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Drug Interactions between Focalin and safinamide

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

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Major

dexmethylphenidate safinamide

Applies to: Focalin (dexmethylphenidate) and safinamide

CONTRAINDICATED: Coadministration of nonselective monoamine oxidase (MAO) inhibitors and sympathomimetic amines has been associated with severe hypertensive reactions. The mechanism involves a synergistic sympathomimetic effect due to enhanced norepinephrine storage in adrenergic neurons (MAOI activity) and increased liberation or decreased reuptake of catecholamines (sympathomimetic activity). Because safinamide is a selective MAO-B inhibitor, hypertensive reactions would not ordinarily be expected when used with sympathomimetic amines. However, one case of hypertensive crisis has been reported in a patient taking ephedrine with the recommended dosage of another selective MAO-B inhibitor.

MANAGEMENT: Coadministration of safinamide and sympathomimetic amines, such as methylphenidate, amphetamine, and their derivatives, is considered contraindicated.

References

  1. Smookler S, Barmudez AJ "Hypertensive crisis resulting from an MAO inhibitor and an over-the counter appetite suppressant." Ann Emerg Med 11 (1982): 482-4
  2. Krisko I, Lewis E, Johnson JE "Severe hyperpyrexia due to tranylcypromine-amphetamine toxicity." Ann Intern Med 70 (1969): 559-64
  3. Elis J, Laurence DR, Mattie H, Prichard BN "Modification by monoamine oxidase inhibitors of the effect of some sympathomimetics on blood pressure." Br Med J 2 (1967): 75-8
  4. Davies B, Bannister R, Sever P "Pressor amines and monoamine-oxidase inhibitors for treatment of postural hypotension in autonomic failure: limitations and hazards." Lancet 1 (1978): 172-5
  5. Goldberg LI "Monoamine oxidase inhibitors: adverse reactions and possible mechanisms." JAMA 190 (1964): 456-62
  6. Horler AR, Wynne NA "Hypertensive crisis due to pargyline and metaraminol." Br Med J 5459 (1965): 460-1
  7. Sjoqvist F "Psychotropic drugs (2) interaction between monoamine oxidase (MAO) inhibitors and other substances." Proc R Soc Med 58 (1965): 967-78
  8. Harrison WM, McGrath PJ, Stewart JW, Quitkin F "MAOIs and hypertensive crises: the role of OTC drugs." J Clin Psychiatry 50 (1989): 64-5
  9. Cuthbert MF, Greenberg MP, Morley SW "Cough and cold remedies: a potential danger to patients on monoamine oxidase inhibitors." Br Med J 1 (1969): 404-6
  10. Humberstone PM "Hypertension from cold remedies." Br Med J 1 (1969): 846
  11. Wright SP "Hazards with monoamine-oxidase inhibitors: a persistent problem." Lancet 1 (1978): 284-5
  12. Boakes AJ, Laurence DR, Teoh PC, Barar FS, Benedikter LT, Pritchard BN "Interactions between sympathomimetic amines and antidepressant agents in man." Br Med J 1 (1973): 311-5
  13. Dally PJ "Fatal reaction associated with tranylcypromine and methylamphetamine." Lancet 1 (1962): 1235-6
  14. Schildkraut JJ, Klerman GL, Friend DG, Greenblatt M "Biochemical and pressor effects of oral d,l-dihydroxyphenylalanine in patients pretreated with antidepressant drugs." Ann N Y Acad Sci 107 (1963): 1005-15
  15. Smookler S, Bermudez AJ "Hypertensive crisis resulting from an MAO inhibitor and an over-the-counter appetite suppressant." Ann Intern Med 11 (1982): 482-4
  16. Mason AM, Buckle RM ""Cold" cures and monoamine-oxidase inhibitors." Br Med J 1 (1969): 845-6
  17. Boakes AJ, Laurence DR, Teoh PC, Barar FS, Benedikter LT, Prichard BN "Interactions between sympathomimetic amines and antidepressant agents in man." Br Med J 1 (1973): 311-5
  18. Goulet JP, Perusse R, Turcotte JY "Contraindications to vasoconstrictors in dentistry: Part III. Pharmacologic interactions." Oral Surg Oral Med Oral Pathol 74 (1992): 692-7
  19. Ban TA "Drug interactions with psychoactive drugs." Dis Nerv Syst 36 (1975): 164-6
  20. Lefebvre H, Noblet C, Morre N, Wolf LM "Pseudo-phaeochromocytoma after multiple drug interactions involving the selective monoamine oxidase inhibitor selegiline." Clin Endocrinol (Oxf) 42 (1995): 95-8
  21. Darcy PF, Griffin JP "Interactions with drugs used in the treatment of depressive illness." Adverse Drug React Toxicol Rev 14 (1995): 211-31
  22. Markowitz JS, Patrick KS "Pharmacokinetic and pharmacodynamic drug interactions in the treatment of attention-deficit hyperactivity disorder." Clin Pharmacokinet 40 (2001): 753-72
  23. "Product Information. Azilect (rasagiline)." Teva Pharmaceuticals USA (2006):
  24. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  25. "Product Information. Vyvanse (lisdexamfetamine)." Shire US Inc (2007):
  26. "Product Information. Xadago (safinamide)." US WorldMeds LLC (2017):
View all 26 references

