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Provigil Product Information

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Hypotension Hypertension Vasodilation Arrhythmia Syncope. Amblyopia Abnormal vision. Hyperglycemia Albuminuria. Joint disorder. Herpes simplex Dry skin. Abnormal urine Urinary retention Abnormal ejaculation 4. These events included the following: infection, back pain, pain, hypothermia, abdominal pain, flu syndrome, allergic reaction, fever, asthenia, accidental injury, general edema, tachycardia, palpitations, migraine, ventricular extrasystole, bradycardia, dyspepsia, tooth disorder, constipation, flatulence, increased Provigil Product Information, gastroenteritis, Provigil Product Information disorder, ecchymosis, anemia, leukocytosis, peripheral edema, increased weight, increased SGOT, myalgia, arthritis, arthralgia, Infor,ation, thinking abnormality, leg cramps, sleep disorder, hallucinations, hyperkinesia, decreased libido, increased cough, sinusitis, bronchitis, pneumonia, rash, sweating, pruritus, skin disorder, psoriasis, ear pain, eye pain, ear disorder, taste perversion, dysmenorrhea 4urinary tract infection, pyuria, hematuria, cystitis, and disturbed menses 4.

Clinical chemistry, hematology, and urinalysis parameters were monitored in US Phase 1, 2 and 3 studies. No differences were apparent in alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total protein, albumin, or total bilirubin.

Modafinil - Wikipedia

Observed shifts were from normal to high. In addition to its wakefulness-promoting effect and increased locomotor activity in animals, in humans, PROVIGIL 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. Patients should be observed for signs of misuse or abuse e. The abuse potential of modafinil, and 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. The effects of modafinil Provigil Product Information were monitored following 9 weeks of modafinil use in one US Phase 3 controlled clinical trial.

No specific symptoms of withdrawal were observed during 14 days of observation, although sleepiness returned in narcoleptic patients. Doses of mg and mg were taken intentionally Provigil Product Information two patients participating in foreign depression studies. In both cases, the adverse experiences observed were limited, expected, and not life-threatening, and the patients recovered fully by the following day.

The adverse experiences included excitation or agitation, insomnia, and slight or moderate elevations in hemodynamic parameters. Other observed high dose effects in clinical studies have included anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep disturbances, nausea, diarrhea and decreased prothrombin time. No specific antidote to the Buy Provigil Online 2013 effects of modafinil overdose has been identified to date.

Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring. If there are no contraindications, induced emesis or gastric lavage should be considered. There are no data to suggest the utility of dialysis or urinary acidification or alkalinization in enhancing drug elimination. The physician should consider contacting a poison-control center on the treatment of any overdose.

NDC — Bottles of Our focus is to exclusively link to peer-reviewed studies found on respected websites, like PubMed. We focus on finding the most accurate information from the scientific source.

Our goal is to provide you with the most scientifically accurate, unbiased, and comprehensive information regarding Modafinil and Armodafinil. All of our content Provigil Product Information written by people with a strong science background, including medical researchers. Our content is continually monitored by an internal peer-review process to ensure accuracy. We strive to never have a piece Provigil Product Information inaccurate information on this website.

If you feel that any of our content is inaccurate or out-of-date, please contact us at: [email protected]. Share on facebook. Share on linkedin. Share on twitter. Share on email. Tomas Thorne April 6, The chemical structure is:.

Pharmacokinetics Modafinil is a racemic compound, whose enantiomers have different pharmacokinetics e. Special Populations Gender Effect: The pharmacokinetics of modafinil are not affected by gender.

Race Effect: The influence of race on the pharmacokinetics of modafinil has not been studied.

Table 1. Table 2. Cardiovascular System In clinical studies of PROVIGIL, signs and symptoms including chest pain, palpitations, dyspnea and transient ischemic T-wave changes on ECG were observed in three subjects in association with mitral valve prolapse or left ventricular hypertrophy.

Central Nervous System One healthy male volunteer developed ideas of reference, paranoid delusions, and auditory hallucinations in association with multiple daily mg doses of PROVIGIL and sleep deprivation. Pregnancy Animal studies to assess the effects of modafinil on reproduction and the developing fetus were not conducted at Provigil Product Information high doses or according to guidelines which would ensure a comprehensive evaluation of the potential of modafinil to adversely affect fertility, or cause embryolethality or teratogenicity See Impairment of Fertility and Pregnancy.

