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Pitolisant Dosage

Medically reviewed by Drugs.com. Last updated on Nov 5, 2020.

Applies to the following strengths: 4.45 mg; 17.8 mg

Usual Adult Dose for Narcolepsy

Initial Up Titration: 8.9 mg orally once a day for 1 week, then 17.8 mg orally once a day for 1 week, then may increase to 36 mg orally once a day
-Adjust dose based on patient response and tolerability
Maintenance dose: 17.8 to 35.6 mg/day
Maximum dose: 35.6 mg/day

Comments:
-Total dose should be administered as a single dose in the morning during breakfast.
-It may take up to 8 weeks for some patients to achieve a clinical response.

Use: For the treatment of excessive daytime sleepiness in patients with narcolepsy.

Renal Dose Adjustments

Moderate to severe renal impairment: Initial dose: 8.9 mg orally once a day for 1 week; then increase to 17.8 mg orally once a day; maximum dose: 17.8 mg/day
ESRD (CrCl less than 15 mL/min/1.73 m2): Use is not recommended

Liver Dose Adjustments

Mild Liver Dysfunction (Child-Pugh A): No adjustment recommended
Moderate Liver Dysfunction (Child-Pugh B): Initial dose: 8.9 mg orally once a day for 1 week; then increase to 17.8 mg orally once a day; maximum dose: 17.8 mg/day
Severe Liver Dysfunction (Child-Pugh C): Contraindicated

Dose Adjustments

CYP450 2D6 Poor Metabolizers:
-Initial dose: 8.9 mg orally once a day; titrate to 17.8 mg orally once a day after 7 days; maximum dose: 17.8 mg/day

Coadministration with Strong CYP450 2D6 Inhibitors:
-For patients on a strong CYP450 2D6: Initiate pitolisant at 8.9 mg orally once a day, increase after 7 days to a maximum dosage of 17.8 mg/day
-For patients initiating a strong CYP450 2D6 inhibitor while on a stable dose of pitolisant; reduce pitolisant dose by one-half

Coadministration with Strong CYP450 3A4 Inducers:
-Assess for loss of efficacy of pitolisant after initiation of a strong CYP450 3A4 inducer
-For patients on a stable pitolisant dose of 8.9 mg or 17.8 mg once a day, double the dose over 7 days
-If a strong CYP450 3A4 inducer is discontinued, decrease pitolisant dose by one-half

Precautions

CONTRAINDICATIONS:
-Severe hepatic impairment

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Take orally once a day in the morning during breakfast

Monitoring:
-Monitor QTc prolongation especially in patients with risk factors

Patient advice:
-Patients should be instructed to read approved patient labeling.
-Patients should be instructed to notify their healthcare professional immediately if they feel faint, lose consciousness, or have heart palpitations.
-Patients should be instructed to inform their healthcare provider regarding all medications they are taking as there are possible drug interactions with this product.
-Women of childbearing potential should be advised to use effective non-hormonal contraception during use and for 21-days after discontinuing therapy; this drug may reduce the efficacy of hormonal contraception.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.