Pitolisant Hydrochloride Tablets Application Scope

Pitolisant hydrochloride tablets, the new and special drug marketed under the brand name WAKIX, are primarily used for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.

Pitolisant Hydrochloride Tablets Characteristics

Ingredients: Each film-coated tablet contains pitolisant hydrochloride equivalent to either 4.45 mg or 17.8 mg of pitolisant.
Properties: Pitolisant is a histamine H3 receptor antagonist/inverse agonist that enhances the activity of histaminergic neurons, thereby promoting wakefulness.

Specification: Available in two strengths: 4.45 mg and 17.8 mg film-coated tablets.
Packaging Specification: Typically supplied in blister packs containing 30 film-coated tablets.
Storage: Store at room temperature, away from moisture and heat.
Expiry Date: Refer to the packaging for the specific expiry date.
Executive Standard: Manufactured in accordance with international pharmaceutical standards.
Approval Number: Refer to the national regulatory authority’s approval number on the packaging.
Date of Revision: Refer to the latest package insert for the date of revision.
Manufacturer: Bioprojet Pharma, 9 rue Rameau, 75002 Paris, France.

Guidelines For The Use Of Pitolisant Hydrochloride Tablets

Dosage and Administration: The recommended starting dose is 8.9 mg once daily in the morning upon waking for one week. The dose may be increased to 17.8 mg once daily for the second week.
Adverse Reactions: Common side effects include insomnia, nausea, and headache.

Medication Limitations

Contraindications: Contraindicated in patients with severe hepatic impairment and those with known hypersensitivity to pitolisant or any of its components.
Precautions: Use with caution in patients with a history of psychiatric disorders, severe renal impairment, or in those taking concomitant medications that prolong the QT interval.

Pitolisant Hydrochloride Tablets Interactions

Pitolisant may interact with other medications metabolized by the CYP2D6 and CYP3A4 enzymes. It may also reduce the effectiveness of hormonal contraceptives; alternative non-hormonal contraceptive methods are recommended.

Note: If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYueMed. It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.