Pitolisant

Generic name: Pitolisant
Brand names: Wakix
Dosage form: oral tablet (17.8 mg; 4.45 mg)
Drug class: CNS stimulants

Usage of Pitolisant

Pitolisant is used to treat excessive daytime sleepiness or cataplexy (sudden loss of muscle strength) in adults with narcolepsy.

Pitolisant may also be used for purposes not listed in this medication guide.

Pitolisant side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Pitolisant may cause serious side effects. Call your doctor at once if you have:

fast or pounding heartbeats;, fluttering in your chest;

shortness of breath; or

sudden dizziness (like you might pass out).

Common side effects of pitolisant may include:

nausea;

anxiety; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Pitolisant

You should not use pitolisant if you are allergic to it, or if you have:

severe liver disease.

Tell your doctor if you have ever had:

liver disease;

kidney disease;

a heart rhythm disorder; or

long QT syndrome (in you or a family member).

Ask a doctor before using pitolisant if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of pitolisant on the baby.

Pitolisant can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using pitolisant, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 21 days after your last dose of pitolisant.

Pitolisant is not approved for use by anyone younger than 18 years old.

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How to use Pitolisant

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 tolerabilityMaintenance 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.

Warnings

You should not use pitolisant if you have severe liver disease.

What other drugs will affect Pitolisant

When you start or stop taking pitolisant, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Pitolisant can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may affect pitolisant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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