Posted 05/02/2007 FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm. |
Why is this medication prescribed? Return to top
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Selegiline is used to help control the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) in people who are taking levodopa and carbidopa combination (Sinemet). Selegiline may help people with Parkinson's disease by decreasing the dose of levodopa/carbidopa needed to control symptoms, stopping the effects of levodopa/carbidopa from wearing off between doses, and increasing the length of time that levodopa/carbidopa will continue to control symptoms. Selegiline is in a group of medications called monoamine oxidase type B (MAO-B) inhibitors. It works by increasing the amount of dopamine (a natural substance that is needed to control movement) in the brain.
How should this medicine be used? Return to top
Selegiline comes as a capsule and an orally disintegrating (dissolving) tablet to take by mouth. The capsule is usually taken twice a day with breakfast and with lunch. The orally disintegrating tablet is usually taken once a day before breakfast without food, water, or other liquids. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take selegiline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you take too much selegiline, you may experience a sudden and dangerous increase in your blood pressure.
If you are taking the orally disintegrating tablet, do not remove the blister that contains the tablets from the outer pouch until you are ready to take a dose. When it is time for your dose, remove the blister card from the outer pouch and use dry hands to peel open one blister. Do not try to push the tablet through the foil. Place the tablet on your tongue and wait for it to dissolve. Do not swallow the tablet. Do not eat or drink anything for 5 minutes before you take the tablet and for 5 minutes after you take the tablet.
If you are taking the orally disintegrating tablet, your doctor may start you on a low dose of selegiline and increase your dose after six weeks.
Tell your doctor if you experience nausea, stomach pain, or dizziness. Your doctor may decrease your dose of levodopa/carbidopa during your treatment with selegiline, especially if you experience these symptoms or other unusual symptoms. Follow these directions carefully and ask your doctor or pharmacist if you do not know how much medication you should take. Do not change the doses of any of your medications unless your doctor tells you that you should.
Selegiline may help to control the symptoms of PD, but it will not cure the condition. Do not stop taking selegiline without talking with your doctor. If you suddenly stop taking medications for Parkinson's disease such as selegiline, you may experience fever, sweating, stiff muscles, and loss of consciousness. Call your doctor if you experience these or other unusual symptoms after you stop taking selegiline.
Other uses for this medicine Return to top
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What storage conditions are needed for this medicine? Return to top
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Throw away any unused orally disintegrating tablets three months after you open the protective pouch. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose Return to top
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- drowsiness
- dizziness
- faintness
- irritability
- hyperactivity
- agitation
- severe headache
- hallucinations (seeing things or hearing voices that do not exist)
- jaw tightness
- stiffness and arching of the back
- seizures
- coma (loss of consciousness for a period of time)
- fast and irregular pulse
- chest pain
- slowed breathing
- sweating
- fever
- cold, clammy skin
What other information should I know? Return to top
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.