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糠酸氟替卡松喷鼻剂(Veramyst)

2009-08-31 17:35:22  作者:新特药房  来源:中国新特药网  浏览次数:441  文字大小:【】【】【
简介: 氟替卡松的新一代产品“Veramyst”,该品是一只含微粉化糠酸氟替卡松水混悬液的鼻腔喷雾剂,其适应症比其他鼻腔用类固醇类药物更广,包括有季节性和常年性过敏性鼻炎;用于缓解包括眼睛和鼻腔刺痒 ...
氟替卡松的新一代产品“Veramyst”,该品是一只含微粉化糠酸氟替卡松水混悬液的鼻腔喷雾剂,其适应症比其他鼻腔用类固醇类药物更广,包括有季节性和常年性过敏性鼻炎;用于缓解包括眼睛和鼻腔刺痒的各种过敏症状,而不仅仅针对鼻腔过敏症状。无论是对专利药还是对仿制药而言,该药物所具有的缓解眼睛过敏症状的能力,是该药物和目前现有的鼻腔用类固醇类药物差异化的重要一点。

Veramyst Side Effects
Generic name: fluticasone nasalSide Effects of Veramyst - for the consumer

Veramyst Spray
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Veramyst Spray:Back pain; cough; headache; minor nosebleed; sore throat.
Seek medical attention right away if any of these SEVERE side effects occur when using Veramyst Spray:
Severe allergic reactions (rash; hives; itching; difficulty breathing; 
tightness in the chest; swelling of the mouth, face, lips, or tongue); 
fever; severe or persistent nosebleed; severe or persistent pain in the nose or throat; slow wound healing; vision changes.

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For the professional

Veramyst
The most common adverse reactions (>1% incidence) included headache, epistaxis, pharyngolaryngeal pain, nasal ulceration, back pain, pyrexia, and cough. (6.1)
       
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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By body system

Endocrine side effects
Endocrine side effects have included suppression of the hypothalamic-pituitary-adrenal axis. The risk of adrenalsuppression is less than that associated with systemic corticosteroids and should be of concern only when using higher than recommended doses. Slight suppression of plasma cortisol has been noted following 250 mcg intranasal doses of fluticasone.
Due to extensive first-pass metabolism of fluticasone to an inactive carboxylic acid, significant systemic effects are not expected from any amount of the drug that may be swallowed via intranasal administration of normally recommended dosages. In one study involving 61 patients, no significant difference was demonstrated in the hypothalamic-pituitary-adrenal axis function among patients given intranasal fluticasone 200 mcg/day or placebo for 1 year.
       
Local side effects
Local side effects have included nasal irritation including burning, dryness, and soreness in 1% to 6% of patients. Nose bleed has been reported in up to 15% of treated patients and sore throat in 2%. 
Intranasal fluticasone may also cause sneezing. Nasal candidiasis has been reported in at least one patient. Alteration or loss of sense of taste or smell has been reported rarely. Nasal septal perforation has also been reported rarely.
       
Nervous system side effects
Nervous system adverse effects have included headache in 2% to 4% ofpatients. Some studies have reported headache in as many as 32% of patients. Dizziness has also been reported.
       
Gastrointestinal side effects
Gastrointestinal side effects have included nausea, vomiting, and dry mouth.
       
Hypersensitivity side effects
Hypersensitivity side effects have included postmarketing reports of a systemic eosinophilic condition. Clinical features of this condition have included a vasculitis consistent with Churg-Strauss syndrome, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy.    Theseeventshaveusuallybeenassociatedwithareductionand/ordiscontinuation of oral corticosteroid therapy following introduction of fluticasone.
Rarely, hypersensitivity reactions have been reported including angioedema, rash, face and tongue edema, pruritus, urticaria, bronchospasm, wheezing, dyspnea and anaphylaxis.
Cases of serious eosinophilic conditions also have been reported with other inhaled corticosteroids in this clinical setting.
      
Ocular side effects
Ocular side effects have included occasional reports of posterior capsular cataracts with inhaled corticosteroids.
      
Immunologic side effects
In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its decision regarding the labeled risks of the use of inhaled corticosteroids during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications of viral infections.
The danger of infections from immune suppression associated with inhaled corticosteroids has been debated. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled fluticasone.

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