Spiolto Respimat

Spiolto Respimat

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per puff Tiotropium 2.5 mcg, olodaterol 2.5 mcg
Indications/Uses
Long term & once-daily maintenance treatment in COPD patients (including chronic bronchitis & emphysema) in reduction of airflow obstruction, associated dyspnoea & exacerbations, to improve quality of life & exercise tolerance.
Dosage/Direction for Use
Adult 2 puffs once daily at the same time of the day.
Contraindications
Hypersensitivity to tiotropium or olodaterol, or atropine or its derivatives eg, ipratropium or oxitropium.
Special Precautions
Hypersensitivity reactions. Discontinue treatment if paradoxical bronchospasm & CV effects occur. Not to be used more frequently than once daily & in asthma. Not for treatment of acute episodes of bronchospasm ie, rescue therapy. 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 QT interval; who are unusually responsive to sympathomimetic amines. Potentiated hypokalaemia in patients w/ severe COPD. Hyperglycemia. Avoid contact w/ eyes. Not to be used in conjunction w/ other medication containing β2-adrenergic agonists. Concomitant use w/ inhaled, short acting β2-adrenergic agonists on a regular basis (eg, 4x daily). May affect ability to drive & use machines. Moderate to severe renal impairment (CrCl <50 mL/min). Severe hepatic impairment. Avoid use during pregnancy. Not to be used during lactation.
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; mild dry mouth, constipation, oropharyngeal candidiasis, dysphagia, GERD, gingivitis, glossitis, stomatitis, intestinal obstruction including ileus paralytic; 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
Not recommended in concomitant use w/ anticholinergics. Potentiated undesirable effects w/ adrenergic agents. Potentiated hypokalemic effect by xanthine derivatives, steroids, or non-K sparing diuretics. Weakened or antagonized effect by β-adrenergic blocker. Potentiated action by MAOIs, or TCAs or other drugs prolonging QTc interval. Increased systemic exposure w/ 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
Packing/Price
((60 puffs)) 1's
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