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Spiolto Respimat

Spiolto Respimat

Manufacturer:

Boehringer Ingelheim

Distributor:

Metro Drug

Marketer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Per puff Tiotropium Br 2.5 mcg, olodaterol HCl 2.5 mcg
Indications/Uses
Long-term, once-daily maintenance treatment in patients w/ COPD (including chronic bronchitis & emphysema), to reduce airflow obstruction, to improve quality of life, to reduce associated dyspnoea, to improve exercise tolerance & to reduce exacerbations.
Dosage/Direction for Use
Adult 2 puffs once daily at the same time of the day.
Contraindications
Hypersensitivity to tiotropium or olodaterol; atropine or its derivatives (eg, ipratropium or oxitropium).
Special Precautions
Immediate hypersensitivity may occur after administration. Not to be used more frequently than once daily. Not to be used in asthma. Not indicated for acute episodes of bronchospasm (ie, as rescue therapy). Discontinue immediately & substitute alternative therapy if paradoxical bronchospasm occurs. Patients w/ narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction; CV disorders especially coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy & HTN; convulsive disorders or thyrotoxicosis; known or suspected prolongation of the QT interval; patients who are unusually responsive to sympathomimetic amines. Do not allow soln or mist to enter into the eyes. May produce clinically significant CV effects, hypokalaemia, & increases in plasma glucose. Not to be used in conjunction w/ other long-acting β2-adrenergic agonists. Contains benzalkonium Cl which may cause wheezing & breathing difficulties, especially in patients w/ asthma. Avoid potentially hazardous tasks eg, driving or operating machinery if patients experience dizziness & blurred vision. Patients w/ severe hepatic & moderate to severe renal impairment (CrCl ≤50 mL/min). Preferable to avoid use during pregnancy. Not to be used in nursing women unless expected benefit outweighs any possible risk to infant. Safety & effectiveness have not been established in paed population.
Adverse Reactions
Nasopharyngitis; dehydration; dizziness, insomnia; glaucoma, increased IOP, blurred vision; atrial fibrillation, palpitations, supraventricular tachycardia, tachycardia; HTN; cough, epistaxis, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis; usually mild dry mouth, constipation, oropharyngeal candidiasis, dysphagia, GERD, gingivitis, glossitis, stomatitis, intestinal obstruction including paralytic ileus; rash, pruritus, angioneurotic oedema, urticaria, skin infection & ulcer, dry skin, hypersensitivity (including immediate reactions); arthralgia, joint swelling, back pain; urinary retention (usually in men w/ predisposing factors), dysuria, UTI.
Drug Interactions
Chronic co-administration of other anticholinergic drugs is not recommended. Undesirable effects may be potentiated w/ other adrenergic agents. Any hypokalaemic effect of adrenergic agonists may be potentiated w/ xanthine derivatives, steroids, or non-K sparing diuretics. Action on CVS may be potentiated w/ MAOIs, TCAs or QTc prolonging drugs. Olodaterol HCl: Effect may be weakened or antagonized w/ β-adrenergic blockers.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AL06 - olodaterol and tiotropium 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
Spiolto Respimat soln for inhalation
Packing/Price
(refill pack: 4 mL cartridge) 60 puff x 1's (P2,321.1/box); (single pack: Respimat reusable inhaler + 4 mL cartridge) 60 puff x 1's (P2,579/box)
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