Provigil warning label
The FDA approved the use of Provigil to help keep awake patients with certain disorders, such as sleep apnea or shift-work sleep disorder Warnings for Patients Taking Psych Drugs Canada, February 2006: Health Canada approved a new warning label for GlaxoSmithKline’s Paxil that read, in part: “A small number of patients taking drugs of provigil warning label this type may feel worse instead of better. narcolepsy, shift work disorder, and obstructive sleep disorder. The warning letter cites the firm for marketing the product for unapproved indications in a promotional piece disseminated to the Maryland Department of Health and Mental Hygiene's Pharmacy and Therapeutics Committee Modafinil is a prescription drug that promotes wakefulness and can be used to treat conditions such as obstructive sleep apnea, hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder Modafinil is available under the following different brand names: Provigil. Modafinil is a racemic compound. Read on to find out more about it and its effects Provigil is a stimulant prescribed to increase wakefulness in patients with excessive sleepiness related to narcolepsy, shiftwork sleep disorder, and obstructive sleep apnea/hypopnea syndrome.Common side effects of Provigil are: headache, dizziness, upper respiratory tract infection, ; nausea, diarrhea, nervousness, anxiety, agitation,. Provigil is sometimes used off-label for uses that are not FDA-approved. Provigil Side Effects Cause SJS. Source: “Provigil (Modafinil) tablets,” FDA Center for Drug Evaluation and Research, October 2010 The FDA recently warned Cephalon for off-label promotion of its wakefulness-promoting agent Provigil. PROVIGIL does not take the place of using your CPAP machine or other treatments that. Provigil is a medication manufactured and marketed by the drug company Cephalon and used to treat sleeping disorders, such as narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep. “PROVIGIL” on one side and “200 MG” on the other. Narcolepsy. Provigil and Nuvigil are also used as an adjunct to standard treatments for the underlying obstruction in OSA (1-2). Modafinil, sold under the brand name Provigil among others, is a medication to treat sleepiness due to narcolepsy, shift work sleep disorder, or obstructive sleep apnea. For example, in the United States, the UK, Hong Kong, and several other countries, it is sold under the brand name Provigil In addition to limited side effects, Provigil lawsuits filed on behalf of users are unlikely because the drug is attached with appropriate warnings. In other cases, Provigil may be. 24, 2007 -- Provigil, a prescription stay-awake drug, is getting new warnings about the risk of life-threatening rash, other serious hypersensitivity reactions, and psychiatric symptoms The FDA recently warned Cephalon for off-label promotion of its wakefulness-promoting agent Provigil. It is sparingly to slightly soluble in methanol and acetone PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch Find patient medical information for Provigil Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings Oct. Modafinil is a prescription drug that promotes wakefulness and can be used to treat conditions such as obstructive sleep apnea, hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder Modafinil is available under the following different brand names: Provigil. If you're taking one, your doctor will need to weigh the pros and cons of adding Provigil to your treatment regimen. Off Label Uses: Provigil has been found effective in the treatment of multiple sclerosis fatigue (3). A boxed warning is the most serious type of warning issued by the FDA for drugs and medical devices, meaning that the side effects can cause serious injury and possibly death. Modafinil is a. V. has added a new warning to the label of its sleep disorder drug Provigil to inform patients about the potential risk for a serious skin rash and psychiatric symptoms Before starting Provigil, warnings and precautions for the drug should be discussed with your healthcare provider to ensure safe treatment. • Nuvigil’s warning section states, “Armodafinil has not been studied in pediatric patients in.