Armodafinil

What is Armodafinil?

• Armodafinil (Nuvigil) is a wakefulness‑promoting agent for oral administration.
• Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers.

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Armodafinil

What are the uses of this medicine?

Armodafinil (Nuvigil) is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

• narcolepsy
• obstructive sleep apnea (OSA). Armodafinil is used with other medical treatments for this sleep disorder. Armodafinil does not take the place of using your CPAP machine or other treatments that your doctor has prescribed for this condition. It is important that you continue to use these treatments as prescribed by your doctor.
• shift work disorder (SWD)

• Armodafinil will not cure these sleep disorders.
• Armodafinil may help the sleepiness caused by these conditions, but it may not stop all your sleepiness.
• Armodafinil does not take the place of getting enough sleep.
• Follow your doctor's advice about good sleep habits and using other treatments.

How does this medicine work?

• The mechanism(s) through which armodafinil promotes wakefulness is unknown.
• Armodafinil (R-modafinil) has pharmacological properties similar to those of modafinil (a mixture of R- and S-modafinil), to the extent tested in animal and in vitro studies.
• Modafinil (moe daf' i nil) is a non-amphetamine central nervous system (CNS) stimulant whose mechanism of action is not entirely clear.
• Modafinil is structurally unrelated to the amphetamines, and it does not appear to affect release of CNS norepinephrine or dopamine.
• Modafinil is a racemic mixture of S and R enantiomers, whereas armodafinil (ar" moe daf' i nil) is the R enantiomer only.
• Both enantiomers have CNS activating actions, but they differ in pharmacokinetics and half-life.
• Modafinil and armodafinil increase wakefulness and both have been shown to be helpful in conditions with excessive sleepiness (narcolepsy, obstructive sleep apnea and shift-work sleep disorder), and have been studied off label to treat fatigue associated with chronic illness such as cancer, Parkinson’s disease, HIV/AIDs and multiple sclerosis.

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Armodafinil molecule ball

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to any of its ingredients.
• have had a rash or allergic reaction to either armodafinil (NUVIGIL®) or modafinil (PROVIGIL®). These medicines are very similar.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• a hormonal birth control method, such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs). Hormonal birth control methods may not work while you take armodafinil. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking armodafinil, and for 1 month after stopping armodafinil. You should use effective birth control while taking armodafinil and for 1 month after your final dose. Talk to your doctor about birth control choices that are right for you while taking armodafinil.
• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• clomipramine (Anafranil)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• diazepam (Valium)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• ketoconazole (Nizoral)
• omeprazole (Prilosec, in Zegerid)
• certain medications for seizures such as carbamazepine (Epitol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek)
• midazolam
• monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• propranolol (Inderal)
• rifampin (Rifadin, Rimactane, in Rifamate)
• triazolam (Halcion)

Armodafinil molecule spacefill

Is this medicine FDA approved?

• Armodafinil is produced by the pharmaceutical company Cephalon Inc.and was approved by the U.S. Food and Drug Administration (FDA) in June 2007.

How should this medicine be used?

Recommended dosage: Dosage in Obstructive Sleep Apnea (OSA) and Narcolepsy:

• The recommended dosage of armodafinil tablets for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning.

Dosage in Shift Work Disorder (SWD):

• The recommended dosage of armodafinil tablets for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.

Dosage Modification in Patients with Severe Hepatic Impairment:

• In patients with severe hepatic impairment, the dosage of armodafinil tablets should be reduced.

Use in Geriatric Patients:

• Consideration should be given to the use of lower doses and close monitoring in geriatric patients.

Administration:

• Take armodafinil exactly as prescribed by your doctor.
• Your doctor will prescribe the dose of armodafinil that is right for you.
• Do not change your dose of armodafinil without talking to your doctor.
• Your doctor will tell you the right time of day to take armodafinil.
• People with narcolepsy or OSA usually take armodafinil one time each day in the morning.
• People with SWD usually take armodafinilabout 1 hour before their work shift.
• Do not change the time of day you take armodafinil unless you have talked to your doctor. If you take armodafinil too close to your bedtime, you may find it harder to go to sleep.
• You can take armodafinil with or without food.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 50 mg, 150 mg, 200 mg, and 250 mg.

