Formulary
Pitolisant: Indications, Dosing, Side Effects and Interactions
Pitolisant is a histamine H 3 -receptor antagonist which enhances the activity of brain histaminergic neurons.
MedNext Academy | 3 min read
Pitolisant: Indications, Dosing, Side Effects and Interactions
Pitolisant is a histamine H 3 -receptor antagonist which enhances the activity of brain histaminergic neurons.
Drug action
Pitolisant is a histamine H 3 -receptor antagonist which enhances the activity of brain histaminergic neurons.
Indications and dose
**Narcolepsy with or without cataplexy (initiated by a specialist)**
- **Adult** (By Mouth): Initially 9 mg once daily for 1 week, then increased if necessary to 18 mg once daily for 1 week, then increased if necessary to 36 mg once daily, dose to be taken in the morning with breakfast, dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day) according to response and tolerance.
Cautions
Acid-related gastric disorders; epilepsy; history of psychiatric disorders; severe anorexia; severe obesity
Side effects
Common or very common Anxiety; asthenia; depression; dizziness; gastrointestinal discomfort; headaches; mood altered; nausea; sleep disorders; tremor; vertigo; vomiting Uncommon Appetite abnormal; arrhythmias; arthralgia; blepharospasm; chest pain; concentration impaired; constipation; diarrhoea; drowsiness; dry mouth; epilepsy; feeling abnormal; fluid retention; gastrointestinal disorders; hallucinations; hot flush; hypertension; hypotension; malaise; metrorrhagia; movement disorders; muscle complaints; muscle weakness; oedema; on and off phenomenon; oral paraesthesia; pain; paraesthesia; QT interval prolongation; sexual dysfunction; skin reactions; suicidal ideation; sweat changes; tinnitus; urinary frequency increased; visual acuity decreased; weight decreased (review treatment if significant); weight increased (review treatment if significant); yawning Rare or very rare Behaviour abnormal; cognitive impairment; confusion; loss of consciousness; memory impairment; obsessive thoughts; photosensitivity reaction; sense of oppression; swallowing difficulty
Pregnancy
Manufacturer advises avoid unless potential benefit outweighs risk-toxicity in animal studies.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution in moderate impairment; avoid in severe impairment. Dose adjustments Manufacturer advises consider dose increase two weeks after initiation in moderate impairment; maximum daily dose of 18 mg.
Renal impairment
Dose adjustments Manufacturer advises use with caution; maximum daily dose should not exceed 18 mg.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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