Advertisement
Advertisement
Spiolto Respimat Reusable

Spiolto Respimat Reusable

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma

Marketer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Per puff Tiotropium 2.5 mcg, olodaterol 2.5 mcg
Indications/Uses
Long-term, once-daily maintenance treatment of patients w/ COPD (including chronic bronchitis & emphysema) to reduce airflow obstruction, associated dyspnoea & exacerbations; to improve quality of life & exercise tolerance.
Dosage/Direction for Use
Adult including elderly 2 puffs once daily at the same time of the day.
Contraindications
Hypersensitivity to tiotropium, olodaterol, atropine or its derivatives (eg, ipratropium, oxitropium).
Special Precautions
Hypersensitivity. Discontinue immediately if paradoxical bronchospasm; clinically significant CV effect eg, increased pulse rate, BP &/or symptoms occur. Not to be used more than once daily; in patients w/ asthma. Not indicated for acute episodes of bronchospasm eg, 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 QT interval prolongation; unusual responsiveness to sympathomimetic amines. ECG changes eg, T wave flattening & ST segment depression; hypokalaemia; potentiated by hypoxia & concomitant treatment in patients w/ COPD; hyperglycaemia. Avoid contact w/ eyes. May affect ability to drive & use machines. Moderate to severe renal impairment (CrCl <50 mL/min). Severe hepatic impairment. Avoid during pregnancy. Not to be used in nursing women.
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; dry mouth (usually mild), constipation, oropharyngeal candidiasis, dysphagia, GERD, gingivitis, glossitis, stomatitis, intestinal obstruction including paralytic ileus; 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. Arrhythmia, myocardial ischemia, angina pectoris, hypotension, tremor, headache, nervousness, nausea, muscle spasms, fatigue, malaise, hypokalaemia, hyperglycaemia, & metabolic acidosis.
Drug Interactions
Potentiated undesirable effects w/ other adrenergic agents. Potentiated hypokalaemic effect of adrenergic agonists w/ xanthine derivatives, steroids, or non-K-sparing diuretics. Weakened or antagonized effect of olodaterol w/ β-adrenergic blockers. Potentiated action on the CV system w/ MAOIs, TCAs or other drugs known to prolong the QTc interval. 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 Reusable inhalation soln
Packing/Price
((60 puffs)) 1's
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement