氣喘或慢性阻塞性肺病 For >15 years of age
1. Allergic rhinitis (perennial or seasonal): Relief of symptoms of seasonal allergic rhinitis. Because the benefits may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have had an inadequate response or intolerance to alternative therapies<20220111>
2. Prophylaxis and chronic treatment of persistent asthma
3. Prevention of exercise-induced bronchoconstriction
#仿單變更2022

Leukotriene Receptor Antagonist
Montelukast sodium is a selective and active leukotriene receptor antagonist. It binds to cysteinyl leukotrienes (CysLT) type-1 receptors found in human airway (smooth muscle cells and macrophages), which prevents airway edema, smooth muscle contraction and other respiratory inflammation.

Absorption:
Mean oral bioavailability: 64% (for tablets)
Distribution:
Protein binding: ＞99%
Metabolism:
Hepatic; extensively via P450 CYP3A4 and CYP2C9
Excretion:
1. Almost exclusively via bile; Fecal: 86%
2. Elimination half- life: 2.7 -5.5 hr

Hypersensitivity to any component of this product

B

Excretion in breast milk unknown/ use caution

Common:
upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis
Significant: Neuropsychiatric reactions (In most cases, these reactions were reversible upon discontinuation), including
1. Nervous system disorders: disturbance in attention, memory impairment, stuttering, tic disorder, seizure
2. Psychiatric disturbances: agitation, aggressive behavior, anxiety, depression, disorientation, hallucination, irritability, obsessive compulsive disorder, restlessness, suicidal ideation, suicidal tendencies, and completed suicide
3. Sleep disturbances: abnormal dreams, insomnia, somnambulism <20220111>

Allergic rhinitis:
Because the benefits may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have had an inadequate response or intolerance to alternative therapies<20220111>
(Adults and Adolescents ≥15 years) 10 mg once daily
Asthma, maintenance therapy:
Note: In patients with mild persistent asthma, may be used as an alternative first-line controller therapy in those who cannot take an inhaled corticosteroid (ICS) (GINA 2020)
(Adults and Adolescents ≥15 years) 10 mg once daily in the evening
Exercise-induced bronchospasm, prevention:
Note: Additional doses should not be administered within 24 hours. Patients receiving montelukast for another indication should not take an additional dose to prevent exercise-induced bronchoconstriction.
(Adults and Adolescents ≥15 years) 10 mg ≥2 hours prior to exercise; limit to 1 dose every 24 hours

No adjustment necessary.

1. Mild to moderate impairment: No dosage adjustment necessary.
2. Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.