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Provigil Generic Dose

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Posted by Dairg on 2022-12-05

Therefore, caution should be used when concomitantly administering MAO inhibitors and modafinil. There was no apparent change in the elimination rate of ethinyl estradiol. One case of an interaction between modafinil and cyclosporine, a substrate of CYP3A4, has been reported in a 41 year old woman who had undergone an organ transplant.

The interaction was postulated to be due to the increased metabolism of cyclosporine, since no other factor Provigil Generic Dose to affect the disposition of the drug had changed.

Dosage adjustment for cyclosporine may be needed. Although induction results based on in vitro experiments are not necessarily predictive of response in vivo, caution needs to be exercised when PROVIGIL is coadministered with drugs that depend on these three enzymes for their clearance.

Specifically, lower blood levels of such drugs could result See Other Drugs, Cyclosporine above. The exposure of human hepatocytes to modafinil in vitro produced an apparent concentration-related suppression of expression of CYP2C9 activity suggesting that there is a potential for a metabolic interaction between modafinil and the substrates of this enzyme e. In vitro studies using human liver microsomes showed that modafinil reversibly inhibited CYP2C19 at pharmacologically relevant concentrations of modafinil.

CYP2C19 is also reversibly inhibited, with similar potency, by a circulating metabolite, modafinil sulfone.

Although the maximum plasma concentrations of modafinil sulfone are much lower than those of parent modafinil, the combined effect of both compounds could produce sustained partial inhibition of the enzyme.

CYP2C19 also provides an ancillary pathway for the metabolism of certain tricyclic antidepressants e. In tricyclic-treated patients deficient in CYP2D6 i. Physicians should be aware that a reduction in the dose of tricyclic agents might be needed in these patients.

The highest dose studied is 1. There was no evidence of tumorigenesis associated with modafinil administration in Provigil Generic Dose studies. However, since Generci mouse study used an inadequate high dose that was not representative of a maximum tolerated dose, a subsequent carcinogenicity study was conducted in the Tg.

AC transgenic mouse. Doses evaluated in the Tg. There was no evidence of tumorigenicity associated with modafinil administration; however, this dermal model may not adequately assess the carcinogenic potential of an orally administered drug.

Modafinil demonstrated no evidence of mutagenic or clastogenic potential in a series Provigil Generic Dose in vitro i. Modafinil was also negative in the unscheduled DNA synthesis assay in rat hepatocytes.

In studies conducted in rats and rabbits, developmental toxicity was observed at clinically relevant exposures. The higher no-effect dose for rat embryofetal developmental toxicity was associated with a plasma modafinil exposure approximately 0. The no-effect dose for rat embryofetal developmental toxicity was associated with a plasma armodafinil exposure AUC approximately one-tenth times the AUC Provigil Generic Dose armodafinil in humans treated with modafinil at the RHD.

No effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring. There are no adequate and well-controlled studies in pregnant women. Two cases of intrauterine growth retardation and one case of spontaneous abortion have been reported in association with armodafinil and modafinil. Although the pharmacology of modafinil and armodafinil is not identical to that of the sympathomimetic amines, they do share some Dosw properties with this class.

Certain of these drugs have been associated with intrauterine growth retardation and spontaneous abortions. Whether the oDse reported are drug-related is unknown. Modafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The Provigil Generic Dose of modafinil on labor and delivery in humans has not been systematically investigated.

It is not known whether modafinil or its metabolites are excreted in human milk. Safety and effectiveness in pediatric patients, below age 16, have not been established.

There were no statistically significant differences favoring modafinil over placebo in prolonging sleep latency as measured by MSLT, or in perceptions of sleepiness as determined by the clinical global impression-clinician scale CGI-C. In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourette's Provigil Generic Dose, insomnia, hostility, increased cataplexy, increased hypnagogic Progigil and suicidal ideation.

Transient leukopenia, which resolved without medical intervention, was also observed. In the controlled clinical study, 3 of 38 girls, ages 12 or older, treated with modafinil experienced dysmenorrhea compared to 0 of 10 girls who received placebo.

Safety and effectiveness Gdneric individuals above 65 years of age have not been established. Experience in a limited number of patients who were greater than 65 years of age in clinical trials showed an incidence of adverse Peovigil similar to other age groups. Modafinil has been evaluated for safety in over patients, of whom more than patients with excessive sleepiness associated with primary disorders of sleep and wakefulness were given Prvigil least one dose of modafinil.

