Spiolto Respimat

Spiolto Respimat

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 at the same time daily.
Contraindications
Hypersensitivity to tiotropium, olodaterol, atropine or its derivatives eg, ipratropium or oxitropium.
Special Precautions
Hypersensitivity. Do not exceed recommended dose. Not to be used in asthma & treatment of acute episodes of bronchospasm. Discontinue immediately & substitute alternative therapy if paradoxical bronchospasm occurs. Patients w/ narrow-angle glaucoma, prostatic hyperplasia, bladder-neck obstruction. Avoid contact w/ the eyes. Dry mouth associated w/ dental caries in long-term use. Patients w/ CV disorders, coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, HTN, convulsive disorders or thyrotoxicosis, known or suspected prolongation of the QT interval & those who are unusually responsive to sympathomimetic amines. Discontinue treatment if increases in pulse rate, BP &/or symptoms occur. History of MI, unstable or life-threatening cardiac arrhythmia, diagnosis of paroxysmal tachycardia (>100 beats/min). Hypokalemia. 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). May affect ability to drive or operate machinery. Avoid use during pregnancy. Lactation. Childn.
Drug Interactions
Not recommended to be co-administered w/ anticholinergic-containing drugs. May potentiate the adverse reactions w/ other adrenergic agents. May potentiate hypokalemic effect w/ xanthine derivatives, steroids or non-K sparing diuretics. May weaken or antagonize the effect w/ β-adrenergic blockers. May potentiate the action on system w/ MAOIs, TCAs or other drugs known to prolong QTc interval. 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 inhalation soln 2.5 mcg/2.5 mcg
Packing/Price
(+ cartridge) 60 puff x 1's
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