Carbex

Selegiline is used to help control the symptoms of Parkinson's disease, and the patch form is used to treat depression in adults. Selegiline belongs to a group of drugs called monamine oxidase (MAO) inhibitors, which affect levels of certain natural substances in the brain. These substances are involved with motor control and also mental balance.

This medication comes in tablet and capsule forms. They are taken twice daily, one dose at breakfast and the second dose at lunch.

This medication is also available as an orally disintegrating tablet. It is taken in the morning before breakfast and without liquid.

This medication additionally comes in the form of a skin patch. It is applied once a day to the upper chest or back, upper thigh, or upper arm.

Common side effects of selegiline include redness in the application area, a large and sudden increase in blood pressure (hypertensive crisis), and low blood pressure (hypotension).  Do not drive or operate machinery until you know how selegiline will affect you.

Oral:

Selegiline is used to help control the symptoms of Parkinson's disease.

Topical:

Selegiline patch form is used to treat depression in adults.

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Oral:

• Selegiline should not be used at daily doses above those recommended (10 mg/day) because of the risks associated with non-selective inhibition of MAO.
• Table/Capsulet: The recommended regimen for the administration of selegiline are 10 mg per day administered as divided doses of 5 mg each taken at breakfast and lunch.
• Orally disintegrating tablet: Treatment should be started with 1.25 mg given once a day for at least 6 weeks. After 6 weeks, the dose may be increased to 2.5 mg given once a day if a desired benefit has not been achieved.

Topical:

• Apply the selegiline patch exactly as prescribed. Follow the directions on your prescription label carefully.
• The recommended starting dose and target dose for selegiline is 6 mg/24 hours. Selegiline has been shown to be effective in a dose range of 6 mg/24 hours to 12 mg/24 hours. 

Topical:

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of selegiline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised for the need for close observation and communication with the prescriber. Selegiline is not approved for use in pediatric patients. Furthermore, selegiline at any dose should not be used in children under the age of 12, even when administered with dietary modifications.

Oral/Topical:

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

Watch for and try to prevent suicidal thoughts and actions:

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

USING ANTIDEPRESSANTS IN CHILDREN AND TEENAGERS

Selegiline at any dose should not be used in children under the age of 12 years even when administered with dietary modifications. selegiline is not approved for use in pediatric patients.

• Selegiline contains a medicine called a monoamine oxidase inhibitor, also called a MAOI. MAOI medicines, including selegiline, can cause a sudden, large increase in blood pressure (hypertensive crisis) if you eat foods and drinks that contain high amounts of tyramine. A hypertensive crisis can be a life-threatening condition. See "Selegiline Side Effects" for signs and symptoms of a hypertensive crisis.
  • You must avoid (not eat or drink) certain foods and drinks while using selegiline and for 2 weeks after stopping selegiline.
    • You do not have to make any diet changes with the selegiline 6 mg/24 hours patch.
  • See "Selegiline Food Interactions" section for more information regarding foods to avoid.

• Selegiline can cause serious and potentially life-threatening reactions if used with certain other medicines. Do not take the following medicines while using selegiline, and for 2 weeks after stopping selegiline: 
       ▪ other medicines to treat depression (antidepressants) including other MAOI medicines
       ▪ medicine which contains selegiline (such as Eldepryl)
       ▪ St. John’s wort (a herbal supplement)
       ▪ Demerol (meperidine), or medicines that contain meperidine (a narcotic pain medicine) or the pain medicines tramadol, methadone, or propoxyphene
       ▪ Tegretol (carbamazepine), or other medicines that contain carbamazepine (a seizure medicine)
       ▪ Trileptal (oxcarbazepine), or other medicines that contain oxcarbazepine (a seizure medicine)
       ▪ Cold or cough preparations that contain dextromethorphan
       ▪ Flexeril or other medicines that contain cyclobenzaprine (a medicine used to treat muscle spasms)
       ▪ decongestant medicines, found in many products to treat cold symptoms
       ▪ over-the-counter diet pills or herbal weight-loss products
       ▪ any herbal or dietary supplement that contains tyramine
       ▪ medicines called amphetamines, also called stimulants or “uppers”
       ▪ BuSpar (buspirone HCl), an anxiety medicine
• Some of these medicines will have to be stopped for at least a week before you can start using selegiline.
• Do not use selegiline if you are allergic to anything in this medication
• You must not eat foods or drink beverages that contain high amounts of tyramine while using selegiline. You do not have to make any diet changes with the selegiline 6 mg/24 hours patch. 
• Do not take other medicines while using selegiline or for 2 weeks after you stop using it unless your doctor has told you it is okay. See “Selegiline Drug Precautions".
• Do not drive or operate dangerous machinery until you know how selegiline affects you. Selegiline may reduce your judgment, ability to think, or coordination.
• Drinking alcoholic beverages is not recommended while using selegiline.
• Selegiline is not to be used if you are also taking meperidine (Demerol). This contraindication is often extended to other opioid medications.

