Relvar Ellipta衛呼

Relvar Ellipta

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
100/25 mcg inhalation Fluticasone furoate 100 mcg, vilanterol trifenatate 25 mcg. 200/25 mcg inhalation Fluticasone furoate 200 mcg, vilanterol trifenatate 25 mcg
Indications/Uses
Regular treatment of asthma in patient ≥12 yr where use of a combination medicinal product is appropriate: patients not adequately controlled w/ inhaled corticosteroids & "as needed" inhaled short acting β2-agonists (SABA); patients already adequately controlled on both inhaled corticosteroid & long-acting β2-agonist (LABA). 100/25 mcg inhalation: Symptomatic treatment of adult w/ COPD w/ FEV1 <70% predicted normal (post-bronchodilator) w/ an exacerbation history despite regular bronchodilator therapy.
Dosage/Direction for Use
Asthma Adult & adolescent ≥12 yr 1 inhalation of 100/25 mcg once daily, may be increased to a max dose of 200/25 mcg once daily. COPD Adult ≥18 yr 1 inhalation of 100/25 mcg once daily.
Special Precautions
Do not use to treat acute asthma symptoms or an acute exacerbation in COPD. Risk of paradoxical bronchospasm; cardiac arrhythmias eg, supraventricular tachycardia & extrasystoles; visual disturbances; pneumonia. Caution in patients w/ severe CV disease or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum K; patients w/ pulmonary TB or w/ chronic or untreated infections. Systemic effects may occur w/ inhaled corticosteroids particularly at high doses prescribed for long periods. Increases in blood glucose levels in diabetic patients. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Patients w/ hepatic impairment. Pregnancy & lactation. 200/25 mcg inhalation: Not indicated for patients w/ COPD.
Adverse Reactions
Headache; nasopharyngitis. Pneumonia, upper resp tract infection, bronchitis, influenza, candidiasis of mouth & throat; oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia; abdominal pain; arthralgia, back pain, fractures, muscle spasms; pyrexia.
Drug Interactions
Weakened or antagonised effect w/ β2-adrenergic blockers. Increased systemic exposure w/ strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, cobicistat-containing products). Potentiated adverse reactions w/ other sympathomimetic drugs.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AK10 - vilanterol and fluticasone furoate ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Relvar Ellipta inhalation powd 200/25 mcg
Packing/Price
14's;30's
Form
Relvar Ellipta inhalation powd 100/25 mcg
Packing/Price
14's;30's
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