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Azilect

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Azilect

Azilect

OVERDOSE

No cases of AZILECT (rasagiline) overdose were reported in clinical trials.

Rasagiline was well tolerated in a single-dose study in healthy volunteers receiving 20 mg/day and in a ten-day study in healthy volunteers receiving 10 mg/day. Adverse events were mild or moderate. In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg of rasagiline there were three reports of cardiovascular side effects (including hypertension and postural hypotension) which resolved following treatment discontinuation.

Symptoms of overdosage, although not observed with rasagiline during clinical development, may resemble those observed with non-selective MAO inhibitors (MAOIs).

Although no cases of overdose have been observed with rasagiline during the clinical development program, the following description of presenting symptoms and clinical course is based upon overdose descriptions of non-selective MAO inhibitors.

Characteristically, signs and symptoms of non-selective MAOI overdose may not appear immediately. Delays of up to 12 hours between ingestion of drug and the appearance of signs may occur. Importantly, the peak intensity of the syndrome may not be reached for upwards of a day following the overdose. Death has been reported following overdosage. Therefore, immediate hospitalization, with continuous patient observation and monitoring for a period of at least two days following the ingestion of such drugs in overdose, is strongly recommended.

The clinical picture of MAOI overdose varies considerably; its severity may be a function of the amount of drug consumed. The central nervous and cardiovascular systems are prominently involved .

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, and coma; rapid and irregular pulse, hypertension, hypotension and vascular collapse; precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis, and cool, clammy skin.

There is no specific antidote for rasagiline overdose. The following suggestions are offered based upon the assumption that rasagiline overdose may be modeled after non-selective MAO inhibitor poisoning. Treatment of overdose with non-selective MAO inhibitors is symptomatic and supportive. Respiration should be supported by appropriate measures, including management of the airway, use of supplemental oxygen, and mechanical ventilatory assistance, as required. Body temperature should be monitored closely. Intensive management of hyperpyrexia may be required. Maintenance of fluid and electrolyte balance is essential. For this reason, in cases of overdose with AZILECT (rasagiline) , dietary tyramine restriction should be observed for several weeks to avoid the risk of a hypertensive/cheese reaction.

A poison control center should be called for the most current treatment guidelines.

A post-marketing report described a single patient who developed a non-fatal serotonin syndrome after ingesting 100 mg of AZILECT (rasagiline) in a suicide attempt. Another patient who was treated in error with 4 mg AZILECT (rasagiline) daily and tramadol also developed a serotonin syndrome. One patient w ho was treated in error with 3 mg AZILECT (rasagiline) daily experienced alternating episodes of vascular fluctuations consisting of hypertension and orthostatic hypotension.

CONTRAINDICATIONS

Meperidine and Certain Other Analgesics

AZILECT (rasagiline) is contraindicated for use with meperidine. Serious adverse reactions have bee n precipitated with concomitant use of meperidine (e.g., Demerol and other trade names) and MAO inhibitors (MAOIs) including selective MAO-B inhibitors. These adverse reactions are often described as “serotonin syndrome”, a potentially serious condition, which can result in death. Typical clinical signs and symptoms include behavioral and cognitive/mental status changes (e.g., confusion, hypomania, hallucinations, agitation, delirium, headache, and coma), autonomic effects (e.g., syncope, shivering, sweating, high fever/hyperthermia, hypertension, hypotension, tachycardia, nausea, diarrhea), and somatic effects (e.g., muscular rigidity , myoclonus, muscle twitching, hyperreflexia manifested by clonus, and tremor). At least 14 days should elapse between discontinuation of AZILECT (rasagiline) and initiation of treatment with meperidine.

For similar reasons, AZILECT (rasagiline) should not be administered with the analgesic agents tramadol, methadone, and propoxyphene.

In the post-marketing period, serotonin syndrome has been reported in a patient erroneously treated with a higher than recommended dose of AZILECT (rasagiline) (4 mg daily) and tramadol.

Other Drugs

AZILECT (rasagiline) should not be used with the antitussive agent dextromethorphan. The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior. AZILECT (rasagiline) is also contraindicated for use with St. John's wort, and cyclobenzaprine (a tricyclic muscle relaxant).

MAO Inhibitors

AZILECT (rasagiline) should not be administered along with any other MAO inhibitor (selective or non-selective) because of the increased risk of non-selective MAO inhibition that may lead to a hypertensive crisis. At least 14 day s should elapse between discontinuation of AZILECT (rasagiline) and initiation of treatment with any MAO inhibitor.

Last reviewed on RxList: 12/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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