Spiolto Respimat

Spiolto Respimat

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Per actuation Tiotropium 2.5 mcg, olodaterol 2.5 mcg
Indications/Uses
Maintenance bronchodilator treatment for symptomatic relief in adult patients w/ COPD.
Dosage/Direction for Use
Contraindications
Hypersensitivity to tiotropium, olodaterol, atropine or its derivatives eg, ipratropium or oxitropium.
Special Precautions
Hypersensitivity. Discontinue use if paradoxical bronchospasm occurs. Not to be used in asthma, acute bronchospasm episodes ie, rescue therapy. Patients w/ narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction; CV disorders eg, history of MI, unstable or life-threatening cardiac arrhythmia, hospitalization due to heart failure, paroxysmal tachycardia; ischaemic heart disease, severe cardiac decompensation, hypertrophic obstructive cardiomyopathy, HTN, aneursym; convulsive disorders or thyrotoxicosis, known or suspected QT interval prolongation & patients unusually responsive to sympathomimetic amines. Dry mouth. Hypokalemia, hyperglycemia. May cause wheezing & breathing difficulties due to benzalkonium Cl. Avoid contact w/ eyes. Not to be used in conjunction w/ other long-acting β2-adrenergic agonists-containing medications. Concomitant use w/ halogenated hydrocarbon anaesth. May affect ability to drive & use machines. Moderate to severe renal impairment (CrCl <50 mL/min). Severe hepatic impairment. Avoid use during pregnancy. Lactation. Paed <18 yr.
Drug Interactions
Not recommended w/ anticholinergic agents. Potentiated undesirable effects w/ other adrenergic agents. Potentiated hypokalemic effect w/ xanthine derivatives, steroids or non-K sparing diuretics. Weakened or antagonized effect by β-blockers. Potentiated action on CV system w/ MAOIs, TCAs or other drugs prolonging QTc interval. Increased systemic exposure w/ ketoconazole.
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
Packing/Price
60 puff x 1's
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