Indication:
U.S. FDA APPROVED DRUGS DURING 2019
Sr.No.20.
Name of the Drug- WAKIK
Active Ingredient - Pitolisant
Pharmacological Classification-
To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy
Date of Approval - 8/14/2019
(Ref- FDA approved List 2019 )
NOT AVAILABLE
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
WAKIX® safely and effectively. See full prescribing information for WAKIX. WAKIX® (pitolisant) tablets, for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy
DOSAGE AND ADMINISTRATION
• Administer once daily in the morning upon wakening.
• The recommended dosage range is 17.8 mg to 35.6 mg daily.
Titrate dosage as follows:
o Week 1: Initiate with 8.9 mg once daily
o Week 2: Increase dosage to 17.8 mg once daily
o Week 3: May increase to the maximum recommended dosage of 35.6 mg once daily (
• Hepatic impairment :
o Moderate hepatic impairment: Initial dosage is 8.9 mg once daily. Titrate to a maximum dosage of 17.8 mg once daily after 14 days
• Renal impairment :
o Moderate and severe impairment: Initial dosage is 8.9 mg once daily. Titrate to maximum dosage of 17.8 mg once daily after 7 days o End stage renal disease (ESRD): Not recommended
• Poor Metabolizers of CYP2D6: Maximum recommended dosage is 17.8 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 4.45 mg and 17.8 mg