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ABOUT PROVIGIL
Provigil price without insurance Provigil (Provigil) is a medication that promotes wakefulness. It is thought to work by altering the natural chemicals (neurotransmitters) in the brain.
Provigil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.
Provigil may also be used for purposes not listed in this medication guide.​Provigil decreases extreme sleepiness due to narcolepsy and other sleep disorders such as difficult/irregular breathing during sleep (e.g., obstructive sleep apnea/hypopnea syndrome-OSAHS). It is also used to help you stay awake during work hours for people with work schedules that interfere with a normal sleep routine (shift work sleep disorder-SWSD). It is not known how Provigil works to increase wakefulness. It is thought to work by affecting certain chemicals in the brain that control the sleep/wake cycle. Provigil does not make up for lack of sleep and should not be used to treat tiredness or hold off sleep in people who do not have a sleep disorder. This medication is not recommended for use in children.Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders.
A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline.
Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis.
How To use Provigil?
Provigil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Provigil refilled.
Provigil is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy. Excessive sleepiness is defined as difficulty maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations.
Special warnings and precautions for use
Diagnosis of sleep disorders
Modafinil should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of narcolepsy, has been made in accordance with ICSD diagnostic criteria. Such an evaluation usually consists, in addition to the patient's history, sleep measurements testing in a laboratory setting and exclusion of other possible causes of the observed hypersomnia.Serious rash, including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Drug Rash with Eosinophilia and Systemic Symptoms Serious rash requiring hospitalisation and discontinuation of treatment has been reported with the use of modafinil occurring within 1 to 5 weeks after treatment initiation. Isolated cases have also been reported after prolonged treatment (e.g., 3 months). In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in paediatric patients (age <17 years); this includes serious rash. No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil. Modafinil should be discontinued at the first sign of rash and not re-started.Rare cases of serious or life-threatening rash, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience.
Paediatric population
Because safety and effectiveness in controlled studies in children have not been established and because of the risk of serious cutaneous hypersensitivity and psychiatric adverse reactions, the use of modafinil is not recommended
Multi-organ hypersensitivity reaction
Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil.
Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening. There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. Other associated manifestations included myocarditis, hepatitis, liver function test abnormalities, haematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia.
Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur.