Artvigil is a generic brand of the drug Armodafinil (Nuvigil, Waklert) manufactured by HAB Pharmaceuticals & Research Ltd. In India.
What is Armodafinil?
Armodafinil (Armodafinil) is a medication that promotes wakefulness.
Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.
Armodafinil may also be used for purposes not listed in this medication guide.
Armodafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
Limitations of Use
In OSA, Armodafinil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Armodafinil for excessive sleepiness.
How should I use Armodafinil?
Use Armodafinil as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Armodafinil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Armodafinil refilled.
- Take Armodafinil by mouth with or without food.
- Your doctor will tell you what time of day to take Armodafinil. Do not change the time of day you take it without talking to your doctor.
- If you miss a dose of Armodafinil, take it as soon as possible. If you do not remember until late afternoon or evening, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Armodafinil.
Uses of Armodafinil in details
Use: Labeled Indications
Narcolepsy: To improve wakefulness in patients with excessive sleepiness associated with narcolepsy.
Obstructive sleep apnea: To improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea (OSA).
Limitations of use: In OSA, Armodafinil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Armodafinil for excessive sleepiness.
Shift-work disorder: To improve wakefulness in patients with excessive sleepiness associated with shift-work disorder.
Armodafinil is enantiopure of the wakefulness-promoting agent modafinil (Provigil), and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Research has shown that Armodafinil significantly improves driving simulator performance in patients with SWD. Armodafinil consists of the (−)-R-enantiomer of the racemic modafinil. Armodafinil is produced by the pharmaceutical company Cephalon Inc. (a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.) and was approved by the U.S. Food and Drug Administration (FDA) in June 2007.
Dosage In Obstructive Sleep Apnea (OSA) And Narcolepsy
The recommended dosage of Armodafinil for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning.
In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well-tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose.
Dosage In Shift Work Disorder (SWD)
The recommended dosage of Armodafinil 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 should be reduced.
Use In Geriatric Patients
Consideration should be given to the use of lower doses and close monitoring in geriatric patients.
Dosage Forms And Strength
- 50 mg – round, white to off-white tablet with C on one side and “205” on the other
- 150 mg – oval, white to off-white tablet with C on one side and “215” on the other
- 200 mg – rounded, rectangular, white to off-white tablet with C on one side and “220” on the other
- 250 mg – oval, white to off-white tablet with on one side and “225” on the other
Storage And Handling
Armodafinil® (Armodafinil) Tablets are available as follows:
50 mg: Each round, white to off-white tablet is debossed with C on one side and “205” on the other. NDC 63459-205-30 – Bottles of 30
150 mg: Each oval, white to off-white tablet is debossed with C on one side and “215” on the other. NDC 63459-215-30 – Bottles of 30
200 mg: Each rounded, rectangular, white to off-white tablet is debossed with C on one side and “220” on the other. NDC 63459-220-30 – Bottles of 30
250 mg: Each oval, white to off-white tablet is debossed with C on one side and “225” on the other. NDC 63459-225-30 – Bottles of 30
Store at 20°- 25C (68°- 77°F).
Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised April 2015
Effects of Armodafinil on CYP3A4/5 Substrates
The clearance of drugs that are substrates for CYP3A4/5 (e.g., steroidal contraceptives, cyclosporine, midazolam, and triazolam) may be increased by Armodafinil via induction of metabolic enzymes, which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when these drugs are used concomitantly with Armodafinil.
The effectiveness of steroidal contraceptives may be reduced when used with Armodafinil and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with Armodafinil and for one month after discontinuation of Armodafinil treatment.
Blood levels of cyclosporine may be reduced when used with Armodafinil. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when used concomitantly with Armodafinil.
Effects of Armodafinil on CYP2C19 Substrates
Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by Armodafinil via inhibition of metabolic enzymes, with resultant higher systemic exposure. Dose reduction of these drugs may be required when these drugs are used concomitantly with Armodafinil.
More frequent monitoring of prothrombin times/INR should be considered whenever Armodafinil is coadministered with warfarin.
Monoamine Oxidase (MAO) Inhibitors
Caution should be used when concomitantly administering MAO inhibitors and Armodafinil.
