"Jan. 1, 2013 -- Antidepressant use during pregnancy, long debated for its safety, is linked with a higher overall risk of stillbirth and newborn death. Now, a new study shows that risk may not be warranted.
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There are no specific antidotes for EMSAM (selegiline transdermal system) .If symptoms of overdosage occur,immediately remove the EMSAM (selegiline transdermal system) system and institute appropriate supportive therapy. For contemporary consultation on the management of poisoning or overdosage,contact the National Poison Control Center at 1-800-222-1222.
EMSAM (selegiline transdermal system) is considered to be an irreversible MAOI at therapeutic doses and,in overdosage,is likely to cause excessive MAO-A inhibition,and may result in the signs and symptoms resembling overdosage with other non-selective,oral MAOI antidepressants (e.g.,tranylcypromine [Parnate®],phenelzine [Nardil®],or isocarboxazide [Marplan®]).
Overdosage with Non-Selective MAO Inhibition
NOTE: The following is provided for reference only; it does not describe events that have actually been observed with selegiline in overdosage. No information regarding overdose by ingestion of EMSAM (selegiline transdermal system) is available.
Typical signs and symptoms associated with overdosage of non-selective MAOI antidepressants may not appear immediately. Delays of up to 12 hours between ingestion of drug and the appearance of signs may occur, and peak effects may not be observed for 24-48 hours. Since death has been reported following overdosage with MAOI agents, hospitalization with close monitoring during this period is essential.
Overdosage with MAOI agents is typically associated with CNS and cardiovascular toxicity.Signs and symptoms of overdosage may include, alone or in combination, any of the following: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonos, convulsions, coma, rapid and irregular pulse, hypertension, hypotension and vascular collapse,precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis, and cool, clammy skin. Type and intensity of symptoms may be related to extent of the overdosage.
Treatment should include supportive measures,with pharmacological intervention as appropriate.Symptoms may persist after drug washout because of the irreversible inhibitory effects of these agents on systemic MAO activity. With overdosage, in order to avoid the occurrence of hypertensive crisis ("cheese reaction"), dietary tyramine should be restricted for several weeks beyond recovery to permit regeneration of the peripheral MAO-A isoenzyme.
EMSAM (selegiline transdermal system) is contraindicated in patients with known hypersensitivity to selegiline or to any component of the transdermal system.
EMSAM (selegiline transdermal system) is contraindicated with selective serotonin reuptake inhibitors (SSRIs,e.g.,fluoxetine,sertraline,and paroxetine); dual serotonin and norepinephrine reuptake inhibitors (SNRIs, e.g., venlafaxine and duloxetine); tricyclic antidepressants (TCAs, e.g., imipramine and amitriptyline); bupropion hydrochloride; meperidine and analgesic agents such as tramadol, methadone, and propoxyphene; the antitussive agent dextromethorphan; St.John's wort; mirtazapine; and cyclobenzaprine. EMSAM (selegiline transdermal system) should not be used with oral selegiline or other MAO inhibitors (MAOIs e.g.,isocarboxazid,phenelzine,and tranylcypromine) (see WARNINGS).
Carbamazepine and oxcarbazepine are contraindicated in patients taking selegiline (see PRECAUTIONS: DRUG INTERACTIONS).
As with other MAOIs, EMSAM (selegiline transdermal system) is contraindicated for use with sympathomimetic amines, including amphetamines as well as cold products and weight-reducing preparations that contain vasoconstrictors (e.g.,pseudoephedrine ,phenylephrine, phenylpropanolamine, and ephedrine).
As with other MAOIs,patients taking EMSAM (selegiline transdermal system) should not undergo elective surgery requiring general anesthesia. Also, they should not be given cocaine or local anesthesia containing sympathomimetic vasoconstrictors. EMSAM (selegiline transdermal system) should be discontinued at least 10 days prior to elective surgery. If surgery is necessary sooner, benzodiazepines,mivacurium, rapacuronium, fentanyl,morphine, and codeine may be used cautiously.
As with other MAOIs, EMSAM (selegiline transdermal system) is contraindicated for use in patients with pheochromocytoma.
EMSAM (selegiline transdermal system) is an irreversible MAO inhibitor. As a class, these compounds have been associated with hypertensive crises caused by the ingestion of foods containing high amounts of tyramine. In its entirety, the data for EMSAM (selegiline transdermal system) 6 mg/24 hours support the recommendation that a modified diet is not required at this dose. Due to the more limited data available for EMSAM (selegiline transdermal system) 9 mg/24 hours and 12 mg/24 hours,patients receiving these doses should follow Dietary Modifications Required for Patients Taking EMSAM 9 mg/24 hours and 12 mg/24 hours.(See WARNINGS and PRECAUTIONS: DRUG INTERACTIONS, Tyramine.)This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/2/2008
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