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Drug Interactions between belladonna / opium and mitotane

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

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Interactions between your drugs

Moderate

opium belladonna

Applies to: belladonna / opium and belladonna / opium

MONITOR: Coadministration of opioids with anticholinergic agents may result in additive central nervous system (CNS), gastrointestinal, and genitourinary effects. The risk and/or severity of adverse effects such as sedation, dizziness, confusion, cognitive and psychomotor impairment, dry mouth, constipation, and urinary retention may increase. Severe constipation may lead to paralytic ileus in some cases.

MANAGEMENT: Caution and close monitoring of central nervous system, gastrointestinal, and genitourinary adverse effects are recommended when opioids are used with anticholinergic agents. Ambulatory patients should be counseled to avoid hazardous activities requiring 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 (19)
  1. (2002) "Product Information. Demerol (meperidine)." Sanofi Winthrop Pharmaceuticals
  2. (2002) "Product Information. Dolophine (methadone)." Lilly, Eli and Company
  3. (2001) "Product Information. Tylenol with Codeine (acetaminophen-codeine)." Janssen Pharmaceuticals
  4. "Product Information. Duragesic Transdermal System (fentanyl)." Janssen Pharmaceutica, Titusville, NJ.
  5. (2001) "Product Information. Ultram (tramadol)." McNeil Pharmaceutical
  6. (2001) "Product Information. OxyContin (oxycodone)." Purdue Frederick Company
  7. (2001) "Product Information. Kadian (morphine)." Astra-Zeneca Pharmaceuticals
  8. (2004) "Product Information. DepoDur (morphine liposomal)." Endo Laboratories LLC
  9. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  10. (2006) "Product Information. Opana (oxymorphone)." Endo Laboratories LLC
  11. (2009) "Product Information. Nucynta (tapentadol)." PriCara Pharmaceuticals
  12. (2010) "Product Information. Exalgo (hydromorphone)." Covidien
  13. (2016) "Product Information. Belbuca (buprenorphine)." Endo Pharmaceuticals Solutions Inc
  14. (2017) "Product Information. Alfentanil Hydrochloride (alfentanil)." Akorn Inc
  15. (2017) "Product Information. SUFentanil Citrate (sufentanil)." Akorn Inc
  16. (2017) "Product Information. Lortab (acetaminophen-hydrocodone)." Akorn Inc
  17. (2017) "Product Information. Levorphanol Tartrate (levorphanol)." Sentynl Therapeutics
  18. (2018) "Product Information. Naloxone HCl-Pentazocine HCl (naloxone-pentazocine)." Actavis U.S. (Amide Pharmaceutical Inc)
  19. (2018) "Product Information. Apadaz (acetaminophen-benzhydrocodone)." KemPharm, Inc
Moderate

opium mitotane

Applies to: belladonna / opium and mitotane

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 (3)
  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
Moderate

belladonna mitotane

Applies to: belladonna / opium and mitotane

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 (3)
  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

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

opium food

Applies to: belladonna / opium

GENERALLY AVOID: Ethanol may potentiate the central nervous system (CNS) depressant effects of opioid analgesics. Concomitant use may result in additive CNS depression and impairment of judgment, thinking, and psychomotor skills. In more severe cases, hypotension, respiratory depression, profound sedation, coma, or even death may occur.

MANAGEMENT: Concomitant use of opioid analgesics with ethanol should be avoided.

References (9)
  1. Linnoila M, Hakkinen S (1974) "Effects of diazepam and codeine, alone and in combination with alcohol, on simulated driving." Clin Pharmacol Ther, 15, p. 368-73
  2. Sturner WQ, Garriott JC (1973) "Deaths involving propoxyphene: a study of 41 cases over a two-year period." JAMA, 223, p. 1125-30
  3. Girre C, Hirschhorn M, Bertaux L, et al. (1991) "Enhancement of propoxyphene bioavailability by ethanol: relation to psychomotor and cognitive function in healthy volunteers." Eur J Clin Pharmacol, 41, p. 147-52
  4. Levine B, Saady J, Fierro M, Valentour J (1984) "A hydromorphone and ethanol fatality." J Forensic Sci, 29, p. 655-9
  5. Sellers EM, Hamilton CA, Kaplan HL, Degani NC, Foltz RL (1985) "Pharmacokinetic interaction of propoxyphene with ethanol." Br J Clin Pharmacol, 19, p. 398-401
  6. Carson DJ (1977) "Fatal dextropropoxyphene poisoning in Northern Ireland. Review of 30 cases." Lancet, 1, p. 894-7
  7. Rosser WW (1980) "The interaction of propoxyphene with other drugs." Can Med Assoc J, 122, p. 149-50
  8. Edwards C, Gard PR, Handley SL, Hunter M, Whittington RM (1982) "Distalgesic and ethanol-impaired function." Lancet, 2, p. 384
  9. Kiplinger GF, Sokol G, Rodda BE (1974) "Effect of combined alcohol and propoxyphene on human performance." Arch Int Pharmacodyn Ther, 212, p. 175-80
Moderate

belladonna food

Applies to: belladonna / opium

GENERALLY AVOID: Use of anticholinergic agents with alcohol may result in sufficient impairment of attention so as to render driving and operating machinery more hazardous. In addition, the potential for abuse may be increased with the combination. The mechanism of interaction is not established but may involve additive depressant effects on the central nervous system. No effect of oral propantheline or atropine on blood alcohol levels was observed in healthy volunteers when administered before ingestion of a standard ethanol load. However, one study found impairment of attention in subjects given atropine 0.5 mg or glycopyrrolate 1 mg in combination with alcohol.

MANAGEMENT: Alcohol should generally be avoided during therapy with anticholinergic agents. Patients should be counseled to avoid activities requiring mental alertness until they know how these agents affect them.

References (1)
  1. Linnoila M (1973) "Drug effects on psychomotor skills related to driving: interaction of atropine, glycopyrrhonium and alcohol." Eur J Clin Pharmacol, 6, p. 107-12

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

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