Taiwan-labeled indications: Treatment of seasonal or perennial allergic rhinitis in adults, adolescents, and children 2 years; treatment of symptoms associated with mild to moderate nasal polyps in adults 18 years.
藥理
Intranasal corticosteroid. Mometasone suppresses the formation, release, and activity of inflammatory mediators; inhibits leukocyte migration and reduces vasodilation and vascular permeability, thereby decreasing nasal mucosal inflammation.
藥動學
Intranasal bioavailability is <1%, and plasma concentrations are generally undetectable. Symptom improvement may begin within 11 hours; maximum effect generally occurs within 1 to 2 weeks. Protein binding is 98% to 99%. Extensively metabolized hepatically via CYP3A4; excretion is primarily biliary.
禁忌症
Hypersensitivity to mometasone or any component of the formulation.
懷孕分類
No formal pregnancy category is assigned. Usual-dose intranasal corticosteroids have not been associated with increased fetal-malformation or preterm-birth risk. Mometasone is likely acceptable because systemic exposure is minimal, although agents with more pregnancy data may be preferred.
哺乳分類
No formal lactation category is assigned. It is unknown whether mometasone is present in human milk after intranasal use; systemic absorption is <1%. Intranasal mometasone is considered compatible with breastfeeding.
副作用
Headache 26%, viral infection 14%, epistaxis up to 13%, pharyngitis 12%, blood in nasal mucosa up to 11%, cough 7%, and upper respiratory infection 6% to 8%. Serious or uncommon reactions include nasal ulceration, candidiasis, nasal septal perforation, blurred vision, angioedema, and anaphylaxis.
劑量和給藥方法
1. Allergic rhinitis, adults and adolescents 12 years: 2 sprays in each nostril once daily; reduce to 1 spray in each nostril once daily after symptoms are controlled.
2. Allergic rhinitis, children 2 to <12 years: 1 spray in each nostril once daily.
3. Nasal polyps, adults 18 years: 2 sprays in each nostril twice daily; 2 sprays in each nostril once daily may be effective after control.
4. Shake well. Prime with 10 actuations before first use. If unused for 7 days, reprime with 2 actuations or until a fine mist appears. Aim slightly away from the nasal septum; avoid spraying into the eyes or mouth. Clean the nozzle regularly without using pins or sharp objects.
小兒調整劑量
Children 2 to <12 years: 1 spray per nostril once daily. Patients 12 years may receive the adult allergic-rhinitis dose. Safety and efficacy are not established in children <2 years. Nasal-polyp treatment is not established in patients <18 years. Monitor growth during prolonged therapy.
腎功能調整劑量
No dosage adjustment is necessary for any degree of kidney dysfunction, including intermittent hemodialysis, peritoneal dialysis, CRRT, or PIRRT.
肝功能調整劑量
No dosage adjustment recommendation is provided. Systemic concentrations may increase with increasing severity of hepatic impairment; use cautiously.
安定性
Store at 25°C; excursions between 15°C and 30°C are permitted. Protect from prolonged exposure to light. Do not freeze unless permitted by the product-specific package insert. Discard after the labeled number of actuations, even if liquid remains.