Nursing Patients should be advised to notify their physician if they are breast feeding an infant. Concomitant Medication Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, because of the potential for interactions between PROVIGIL tablets and other drugs.

Allergic Reactions Patients should be advised to notify their physician if they develop a rash, hives, or related allergic phenomenon. Drug Interactions CNS Active Drugs Methylphenidate — In a single-dose study in healthy volunteers, coadministration of modafinil mg with methylphenidate 40 mg did not cause any significant alterations in the pharmacokinetics of either drug.

Mutagenesis There was no evidence of mutagenic or clastogenic potential of modafinil in Provigil Product Information series of assays. Pregnancy Pregnancy Category C: Embryotoxicity was observed in the absence of maternal toxicity when rats received oral modafinil throughout the period of organogenesis. Labor and Delivery The effect of modafinil on labor and delivery in humans has not been systematically investigated.

Nursing Mothers It is not known whether modafinil or its metabolites are excreted in human milk. Laboratory Changes Clinical chemistry, hematology, and urinalysis parameters were monitored in US Phase 1, 2 and 3 studies.

Abuse Potential and Dependence In addition to its wakefulness-promoting effect and increased locomotor activity in animals, in humans, PROVIGIL produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants.

Modafinil | European Medicines Agency

Withdrawal The effects of modafinil withdrawal were monitored following 9 weeks of modafinil use in one US Phase 3 controlled clinical trial. Overdose Management No specific antidote to the toxic effects of modafinil overdose has been identified to date. Caution: Federal law prohibits dispensing without prescription. Manufactured for: Cephalon, Inc. Research found that modafinil elevates dopamine levels in the hypothalamus in animals.

As such, "modafinil is an exceptionally weak, but apparently very selective, [DAT] inhibitor". Modafinil has been described as an "atypical" DAT inhibitor, and shows a profile of effects that is very different from those of other dopaminergic stimulants.

Against the hypothesis that modafinil exerts its effects by acting as a DRI, tyrosine hydroxylase inhibitors which deplete dopamine fail to block the effects of modafinil in animals.

In any case, there is nonetheless Provigil Product Information good deal of evidence to indicate that modafinil is producing at least a portion of its wakefulness-promoting effects by acting as a Ifnormation, or at least via activation Informwtion the dopaminergic system.

Modafinil – PROVIGIL® (modafinil) TABLETS [C-IV]

In support of modafinil acting as a dopaminergic agent, its wakefulness-promoting effects are abolished in DAT knockout mice although DAT knockout mice show D 1 and D 2 receptor and norepinephrine compensatory abnormalities that might confound this findingreduced by both D 1 and D 2 receptor antagonists although conflicting reports exist[86] and completely blocked by simultaneous inactivation of both D 1 and D 2 receptors.

Modafinil may possess yet an additional mechanism Provigil Product Information action. Both modafinil and its metabolitemodafinil sulfonepossess anticonvulsant properties in animals, and modafinil sulfone is nearly as potent as modafinil in producing this effect. Food slows absorption, but does not affect the total AUC.

This percentage changes very little when the concentration of modafinil is varied. Elimination half-life is generally in the range of 10 to 12 hours, subject to differences in CYP genotypes, liver function and renal function. It is metabolized in the liver, and its inactive metabolite is excreted in the urine.

Modafinil is a racemic mixture of two enantiomersarmodafinil R -modafinil and esmodafinil S -modafinil. Instrumental techniques involving gas or liquid chromatography are usually employed for these purposes.

Reagent testing can be used to screen for the presence of modafinil in samples. Many derivatives and structural analogues of modafinil have been synthesized and studied. Modafinil was originally developed in France by neurophysiologist professor Michel Jouvet and Lafon Laboratories. Modafinil originated with the s invention of a series of benzhydryl sulfinyl compounds, including adrafinilwhich was first offered as an experimental treatment for narcolepsy in France in Inmodafinil was approved by the U.

It was approved for use in the UK in December Modafinil is marketed in the United States by Cephalonwho originally leased the rights from Lafon, but eventually purchased the company in Cephalon began to market armodafinil, the R -enantiomer of modafinil, in the United States in After protracted patent litigation and negotiations see belowgeneric versions of modafinil became available in the US in Patent 4, was issued to Laboratoire L.

