Stati Uniti - inglese - NLM (National Library of Medicine)

direct_rx - armodafinil (unii: v63xwa605i) (armodafinil - unii:v63xwa605i) - armodafinil tablets are 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 tablets are 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 tablets for excessive sleepiness. armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)]. 8.1 pregnancy risk summary limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes. intrauterine growth restriction and spontaneous abortion have been reported in association with armoda

Stati Uniti - inglese - NLM (National Library of Medicine)

hikma pharmaceutical - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets, usp, are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. in osa, modafinil tablets, usp are indicated as an adjunct to standard treatment(s) 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 modafinil tablets, usp. if modafinil tablets usp are used adjunctively with cpap, the encouragement of and periodic assessment of cpap compliance is necessary. in all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness. the effectiveness of modafinil in long-term use (greater than 9 weeks in narcolepsy clinical trials and 12 weeks in osa an

Stati Uniti - inglese - NLM (National Library of Medicine)

par pharmaceutical inc. - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil 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 and during treatment with modafinil for excessive sleepiness. modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r- and s-modafinil) and armodafinil (the r-enantiomer of modafi

Stati Uniti - inglese - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets are 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 and during treatment with modafinil tablets for excessive sleepiness. modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . teratogenic effects pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r- and s-modaf

Stati Uniti - inglese - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - armodafinil (unii: v63xwa605i) (armodafinil - unii:v63xwa605i) - armodafinil 50 mg - armodafinil tablets are 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 tablets are 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 tablets for excessive sleepiness. armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . risk summary limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes. intrauterine growth restriction and spontaneous abortion have been reported in association with armodafinil and mod

Stati Uniti - inglese - NLM (National Library of Medicine)

avkare - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets are 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 and during treatment with modafinil tablets for excessive sleepiness. modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions ( 5.1 , 5.2 , 5.3 )]. pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r-an

Stati Uniti - inglese - NLM (National Library of Medicine)

avpak - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets are 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 and during treatment with modafinil tablets for excessive sleepiness. modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . teratogenic effects pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant

Stati Uniti - inglese - NLM (National Library of Medicine)

american health packaging - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets are 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 and during treatment with modafinil tablets for excessive sleepiness. modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)]. teratogenic effects pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r- and s-modafinil) and armodafinil (the r-enantiomer of modafinil). although the pharmacology of modafinil is not identical to that of the sympathomimetic amines, it does share some pharmacologic properties with this class. certain of these drugs have been associated with intrauterine growth restriction and spontaneous abortions. whether the cases reported with modafinil are drug-related is unknown. in studies of modafinil and armodafinil conducted in rats (modafinil, armodafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant plasma exposures. modafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis caused, in the absence of maternal toxicity, an increase in resorptions and an increased incidence of visceral and skeletal variations in the offspring at the highest dose tested. the higher no-effect dose for embryofetal developmental toxicity in rats (100 mg/kg/day) was associated with a plasma modafinil auc less than that in humans at the recommended human dose (rhd) of modafinil (200 mg/day). however, in a subsequent study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed. oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in increased incidences of fetal visceral and skeletal variations and decreased fetal body weight at the highest dose tested. the highest no-effect dose for embryofetal developmental toxicity in rats (200 mg/kg/day) was associated with a plasma armodafinil auc less than that in humans at the rhd of modafinil. modafinil administered orally to pregnant rabbits throughout organogenesis at doses of up to 100 mg/kg/day had no effect on embryofetal development; however, the doses used were too low to adequately assess the effects of modafinil on embryofetal development. in a subsequent developmental toxicity study evaluating doses of 45, 90, and 180 mg/kg/day in pregnant rabbits, the incidences of fetal structural alterations and embryofetal death were increased at the highest dose. the highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma modafinil auc similar to that in humans at the rhd of modafinil. modafinil administration to rats throughout gestation and lactation at oral doses of up to 200 mg/kg/day resulted in decreased viability in the offspring at doses greater than 20 mg/kg/day, a dose resulting in a plasma modafinil auc less than that in humans at the rhd of modafinil. no effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring. it is not known whether modafinil or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when modafinil is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. modafinil is not approved in this population for any indication. serious skin rashes, including erythema multiforme major (emm) and stevens-johnson syndrome (sjs) have been associated with modafinil use in pediatric patients [see warnings and precautions (5.1)]. in a controlled 6-week study, 165 pediatric patients (aged 5 to 17 years) with narcolepsy were treated with modafinil (n=123), or placebo (n=42). 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 reactions of the psychiatric and nervous system included tourette’s syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations, 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. there were three 7 to 9 week, double-blind, placebo-controlled, parallel group studies in children and adolescents (aged 6 to 17 years) with attention-deficit hyperactivity disorder (adhd). two of the studies were flexible-dose studies (up to 425 mg/day), and the third was a fixed-dose study (340 mg/day for patients <30 kg and 425 mg/day for patients ≥30 kg). although these studies showed statistically significant differences favoring modafinil over placebo in reducing adhd symptoms as measured by the adhd-rs (school version), there were 3 cases of serious rash including one case of possible sjs among 933 patients exposed to modafinil in this program. modafinil is not approved for use in treating adhd. in clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups. in elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. therefore, consideration should be given to the use of lower doses and close monitoring in this population [see dosage and administration (2.4) and clinical pharmacology (12.3)]. in patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function [see dosage and administration (2.3) and clinical pharmacology (12.3)]. modafinil, a schedule iv controlled substance. 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). in one placebo-controlled clinical trial, the effects of modafinil withdrawal were monitored following 9 weeks of modafinil use. there were no reported withdrawal symptoms with modafinil during 14 days of observation, although sleepiness returned in narcoleptic patients.

Stati Uniti - inglese - NLM (National Library of Medicine)

actavis pharma, inc. - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets are 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 and during treatment with modafinil tablets for excessive sleepiness. modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions ( 5.1 , 5.2 , 5.3 )]. pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r-and s-modafinil

Stati Uniti - inglese - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use:  in osa, modafinil tablets are 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 and during treatment with modafinil tablets for excessive sleepiness. modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r- and s-modafinil) and armodafinil (the r-ena