Spiolto Respimat re-usable

Spiolto Respimat re-usable

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Tiotropium Br monohydrate 2.5 mcg, olodaterol HCl 2.5 mcg
Indications/Uses
Maintenance bronchodilator treatment to relieve symptoms in adult patients w/ COPD.
Dosage/Direction for Use
Adult 2 puffs once daily at the same time of the day.
Contraindications
Hypersensitivity to tiotropium, olodaterol, atropine or its derivatives (eg, ipratropium or oxitropium).
Special Precautions
Immediate hypersensitivity reactions may occur. Not to be used more frequently than once daily. Not to be used in asthma & for acute episodes of bronchospasm (ie, rescue therapy). Immediately discontinue & substitute alternative therapy if paradoxical bronchospasm occurs. Patients w/ narrow-angle glaucoma, prostatic hyperplasia, bladder-neck obstruction. Avoid contact w/ eyes; discontinue use if precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary vision blurring, visual halos or coloured images in association w/ red eyes from conjunctival congestion & corneal oedema occur. Dry mouth associated w/ dental caries (long-term use). Patients w/ CV disorders, coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, HTN, convulsive disorders or thyrotoxicosis, known or suspected QT interval prolongation & in those who are unusually responsive to sympathomimetic amines. Discontinue treatment if increased pulse rate, BP &/or symptoms occur. History of MI during the previous yr, unstable or life-threatening cardiac arrhythmia, hospitalized for heart failure during the previous yr, or w/ diagnosis of paroxysmal tachycardia (>100 beats/min). Hypokalaemia; may be potentiated by hypoxia in patients w/ severe COPD. May increase plasma glucose. Not to be used in conjunction w/ long-acting β2-adrenergic agonists or long-acting muscarinic antagonists. Contains benzalkonium Cl which may cause wheezing & breathing difficulties. Moderate to severe renal impairment (CrCl ≤50 mL/min). Severe hepatic impairment. Avoid potentially hazardous tasks eg, driving or operating machinery if dizziness &/or blurred vision occur. Avoid use during pregnancy. Lactation. Childn.
Drug Interactions
Not recommended to be co-administered w/ other anticholinergic-containing drugs. Undesirable effects may be potentiated w/ other adrenergic agents. May potentiate hypokalaemic effect w/ xanthine derivatives, steroids or non-K sparing diuretics. May weaken or antagonize olodaterol effect by β-adrenergic blockers. Action on the CV system may be potentiated by MAOIs, TCAs or other QTc prolonging drugs. Increased systemic exposure of olodaterol w/ strong dual CYP & P-gp inhibitor (ketoconazole).
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 re-usable inhalation soln 2.5 mcg/2.5 mcg/puff
Packing/Price
(+ cartridge) 60 puff x 1's
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