Indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA HANDIHALER is indicated to reduce exacerbations in COPD patients.
Antimuscarinic; Bronchodilator
Tiotropium is a long-acting, antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors, M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3-receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. The bronchodilation following inhalation of Tiotropium is predominantly a site-specific effect.
INHALATION Maintenance therapy In chronic obstructive pulmonary disease: Adult: >18 yr: 1 cap (18 mcg of tiotropium) inhaled daily, w/ the Inhalation device, at the same time of day.
An interaction study with Tiotroplum (14.4 mcg intravenous infusion over 15 minutes) and cimetidine 400 mg three times daily or ranitidine 300 mg once daily was conducted. Concomitant administration of cimetidine with Tiotroplum resulted in a 20% increase in the AUC 0-4 hour, a 28% decrease in the renal clearance of Tiotroplum and no significant change in the Cmax and amount excreted in urine over 96 hours. Co-administration of Tiotroplum with ranitidine did not affect the pharmacokinetics of Tiotroplum.
Hypersensitivity to atropine & its derivatives (e.g. ipratropium). Narrow-angle glaucoma: prostatic hypertrophy or bladder-neck obstruction; renal impairment. Pregnancy & lactation. Discontinue If immediate hypersensitivity (e.g. angioedema) or paradoxical bronchospasm occurs. Discontinue If eye pain, red eye, visual halos, & other signs of acute narrow-angle glaucoma.
Dry mouth, constipation, cough & local irritation, tachycardia. urinary retention, UTI, upper resp tract infection, hypersensitivity reactions, pupil dilation, blurred vision, myalgia, dyspepsia, rash. Pharyngitis, sinusitis, rhinitis & epistaxis reported w/ the use of inhalation powder.
Use should be avoided during pregnancy. Use is not recommended while breastfeeding unless the benefit to mother outweighs the potential risk to the infant.
High doses of Tiotropium may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 282 mcg Tiotropium in 6 healthy volunteers. In a study of 12 healthy volunteers, bilateral conjunctivitis and dry mouth were seen following repeated once-daily inhalation of 141 mcg of Tiotropium
Tiotropium Dry Powder Inhaler capsules must not be swallowed. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from children.
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