Tropex 18 mcg

Description

Indications
Tropex is indicated for the long-term treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is used to help manage symptoms and improve airflow in these conditions.
Take the medicine according to the advice of a registered physician.

Pharmacology
Tiotropium is a long-acting, antimuscarinic agent, commonly referred to as an anticholinergic. It has a similar affinity for the subtypes of muscarinic receptors, M1 to M5. In the airways, it exhibits pharmacological effects by inhibiting M3-receptors in the smooth muscle, leading to bronchodilation. The competitive and reversible nature of this antagonism was demonstrated with both human and animal receptors, as well as isolated organ preparations. In preclinical in vitro and in vivo studies, Tiotropium prevented methacholine-induced bronchoconstriction in a dose-dependent manner, with effects lasting longer than 24 hours. The bronchodilation following inhalation of Tiotropium is predominantly a localized effect in the airways.

Dosage & Administration
For adults over 18 years: The recommended dose is 18 mcg (1 capsule) once daily using the Tiotropium Dry Powder Inhaler device.

The contents of the Tiotropium Dry Powder Inhaler capsules are intended for oral inhalation only and should be used exclusively with the device.

No dosage adjustment is required for geriatric patients or those with liver or kidney impairments. However, patients with moderate to severe renal impairment should be monitored closely for anticholinergic effects.
Take the medicine according to the advice of a registered physician.

Interaction
An interaction study was conducted with Tiotropium (14.4 mcg intravenous infusion over 15 minutes) and cimetidine (400 mg three times daily) or ranitidine (300 mg once daily). Co-administration of cimetidine with Tiotropium resulted in a 20% increase in the AUC (area under the curve) over 0-4 hours, a 28% reduction in renal clearance, and no significant change in Cmax or excretion in urine. 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 effect is dry mouth, which is generally mild and often resolves with continued use. Other potential side effects consistent with anticholinergic effects may include constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention.

Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tiotropium should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. The safety and efficacy of Tiotropium have not been studied during labor and delivery.

Precautions & Warnings
As an anticholinergic drug, Tropex may exacerbate symptoms in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction. It should be used with caution in individuals with these conditions.

Overdose Effects
High doses of Tropex may cause anticholinergic signs and symptoms. However, no systemic anticholinergic adverse effects were observed following a single inhalation dose of up to 282 mcg in six healthy volunteers. In a study involving 12 healthy volunteers, repeated once-daily inhalation of 141 mcg resulted in bilateral conjunctivitis and dry mouth.

Therapeutic Class
Anticholinergic bronchodilators

Storage Conditions
Tropex Dry Powder Inhaler capsules must not be swallowed. Store below 30°C, away from direct sunlight and heat. Keep out of reach of children.