This medicine is available in fallowing brand namesː

• Nuvigil

What side effects can this medication cause?

The most common side effects of this medicine may include:

• headache
• dizziness
• nausea
• trouble sleeping

Less common, but serious side effects may include:

• serious rash or a serious allergic reaction
• mental (psychiatric) symptoms
• symptoms of a heart problem

What special precautions should I follow?

• Advise patients and caregivers about the risk of potentially fatal serious skin reactions. Educate patients about the signs and symptoms that may signal a serious skin reaction. Instruct patients to discontinue armodafinil and consult with their healthcare provider immediately if a skin reaction such as rash, mouth sores, blisters, or peeling skin occurs during treatment with armodafinil
• Instruct patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately
• Advise patients of life-threatening symptoms suggesting anaphylaxis or angioedema (such as hives, difficulty in swallowing or breathing, hoarseness, or swelling of the face, eyes, lips, or tongue) that can occur with armodafinil. Instruct them to discontinue armodafinil and immediately report these symptoms to their healthcare provider
• Advise patients that treatment with armodafinil will not eliminate their abnormal tendency to fall asleep. Advise patients that they should not alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment with armodafinil has been shown to produce levels of wakefulness that permit such activities. Advise patients that armodafinil is not a replacement for sleep.
• Advise patients to stop taking armodafinil and contact their physician right away if they experience, depression, anxiety, or signs of psychosis or mania.
• Do not drive a car or do other dangerous activities until you know how armodafinil affects you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay.
• You should avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking armodafinil.
• Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to armodafinil during pregnancy. Caution females regarding the potential increased risk of pregnancy when using hormonal contraceptives (including depot or implantable contraceptives) with armodafinil and advise females who are using a hormonal method of contraception to use an additional barrier method or an alternative non-hormonal method of contraception during treatment with armodafinil and for one month after discontinuation of armodafinil.
• It is not known if armodafinil passes into your milk. Talk to your doctor about the best way to feed your baby if you take armodafinil.
• Both modafinil and armodafinil are associated with a low rate of serum aminotransferase elevations during therapy, but they have not been implicated in cases of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Trouble sleeping
• Confusion
• Feeling excited
• Nausea and diarrhea
• Chest pain
• Anxiety
• Restlessness
• Feeling disoriented
• Hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
• A fast or slow heartbeat
• Increased blood pressure
• Shortness of breath

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• No specific antidote exists for the toxic effects of an armodafinil overdose.
• Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.

Can this medicine be used in pregnancy?

• It is not known if armodafinil will harm your unborn baby.
• There is a registry for women who become pregnant during treatment with armodafinil.
• The purpose of this registry is to collect information about the safety of armodafinil during pregnancy.
• Contact the registry as soon as you learn that you are pregnant, or ask your doctor to contact the registry for you. You or your doctor can get information and enroll you in the registry by calling 1-866-404-4106.
• are breastfeeding. It is not known if armodafinil passes into your milk.
• Talk to your doctor about the best way to feed your baby if you take armodafinil.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established. Serious rash has been seen in pediatric patients receiving modafinil.

What are the active and inactive ingredients in this medicine?

• Active ingredient: armodafinil

• Inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.

Who manufactures and distributes this medicine?

Manufactured for:

• Teva Pharmaceuticals, Parsippany, NJ

What should I know about storage and disposal of this medication?

• Store armodafinil at room temperature between 68° to 77°F (20° to 25°C).
• Keep armodafinil and all medicines out of the reach of children.

The following are CNS stimulants

• Amphetamines (including ecstasy or methylenedioxymetamphetamine)
• Armodafinil
• Atomoxetine
• Cocaine
• Methylphenidate
• Modafinil

• Dailymed label info on Armodafinil
• FDA Armodafinil

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