Tiotrop 18 mcg

Description

Indications
Tiotrop is indicated for the long-term management of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It helps maintain open airways and is used to control symptoms in patients with these conditions.

Pharmacology
Tiotropium is a long-acting, antimuscarinic agent, often classified as an anticholinergic. It selectively targets muscarinic receptors, M1 to M5, and in the airways, it primarily works by blocking M3 receptors on smooth muscle, leading to bronchodilation. Tiotropium demonstrates competitive and reversible antagonism in both human and animal receptor studies, showing a dose-dependent and long-lasting effect. The bronchodilatory effect of Tiotropium after inhalation is predominantly localized in the airways, where it can prevent bronchoconstriction caused by methacholine for over 24 hours.

Dosage & Administration
For adults over 18 years, the recommended dosage is 18 mcg (one capsule) once daily via the Tiotropium Dry Powder Inhaler device. The capsules are for oral inhalation only and should not be ingested directly.

No dosage adjustments are required 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.

Interaction
Tiotropium has been studied for interactions with cimetidine and ranitidine. Co-administration of Tiotropium with cimetidine (400 mg three times daily) resulted in a 20% increase in the AUC (area under the curve) over 4 hours and a 28% reduction in renal clearance, with no significant changes in the peak plasma concentration (Cmax) or excretion in urine. On the other hand, the interaction with ranitidine did not affect the pharmacokinetics of Tiotropium.

Contraindications
Tiotropium is contraindicated in individuals with a known hypersensitivity to atropine or its derivatives, including ipratropium, or to any other components of the product.

Side Effects
The most frequently reported side effect of Tiotropium is dry mouth, which is typically mild and may resolve with continued use. Other potential anticholinergic effects include constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention.

Pregnancy & Lactation
Tiotropium is classified as Pregnancy Category C. Adequate and well-controlled studies in pregnant women are lacking. It should only be used during pregnancy if the potential benefits justify the risks to the fetus. The safety and efficacy of Tiotropium have not been established during labor and delivery, and caution is advised.

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

Overdose Effects
In cases of overdose, high doses of Tiotropium may lead to anticholinergic effects. However, no systemic adverse reactions were noted following a single inhalation dose of up to 282 mcg in healthy volunteers. Mild symptoms such as dry mouth and conjunctivitis were reported following repeated daily inhalations of 141 mcg.

Therapeutic Class
Tiotropium is classified as an anticholinergic bronchodilator.

Storage Conditions
Tiotrop Dry Powder Inhaler capsules should not be swallowed and must be stored below 30°C. Avoid direct sunlight or heat. Keep the product out of reach of children.