Patients receiving EMSAM should be warned against undergoing elective surgery that requires general anesthesia or sympathomimetic vasoconstricting agents. The https:// ensures that you are connecting to the The only reported adverse events that were significantly different between selegiline and placebo were skin and application site reactions. The reaction also occurred in a subsequent ingestion (ie, rechallenge) of cheese on toast with co-ingestion of tranylcypromine. Contraindicated. Differences in other cardiovascular measures (eg, heart rate, electrocardiogram) were not observed. Inclusion in an NLM database does not imply endorsement of, or agreement with, At these doses, oral selegiline significantly inhibits MAO-A and MAO-B in the peripheral and central tissues. Kessler RC, Berglund P, Demler O, et al. Consult your doctor or dietician for more details and a complete list of other tyramine-containing foods you should limit or avoid. Da Prada M, Zurcher G, Wuthrich I, et al. In both short- and long-term clinical studies, a lack of significant weight gain and sexual dysfunction was observed with STS treatment. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Dizziness, abdominal pain, dry mouth, nausea, stomach upset, trouble sleeping, and headache may occur. See also Side Effects section. A review of the recent literature revealed no documented reports of clinically significant hypertensive events or fatalities occurring when the stimulant was cautiously added to a MAOI (Feinberg 2004). Make sure laboratory personnel and all your doctors know you use this drug. Furthermore, the dietary restrictions are advised for at least 2 weeks after either dose reduction (eg, from 9 mg or 12 mg/24 hours to 6 mg/24 hours) or discontinuation of the 9 mg or 12 mg/24 hour patches. Limit foods high in tryptophan at one meal. Cheeses made from pasteurized milk contain very low amounts of tyramine (less than 50 mg/kg) (Da Prada et al 1988) and a whole pizza with a double-cheese topping has been reported to contain less than 1 mg tyramine (Shulman and Walker 1999). Concomitant administration of amantadine and anticholinergic drugs can lead to an increased occurrence of side-effects. Tyramine kinetics and pressor sensitivity during monoamine oxidase inhibition by selegiline. privacy practices. Hypertensive interactions between monoamine oxidase inhibitors and foodstuffs. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. The dosage is based on your medical condition and response to treatment. Check with your doctor right away if you have anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there. Given the unique pharmacokinetic profile of STS (in which transdermally administered selegiline bypasses the gut and liver), studies specifically investigating drug interactions with STS are warranted. Major Moderate Minor Unknown Abilify (aripiprazole) Adderall (amphetamine / dextroamphetamine) Ambien (zolpidem) Aspirin Low Strength (aspirin) Ativan (lorazepam) Azilect (rasagiline) Benadryl (diphenhydramine) CoQ10 (ubiquinone) Take this medication by mouth as directed by your doctor, usually twice daily with breakfast and lunch. Transdermal selegiline may potentially play a role in conditions other than MDD. WebMD does not provide medical advice, diagnosis or treatment. beneficial effects of adjunctive selegiline is unknown. Following a crossover design with a washout period of 3 months between active treatments, the pressor effects of tyramine following treatment with STS was compared with that obtained with oral selegiline (10 mg/day). This drug may make you dizzy or drowsy. Drug interactions may change how your medications work or increase your risk for serious side effects. The transdermal patches are composed of three layers (backing, adhesive containing the drug, and the release liner) and contain 1 mg of selegiline per cm2 (Somerset Pharmaceuticals 2006). However, at high oral dosages of selegiline, the specificity for MAO-B is lost and non-selective inhibition of MAO (ie, MAO-A and MAO-B) confers antidepressant effects with the attendant risk of a tyramine-provoked event. Schulz R, Antonin KH, Hoffmann E, et al. Healthy male subjects were challenged with encapsulated tyramine HCl under various conditions (Table 1) (Azzaro et al 2006). Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. The American Psychiatric Association recommends that MAOIs may be beneficial in patients with atypical depression and patients who have failed trials with other antidepressants (APA 2000). MAOIs may also be advantageous for treatment of depression in the elderly (Georgotas et al 1986), panic disorder (Liebowitz et al 1990), and phobias (Liebowitz et al 1992). Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (such as stroke), heart problems (such as congestive heart failure, heart attack), bleeding problems, history of severe/frequent headaches, peptic ulcer, diabetes, personal/family history of mental/mood disorders (such as schizophrenia, bipolar disorder), personal/family history of high blood pressure, liver disease, overactive thyroid (hyperthyroidism). EMSAM is available in 3 doses, 6 mg/24 hours (20 mg/20 cm2), 9 mg/24 hours (30 mg/30 cm2), and 12 mg/24 hours (40 mg/40 cm2). Before The selegiline transdermal system is the only MAOI available in the US for the treatment of MDD that does not require dietary restriction at the clinically effective dose of 6 mg/24 hours. Do not double the dose to catch up. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. An update. Daily transdermal administration of selegiline to guinea-pigs preferentially inhibits monoamine oxidase activity in brain when compared with intestinal and hepatic tissues. Federal government websites often end in .gov or .mil. Only one of the four studies assessed dosages exceeding 6 mg/24 hours; therefore, it is uncertain whether higher doses correspond to better efficacy. At dosages of 612 mg/24 hours, EMSAM has been shown to improve symptoms of depression, have good tolerability, and have high rates of medication adherence. Transdermal selegiline may also be potentially advantageous in patients who are not able to tolerate oral medications due to systemic side effects or who prefer a transdermal dosage formulation. These may be symptoms of a serious side effect that should have a doctor's attention. Selegiline may cause dryness of the mouth. [online] URL: Amsterdam JD. Many people using this medication do not have serious side effects. The plasma concentrations of selegiline were increased approximately two-fold in patients who received carbamazepine 400 mg/day for 14 days. Cooper AJ. If you take too much selegiline, you may experience a sudden and dangerous increase in your blood pressure. On tyramine, food, beverages and the reversible MAO inhibitor moclobemide. A double-blind, placebo-controlled trial of the safety and efficacy of selegiline transdermal system without dietary restrictions in patients with major depressive disorder. In a second multi-center, 8 week study, 289 adult patients with moderate to severe MDD were randomized in a double-blind fashion to either selegiline transdermal system 20 mg/20 cm2 (6 mg/24 hours) or placebo (Amsterdam 2003). Selegiline is an irreversible inhibitor of MAO enzymes. It should also be noted that 56% of patients who were randomized were prematurely discontinued from the study for reasons other than meeting relapse criteria. However, in the early 1960s, published case reports described an acute hypertensive reaction (tyramine-provoked event), sometimes fatal, between MAOIs and foods containing tyramine (Blackwell 1963; Blackwell and Mabbitt 1965; Blackwell et al 1967). Before taking selegiline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Taavitsainen P, Anttila M, Nyman L, et al. It also may be given with levodopa upon onset of disability. other information we have about you. Clinical pharmacology of monoamine oxidase inhibitors. At baseline and on the final day, subjects ingested aged cheeses for breakfast (equivalent to approximately 100 mg tyramine content) and for dinner (equivalent to approximately 320 mg tyramine content). the contents by NLM or the National Institutes of Health. See also Precautions section. Each isoenzyme demonstrates distinct substrate specificity, inhibitor selectivity, and a unique tissue distribution. APA. If it is near the time of the next dose, skip the missed dose. Of note, 4 of the 16 (25%) enrolled subjects were unable to consume the protocol defined amount of cheese during baseline testing. National Library of Medicine In addition, there is interest in studying the effects of STS in the treatment of cocaine abuse (Houtsmuller et al 2004) and nicotine dependence (ClinicalTrials 2007). Selegiline-treated patients exhibited a significantly improved sexual function compared with placebo-treated patients (F = 4.78, df = 1, 145, p = 0.03). Selegiline is not highly protein bound (89%) and transdermally