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Drug Interactions between mitotane and Phrenilin Forte

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

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Interactions between your drugs

Moderate

acetaminophen butalbital

Applies to: Phrenilin Forte (acetaminophen / butalbital / caffeine) and Phrenilin Forte (acetaminophen / butalbital / caffeine)

Using acetaminophen together with butalbital may alter the effects of acetaminophen and cause serious side effects that may affect your liver. Call your doctor immediately if you experience a fever, chills, joint pain or swelling, excessive tiredness or weakness, unusual bleeding or bruising, skin rash or itching, loss of appetite, nausea, vomiting, or yellowing of the skin or the whites of your eyes. If your doctor does prescribe these medications together, you may need a dose adjustment or special tests to safely take both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

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Moderate

mitotane butalbital

Applies to: mitotane and Phrenilin Forte (acetaminophen / butalbital / caffeine)

Consumer information for this interaction is not currently available.

MONITOR: Coadministration with alcohol or other central nervous system (CNS) depressants may enhance the sedative effects of mitotane and increase the likelihood and/or severity of central nervous system (CNS) side effects. In clinical studies and post marketing reports, CNS side effects occurred in 40% of patients, primarily consisting of depression as manifested by lethargy and somnolence (25%), and dizziness or vertigo (15%). Mitotane plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of severe neurologic toxicity. Clinical data are not available for the concomitant use of mitotane with other CNS depressants.

MANAGEMENT: Caution and clinical monitoring for increased CNS adverse effects is advised if mitotane is coadministered with alcohol, other CNS depressants, or agents that cause dizziness or vertigo. Patients should not drive, operate machinery, or engage in hazardous activities requiring mental alertness and motor coordination until they know how the medications affect them. In addition, more frequent monitoring of serum mitotane levels may be considered.

References

  1. "Product Information. Lysodren (mitotane)." HRA Pharma America (2023):
  2. "Product Information. Lysodren (mitotane)." Medunik Canada (2023):
  3. "Product Information. Lysodren (mitotane)." HRA Pharma UK & Ireland Ltd (2023):

Drug and food interactions

Major

acetaminophen food

Applies to: Phrenilin Forte (acetaminophen / butalbital / caffeine)

Ask your doctor before using acetaminophen together with ethanol. This can cause serious side effects that affect your liver. Call your doctor immediately if you experience a fever, chills, joint pain or swelling, excessive tiredness or weakness, unusual bleeding or bruising, skin rash or itching, loss of appetite, nausea, vomiting, or yellowing of the skin or the whites of your eyes. If your doctor does prescribe these medications together, you may need a dose adjustment or special tests to safely take both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

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Major

butalbital food

Applies to: Phrenilin Forte (acetaminophen / butalbital / caffeine)

Ask your doctor before using butalbital together with ethanol, this can add to dizziness, drowsiness and other side effects of butalbital. Be careful if you drive or do activities that require you to be awake and alert. Talk with your doctor before using any medications together, or drinking alcohol with butalbital. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

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Moderate

mitotane food

Applies to: mitotane

Consumer information for this interaction is not currently available.

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

  1. "Product Information. Lysodren (mitotane)." HRA Pharma America (2023):
  2. "Product Information. Lysodren (mitotane)." Medunik Canada (2023):
  3. "Product Information. Lysodren (mitotane)." HRA Pharma UK & Ireland Ltd (2023):
  4. Moolenaar AJ, van Slooten H, van Seters AP, Smeenk D "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" (2023):
View all 4 references
Minor

caffeine food

Applies to: Phrenilin Forte (acetaminophen / butalbital / caffeine)

Information for this minor interaction is available on the professional version.

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.