Tropex 18 mcg (Inhalation Capsule)

Indications

• Long-term treatment of bronchospasm associated with COPD, chronic bronchitis, and emphysema

Pharmacology

• Tiotropium is a long-acting antimuscarinic agent
• It exhibits pharmacological effects through inhibition of M3-receptors at the smooth muscle leading to bronchodilation
• Prevention of methacholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours

Dosage & Administration

• Recommended dose of Tiotropium Dry Powder Inhaler capsule is 18 mcg once-daily for adults over 18 years
• Contents of the capsule are for oral inhalation and should only be used with the device
• No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients

Interaction

• Concomitant administration with cimetidine resulted in a 20% increase in the AUC 0-4 hour and a 28% decrease in the renal clearance of Tiotropium
• Co-administration with ranitidine did not affect the pharmacokinetics of Tiotropium

Contraindications

• Tiotropium is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, including ipratropium, or to any component of this product

Side Effects

• The most commonly reported adverse drug reaction was dry mouth
• Other reactions included constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention

Pregnancy & Lactation

• Pregnancy Category C - should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Precautions & Warnings

• May potentially worsen symptoms and signs associated with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction
• Should be used with caution in patients with any of these conditions

Overdose Effects

• High doses may lead to anticholinergic signs and symptoms
• No systemic anticholinergic adverse effects following a single inhaled dose of up to 282 mcg in healthy volunteers
• Bilateral conjunctivitis and dry mouth were seen following repeated once-daily inhalation of 141 mcg of Tropex in a study of 12 healthy volunteers

Therapeutic Class

• Anticholinergic bronchodilators

Storage Conditions

• Capsules must not be swallowed
• Avoid storage in direct sunlight or heat
• Store below 30°C
• Keep away from children

Related Brands

• Dilriva 18 mcg (Inhalation Capsule) - unimed-unihealth-pharmaceuticals-ltd
• Tioriva 18 mcg (Inhalation Capsule) - beximco-pharmaceuticals-ltd
• Topium 18 mcg (Inhalation Capsule) - acme-laboratories-ltd