delivered selegiline has 75% bioavailability (Somerset Pharmaceuticals 2006) compared with approximately 10% for the oral conventional formulation (Mahmood 1997). It may slow progression of the clinical disease and delay the requirement for levodopa therapy. While analysis of all antidepressant trials in pediatric patients found that the risk of suicidal behaviors was approximately twice as high in those who received an antidepressant versus those who received placebo (Simon 2006), others argue that the benefits of antidepressants outweigh the risk of suicide or suicide attempt (Bridge et al 2007). It is unknown whether selegiline is excreted in breast milk in humans. You may report side effects to Health Canada at 1-866-234-2345. Oral versus transdermal selegiline: antidepressant-like activity in rats. Follow your doctor's instructions carefully. Handbook of neurochemistry Enzymes in the nervous system. Do not share this medication with others. Do not store in the bathroom. In a small double-blind, randomized, crossover study with placebo, treatment-resistant elderly patients who received oral selegiline 60 mg/day for 3 weeks had significant improvements in the Hamilton Depression Rating Scale 17-item (HAM-D-17) score (15.4 9.2 vs 24.6 6.4, p < 0.01), the Global Depression score (5.8 2.7 vs 7.5 2.3, p = 0.05), and the Brief Psychiatric Rating Scale (p = 0.01 for 18- and 28-item scores) (Sunderland et al 1994). Transdermal selegiline in major depression: a double-blind, placebo-controlled, parallel-group study in out-patients. CYP2B6 and CYP2C19 as the major enzymes responsible for the metabolism of selegiline, a drug used in the treatment of Parkinsons disease, as revealed from experiments with recombinant enzymes. Minimally clinically significant. The discontinuation rate due to adverse effects was low, 6.7% and 5.3% in the selegiline and placebo groups, respectively, and application site reaction was the only adverse event that differed significantly between the two groups (31.5% for selegiline vs 15.1% for placebo, p = 0.001). Furthermore, 48% of patients received 12 mg/24 hours of selegiline versus 63% of patients in the placebo group. Goodman and Gilmans The Pharmacological basis of therapeutics. This medicine is a white, round, tablet imprinted with "logo" and "3438". Tyramine pressor responses were assessed in fasted and fed states. Treatment should be initiated at the lowest dose of 6 mg/24 hours (Somerset Pharmaceuticals 2006). Mann JJ, Aarons SF, Wilner PJ, et al. Cardiovascular response was monitored after the meals and no clinically significant changes in vital signs (eg, SBP) were observed. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. The patch should be applied approximately at the same time every day and dosage adjustment is not required in patients with moderate liver impairment (Child-Pugh classifications of A or B) although there is no data regarding severe liver impairment. In individuals treated with conventional oral MAOIs, ingestion of small amounts of tyramine (eg, 8 mg) can result in the cheese reaction. Transdermal selegiline in HIV-associated cognitive impairment: pilot, placebo-controlled study. Do not take other medicines unless they have been discussed with your doctor. Delivery of selegiline transdermally (EMSAM) bypasses hepatic first pass metabolism, thereby avoiding significant inhibition of gastrointestinal and hepatic MAO-A activity (ie, reduced risk of tyramine-provoked events) while still providing sufficient levels of selegiline in the brain to produce an antidepressant effect. Patients and clinicians should monitor for signs of suicidality, worsening of symptoms, and/or changes in behavior, especially at the initiation of treatment and during dosage changes. It should be noted that while patients should replace the patch daily, they may still derive therapeutic benefit if the patch is left on the skin for more than 24 hours. Talk to your pharmacist for more details. Do not take more or less of it or take it more often than prescribed by your doctor. Most of the restrictions for STS, however, are extrapolated from known experience with or theoretical concerns about drug interaction sequelae involving other MAOIs . There are 3 alcohol/food interactions with selegiline. Take selegiline exactly as directed. A selective monoamine oxidase inhibitor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Monoamine oxidases are ubiquitous enzymes that exist in mammalian tissues