Spiolto Respimat史氣順

Spiolto Respimat

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Tiotropium Br, olodaterol HCl
Indications/Uses
Maintenance bronchodilator treatment to relieve symptoms in adult patients w/ COPD.
Dosage/Direction for Use
Adult 2 puffs (5 mcg tiotropium & 5 mcg olodaterol) once daily, at the same time of the day.
Contraindications
Hypersensitivity to tiotropium, olodaterol, atropine or its derivatives eg, ipratropium or oxitropium.
Special Precautions
Should not be used in asthma. Not for treatment of acute episodes of bronchospasm ie, as rescue therapy. Paradoxical bronchospasm. Caution in patients w/ narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Avoid getting the spray into the eyes. Dry mouth, which has been observed w/ anticholinergic treatment, may in the long term be associated w/ dental caries. Patient w/ moderate to severe renal impairment (CrCl ≤50 mL/min). Caution in patients w/ history of MI during the previous yr, unstable or life-threatening cardiac arrhythmia, heart failure during the previous yr or w/ a diagnosis of paroxysmal tachycardia (>100 beats/min); patients w/ CV disorders especially ischaemic heart disease, severe cardiac decompensation, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, HTN & aneurysm, convulsive disorders or thyrotoxicosis, known or suspected prolongation of the QT interval (eg, QT >0.44 s), patients unusually responsive to sympathomimetic amines. Hypokalaemia in patients w/ potential to produce adverse CV effects. Hyperglycaemia. Caution in case of planned operation w/ halogenated hydrocarbon anaesth. Do not use in conjunction w/ other long-acting β2-adrenergic agonists. Immediate hypersensitivity reactions may occur after administration. Do not use more frequently than once daily.
Adverse Reactions
Dizziness, headache, tachycardia, cough, dysphonia, dry mouth.
Drug Interactions
Possible potentiation of undesirable effects w/ other adrenergic agents. Possible potentiation of hypokalemic effect w/ xanthine derivatives, steroids or non-K sparing diuretics. β-blockers may weaken or antagonise the effect of olodaterol. Possible potentiation of action on CV system w/ MAOIs, TCAs or other drugs known to prolong QTc interval.
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 inhalation soln 2.5 mcg/2.5 mcg per puff
Packing/Price
60 puff x 1's
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