Rasagiline

The recommended dose of rasagiline is 1 mg once daily when used alone (monotherapy). When combined with levodopa the recommended starting dose is 0.5 mg once daily. The dose may be increased to 1 mg once daily if the response is not adequate. Patients with mild liver disease should not use more than 0.5 mg daily. It should not be used by patients with moderate or severe liver disease. Tyramine rich food, beverages and supplements should be avoided while taking rasagiline.

Tablets: 0.5 and 1 mg.

Tablets should be stored at 15 C - 30 C (59 F - 86 F).

• Questions About Parkinson's Disease
• Does Parkinson's Make You More Likely to Have a UTI?
• Top Cause of Hearing Loss

• 13 Best Quit-Smoking Tips Ever
• What Stress Does to Your Mouth
• Healthy Home: To Buy or Not to Buy Organic?

• Frequent Constipation?
• Greater Food Accessibility

Certain medicines should not be taken together with rasagiline. Before you take this medication, tell your doctor about all other medications you are using, especially muscle relaxers, narcotic pain medicine, over-the-counter cough medicine, or St. John's wort.

Do not use rasagiline if you have taken another MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use rasagiline before the other MAO inhibitor has cleared from your body.

Before you take rasagiline, tell your doctor if you have liver disease.

There are many other drugs that can cause serious medical problems if you take them together with rasagiline. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

While you are taking rasagiline and for 2 weeks after you stop taking it, you may not be able to eat certain types of cheese. Follow your doctor's instructions.

Rasagiline may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Rasagiline may be found in some form under the following brand names:

• Azilect

Serious side effects have occurred with rasagiline when taken with antidepressant medicines. Tell your doctor if you are taking an antidepressant.

You should not take rasagiline if you have moderate to severe liver disease.

You should not take more than 1 mg of rasagiline per day. When taken in amounts greater than 1 mg per day, rasagiline may cause a serious and possibly dangerous increase in blood pressure called hypertensive crisis.

Talk to your doctor about monitoring for skin cancer (melanoma) on a regular basis. People taking rasagiline may have a higher risk of melanoma.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, dizziness, severe headache, hallucinations, feeling agitated or irritable, fast and uneven heart rate, muscle spasms, sweating, cold or clammy skin, shallow breathing, fainting, or seizure (convulsions).

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• arm, back, or jaw pain
• black, tarry stools
• chest pain or discomfort
• chest tightness or heaviness
• chills
• cloudy urine
• cough
• diarrhea
• difficulty swallowing
• dizziness
• fainting
• fast or irregular heartbeat
• fever
• hives, itching, or skin rash
• loss of appetite
• nausea
• painful or difficult urination
• persistent, non-healing sore
• pink growth on the skin
• puffiness or swelling of the eyelids or around the eyes
• reddish patch or irritated area
• redness, blistering, peeling, or loosening of the skin
• seeing, hearing, or feeling things that are not there
• shiny bump
• sore throat
• sores, ulcers, or white spots on lips or in mouth
• sweating
• swollen glands
• tests that show problems with the liver
• tightness in the chest
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness
• white, yellow or waxy scar-like area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• difficulty with moving
• headache
• heartburn
• indigestion
• muscle pain or stiffness
• pain in the joints
• stomach discomfort or upset

• Bruising
• burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feelings
• burning, dry, or itching eyes
• decreased interest in sexual intercourse
• difficulty breathing
• difficulty with moving
• discouragement
• excessive tearing
• eye discharge
• fall
• feeling of constant movement of self or surroundings
• feeling sad or empty
• general feeling of discomfort or illness
• hair loss
• inability to have or keep an erection
• irritability
• joint pain
• lack of appetite
• large, flat, blue or purplish patches in the skin
• lightheadedness
• loss in sexual ability, desire, drive, or performance
• loss of interest or pleasure
• muscle aches
• neck pain
• noisy breathing
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• sensation of spinning
• shivering
• sneezing
• stuffy nose
• swelling or redness in the joints
• thinning of the hair
• tiredness
• trouble concentrating
• trouble sleeping
• vomiting
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg of Rasagiline tablets 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 tablets 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. Delays of up to 12 hours after ingestion of drug and the appearance of signs may occur. The peak intensity of the syndrome may not be reached until for a day following the overdose. Death has been reported following overdose; therefore, immediate hospitalization, with continuous patient observation and monitoring for at least two days following the ingestion of such drugs in overdose, is strongly recommended.

The severity of the clinical signs and symptoms of MAOI overdose varies and may be related to the amount of drug consumed. The central nervous and cardiovascular systems are prominently involved.

Signs and symptoms of MAOI overdose may include: 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 tablets overdose. The following suggestions are offered based upon the assumption that Rasagiline tablets overdose may be modeled after nonselective MAO inhibitor poisoning. Treatment of overdose with nonselective 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 Rasagiline tablets, dietary tyramine restriction should be observed for several weeks to reduce the risk of hypertensive tyramine reaction.

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

A postmarketing report described a single patient who developed a nonfatal serotonin syndrome after ingesting 100 mg of Rasagiline tablets in a suicide attempt. Another patient who was treated in error with 4 mg Rasagiline tablets daily and tramadol also developed a serotonin syndrome. One patient who was treated in error with 3 mg Rasagiline tablets daily experienced alternating episodes of vascular fluctuations consisting of hypertension and orthostatic hypotension.

Administer without regard to meals.

May be taken without regard to meals. Avoid products containing high amounts of tyramine (>150 mg), such as aged cheeses (eg, Stilton cheese). Restriction of tyramine-containing products with lower amounts (<150 mg) of tyramine is not necessary in patients taking recommended doses. Some examples of tyramine-containing products include aged or matured cheese, air-dried or cured meats (including sausages and salamis), fava or broad bean pods, tap/draft beers, Marmite concentrate, sauerkraut, soy sauce and other soybean condiments. Food’s freshness is also an important concern; improperly stored or spoiled food can create an environment where tyramine concentrations may increase.

Monotherapy:
Recommended dose: 1 mg orally once a day

Adjunct therapy:
Initial dose (in patients on concomitant levodopa): 0.5 mg orally once a day
Initial dose (in patients not on concomitant levodopa): 1 mg orally once a day
Maintenance dose: 0.5 mg to 1 mg orally once a day

Maximum dose: 1 mg orally once a day

Comments: May be used as adjunct therapy in patients on levodopa therapy, with or without other drugs used in the treatment of Parkinson's disease.