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Drug Interactions between Fiorinal and tofacitinib

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

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Interactions between your drugs

Moderate

aspirin tofacitinib

Applies to: Fiorinal (aspirin / butalbital / caffeine) and tofacitinib

MONITOR: Coadministration of Janus kinase (JAK) inhibitors with corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or opioids may increase the risk of gastrointestinal (GI) perforation. Patients with a prior history of peptic ulceration or diverticular disease may also have an increased risk. Adverse events of diverticulitis and GI perforation have been infrequently reported in clinical studies and postmarketing use of JAK inhibitors such as baricitinib, ruxolitinib, tofacitinib, and upadacitinib. However, the role of JAK inhibition in these events has not been determined. In studies with rheumatoid arthritis and ulcerative colitis patients, many were receiving background therapy with NSAIDs or corticosteroids.

MANAGEMENT: Caution is recommended when using JAK inhibitors in patients with a history of peptic ulceration or diverticular disease and in patients receiving concomitant treatment with drugs associated with an increased risk of GI perforation such as corticosteroids, NSAIDs, and opioids. Patients should be advised to contact their healthcare provider if they experience signs and symptoms of GI perforation such as severe abdominal pain, fever, chills, nausea, or vomiting.

References (15)
  1. Strate LL, Liu YL, Huang ES, Giovannucci EL, Chan AT (2011) "Use of aspirin or nonsteroidal anti-inflammatory drugs increases risk for diverticulitis and diverticular bleeding." Gastroenterology, 140, p. 1427-33
  2. Medicines and Healthcare products Regulatory Agency (2020) Baricitinib (Olumiant¥): increased risk of diverticulitis, particularly in patients with risk factors. https://www.gov.uk/drug-safety-update/baricitinib-olumiant-increased-risk-of-diverticulitis-particularly-in-patients-with-risk-factors
  3. (2021) "Product Information. Olumiant (bARICITinib)." Eli Lilly Australia Pty Ltd, vA7_April2021
  4. (2023) "Product Information. Olumiant (baricitinib)." Eli Lilly and Company Ltd
  5. Hoisnard L, Lebrun-Vignes B, Maury S, et al. (2022) "Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database." Sci Rep, 12, p. 7140
  6. (2023) "Product Information. Olumiant (baricitinib)." Lilly, Eli and Company, DailyMed
  7. (2023) "Product Information. Xeljanz (tofacitinib)." Pfizer U.S. Pharmaceuticals Group
  8. (2023) "Product Information. Xeljanz (tofacitinib)." Pfizer Ltd
  9. (2023) "Product Information. Xeljanz (tOFACitinib)." Pfizer Australia Pty Ltd, pfpxelja10423
  10. (2023) "Product Information. Rinvoq (upadacitinib)." AbbVie US LLC
  11. (2023) "Product Information. Rinvoq (upadacitinib)." AbbVie Ltd
  12. (2023) "Product Information. Rinvoq (upadacitinib)." AbbVie Pty Ltd, 8
  13. (2022) "Product Information. Olumiant (baricitinib)." Eli Lilly Canada Inc, 260967
  14. (2022) "Product Information. Xeljanz (tofacitinib)." Pfizer Canada ULC, 258173
  15. (2022) "Product Information. Rinvoq (upadacitinib)." AbbVie Corporation, 262176
Moderate

butalbital tofacitinib

Applies to: Fiorinal (aspirin / butalbital / caffeine) and tofacitinib

MONITOR: Coadministration with moderate inducers of CYP450 3A4 may decrease the plasma concentrations of tofacitinib, which is primarily metabolized by the isoenzyme. The interaction may result in loss of or reduced clinical response; however, the extent to which these medications interact with tofacitinib has not been established. In study subjects, administration with the potent CYP450 3A4 inducer rifampin decreased tofacitinib peak plasma concentration (Cmax) and systemic exposure (AUC) by approximately 74% and 84%, respectively, compared to administration of tofacitinib alone.

MANAGEMENT: Caution is recommended if tofacitinib is to be used in combination with moderate CYP450 3A4 inducers. Alternative agents with no or minimal CYP450 3A4 induction potential are recommended when possible.

References (2)
  1. Cerner Multum, Inc. "Australian Product Information."
  2. (2012) "Product Information. Xeljanz (tofacitinib)." Pfizer U.S. Pharmaceuticals Group
Minor

aspirin caffeine

Applies to: Fiorinal (aspirin / butalbital / caffeine) and Fiorinal (aspirin / butalbital / caffeine)

One study has reported that coadministration of caffeine and aspirin lead to a 25% increase in the rate of appearance and 17% increase in maximum concentration of salicylate in the plasma. A significantly higher area under the plasma concentration time curve of salicylate was also reported when both drugs were administered together. The exact mechanism of this interaction has not been specified. Physicians and patients should be aware that coadministration of aspirin and caffeine may lead to higher salicylate levels faster.

