pitolisant hydrochloride 4.45 mg

1 INDICATIONS AND USAGE WAKIX is indicated for the: treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy. WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the: treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy ( 1 ) treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy ( 1 )

harmony biosciences, llc

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] fatigue` `[3] nausea` `[4] diarrhoea` `[5] drug ineffective` `[6] dizziness` `[7] headache` `[8] off label use` `[9] pain` `[10] asthenia`

7 months ago

ROUND WHITE S

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied WAKIX (pitolisant) tablets are available as: 4.45 mg: white, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “S” on one side and plain on the other side. NDC 72028-045-03 – Bottles of 30 17.8 mg: white, round, biconvex film-coated tablet, 7.5 mm diameter, marked with “H” on one side and plain on the other side. NDC 72028-178-03 – Bottles of 30 16.2 Storage and Handling Store at 20° C to 25° C (68° F to 77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature].

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