Topium Inhalation Capsule 18 mcg

Uses

Topium Inhalation Capsule 18 mcg is used for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Topium Inhalation Capsule 18 mcg is also used to associated treatment for these conditions: Asthma, Bronchitis, Bronchoconstriction, Chronic Bronchitis, Chronic Obstructive Airways Disease Exacerbated, Chronic Obstructive Pulmonary Disease (COPD), Chronic Obstructive Respiratory Diseases, Emphysema

How Topium Inhalation Capsule 18 mcg works

Topium Inhalation Capsule 18 mcg is an antagonist of muscarinic receptors M₁ to M₅. Inhibition of the M₃ receptor in the smooth muscle of the lungs leads to relaxation of smooth muscle and bronchodilation.

Dosage

Topium Inhalation Capsule 18 mcg dosage

Adults and adolescents 12 years and older: The recommended dosage of Topium Inhalation Capsule 18 mcg bromide is the inhalation of 2 puffsonce daily.

Side Effects

The most commonly reported adverse drug reaction was dry mouth. Dry mouth was usually mild and often resolved during continued treatment. Other reactions reported in individual patients and consistent with possible anticholinergic effects included constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention.

Toxicity

Symptoms of overdose include altered mental status, tremors, abdominal pain, and severe constipation. However, doses of up to 282µg did not lead to systemic anticholinergic effects in a trial of 6 patients. In case of overdose, stop tiotropium and being symptomatic and supportive therapy.

Precaution

As an anticholinergic drug, Topium Inhalation Capsule 18 mcg may potentially worsen symptoms and signs associated with narrow angle glaucoma, prostatic hyperplasia or bladder-neck obstruction and should be used with caution in patients with any of these conditions. As a predominantly renally excreted drug, patients with moderate to severe renal impairment treated with Topium Inhalation Capsule 18 mcg should be monitored closely.

Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema may be signs of acute narrow angle glaucoma. Should any of these signs and symptoms develop, consult a physician immediately. Miotic eye drops alone are not considered to be effective treatment.

Interaction

Topium Inhalation Capsule 18 mcg has been used concomitantly with other drugs commonly used in COPD without increases in adverse drug reactions. These include sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids. However, the co-administration of Topium Inhalation Capsule 18 mcg with other anticholinergic-containing drugs (e.g., ipratropium) has not been studied and is therefore not recommended.

Food Interaction

• Take with or without food. Food is not expected to interfere with absorption.

Topium Inhalation Capsule 18 mcg Drug Interaction

Moderate: albuterol / ipratropium, albuterol / ipratropiumUnknown: fluticasone / salmeterol, aspirin, aspirin, omega-3 polyunsaturated fatty acids, fluticasone nasal, furosemide, metoprolol, metoprolol, polyethylene glycol 3350, nitroglycerin, acetaminophen, albuterol, budesonide / formoterol, albuterol, albuterol, cyanocobalamin, ascorbic acid, cholecalciferol

Topium Inhalation Capsule 18 mcg Disease Interaction

Moderate: angioedema, anticholinergic effects, tachycardia, liver, renal dysfunction

Volume of Distribution

The volume of distribution of tiotropium is 32L/kg.

Elimination Route

33% of an inhaled solution reaches systemic circulation, while oral solutions have a bioavailability of 2-3%. A dry powder for inhalation is 19.5% bioavailable. Topium Inhalation Capsule 18 mcg metered spray for inhalation reaches a maximum concentration in 5-7 minutes.

Half Life

The terminal half life of tiotropium is 24 hours in patients with COPD and 44 hours in patients with asthma.

Clearance

The total clearance of tiotropium is 880mL/min in healthy subjects receiving 5µg daily. The renal clearance of tiotropium was 669mL/min. Patients 2 This decreased clearance is not associated with increased AUC or C_max.

Elimination Route

74% of intravenous tiotropium was excreted unchanged in urine. 14% of a dry powder inhalation dose was excreted unchanged in the urine. 24 hour urinary excretion after 21 days of 5µg once daily inhalation in patients with COPD is 18.6% and in patients with asthma is 12.8%.

Pregnancy & Breastfeeding use

Pregnancy Category C. Topium Inhalation Capsule 18 mcg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in Labor and Delivery: The safety and effectiveness of Topium Inhalation Capsule 18 mcg has not been studied during labor and delivery.

Nursing Mothers: Clinical data from nursing women exposed to Topium Inhalation Capsule 18 mcg are not available. caution should be exercised if administered to a nursing woman.

Contraindication

Topium Inhalation Capsule 18 mcg is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, including ipratropium, or to any component of this product.

Special Warning

Pediatric Use: The safety and effectiveness of Topium Inhalation Capsule 18 mcg in pediatric patients have not been established.

Geriatric use: No adjustment of Topium Inhalation Capsule 18 mcg dosage in geriatric patients is warranted.

Acute Overdose

High doses of Topium Inhalation Capsule 18 mcg may lead to anticholinergic signs and symptoms. Acute intoxication by inadvertent oral ingestion of Topium Inhalation Capsule 18 mcg Bromide unlikely since it is not well-absorbed systemically.

Storage Condition

The inhaler should be stored in a dry, cool place away from direct sunlight and heat. The canister should not be broken, punctured or burnt, even when apparently empty. Keep away from eyes. Keep out of reach of children.

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