposure (AUC) by 57% and 68%, respectively. Reduced efficacy of ganaxolone may occur. The interaction has not been studied with moderate or weak CYP450 inducers.

MANAGEMENT: Concomitant use of ganaxolone with potent or moderate CYP450 3A4 inducers should be avoided when possible. If coadministration is necessary, a dosage increase of ganaxolone should be considered; however, the maximum recommended dosage should not be exceeded. In patients on a stable ganaxolone dosage who are initiating or increasing their dosage(s) of enzyme-inducing antiepileptic drug(s) such as carbamazepine, phenytoin, phenobarbital or primidone, an increase in the ganaxolone dosage may be required, not to exceed the maximum daily dosage.

References

  1. (2022) "Product Information. Ztalmy (ganaxolone)." Marinus Pharmaceuticals, Inc

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Drug and food interactions

Moderate

ganaxolone food

Applies to: ganaxolone

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of ganaxolone. When administered with a high-fat meal, ganaxolone peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 3- and 2-fold, respectively, compared to administration under fasted conditions. Ganaxolone was administered with food in the premarketing study population. The efficacy of ganaxolone when administered in the fasted state is unknown.

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

MANAGEMENT: Ganaxolone must be administered with food according to the manufacturer. 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

  1. (2022) "Product Information. Ztalmy (ganaxolone)." Marinus Pharmaceuticals, Inc

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Minor

modafinil food

Applies to: Provigil (modafinil)

Administration with food may delay the absorption of modafinil (the racemate) and armodafinil (the R-enantiomer) without significantly affecting their overall bioavailability. According to the product labeling, modafinil's absorption may be delayed by approximately one hour if taken with food. Similarly, the time to reach peak plasma concentration (Tmax) of armodafinil may be delayed by approximately 2 to 4 hours in the fed state.

References

  1. (2001) "Product Information. Provigil (modafinil)." Cephalon, Inc
  2. (2007) "Product Information. Nuvigil (armodafinil)." Cephalon Inc

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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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.