藥品名稱
drug name
Levocetirizine (Xyzal / Levozine(舊名), 驅異樂膜衣錠) 5 mg/tab
藥檔狀態使用中
成  份
Ingredient
Levocetirizine dihydrochloride
單位含量5 mg/tab
Dosage FormsFilm-coated tablet: 5 mg
外觀描述橢圓形 白色 口服/錠劑
Appearanceoval white oral/tablet
標  示
outward
Y
廠商名稱
Manufacturer
荷商葛蘭素史克藥廠股份有限公司台灣分公司
製 造 商
Manufacturer
UCB FARCHIM S.A., SWITZERLAND
字  號
Product ID
衛署藥輸字第023792號
藥理分類
Pharmacologic Category
Respiratory Agents/ Antihistamines/ Non-Sedation
作用機轉
Mechanism of action
Levocetirizine is an antihistamine which selectively competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract. Levocetirizine, the active enantiomer of cetirizine, has twice the binding affinity at the H1-receptor compared to cetirizine.
用途/適應症抗組織胺,緩解過敏之各種症狀
Use Treatment of symptoms associated with allergic conditions such as seasonal allergic rhinitis and perennial allergic rhinitis
衛福部核准適用症狀
MOHW approved indications
治療成人及六歲以上孩童因過敏性鼻炎、慢性蕁麻疹等所引起的各種過敏徵狀。
Dose Administration: Oral

【Adult】:
5 mg QD (in the evening); some patients may experience relief of symptoms with 2.5 mg QD
In one clinical trial, the titrated use of higher doses (up to 10 mg QD ) in adults demonstrated clinical improvement (Staevska 2010).

【Geriatric】:
Refer to adult dosing; dosing should begin at the lower end of the dosing range.

【Pediatric】:
6 months to 5 years: 1.25 mg QD (in the evening); max: 1.25 mg
6-11 years: 2.5 mg QD (in the evening); max: 2.5 mg/day
≧12 years: 5 mg QD (in the evening); some patients may experience relief of symptoms with 2.5 mg QD


【Dosage Adjustment in Renal Impairment】:
6 months to 11 years with renal impairment: Contraindicated.
≧12 & Adults:
Clcr 50-80 mL/min: 2.5 mg QD
Clcr 30-50 mL/min: 2.5 mg QOD
Clcr 10-30 mL/min: 2.5 mg BIW (every 3 or 4 days)
Clcr <10 mL/min, HD patients: Contraindicated
懷孕分級
Pregnancy Risk Factor
B
Lactation:Enters breast milk/not recommended
禁忌症 1.對levocetirizine、cetirizine、hydroxyzine、piperazine衍生物過敏,或對本藥中任何成分過敏者。
2.需要透析治療的末期腎臟疾病病人(eGFR < 15 ml/min)。
Contraindications Known hypersensitivity to levocetirizine, cetirizine, or any component of the formulation; end-stage renal disease (CrCl <10 mL/minute); hemodialysis
常見副作用昏昏欲睡,口乾,胃痛或噁心
Common adverse drug reactionssleepy, dry mouth, stomachach or nausea
Adverse Reactions >10%:
Gastrointestinal: Diarrhea (children 4% to 13%)

1% to 10%:
Central nervous system: Drowsiness (2% to 6%), fatigue (1% to 4%)
Gastrointestinal: Constipation (children 7%), vomiting (children 4%), xerostomia (2% to 3%)
Neuromuscular & skeletal: Weakness (2%)
Otic: Otitis media (children 3%)
Respiratory: Nasopharyngitis (4% to 6%), cough (children 3%), epistaxis (children 2%), pharyngitis (1% to 2%)
Miscellaneous: Fever (children 4%)

<1% (Limited to important or life-threatening): Aggressive behavior, agitation, anaphylaxis, angioedema, dysuria, fixed-drug eruption, hepatitis, hypersensitivity, increased serum bilirubin, increased serum transaminases, movement disorder (including dystonia and oculogyric crisis), myalgia, nausea, palpitations, paresthesia, pruritus, skin rash, seizure, suicidal ideation, syncope, urinary retention, urticaria, visual disturbances, weight gain
監測
Monitoring
Creatinine clearance (prior to treatment for dosing adjustment)
警語與注意事項酒精性飲料可能加重嗜睡。1130730換廠為"UCB FARCHIM S.A."。
Warnings & precautions 
針劑溶解條件
針劑稀釋條件
針劑不相容性
針劑施打條件
針劑保存安定性 室溫儲存。
最近修改日期時間
Updated
7/30/2024 10:38:16 AM
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