Spiolto Respimat

Spiolto Respimat

Manufacturer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Tiotropium 2.5 mcg, olodaterol 2.5 mcg
Indications/Uses
2nd line treatment in patients w/ COPD when tiotropium or olodaterol alone does not provide adequate responses to reduce airflow obstruction, to improve quality of life & to reduce associated dyspnoea.
Dosage/Direction for Use
Adult 2 puffs once daily at the same time of the day.
Contraindications
Hypersensitivity to tiotropium or olodaterol & atropine or its derivatives (eg, ipratropium or oxitropium).
Special Precautions
Hypersensitivity reactions may occur. Not to be used more frequently than once daily. Not to be used in asthma & acute episodes of bronchospasm. Do not initiate in patients w/ acutely deteriorating COPD. Discontinue immediately & substitute alternative therapy if paradoxical bronchospasm occurs. Patients w/ narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction, eye symptoms, CV disorders, coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy & HTN, convulsive disorder or thyrotoxicosis, QT interval prolongation, those unusually responsive to sympathomimetic amines. History of MI, unstable or life-threatening cardiac arrhythmia, heart failure or paroxysmal tachycardia. May produce hypokalemia or hyperglycemia. Contains benzalkonium chloride 0.0011 mg/actuation which may cause wheezing & breathing difficulties. May impair ability to drive or operate machinery. Moderate to severe renal impairment & severe hepatic impairment. Pregnancy & lactation. Childn.
Adverse Reactions
Nasopharyngitis, pneumonia, bronchitis, flu, UTI, sinusitis; cough, dyspnoea; back pain; dry mouth. Arrhythmia, myocardial ischemia, angina pectoris, hypotension, tremor, headache, nervousness, nausea, muscle spasms, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis.
Drug Interactions
Chronic co-administration of other anticholinergic drugs, adrenergic agents, xanthine derivatives, steroids or diuretics. Adrenergic agents may potentiate adverse effects. Xanthine derivatives, steroids & non-K sparing diuretics may potentiate hypokalaemic effects of adrenergic agonists. β-adrenergic blockers may weaken or antagonize effect of olodaterol. MAOIs, TCAs or other drugs known to prolong QTc interval may potentiate action on the CVS. Increased systemic exposure 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 soln for inhalation
Packing/Price
(2.5 mcg/puff (1 inhaler + 1 cartridge)) 60 puff x 1's
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