in two genetically distinct forms, referred to as MAO-A and MAO-B (Youdim and Finberg 1983). You may need to stop taking this drug beforehand. Store at room temperature away from light and moisture. Correspondence: Kelly C Lee, UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences, 9500 Gilman, Drive, La Jolla, CA 92093-0714, USA, Tel +1 858 822 3462, Fax +1 858 822 6857, Email. Following a crossover design with a washout period of 8 weeks between active treatments, the pressor effects of tyramine following treatment with STS was compared with that obtained with tranylcypromine. Check with your doctor right away if you have pain when swallowing, pain in the mouth, redness, swelling, or sores in your mouth while receiving this medicine. MAO-A is primarily responsible for degrading serotonin and norepinephrine, as well as exogenous monoamines such as tyramine. Realistically, it is not reasonably possible to consume sufficient amounts of tyramine in the form of cheeses to induce a clinically significant tyramine response in STS-treated patients. The most recent study was a fixed-dose relapse prevention study of 322 patients that lasted 1 year (Amsterdam and Bodkin 2006). Monoamine oxidase inhibitors (MAOIs) have experienced cyclical popularity. Adherence was high in both the selegiline and placebo groups (84.2% and 89.6% respectively) and discontinuation rates due to adverse event were higher for the STS group (13.2% vs 6.1%, respectively). Review/update the A placebo-controlled comparison. Avoid combinations; the risk of the interaction outweighs the benefit. One individual taking selegiline together with ephedrine experienced a serious side effect known as hypertensive crisis, in which blood pressure can reach dangerous levels. In a third study enrolling 265 patients with MDD, patients were randomized, in a double-blind manner, to STS or placebo (Feiger et al 2006). Selegiline is used in combination with levodopa or levodopa and carbidopa combination to treat Parkinson's disease (sometimes called "shaking palsy" or "paralysis agitans"). A controlled study of the antidepressant efficacy and side effects of ()-deprenyl. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Conversely, if EMSAM is discontinued, at least 2 weeks should elapse before initiating therapy with a drug that is contraindicated. Adderall (amphetamine / dextroamphetamine), Fish Oil (omega-3 polyunsaturated fatty acids), Email this report to a friend, doctor, or patient, Drug class: dopaminergic antiparkinsonism agents. Kamada T, Chow T, Hiroi T, et al. Taylor JJ, Wilson JW, Estes LL. Patients were also limited to use of concomitant medications that may interact with selegiline, although sleep agents such as chloral hydrate, zolpidem, and antihistamines were allowed. Interpretation of the actual risk of suicidality in children and adolescents seen in studies is complex and has resulted in controversy over the decision to treat or not to treat this population. Identification, excretion, and stereochemistry of urine metabolites. In these cases, your doctor may want to change the dose, or other . Discuss the risks and benefits with your doctor. Selected from data included with permission and copyrighted by First Databank, Inc. Home CBD-Drug Interactions Taking Cannabidiol With Other Medications: CBD-Drug Interaction Checker We cover over 25 separate classes of drugs and the most common interactions to be aware of before using CBD. gov. Low levels of this chemical are associated with Parkinson's disease. Geriatric . Bodkin JA, Amsterdam JD. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, dextromethorphan, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine, TCAs such as amitriptyline/doxepin), certain opioid medications (such as meperidine, methadone, pentazocine, propoxyphene, tramadol, tapentadol), among others. Continuity of antidepressant treatment for adults with depression in the United States. Saura Marti J, Kettler R, Da Prada M, et al. To prevent a very serious high blood pressure reaction, it is very important that you follow a special diet recommended by your doctor or dietician in order to limit your intake of tyramine while you are taking this medicine. One individual taking selegiline together with ephedrine experienced a serious side effect known as hypertensive crisis, in which blood pressure can reach dangerous levels. In the US, the selegiline transdermal system (STS; EMSAM) is the first antidepressant transdermal delivery