United States - English - 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.

United States - English - 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

United States - English - 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

United States - English - 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

United States - English - NLM (National Library of Medicine)

alembic 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)] .  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 arm

United States - English - NLM (National Library of Medicine)

major pharmaceuticals - 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 (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets, usp 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, usp 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-

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals limited - 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) and arm

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - 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 modafinil. although the pharmacology of armodafinil is not identical to that of the sympathomimetic amines, armodafinil shares some pharmacologic properties with this class [see clinical pharmacology (12.1)] . some sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions. in animal reproduction studies of armodafinil (r-modafinil) and modafinil (a mixture of r-and s-modafinil) conducted in pregnant rats (armodafinil, modafinil) and rabbits (modafinil) during organogenesis, evidence of developmental toxicity (increased embryofetal and offspring mortality, decreased fetal growth) was observed at clinically relevant plasma exposures. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in decreased fetal body weight and increased incidences of fetal variations indicative of growth delay at the highest dose, which was also maternally toxic. the highest no-effect dose for embryofetal developmental toxicity in rat (200 mg/kg/day) was associated with a plasma armodafinil exposure (auc) less than that in humans at the maximum recommended human dose (mrhd) of armodafinil (250 mg/day). modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis produced an increase in resorptions and an increased incidence of fetal variations at the highest dose tested. the higher no-effect dose for embryofetal developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil auc less than that in humans at the mrhd of armodafinil. however, in a subsequent rat study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed. in a study in which modafinil (45, 90, or 180 mg/kg/day) was orally administered to pregnant rabbits during organogenesis, embryofetal death was increased at the highest dose. the highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil auc less than that in humans at the mrhd of armodafinil. 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 armodafinil auc less than that in humans at the mrhd of armodafinil. no effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring. risk summary there are no data on the presence of armodafinil or its metabolites in human milk, the effects on the breastfed infant, or the effect of this drug on milk production. modafinil was present in rat milk when animals were dosed during the lactation period. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for armodafinil and any potential adverse effects on the breastfed child from armodafinil or from the underlying maternal condition. the effectiveness of hormonal contraceptives may be reduced when used with armodafinil and for one month after discontinuation of therapy. advise women who are using a hormonal method of contraception to use an additional barrier method or an alternative non-hormonal method of contraception during treatment with armodafinil and for one month after discontinuation of armodafinil treatment [see drug interactions (7) and clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients have not been established. serious rash has been seen in pediatric patients receiving modafinil [see warnings and precautions (5.1)] . in elderly patients, elimination of armodafinil 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)]. the dosage of armodafinil should be reduced in patients with severe hepatic impairment [see dosage and administration (2.3) and clinical pharmacology (12.3)] . armodafinil is a schedule iv controlled substance. abuse of armodafinil has been reported in patients treated with armodafinil. patterns of abuse have included euphoric mood and use of increasingly large doses or recurrent use of armodafinil for a desired effect. drug diversion has also been noted. during the postmarketing period, misuse of armodafinil has been observed (e.g., taking armodafinil against a physician’s advice, and obtaining armodafinil from multiple physicians). abuse of armodafinil, the active ingredient of armodafinil, poses a risk of overdosage similar to that seen for modafinil, which may lead to tachycardia, insomnia, agitation, dizziness, anxiety, nausea, headache, dystonia, tremor, chest pain, hypertension, seizures, delirium, or hallucinations. other signs and symptoms of cns stimulant abuse include tachypnea, sweating, dilated pupils, hyperactivity, restlessness, decreased appetite, loss of coordination, flushed skin, vomiting, and abdominal pain. 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). physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. physical dependence can occur in patients treated with armodafinil. abrupt cessation or dose reduction following chronic use can result in withdrawal symptoms, including shaking, sweating, chills, nausea, vomiting, confusion, aggression, and atrial fibrillation. drug withdrawal convulsions, suicidality, fatigue, insomnia, aches, depression and headache have also been observed during the postmarketing period. also, abrupt withdrawal has caused deterioration of psychiatric symptoms such as depression. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). multiple cases of development of tolerance to armodafinil have been reported during the postmarketing period.

United States - English - 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

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - 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