References (1)
  1. Yoovathaworn KC, Sriwatanakul K, Thithapandha A (1986) "Influence of caffeine on aspirin pharmacokinetics." Eur J Drug Metab Pharmacokinet, 11, p. 71-6

Drug and food interactions

Major

butalbital food

Applies to: Fiorinal (aspirin / butalbital / caffeine)

GENERALLY AVOID: Concurrent acute use of barbiturates and ethanol may result in additive CNS effects, including impaired coordination, sedation, and death. Tolerance of these agents may occur with chronic use. The mechanism is related to inhibition of microsomal enzymes acutely and induction of hepatic microsomal enzymes chronically.

MANAGEMENT: The combination of ethanol and barbiturates should be avoided.

References (5)
  1. Gupta RC, Kofoed J (1966) "Toxological statistics for barbiturates, other sedatives, and tranquilizers in Ontario: a 10-year survey." Can Med Assoc J, 94, p. 863-5
  2. Misra PS, Lefevre A, Ishii H, Rubin E, Lieber CS (1971) "Increase of ethanol, meprobamate and pentobarbital metabolism after chronic ethanol administration in man and in rats." Am J Med, 51, p. 346-51
  3. Saario I, Linnoila M (1976) "Effect of subacute treatment with hypnotics, alone or in combination with alcohol, on psychomotor skills related to driving." Acta Pharmacol Toxicol (Copenh), 38, p. 382-92
  4. Stead AH, Moffat AC (1983) "Quantification of the interaction between barbiturates and alcohol and interpretation of fatal blood concentrations." Hum Toxicol, 2, p. 5-14
  5. Seixas FA (1979) "Drug/alcohol interactions: avert potential dangers." Geriatrics, 34, p. 89-102
Moderate

tofacitinib food

Applies to: tofacitinib

MONITOR: Grapefruit juice may increase the plasma concentrations of tofacitinib. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits. The extent and clinical significance are unknown. Moreover, pharmacokinetic alterations associated with interactions involving grapefruit juice are often subject to a high degree of interpatient variability.

MANAGEMENT: Until more information is available, some authorities recommend avoiding consumption of grapefruit juice during tofacitinib therapy (Canada). Patients receiving tofacitinib therapy who ingest grapefruits or grapefruit juice should be monitored for adverse effects and undue fluctuations in plasma drug levels.

References (1)
  1. (2024) "Product Information. Xeljanz (tofacitinib)." Pfizer Canada ULC
Moderate

aspirin food

Applies to: Fiorinal (aspirin / butalbital / caffeine)

GENERALLY AVOID: The concurrent use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) and ethanol may lead to gastrointestinal (GI) blood loss. The mechanism may be due to a combined local effect as well as inhibition of prostaglandins leading to decreased integrity of the GI lining.

MANAGEMENT: Patients should be counseled on this potential interaction and advised to refrain from alcohol consumption while taking aspirin or NSAIDs.

References (1)
  1. (2002) "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn
Minor

caffeine food

Applies to: Fiorinal (aspirin / butalbital / caffeine)

The effect of grapefruit juice on the pharmacologic activity of caffeine is controversial. One report suggests that grapefruit juice increases the effect of caffeine. The proposed mechanism is inhibition of cytochrome P-450 metabolism of caffeine. However, a well-conducted pharmacokinetic/pharmacodynamic study did not demonstrate this effect. The clinical significance of this potential interaction is unknown.

References (2)
  1. (1995) "Grapefruit juice interactions with drugs." Med Lett Drugs Ther, 37, p. 73-4
  2. Maish WA, Hampton EM, Whitsett TL, Shepard JD, Lovallo WR (1996) "Influence of grapefruit juice on caffeine pharmacokinetics and pharmacodynamics." Pharmacotherapy, 16, p. 1046-52
Minor

aspirin food

Applies to: Fiorinal (aspirin / butalbital / caffeine)

One study has reported that coadministration of caffeine and aspirin lead to a 25% increase in the rate of appearance and 17% increase in maximum concentration of salicylate in the plasma. A significantly higher area under the plasma concentration time curve of salicylate was also reported when both drugs were administered together. The exact mechanism of this interaction has not been specified. Physicians and patients should be aware that coadministration of aspirin and caffeine may lead to higher salicylate levels faster.

References (1)
  1. Yoovathaworn KC, Sriwatanakul K, Thithapandha A (1986) "Influence of caffeine on aspirin pharmacokinetics." Eur J Drug Metab Pharmacokinet, 11, p. 71-6

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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