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Drugs reference index «armodafinil»

armodafinil (Oral route)

ar-moe-DAF-i-nil

Commonly used brand name(s):

In the U.S.

  • Nuvigil

Available Dosage Forms:

  • Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For armodafinil

Armodafinil is used to help people who have narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), or shift work sleep disorder (SWSD) to stay awake during the day. armodafinil does not cure these conditions and will only work as long as you continue to take it .

armodafinil is available only with your doctor's prescription .

Before Using armodafinil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For armodafinil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to armodafinil or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of armodafinil in children below 17 years of age. Safety and efficacy have not been established .

Geriatric

Although appropriate studies on the relationship of age to the effects of armodafinil have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of armodafinil in the elderly. However, elderly patients may have a slower removal of armodafinil from the body, which may require an adjustment of dosage in patients receiving armodafinil .

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using armodafinil with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Midazolam
  • Omeprazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of armodafinil. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angina (severe chest pain), recent or
  • Heart attack, recent or
  • Heart disease (e.g., mitral valve prolapse) or
  • High blood pressure—Use with caution. armodafinil may worsen these conditions .
  • Drug abuse or dependence, history of—Dependence may be more likely to develop .
  • Kidney disease, severe—Limited information is available on the safety and efficacy of armodafinil in patients with this condition .
  • Liver disease, severe—Patients with this condition should receive a lower dose .
  • Mental illness, history of—Use with caution. armodafinil may cause the illness to return .

Proper Use of armodafinil

armodafinil does not take the place of getting enough sleep. It should not be used for occasional sleepiness that has not been diagnosed as narcolepsy, sleep apnea, or shift work sleep problems. Ask your doctor for advice about good sleep habits .

If you have sleep apnea and use a continuous positive airway pressure (CPAP) machine at night, continue using this machine with the medicine .

Dosing

The dose of armodafinil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of armodafinil. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For narcolepsy or obstructive sleep apnea/hypopnea syndrome:
      • Adults—150 milligrams (mg) or 250 mg once a day in the morning.
      • Children—Use and dose must be determined by your doctor .
    • For shift work sleep disorder:
      • Adults—150 milligrams (mg) one hour before you begin working.
      • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of armodafinil, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using armodafinil

It is very important that your doctor check your progress at regular visits to make sure armodafinil is working properly and to check for unwanted effects .

armodafinil may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking armodafinil and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using armodafinil .

If you are using a medicine for birth control, such as birth control pills or implants, it may not work properly while you are taking armodafinil and for one month after stopping armodafinil. Another form of birth control should be used during this time .

Until you know how armodafinil affects you, do not drive, use machines, or do anything else that could be dangerous if you are not alert .

If you have been taking armodafinil for a long time or in large doses and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on armodafinil are:

  • a strong desire or need to continue taking the medicine.
  • a need to increase the dose to receive the effects of the medicine.
  • withdrawal side effects when you stop taking the medicine .

armodafinil Side Effects

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:

Less common
  • Blistering, burning, crusting, dryness, or flaking of skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • difficult or labored breathing
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever
  • frequent urination
  • headache, severe and throbbing
  • increased volume of pale, dilute urine
  • itching, scaling, severe redness, soreness, or swelling of skin
  • rash
  • shakiness in legs, arms, hands, or feet
  • shortness of breath
  • tightness in chest
  • trembling or shaking of hands or feet
  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Anxiety
  • blurred vision
  • chest pain or discomfort
  • confusion about identity, place, and time
  • diarrhea
  • dry mouth
  • headache
  • hyperventilation
  • irritability
  • lightheadedness, dizziness, or fainting
  • nausea
  • nervousness
  • pounding in the ears
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • sleeplessness
  • slow heartbeat
  • trouble sleeping
  • unable to sleep
  • unusual tiredness or weakness

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:

Less common
  • Acid or sour stomach
  • belching
  • chills
  • cough
  • depression
  • difficulty having a bowel movement (stool)
  • discouragement
  • feeling sad or empty
  • general feeling of discomfort or illness
  • heartburn
  • indigestion
  • joint pain
  • loss of appetite
  • loss of interest or pleasure
  • mood or mental changes
  • muscle aches and pains
  • runny nose
  • shivering
  • sore throat
  • stomach discomfort, upset, or pain
  • sweating
  • thirst
  • tiredness
  • trouble concentrating
  • 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.

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  • Armodafinil Professional Patient Advice (Wolters Kluwer)
  • Armodafinil MedFacts Consumer Leaflet (Wolters Kluwer)
  • Nuvigil Prescribing Information (FDA)
  • Nuvigil Consumer Overview

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