In clinical trials, modafinil has been found to be generally well tolerated and most adverse experiences were mild to moderate.

The adverse event profile was similar across these studies. The Proviil should be aware that the figures provided below cannot be used to predict the frequency of adverse experiences in the course of usual medical practice, where patient characteristics and other factors may differ from those occurring during clinical studies. Similarly, the cited frequencies Pgovigil be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators.

Review of these frequencies, however, provides prescribers with a basis to estimate the relative contribution of drug and non-drug factors to the incidence of adverse events in the population studied. These events included the following: infection, pain, accidental injury, abdominal pain, hypothermia, allergic reaction, asthenia, fever, viral infection, neck pain, migraine, abnormal electrocardiogram, hypotension, tooth disorder, vomiting, periodontal abscess, increased appetite, ecchymosis, hyperglycemia, peripheral edema, Geneeic loss, weight gain, myalgia, leg cramps, arthritis, cataplexy, thinking abnormality, sleep disorder, increased cough, sinusitis, dyspnea, bronchitis, rash, conjunctivitis, ear pain, dysmenorrhea 4urinary tract infection.

There were no clinically significant differences in body weight change in patients treated with PROVIGIL compared to placebo-treated patients in the placebo-controlled clinical trials.

Clinical chemistry, hematology, and urinalysis parameters were monitored in Phase 1, 2, and 3 studies. No differences were apparent in alanine aminotransferase, aspartate aminotransferase, total protein, albumin, or total bilirubin. Because these reactions are reported voluntarily from a population of uncertain size, it is not Provgiil to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of Genwric following factors: 1 seriousness of the reaction, 2 frequency of the reporting, or 3 strength of causal connection to PROVIGIL.

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 withdrawal 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.

In addition, several intentional acute overdoses Generid the two largest being mg and mg taken by two subjects participating in foreign depression studies. None of these study subjects experienced any unexpected or life-threatening effects. Adverse experiences that were reported at these doses 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.

From post-marketing experience, there have been no reports of fatal overdoses involving modafinil alone doses up to 12 grams. Overdoses involving multiple drugs, including modafinil, have resulted in fatal outcomes.

Symptoms most often accompanying modafinil overdose, alone or in combination with other drugs have included: insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension and chest pain. The child remained stable. The symptoms associated with overdose in children were similar to those observed in adults.

No specific antidote to the toxic effects of Peovigil 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 Provigul. 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 Provigil Generic Dose. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

PROVIGIL is a prescription medicine used to improve awakeness in adults who are very sleepy due to one Provigil Generic Dose the following diagnosed sleep problems:. Sleepiness can be a symptom of other medical conditions that need to be treated. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Modafinil (Oral Route) Proper Use - Mayo Clinic

Tell your doctor about all of your health conditions including, if you:. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially, tell your doctor if you use a hormonal birth control method. Hormonal birth control methods include pills, shots, implants, patches, vaginal rings, and intrauterine devices IUDs.

Keep a list of all the medicines you take. Call your doctor or get emergency help if you get any of the following:. The most common side effects of PROVIGIL are headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, Provigil Generic Dose sleeping, dizziness, and upset stomach.

For more information, ask your doctor or pharmacist.

Provigil (Modafinil) - Oral

Medicines are sometimes prescribed for conditions that are not listed in patient information leaflets. It may harm them and it is against Gensric law. If you would like more information, talk with your doctor. For more information, please callor go to www. Inactive Ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Provigil Generic Dose browser, or e-mail depending on the Proovigil Reader you select to use.

The recommended dosage of PROVIGIL for patients with narcolepsy or OSA is mg taken orally once a day as a single dose in the morning. Obstructive Sleep Apnea. Indicated to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea (OSA). mg PO qAM.

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImagewe no longer display the RxImage pill images associated with drug labels.

We anticipate reposting Geheric images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. The chemical structure is: Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. Mechanism of Action and Pharmacology The precise mechanism s through which modafinil promotes wakefulness is unknown. 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 Provugil The influence of race on the pharmacokinetics of modafinil has not been studied. Hepatic Impairment: Pharmacokinetics and metabolism were examined in patients with cirrhosis of the liver 6 males and 3 females.

Table Gfneric. Table 2. Serious Rash, including Stevens-Johnson Syndrome Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil.

Angioedema and Anaphylactoid Reactions One serious case of angioedema and one case of hypersensitivity with rash, dysphagia, and bronchospasmwere observed among 1, patients treated with armodafinil, the R enantiomer of modafinil which is the racemic mixture. Multi-organ Hypersensitivity Reactions Multi-organ hypersensitivity reactions, including at least Provigil Generic Dose fatality in postmarketing experience, have occurred in close temporal association median time to detection 13 days: range to the initiation of modafinil.

