Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - modafinil, quantity: 100 mg - tablet, uncoated - excipient ingredients: povidone; aluminium magnesium silicate; lactose monohydrate; purified talc; maize starch; croscarmellose sodium; magnesium stearate - modafinil is indicated:,? to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy;,? to treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate;,? as an adjunct to continuous positive airways pressure (cpap) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - modafinil, quantity: 100 mg - tablet, uncoated - excipient ingredients: aluminium magnesium silicate; lactose monohydrate; croscarmellose sodium; povidone; maize starch; magnesium stearate; purified talc - modafinil is indicated:,? to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy;,? to treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate;,? as an adjunct to continuous positive airways pressure (cpap) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - modafinil, quantity: 100 mg - tablet - excipient ingredients: magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; methylcellulose - modafinil is indicated: ? to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy; ? to treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate; ? as an adjunct to continuous positive airways pressure (cpap) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.

United States - English - 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

United States - English - 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

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 armod

United States - English - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - modafinil, quantity: 100 mg - tablet, uncoated - excipient ingredients: purified talc; aluminium magnesium silicate; lactose monohydrate; povidone; croscarmellose sodium; maize starch; magnesium stearate - modafinil is indicated: ? to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy; ? to treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate; ? as an adjunct to continuous positive airways pressure (cpap) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.

United States - English - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - modafinil, quantity: 100 mg - tablet - excipient ingredients: lactose monohydrate; pregelatinised maize starch; croscarmellose sodium; povidone; magnesium stearate; microcrystalline cellulose - modafinil-teva is indicated: to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy; to treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate; as an adjunct to continuous positive airways pressure (cpap) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.