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Drug and food interactions

Moderate

safinamide food

Applies to: safinamide

GENERALLY AVOID: Foods that contain large amounts of tyramine may precipitate a hypertensive crisis in patients treated with safinamide. The proposed mechanism involves potentiation of the tyramine pressor effect due to inhibition of monoamine oxidase (MAO) by safinamide. Monoamine oxidase in the gastrointestinal tract and liver, primarily type A (MAO-A), is the enzyme responsible for metabolizing exogenous amines such as tyramine and preventing them from being absorbed intact. Once absorbed, tyramine is metabolized to octopamine, a substance that is believed to displace norepinephrine from storage granules causing a rise in blood pressure. In vitro, safinamide inhibits MAO-B with greater than 1000-fold selectivity over MAO-A, and neither safinamide nor its major metabolites inhibit MAO-A at clinically relevant concentrations. Results from an oral tyramine challenge study also suggest that safinamide is a selective inhibitor of MAO-B at the recommended dosages of 50 or 100 mg/day. However, this selectivity is not absolute and may diminish in a dose-related manner above the maximum recommended daily dosage. In clinical trials, the incidence of hypertension was 7% and 5% for safinamide 50 mg and 100 mg, respectively, versus 4% for placebo. There were no reported cases of hypertensive crisis.

Administration of safinamide following intake of a high-fat, high-caloric breakfast resulted in a slight delay in the absorption of safinamide, but had no effects on safinamide peak plasma concentration (Cmax) and systemic exposure (AUC) compared to administration under fasted conditions.

MANAGEMENT: Dietary restriction is not ordinarily required during safinamide treatment with respect to most foods and beverages that contain tyramine, which usually include aged, fermented, cured, smoked, or pickled foods (e.g., air-dried and fermented meats or fish, aged cheeses, most soybean products, yeast extracts, red wine, beer, sauerkraut). However, certain foods like some of the aged cheeses (e.g., Boursault, Liederkrantz, Mycella, Stilton) and pickled herring may contain very high amounts of tyramine and could potentially cause a hypertensive reaction in patients taking safinamide, even at recommended dosages, due to increased sensitivity to tyramine. Patients should be advised to avoid the intake of very high levels of tyramine (e.g., greater than 150 mg) and to promptly seek medical attention if they experience potential signs and symptoms of a hypertensive crisis such as severe headache, visual disturbances, confusion, stupor, seizures, chest pain, unexplained nausea or vomiting, and stroke-like symptoms. Blood pressure should be regularly monitored and managed accordingly. Medication adjustment may be necessary if blood pressure elevations are sustained or not adequately controlled. Safinamide should not be used at dosages exceeding 100 mg/day, or 50 mg/day in patients with moderate hepatic impairment (Child-Pugh B, 7-9), as it may increase the risk of hypertensive crisis and other adverse reactions associated with nonselective inhibition of MAO. Safinamide can be administered with or without food.

References

  1. "Product Information. Xadago (safinamide)." US WorldMeds LLC (2023):
  2. "Product Information. Onstryv (safinamide)." Valeo Pharma (2020):
  3. "Product Information. Xadago (safinamide)." Seqirus Pty Ltd (2022):
  4. "Product Information. Xadago (safinamide)." Zambon UK Ltd (2021):
View all 4 references

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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.

See also

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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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