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FDA批准左西替利嗪可以用于6个月以上的儿童的新适应证
2013-10-21 08:53:28 来源: 作者: 【 】 浏览:707次 评论:0

2009年,美国FDA批准了UCB和Sanofi—Aventis两公司共同销售的二盐酸左西替利嗪(1evocetirizine dihydrochloride/Xyzal)三种新适应证,即用于缓解≥6个月幼儿的常年性变应性鼻炎和慢性特发性荨麻疹症状及用于缓解≥2岁儿童的季节性变应性鼻炎症状。二盐酸左西替利嗪不应用于肾功能受损儿科人群,其在1~5岁幼儿和儿童患者中的副反应可能包括发热、腹泻、呕吐和耳感染;在6~12个月婴、幼儿患者中的副反应可能包括腹泻和便秘。
XYZAL ORAL SOLUTION
Generic Name and Formulations:
Levocetirizine dihydrochloride 0.5mg/mL.

Company:
UCB and Sanofi Aventis
Indications for XYZAL ORAL SOLUTION:
Seasonal allergic rhinitis (for patients ≥2 years old). Perennial allergic rhinitis, chronic idiopathic urticaria (for patients ≥6 months old).

Adult Dose for XYZAL ORAL SOLUTION:
2.5mg–5mg once daily in the PM. Renal dysfunction: CrCl 50–80mL/min: 2.5mg once daily; CrCl 30–50mL/min: 2.5mg every other day; CrCl 10–30mL/min: 2.5mg twice per week (every 3–4 days); CrCl <10mL/min or hemodialysis: contraindicated.

Children's Dose for XYZAL ORAL SOLUTION:
<6mos: not recommended. 6mos–5yrs: max 1.25mg once daily in the PM. 6–11yrs: max 2.5mg once daily in the PM. Renal dysfunction: contraindicated.

See Also:
XYZAL

Pharmacological Class:
Antihistamine.

Contraindications:
End-stage renal disease (CrCl <10mL/min) or hemodialysis. Impaired renal function (<12yrs of age).

Warnings/Precautions:
Do not exceed recommended dose. Predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia). Discontinue if urinary retention occurs. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:
Avoid alcohol, other CNS depressants. May be potentiated by theophylline. Potentiated by ritonavir.

Adverse Reactions:
Adults: somnolence, nasopharyngitis/pharyngitis, fatigue, dry mouth. Children: pyrexia, somnolence, cough, epistaxis, diarrhea, constipation, vomiting, otitis media.

Metabolism:
Hepatic (minimal).

Elimination:
Renal (primarily), fecal.

Generic Availability:
YES

How Supplied:
Tabs—90; Soln—150mL 

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