Indications
Tropex is prescribed for the long-term management of bronchospasm linked to chronic obstructive pulmonary disease (COPD), including conditions like chronic bronchitis and emphysema.
Pharmacology
Tiotropium is a long-acting antimuscarinic agent, commonly classified as an anticholinergic. It binds to various muscarinic receptor subtypes (M1 to M5) with similar affinity. In the respiratory tract, it primarily functions by inhibiting M3 receptors in smooth muscle, leading to bronchodilation. Research has demonstrated its competitive and reversible antagonism through studies using both human and animal receptors, as well as isolated organ preparations. Preclinical in vitro and in vivo studies indicate that the prevention of bronchoconstriction induced by methacholine is dose-dependent and persists for over 24 hours. The bronchodilation effect of Tiotropium inhalation is mainly site-specific.
Dosage & Administration
For adults over 18 years, the recommended dosage of the Tiotropium Dry Powder Inhaler is 18 mcg (one capsule) taken once daily using the device. The contents of the capsules are intended solely for oral inhalation and must be used with the inhalation device.
No dosage adjustments are necessary for elderly patients or those with liver or kidney impairment. However, patients with moderate to severe renal impairment should be closely monitored for potential anticholinergic effects when using Tiotropium.
Always consult a registered healthcare professional before use.
Interactions
In a study involving Tiotropium (14.4 mcg intravenous infusion over 15 minutes) with cimetidine (400 mg three times daily) or ranitidine (300 mg once daily), cimetidine was found to increase the AUC (0-4 hours) of Tiotropium by 20% and decrease its renal clearance by 28%, with no significant change in Cmax or urinary excretion over 96 hours. Ranitidine did not affect the pharmacokinetics of Tiotropium.
Contraindications
Tiotropium should not be used by individuals with a known hypersensitivity to atropine, its derivatives (including ipratropium), or any component of Tropex.
Side Effects
The most frequently reported side effect of Tropex is dry mouth, which is typically mild and resolves with ongoing treatment. Other potential anticholinergic effects may include constipation, increased heart rate, blurred vision, glaucoma, urinary difficulties, and urinary retention.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies of Tiotropium in pregnant women. It should only be used during pregnancy if the potential benefits outweigh the risks to the fetus. The safety and effectiveness of Tiotropium have not been established during labor and delivery.
Precautions & Warnings
As an anticholinergic agent, Tropex may exacerbate symptoms in individuals with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction. Caution is advised in patients with these conditions.
Overdose Effects
Excessive doses of Tropex may lead to anticholinergic symptoms. However, a single inhalation of up to 282 mcg did not result in systemic anticholinergic adverse effects in six healthy volunteers. In a study with 12 healthy volunteers, repeated inhalation of 141 mcg led to occurrences of bilateral conjunctivitis and dry mouth.
Therapeutic Class
Anticholinergic Bronchodilators
Storage Conditions
Tropex Dry Powder Inhaler capsules should never be swallowed. Store in a cool, dry place, away from direct sunlight and heat, below 30°C. Keep out of reach of children.
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