Rasagiline

Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD). Rasagiline Tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson's disease ( 1 )

• Monotherapy: Rasagiline Tablets 1 mg once daily As adjunct without levodopa: Rasagiline Tablets 1 mg once daily As adjunct to levodopa: Rasagiline Tablets 0.5 mg once daily
• Increase dose to 1 mg daily as needed for sufficient clinical response Patients taking ciprofloxacin or other CYP1A2 inhibitors: Rasagiline Tablets 0.5 mg once daily Patients with mild hepatic impairment: Rasagiline Tablets 0.5 mg once daily
• Rasagiline Tablets should not be used in patients with moderate or severe hepatic impairment General Dosing Recommendations When rasagiline tablets are prescribed as monotherapy or as adjunct therapy in patients not taking levodopa, patients may start rasagiline tablets at the recommended dose of 1 mg administered orally once daily
• In patients taking levodopa, with or without other PD drugs (e.g., dopamine agonist, amantadine, anticholinergics), the recommended initial dose of rasagiline tablet is 0.5 mg once daily
• If the patient tolerates the daily 0.5 mg dose, but a sufficient clinical response is not achieved, the dose may be increased to 1 mg once daily
• When rasagiline tablets are used in combination with levodopa, a reduction of the levodopa dose may be considered, based upon individual response
• The recommended doses of rasagiline tablets should not be exceeded because of risk of hypertension [see Warnings and Precautions ]. …

Rasagiline 0.5 mg Tablets: White to off white round shaped flat faced, beveled uncoated tablets debossed with '47' on one side and plain on other side. Rasagiline 1 mg Tablets: White to off white round shaped flat faced, beveled uncoated tablets debossed with '46' on one side and plain on other side. Rasagiline 0.5 mg tablets (3) Rasagiline 1 mg tablets (3)

• Hyp erte nsion Advise patients that treatment with recommended doses of rasagiline tablets may be associated with elevations of blood pressure
• Tell patients who experience elevation of blood pressure while taking rasagiline tablets to contact their healthcare provider
• The risk of using higher than recommended daily doses of rasagiline tablets should be explained, and a brief description of the tyramine associated hypertensive reaction provided
• Advise patients to avoid certain foods (e.g., aged cheese) containing a very large amount of tyramine while taking recommended doses of rasagiline tablets because of the potential for large increases in blood pressure. …

• Rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome [See Warnings and Precautions ]
• At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications
• Rasagiline is contraindicated for use with St
• John's wort and with cyclobenzaprine. …

Meperidine: Risk of serotonin syndrome (4, 7.1) Dextromethorphan: Risk of psychosis or bizarre behavior (4, 7.2) MAO inhibitors: Risk of non-selective MAO inhibition and hypertensive crisis (4, 7.3) 7.1 Meperidine Serious, sometimes fatal reactions have been precipitated with concomitant use of meperidine (e.g., Demerol and other tradenames) and MAO inhibitors including selective MAO-B inhibitors [see Contraindications (4)] . 7.2 Dextromethorphan The concomitant use of rasagiline tablets and dextromethorphan was not allowed in clinical studies. The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior. …

May cause hypertension (including severe hypertensive syndromes) at recommended doses (5.1) May cause serotonin syndrome when used with antidepressants (5.2) May cause falling asleep during activities of daily living, daytime drowsiness, and somnolence (5.3) May cause hypotension, especially orthostatic (5.6) May cause or exacerbate dyskinesia. Decreasing the levodopa dose may lessen or eliminate this side effect (5.7) May cause hallucinations and psychotic-like behavior (5.8) May cause impulse control/compulsive behaviors (5.9) May cause withdrawal-emergent hyperpyrexia and confusion (5.10) 5.1 Hypertension Exacerbation of hypertension may occur during treatment with rasagiline tablets. …

The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: Hypertension [ see Warnings and Precautions (5.1) ] Serotonin Syndrome [ see Warnings and Precautions (5.2) ] Falling Asleep During Activities of Daily Living and Somnolence [ see Warnings and Precautions (5.3) ] Hypotension / Orthostatic Hypotension [ see Warnings and Precautions (5.6) ] Dyskinesia [ see Warnings and Precautions (5.7) ] Hallucinations / Psychotic-Like Behavior [ see Warnings and Precautions (5.8) ] Impulse Control /Compulsive Behaviors [ see Warnings and Precautions (5.9) ] Withdrawal-Emergent Hyperpyrexia and Confusion [ see Warnings and Precautions (5.10) ] M …

IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. (8.1) 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of rasagiline in pregnant women. In animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically. …

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. 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 nonselective MAO inhibitors. The signs and symptoms of nonselective MAOI overdose may not appear immediately. …

9.1 Controlled Substance Rasagiline is not a controlled substance. 9.2 Abuse Studies conducted in mice and rats did not reveal any potential for drug abuse and dependence. Clinical trials have not revealed any evidence of the potential for abuse, tolerance, or physical dependence; however, systematic studies in humans designed to evaluate these effects have not been performed. 9.3 Dependence Studies conducted in mice and rats did not reveal any potential for drug abuse and dependence. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.