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Armodafanil

 
  Generic Name: Armodafanil (ar moe DAF i nil)
 
  Brand Names: Nuvigil  
     
   
 

What is armodafanil?

Armodafanil is a medication that promotes wakefulness.

Armodafanil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafanil may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about armodafanil?

You should not use this medication if you are allergic to armodafanil or modafanil (Provigil).

Before using armodafanil, tell your doctor if you have angina (chest pain), liver or kidney disease, a heart problem, a history of drug addiction, if you take blood pressure medication, or if you have recently had a heart attack.

Armodafanil affects the central nervous system. This can cause effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Stop taking armodafanil and call your doctor if you have a skin rash, no matter how mild. A medicine similar to armodafanil has caused severe skin reactions serious enough to require hospitalization. Other signs of a severe reaction include fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash.

There may be other drugs that can interact with armodafanil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I discuss with my health care provider before taking armodafanil?

You should not use this medication if you are allergic to armodafanil or modafanil (Provigil).

Before using armodafanil, tell your doctor if you are allergic to any drugs, or if you have:

  • angina (chest pain);

  • cirrhosis or other liver problem;

  • kidney disease;

  • a heart muscle or valve disorder such as mitral valve prolapse;

  • a history of drug addiction;

  • if you take blood pressure medications; or

  • if you have recently had a heart attack.

If you have any of these conditions, you may not be able to use armodafanil, or you may need dosage adjustments or special tests during treatment.

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafanil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafanil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Armodafanil can make certain types of birth control pills less effective, which could result in an unplanned pregnancy. Talk with your doctor about the best methods of birth control to use while taking armodafanil. It is not known whether armodafanil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give armodafanil to anyone younger than 17 years old.

How should I take armodafanil?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Armodafanil is usually given for 12 weeks or less. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Armodafanil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

If you are taking armodafanil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafanil may be necessary to best treat your condition.

Armodafanil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder.

Talk with your doctor if you continue to have excessive sleepiness even while taking armodafanil.

Taking this medication does not take the place of getting enough sleep.

Store armodafanil at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafanil. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling excited or agitated, confusion, trouble sleeping, nausea, or diarrhea.

What should I avoid while taking armodafanil?

Armodafanil affects the central nervous system. This can cause effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafanil.

Armodafanil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using armodafanil and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;

  • bruising, severe tingling, numbness, pain, muscle weakness;

  • easy bruising or bleeding;

  • white patches or sores inside your mouth or on your lips;

  • hallucinations, unusual thoughts or behavior;

  • depression, anxiety; or

  • chest pain, uneven heart beats.

Less serious side effects may include:

  • headache, dizziness;

  • feeling nervous or agitated;

  • nausea, diarrhea;

  • trouble sleeping (insomnia); or

  • dry mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Armodafanil Dosing Information

Usual Adult Dose for Narcolepsy:

150 mg or 250 mg orally once daily in the morning

It is not clear if doses beyond 150 mg daily confer additional benefit.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 mg or 250 mg orally once daily in the morning

It is not clear if doses beyond 150 mg daily confer additional benefit.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once daily one hour prior to the start of the work shift

What other drugs will affect armodafanil?

Before using armodafanil, tell your doctor if you are using any of the following drugs:

  • cyclosporine (Neoral, Sandimmune, Gengraf);

  • propranolol (Inderal);

  • omeprazole (Prilosec);

  • rifampin (Rifadin, Rimactane, Rifater);

  • a sedative such as diazepam (Valium), midazolam (Versed), or triazolam (Halcion);

  • seizure medication such as carbamazepine (Carbatrol, Tegretol) or phenobarbital (Luminal, Solfoton);

  • an antidepressant such as clomipramine (Anafranil), isocarboxazid (Marplan), or phenelzine (Nardil); or

  • an antibiotics such as erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin) or ketoconazole (Nizoral).

This list is not complete and there may be other drugs that can interact with armodafanil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about armodafanil.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 12/13/2008 9:35:28 AM.;
 
 
 
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