system to receive Food and Drug Administration (FDA) approved labeling for the treatment of major depressive disorder (MDD). FOIA In an open-label study, 16 healthy adult male subjects were enrolled to receive STS 6 mg/24 hours for 13 days (Blob et al 2007). Selegiline transdermal system for the treatment of major depressive disorder: an 8-week, double-blind, placebo-controlled, flexible-dose titration trial. However, because selectivity for MAO-B is lost (at doses exceeding 20 mg/day), the attendant risk of developing a tyramine-provoked event is increased (Schulz et al 1989). [13] Consult your pharmacist or local waste disposal company. The efficacy of the MAOI class in treatment-resistant patients and patients with atypical depression may provide a rationale for the use of selegiline transdermal system given its favorable tolerability profile and recent data supporting improved dietary and drug interaction safety. Overall, 80% and 74% of patients in the STS and the placebo groups had an adverse event and the most frequent event observed was application-site reaction (40% and 20%, respectively). Avoid high tyramine . Over 40 years later, the MAOI-tyramine interaction is one of the most publicized drug interactions in the medical literature. A study was performed to assess for differences in tyramine pressor dose between STS 6 mg/24 hours and oral tranylcypromine sulfate 30 mg/day (Azzaro et al 2006). The STS appeared to be well-tolerated at the higher doses since approximately half of the patients received the higher doses of 9 and 12 mg/24 hours. In vitro experiments have identified CYP2B6-, CYP2C9-, and CYP3A isoenzymes as having a significant role in the metabolism of selegiline. Derived from Somerset Pharmaceuticals (2006), Taylor et al (2006). During pregnancy, selegiline should be used only when clearly needed. selegiline, deutetrabenazine. Azzaro AJ, Ziemniak J, Kemper E, et al. If you do, you may develop agitation, confusion, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe seizures. The overall reaction involves oxidative deamination and can be characterized as: RCH2NH2 + H2O + O2 RCHO + NH3 + H2O2. Non-selective inhibition of monoamine oxidase (MAO) enzymes (ie, isoforms A and B) in the brain are associated with clinically significant antidepressant effects. selegiline + methylene blue injection contraindicated w/in 14 days of selegiline use; hold selegiline if emergency use; monitor BP, serotonin syndrome sx up to 4h after last methylene blue dose; may resume selegiline 72h after last methylene blue dose: combo may incr. However, it should be noted that the tyramine challenge studies enrolled male subjects, and sex-based differences in tyramine response have been observed, with females tending to show greater pressor sensitivity than males (Reimann et al 1992). All patients followed a low-tyramine diet and the incidence of adverse events, including cardiovascular effects, did not differ between the selegiline and placebo groups. When co-administered with food, the risk of tyramine-provoked events appears to be minimal even at 12 mg/24 hours. Goldberg LI. If the problem continues or gets worse, check with your doctor. [Accessed June 26, 2007]. This medicine may make you drowsy. Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Consult your doctor before breast-feeding. Get medical help right away if you notice symptoms of very high blood pressure such as unusually fast/slow heartbeat, vomiting, unexplained sweating, headache, chest pain, sudden vision changes, weakness on one side of the body, trouble speaking. No effects are caused by butter or milkIf cheese is indeed the factor, it could perhaps explain the sporadic nature of incidence of the side-effect. (Blackwell et al 1967). Talk with your doctor if the medication stops working well or if your condition worsens. This survey is being conducted by the WebMD marketing sciences department. Selegiline is used together with other medicines to treat symptoms of Parkinson's disease. In EMSAM-treated patients, application site reactions occurred in 24% compared with 12% in those receiving placebo. Monoamine oxidase. Do not stop or change the dose of any of your medications without first talking with your doctor. Hoffman BB, Lefkowitz RJ. Tell your doctor right away if you have any serious side effects, including: fainting, loss of balance, mental/mood changes (such as agitation, confusion, depression, hallucinations), unusual strong urges (such as