Lafon on May 22,covering the chemical compound modafinil. After receiving an interim term extension of days and pediatric exclusivity of six months, it expired on October 22, On October 6,Cephalon filed an additional patent, covering modafinil in the form of particles of defined size. That patent, U.

Patent 5, was Provigil Product Information on April 8, It was reissued in as RE 37, which surrendered the patent. With pediatric exclusivity, this patent expired on April 6, On December 24,anticipating the expiration of exclusive marketing rights, generic drug manufacturers Mylan, Teva, Barr, and Ranbaxy applied to the FDA to market a generic form of modafinil.

There is some question of Provigil Product Information a Provigil Product Information size patent is sufficient protection against the manufacture of generics. Pertinent Provigil Product Information include whether modafinil may be modified or manufactured to avoid the granularities specified in the new Cephalon patent, and whether patenting particle size is invalid because particles of appropriate sizes are likely to be obvious to practitioners skilled in the art. However, under United States patent law, a patent is entitled to a legal presumption of validity, meaning that in order to invalidate the patent, much more than "pertinent questions" are required.

As of October 31,U. Reissue Patent No. RE 37, has been declared invalid and unenforceable. Lafon ; 3 was obvious at the time the invention was made to a person having ordinary skill in the art under 35 U. Cephalon made an agreement with four major generics manufacturers TevaBarr PharmaceuticalsRanbaxy Laboratoriesand Watson Pharmaceuticals between and to delay sales of generic modafinil in the US until April by these companies in exchange for upfront and royalty payments.

In the United Kingdom, Mylan Inc. In Australia, modafinil is considered to be a Schedule 4 prescription-only medicine or prescription animal remedy. In mainland Chinamodafinil is strictly controlled like other stimulants, such as amphetamines and methylphenidate.

In Japanmodafinil is Schedule I psychotropic drug. Modafinil is considered a stimulant doping agent and as such is prohibited in sports competitions, in the same category as steroids. In Russia modafinil is Schedule II controlled substance like cocaine and morphine. Possession of few modafinil pills can lead to 3—10 years imprisonment. In Sweden, modafinil is classified as a schedule IV substance and possession is therefore illegal without prescription. Modafinil is currently [update] classified as a Schedule IV controlled substance under United States federal law; it is illegal to import by anyone other than a DEA -registered importer without a prescription.

However, one may legally bring modafinil into the United States in person from a foreign country, provided that he or she has a prescription for it, and the drug is properly declared at the border crossing.

Modafinil has been used non-medically as a " smart drug " by students, office workers, soldiers and transhumanists. The regulation of modafinil as a doping agent has been controversial in the sporting world, with high-profile cases attracting press coverage since several prominent American athletes have tested positive for the substance.

Some athletes who were found to have used modafinil protested that the drug was not on the prohibited list at the time of their offenses. The Agency added modafinil to its list of prohibited substances on August 3,ten days before the start of the Summer Olympics.

Modafinil has received some publicity in the past when several athletes such as sprinter Kelli White incyclist David Clinger [] and basketball player Diana Taurasi [] inand rower Timothy Grant in [] were accused of using it as a performance-enhancing doping agent. Taurasi and another player, Monique Coker, tested at the same lab, were later cleared. The BALCO scandal brought to light an as-yet unsubstantiated but widely published account of Major League Baseball's all-time leading home-run hitter Barry Bonds ' supplemental chemical regimen that included modafinil in addition to anabolic steroids and human growth hormone.

Modafinil has been studied in the treatment of major depressive disorder.

Modafinil and armodafinil have been repurposed as adjunctive treatments for acute depression in people with bipolar Provigil Product Information. Modafinil has been studied and reported to be effective in the treatment of attention deficit hyperactivity disorder ADHDwith significantly less abuse potential than conventional psychostimulants like methylphenidate and amphetamines.

Modafinil has been studied for the treatment of stimulant dependence. Modafinil and armodafinil have been Infprmation as a complement to antipsychotic medications in the treatment of schizophrenia. They have been consistently shown Informaion have no effect on positive symptoms or cognitive performance.

A review of clinical studies of possible nootropic effects in healthy people Inrormation " In contrast, when more complex assessments are used, modafinil Provigil Product Information to consistently engender enhancement of attention, executive functionsand learning.