Drug Abuse And Dependence
Armodafinil contains Armodafinil, a Schedule IV controlled substance.
Although the abuse potential of Armodafinil has not been specifically studied, its abuse potential is likely to be similar to that of modafinil. In humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants. In in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. Modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. In some studies, modafinil was also partially discriminated as stimulant-like. Physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse. Patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior).
The abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. Results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled CNS stimulants (methylphenidate).
Armodafinil side effects
Applies to Armodafinil: oral tablet
As well as its needed effects, Armodafinil (the active ingredient contained in Armodafinil) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Armodafinil, check with your doctor immediately:
You should not use this medication if you are allergic to Armodafinil or modafinil (Provigil).
Before using Armodafinil, tell your doctor if you have liver or kidney disease, heart disease or high blood pressure, a heart valve disorder, a history of mental illness, a history of drug or alcohol addiction, or if you have recently had a heart attack.
Armodafinil 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 Armodafinil and call your doctor if you have a skin rash, no matter how mild. A medicine similar to Armodafinil 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 Armodafinil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Active ingredient matches for Armodafinil:
Modafinil promotes wakefulness. It is thought to work by altering the natural chemicals (neurotransmitters) in the brain.
Modafinil may also be used for purposes not listed in this medication guide.
Artvigil (Armodafinil) helps to promote wakefulness and alertness in patients with narcolepsy or shift work disorder. Experts believe that it works by acting on neurons in the central nervous system. The main ingredient in this medicine is an R-enantiomer of the racemic modafinil, and this means that they both act in a similar way. Although all details related to its precise mechanism of action are not yet fully understood, it has been theorized that it may act by enhancing the signalling of certain substances in the brain.
In addition to this, it may affect the GABA system, thereby helping to further improve wakefulness. Dopamine reuptake is also inhibited. Patients with narcolepsy or other conditions that cause them to be tired and sleepy throughout the day are often treated with this medicine, so as to help them feel more awake and alert, thereby minimizing disruption to their daily schedule.
A study has been conducted by experts to examine its effects if used for ADHD. It has also been researched for depression, weight loss, fatigue associated with fibromyalgia, the improving of cognition in patients with multiple sclerosis and depression. Many students believe it can improve memory function and have taken it as a nootropic.
Dosage and Administration
Artvigil (Armodafinil) comes in the form of uncoated tablets, which are administered orally. Prior to the commencement of treatment, you will need to consult a doctor. This will help to ensure that the correct dosage can be properly calculated, and it will also allow the suitability of this medicine as a treatment for your condition to be assessed. In some cases, adults being treated for narcolepsy have been told by their doctor to take 150mg per day, administered in the morning. Patients must never exceed the dosage recommended to them by their doctor.
Artvigil (Armodafinil) could cause:
- Poor appetite
- Spinning sensation
- Problems getting asleep
Make sure that all side effects are reported to your doctor. Should you suffer from any serious reactions, immediate medical attention will be needed. These may include bruises, nosebleeds, a weak feeling in the muscles, hallucinations, aggressive behaviour and other potentially severe side effects not listed here.
Prolonged use may increase the risk of dependence. To avoid this, your doctor will direct you to only use it for the minimum amount of time required to relieve your symptoms.
This medicine will not cure your condition and it is also not to be used as a substitute for sleep. You will still need to get sufficient sleep every night during treatment.
Seek immediate emergency medical attention if you suffer an allergic reaction. Symptoms to watch for, which may be indicative of a reaction, include skin rashes, hives, swelling of the face or limbs, trouble breathing, and trouble swallowing.
Always use Artvigil (Armodafinil) as you have been prescribed by your doctor. Never self-medicate or change your dosage without first consulting your doctor. The correct dosage can vary depending on your health, medical history, and the severity of the condition being treated.
This medication may not be safe for all patients. Before you begin using it always disclose the following to your doctor:
- If you are pregnant or breastfeeding.
- If you suffer from any allergies.
- If you suffer from any other health conditions or illnesses.
- If you are using any other medicine (including all non-prescription).
- If you are using any supplements, vitamins, or herbal products of any kind.
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