Psychiatric Symptoms Psychiatric adverse experiences have been reported in patients treated with modafinil. General Although modafinil has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Cardiovascular System Modafinil has not been evaluated in patients with a recent history Provigil Generic Dose myocardial infarction or unstable angina, and such patients should be treated with caution.

Patients with Severe Renal Impairment There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment. Elderly Patients In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging.

Pregnancy Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Nursing Patients should be advised to notify their physician if they are breastfeeding 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 and other drugs.

Allergic Reactions Patients should be advised to stop taking PROVIGIL and Provigil Generic Dose notify their physician if Privigil develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing or a related allergic phenomenon.

Drug Interactions CNS Active Drugs Methylphenidate In a single-dose study in healthy volunteers, Provigil Generic Dose administration of modafinil mg with methylphenidate 40 mg did not cause any significant alterations in the pharmacokinetics of either drug.

Dextroamphetamine In a single dose study in healthy volunteers, simultaneous administration Porvigil modafinil mg with dextroamphetamine 10 mg did not cause any significant alterations in the pharmacokinetics of either drug. Cyclosporine One case of an interaction between modafinil and cyclosporine, Dos substrate of CYP3A4, has been reported in a 41 year old woman who had undergone an organ transplant.

Tricyclic antidepressants CYP2C19 also provides an ancillary pathway for the metabolism of certain tricyclic antidepressants e.

Provigil is used to treat sleepiness caused by sleep apnea or narcolepsy. Learn about side effects, interactions and indications. Recommended Provigil Dosage instructions for studying, focus and ADHD. What is the maximum safe dose for adults and how to prevent tolerance?

Mutagenesis Modafinil demonstrated no evidence of mutagenic or clastogenic potential in a series of in vitro i. Pregnancy Category C: In studies conducted in rats and rabbits, developmental toxicity was observed at clinically relevant exposures. Table 3. Weight Changes There were no clinically significant differences in body weight change in patients treated with PROVIGIL compared to placebo-treated patients in the placebo-controlled clinical trials.

Laboratory Changes Clinical chemistry, hematology, and urinalysis parameters were monitored in Phase 1, 2, and 3 studies. Hematologic: agranulocytosis. Provigil Generic Dose 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.

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. Manufactured for: Cephalon, Inc. Frazer, PA U. Patent Nos. Tulsa, OK Source PROVIGIL and call your doctor right away or get emergency treatment if you have any of the following: skin rash, hives, sores in your mouth, or your skin blisters and peels swelling of your face, eyes, lips, tongue, or throat trouble swallowing or breathing hoarse voice 2.

It is important that you continue to use your CPAP machine while sleeping. Follow your doctor's advice about good sleep habits and using other treatments. The active ingredient is modafinil. See the end of this leaflet for a complete list of ingredients. Tell your doctor about all of your health conditions including, if you: have a history of mental health problems have heart problems or had a heart attack have high blood Provigil Generic Dose have liver or kidney problems have a history of drug or alcohol abuse or addiction have ever had a mental problem called psychosis.

If you take more than Provigil Generic Dose prescribed dose or overdose, call your doctor or poison control center right away. It is very important that you read and understand this Provigil Generic Dose. Be sure to ask your doctor about anything you do not understand. This medicine does not take the place of getting enough sleep. It should not be used for occasional sleepiness that has not been diagnosed as narcolepsy, sleep apnea, or shift work sleep problems.

Ask your doctor for advice about good sleep habits. If you have sleep apnea and use a continuous positive airway pressure CPAP machine at night, continue using this machine with modafinil. Take this medicine at the same time each day. Do not change the time of day you take modafinil without talking first with your doctor. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label.

The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. If you miss a dose of this medicine, skip the missed dose and go back Autoimmune Fatigue For Provigil Provigil Generic Dose regular dosing schedule.

Do not double doses. If you miss a dose of modafinil and you remember it before noon the same day, take the missed dose as soon as possible. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. There is a problem with information submitted for this request. Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID, plus expertise on managing health.

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The recommended starting daily dose is mg. The total daily dose may be taken as a single dose in the morning or as two doses, one in the morning and one at. Provigil (modafinil) is a prescription medication. It's most often used to treat excessive sleepiness caused by narcolepsy, obstructive sleep.

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