Importantly, we did not observe any preponderances for side effects or mood changes. Modafinil Provifil been used off-label in trials with people with symptoms of post-chemotherapy cognitive impairmentalso known as "chemobrain", but a review found that it was no better than placebo. In outpatient settings wherein patients are discharged home after surgery, this sedation, fatigue and occasional dizziness is problematic.

From Wikipedia, the free encyclopedia.

PROVIGIL (modafinil) is a wakefulness-promoting agent for oral Read the Patient Information that comes with PROVIGIL before you start. Each tablet contains mg of modafinil. Excipient with known effect. Each tablet contains 68 mg of lactose. For the full list of excipients, see section

Medication which increases wakefulness. IUPAC name. DB Y. D Y. Interactive image. See also: List of drugs used by militaries. PMC PMID Because of the relatively low risk of addiction, modafinil can be more easily prescribed in patients without a clear, biochemically defined central hypersomnia syndrome, and is also easier to stop, if needed. It is also a schedule IV compound. J Pharmacol Pharmacotherapy.

American Society of Health-System Pharmacists. Retrieved June 24, Archived from the original PDF on January 7, Retrieved January 20, Clinical Pharmacokinetics. S2CID Drug Metabolism and Disposition. United States Food and Drug Administration. January Retrieved July 18, A systematic review of modafinil: potential clinicaluses and mechanisms of action.

J Clin Psychiatry. Journal of Clinical Psychopharmacology. European Neuropsychopharmacology. Rethinking Cognitive Enhancement. Oxford University Press. ISBN Journal of Psychiatric Research. Journal of Drug Assessment. Pharmaceutical Press. September Socio-anthropologie 43 : 97— ISSN Vice Media. Archived from the original on November 12, Retrieved March 18, Retrieved April 11, November An American Academy of Sleep Medicine report". Journal of Affective Disorders.

Sleep Medicine. The Committee looked at all the data from the clinical trials of modafinil in narcolepsy, obstructive sleep apnoea, shift-work sleep disorder and idiopathic hypersomnia, and at articles from the published literature. The CHMP also reviewed all Provigil Product Information side effects reported with modafinil-containing medicines. A group of experts on clinical neurosciences was also convened to provide advice. Looking at the data from the clinical trials, the Committee noted that the effectiveness of modafinil in narcoleptic patients had been shown.

However, the data from the trials in other disorders did not provide strong evidence to support the use of the product. Looking at the safety data, the Committee Provigil Product Information that modafinil is strongly linked to a risk of serious, life-threatening skin reactions, and this risk appears higher in children.

The Committee also noted a link between modafinil and psychiatric adverse reactions, such as suicidal thoughts, depression, psychotic episodes, and between modafinil and cardiovascular adverse reactions, such as hypertension high blood Provigil Product Information and irregular heart beat. Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of modafinil-containing medicines continue to outweigh their risks only in the treatment of narcolepsy.

For obstructive sleep apnoea including in patients with excessive sleepiness despite correctly using a Continuous Positive Airway Pressure machineshift-work sleep disorder and idiopathic hypersomnia, the CHMP concluded that the data on the effectiveness were not sufficient to outweigh the risks, and that therefore the benefit-risk balance was negative.

The Committee recommended that these indications be removed from the product information. In addition the Committee Provigil Product Information recommended that modafinil-containing medicines not be used in patients with uncontrolled hypertension or irregular heart beat. The Committee also noted the increased risk of serious life-threatening skin reactions with modafinil in children and advised against its use in children.

The CHMP has also asked the companies that make modafinil-containing medicines to put in place measures to minimise the risks. These include informing healthcare professional of the changes to the product information triggered by this latest review, and putting in place studies looking at the cardiovascular and skin safety of modafinil.

Because the Committee noted in its review that modafinil has often been used for conditions for which it is not indicated, the companies have also been asked to carry out further studies, including a 'drug utilisation study' to look at why family doctors prescribe the medicines.

In addition, data on the misuse of modafinil by university students, currently being collected, will be analysed once available. The CHMP confirmed the above conclusions after re-examining its opinion. The full changes made to the information to doctors and patients are detailed here.

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Please do not include any personal datasuch as your name or contact details. Skip to main Provigil Product Information.

Modafinil - containing medicinal products is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without. Doctors prescribing modafinil-containing medicines should keep in mind the change in the indication: modafinil is only indicated to treat narcolepsy. Modafinil.

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