#特殊劑型：不建議磨粉、管灌藥品

氣喘或慢性阻塞性肺病 For 2-5 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
#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: 73% (for the chewable tablet) in the fasted state
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 the product

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>
1. Perennial: (2 to 5 years) 4 mg once daily
2. Seasonal: (2 to 5 years 4 mg once daily
Asthma, maintenance therapy:
Note: Not preferred therapy for any level of asthma severity; may be considered an alternative option for Step 2 or greater management; inhaled corticosteroids are preferred (GINA 2020)
(2 to 5 years) 4 mg once daily in the evening

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.