increased gambling, increased sexual urges), worsening muscle stiffness/twitching, changes in sexual ability/interest, increased shaking (tremor), swollen ankles/legs, difficulty urinating, unusual weight gain, easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds. Gordon MN, Muller CO, Sherman KA, et al. In one group of 12 subjects treated with STS 6 mg/24 hours for 9 days and then 33 days (with a 3 month washout between treatments), the mean tyramine pressor doses (ie, dose of tyramine HCl required to achieve a sustained increase above baseline in systolic blood pressure (SBP) of 30 mmHg for 3 consecutive readings), in the absence of food, at 9 and 33 days were 292 mg and 204 mg, respectively (p < 0.05). These reductions on all three scales were observed as early as week 1. Interest in the use of MAOIs for MDD has re-emerged in part by results from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial (McGrath et al 2006). There is a problem with It may even cause you to fall asleep without warning while you drive, talk, or eat. Evans RW, Bigal ME, Grosberg B, et al. This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Sacktor N, Schifitto G, McDermott MP, et al. This medication is used to treat movement disorders caused by Parkinson's disease. However, this potentially severe side effect could have been largely avoided by the implementation of simple dietary precautions. Within- and between subject variances and sex differences. In STS 12 mg/24 hours-treated subjects, the presence of food significantly increased, by approximately 3-fold, the mean tyramine dose required to elicit a clinically significant pressor response (Table 1). Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Some mixtures of medications can lead to serious and even fatal consequences. The site is secure. Walker SE, Shulman KI, Tailor SA, Gardner D. Tyramine content of previously restricted foods in monoamine oxidase inhibitor diets. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses, fava or broad bean pods, yeast or meat extracts, smoked or pickled meat, poultry, or fish, fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat, sauerkraut, or any overripe fruit. Experimental studies have demonstrated that the antidepressant-like effect of selegiline requires greater than 70% inhibition of MAO-A activity (Gordon et al 1999). Treatment of tricyclic refractory depression with a monoamine oxidase inhibitor antidepressant. Selegiline transdermal system (STS) was designed to treat MDD and overcome the dietary safety concerns that exist with the conventional oral MAOIs. Interactions What is selegiline? The STS may also play a role in the treatment of atypical depression, treatment resistant MDD, and anxiety disorders. This content does not have an Arabic version. Do not stop taking this medicine without first checking with your doctor. Derived from Tables II, III and IV from Azzaro et al (2006). Feinberg SS. 2, 13 Betahistine is a histamine-like antivertigo drug used for treating symptoms associated with Mnire's disease. Enhancing adherence to prevent depression relapse in primary care. Elderly patients were more likely to experience orthostatic hypotension. The patch should be applied to dry, intact skin on the upper torso (below the neck and above the waist), upper thigh, or the outer surface of the upper arm once every 24 hours. Usually avoid combinations; use it only under special circumstances. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 7 days after the last dose. Keep all medications away from children and pets. Patients who received STS had significant improvement in the primary efficacy measure, HAM-D-28, compared with patients who received placebo (p = 0.03) at weeks 5 and 8. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. information submitted for this request. In placebo-controlled trials, 7.1% of patients discontinued EMSAM treatment versus 3.6% of patients receiving placebo; application site reaction was the only adverse event contributing to discontinuation of treatment. A study was performed to assess for differences in tyramine pressor dose between STS and conventional oral selegiline treatment. Barrett JS, Hochadel TJ, Morales RJ, et al. This was a major factor in the subsequent general disuse of the irreversible MAOIs. Copyright: Merative US L.P. 1973, 2023. There are no well-controlled studies in pregnant women with EMSAM (Pregnancy Category C). 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