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Anoro Ellipta

Anoro Ellipta

umeclidinium + vilanterol

Manufacturer:

GlaxoSmithKline Indonesia
Concise Prescribing Info
Contents
Per pre-dispensed dose Umeclidinium 62.5 mcg, vilanterol trifenatate 25 mcg
Indications/Uses
Maintenance bronchodilator treatment to relieve symptoms associated w/ COPD.
Dosage/Direction for Use
Adult 1 inhalation once daily. Administer at the same time each day.
Contraindications
Hypersensitivity. Patients w/ severe milk-protein allergy.
Special Precautions
Not to be used in patients w/ asthma. Discontinue treatment if paradoxical bronchospasm occurs. Not for treatment of acute episodes of bronchospasm. Re-evaluate patient & treatment regimen in the event of COPD deterioration during treatment. Patients w/ severe CV disease; urinary retention or narrow-angle glaucoma; convulsive disorders or thyrotoxicosis & in those who are unusually responsive to β2-adrenergic agonists. Concomitant use w/ other drugs that have potential to cause hypokalaemia. Closely monitor plasma glucose in diabetic patients upon initiation of treatment. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Severe hepatic impairment. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
UTI, sinusitis, nasopharyngitis, pharyngitis, URTI; headache; cough, oropharyngeal pain; constipation, dry mouth.
Drug Interactions
May potentiate adverse reactions w/ other long-acting muscarinic antagonists & β2-adrenergic agonists. May potentiate possible hypokalaemic effect w/ methylxanthine derivatives, steroids or non-K-sparing diuretics. Vilanterol: May weaken or antagonize effect w/ either non-selective or selective β-adrenergic blockers. May inhibit metabolism & increased systemic exposure w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin).
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AL03 - vilanterol and umeclidinium bromide ; Belongs to the class of combination of adrenergics with anticholinergics, that may also include a corticosteroid. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Anoro Ellipta 62.5 mcg/25 mcg inhalation powd
Packing/Price
((30 doses)(pre-dispensed)) 1's
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