Oral/Topical:

• Selegiline can cause a sudden, large increase in blood pressure (‘‘hypertensive crisis’’) if you eat certain foods and drinks during treatment. See “Drug Precautions”. A hypertensive crisis can lead to stroke and death. Symptoms of a hypertensive crisis include the sudden onset of severe headache, nausea, stiff neck, a fast heartbeat or a change in the way your heart beats (palpitations), a lot of sweating, and confusion. If you suddenly have these symptoms, get medical care right away.
• Selegiline can cause serious and potentially life-threatening reactions if used with certain other medicines. See “Selegiline Drug Precautions”.
• Selegiline may worsen your depression, give you suicidal thoughts, or cause unusual changes in behavior.  Call your doctor right away if you feel worse with selegiline.
• Selegiline may cause a mental condition called mania or hypomania (mental condition which causes high moods) in people who have a history of mania.
• Selegiline can cause low blood pressure. Lie down if you feel dizzy, faint, or lightheaded. Change your position slowly if low blood pressure is a problem for you. Tell your doctor if you have these symptoms. You may need a lower dose of selegiline.

Oral:

The most common side effects with selegiline include the following dizziness, nausea, pain, headache, insomnia, runny nose, involuntary movement, back pain, mouth inflammation, and upset stomach.

Topical:

The most common side effect of selegiline is a skin reaction where the patch is placed. You may see mild redness at the site when a patch is removed. This redness should go away within several hours after removing the patch. If irritation or itching continues, tell your doctor.

These are not all the side effects of selegiline. For more information, ask your doctor or pharmacist.

Selegiline can cause serious and potentially life-threatening reactions if used with certain other medicines. Do not take the following medicines while using selegiline, and for 2 weeks after stopping selegiline:

• other medicines to treat depression (antidepressants) including other MAOI medicines
• medicine which contains selegiline (such as Eldepryl)
• St. John’s wort (a herbal supplement)
• Demerol (meperidine), or medicines that contain meperidine (a narcotic pain medicine) or the pain medicines tramadol, methadone, or propoxyphene
• Tegretol (carbamazepine), or other medicines that contain carbamazepine (a seizure medicine)
• Trileptal (oxcarbazepine), or other medicines that contain oxcarbazepine (a seizure medicine)
• Cold or cough preparations that contain dextromethorphan
• Flexeril or other medicines that contain cyclobenzaprine (a medicine used to treat muscle spasms)
• decongestant medicines, found in many products to treat cold symptoms
• over-the-counter diet pills or herbal weight-loss products
• any herbal or dietary supplement that contains tyramine
• medicines called amphetamines, also called stimulants or “uppers”
• BuSpar (buspirone), an anxiety medicine

Some of these medicines will have to be stopped for at least a week before you can start using selegiline. Be sure to tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

This is not a complete list of selegiline drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if selegiline passes into your milk or if it can harm your baby.

Antidepressant medicines may increase suicidal thoughts or actions in some patients within the first few months of treatment.

Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

Drinking alcoholic beverages is not recommended while using selegiline.

Selegiline can cause serious and potentially life-threatening reactions if used with certain other medicines. See "Selegiline Drug Interactions" section for more information.

You must avoid (not eat or drink) certain foods and drinks while using selegiline and for 2 weeks after stopping selegiline. See "Selegiline Food Interactions" section for more information regarding foods to avoid.