Monday 7 July 2014

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AFRELECT (rasagiline tablets) is a medication used for treatment of many symptoms of Parkinson's disease. Because Afrelect helps prevent dopamine in your brain, it can help you move freely so everyday activites may become less difficult. Afrelect is a once-daily medication that can be taken alone in early Parkinson's disease or with other Parkinson's medications as the disease progresses.


 KEY POINTS:
  • Rasagiline, like selegiline, is an irreversible monoamine oxidase type B (MAO-B) inhibitor
    It inhibits the breakdown of dopamine in the brain and can be used as monotherapy or as an adjunct to levodopa.
  • Rasagiline (1 mg) is taken once a day
    Rasagiline can be taken at any time of day. Increasing the dose does not increase the therapeutic effect but does increase the risk of adverse events.
  • Adjunctive therapy may increase levodopa-associated adverse events such as dyskinesia
    Incidence of hallucination and hypersomnolence was similar to that for placebo or levodopa alone in trials. Impulse control disorders were not observed in trials.
  • There are no direct comparisons with dopamine agonists or selegiline; efficacy as adjunctive therapy may be similar to that of entacapone
    Indirect comparisons as adjunctive therapy suggest less efficacy than dopamine agonists.
  • There is a risk of hypertensive crisis or serotonin toxicity if rasagiline is used concomitantly with certain medications
    Use with other MAO inhibitors, dextromethorphan and certain opioid analgesics is contraindicated. Obtain specialist advice before combining with antidepressants.
  • Rasagiline is contraindicated in people with liver impairment
    Rasagiline is metabolised in the liver by the enzyme CYP1A2. Potent inhibitors of CYP1A2 (e.g. ciprofloxacin, cimetidine or fluvoxamine) are contraindicated.



 IMPORTANT SAFETY INFORMATION ABOUT AFRELECT
  • Do not take AFRELECT if you are taking meperidine as it could result in a serious reaction such as coma or death. Also, do not take AFRELECT with tramadol, methadone, propoxyphene, dextromethorphan, St. John's wort, or cyclobenzaprine.
  • You also should not take AFRELECT with other monoamine oxidase inhibitors (MAOIs).
  • Inform your physician if you are taking, or planning to take, any prescription or over-the-counter drugs, especially antidepressants and ciprofloxacin.
  • If you have moderate to severe liver disease, you should not take AFRELECT.
  • You should not exceed a dose of 1 mg per day of AFRELECT in order to prevent a possibly dangerous increase in blood pressure. All PD patients should be monitored for melanoma (skin cancer) on a regular basis.
  • Side effects seen with AFRELECT alone are flu syndrome, joint pain, depression, and indigestion.
  • Side effects seen with AFRELECT when taken with levodopa are uncontrolled movements (dyskinesia), accidental injury, weight loss, low blood pressure when standing, vomiting, anorexia, joint pain, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, and fall.

HOW TO USE AFRELECT (RASAGILINE TABLETS)?
Use Afrelect (rasagiline tablets) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
  • Take rasagiline by mouth with or without food.
  • Do not suddenly stop taking rasagiline without checking with your doctor. You may experience side effects such as fever or confusion.
  • If you miss a dose of rasagiline, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use rasagiline.

POSSIBLE SIDE EFFECTS OF AFRELECT (RASIGILINE TABLETS)
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation, diarrhea; drowsiness; dry mouth; flu-like symptoms; headache; joint pain; loss of appetite, mild stomach pain; stomach upset; stuffy nose; weight loss.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; blood in the urine; blurred vision or other vision changes; burning, numbness, or tingling; changes in sexual ability or desire; chest pain; confusion; decreased coordination; enlarged pupils; eye pain or inflammation; fainting; fast or irregular heartbeat; fever; hallucinations; inability to sit still; mental or mood changes (eg, agitation, depression, paranoia); one-sided weakness; seizures; sensitivity to light; severe or persistent headache, dizziness, or light-headedness; severe or persistent stomach pain or diarrhea; shortness of breath; skin changes; sore or stiff neck; speech problems; stiff muscles; tremor; trouble thinking or walking; unexplained nausea or vomiting; unusual sweating.

AFRELECT (RASAGILINE TABLETS) DOSAGE INFORMATION:
Usual Adult Dose for Parkinson's Disease:
Monotherapy: 1 mg orally once daily

Adjunctive therapy (in combination with levodopa): 0.5 mg orally once daily. If a sufficient clinical response is not achieved, the dose may be increased to 1 mg orally daily.

OTHER DRUGS THAT MAY AFFECT AFRELECT (RASAGILINE TABLETS):
Tell your doctor about all other medicines you have used within the past 14 days, especially:
  • Ciprofloxacin ;
  • Over-the-counter cough, cold, or allergy medicines; or
  • An antidepressant such as amitriptyline, citalopram, doxepin, desipramine, duloxetine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, sertraline, venlafaxine, and others.