Topium 18 mcg

Description

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

Pharmacology
Topium is a long-acting, antimuscarinic agent, commonly referred to as an anticholinergic. It exhibits a similar affinity for muscarinic receptor subtypes M1 to M5. In the airways, Topium works by inhibiting M3 receptors on smooth muscle, leading to bronchodilation. Its competitive and reversible antagonism was demonstrated through receptor studies using both human and animal tissues. In preclinical studies, both in vitro and in vivo, Topium was shown to prevent methacholine-induced bronchoconstriction in a dose-dependent manner, with effects lasting longer than 24 hours. The bronchodilatory effect is primarily localized in the airways following inhalation.

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

The capsules should be used only for oral inhalation with the provided device and not swallowed.

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

Interaction
An interaction study involving Tiotropium (14.4 mcg intravenous infusion) with cimetidine (400 mg three times daily) or ranitidine (300 mg once daily) showed that the concomitant use of cimetidine with Tiotropium led to a 20% increase in the AUC (area under the curve) over 4 hours, a 28% reduction in renal clearance, and no significant change in peak plasma concentration (Cmax) or excretion in urine. Co-administration with ranitidine had no impact on Tiotropium’s pharmacokinetics.

Contraindications
Topium is contraindicated in individuals with a known hypersensitivity to atropine, its derivatives (including ipratropium), or any component of this product.

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

Pregnancy & Lactation
Topium is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefits outweigh the risks to the fetus. Its safety and efficacy during labor and delivery have not been established.

Precautions & Warnings
As an anticholinergic, Topium may worsen symptoms of 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 case of overdose, high doses of Topium may lead to anticholinergic effects. However, no systemic adverse reactions were observed after a single inhalation dose of up to 282 mcg in six healthy volunteers. In another study involving 12 healthy volunteers, repeated inhalation of 141 mcg resulted in bilateral conjunctivitis and dry mouth.

Therapeutic Class
Anticholinergic bronchodilators

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