Indications of Topium Rotacap

Tiotropium bromide is indicated for the long-term treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Pharmaceutical Name

ACME Laboratories Ltd.

Pharmacology

Tiotropium bromide is a long-acting antimuscarinic agent, often referred to as an anticholinergic agent. It has a similar affinity for muscarinic receptor subtypes M1 to M5. In the airways, it exhibits pharmacological effects by inhibiting M3 receptors in smooth muscles to cause bronchiectasis. Human and animal receptors and isolated organ preparations show competitive and reversible antagonistic effects. In preclinical in vitro and in vivo studies, prevention of methacholine-induced bronchoconstriction is dose dependent and lasts longer than 24 hours. Bronchiectasis after tiotropium bromide inhalation is primarily a site-specific effect.

Dosage & Administration of Topium Rotacap

Adult over 18 years: The recommended dose of Tiotropium Dry Powder Inhaler capsule is 18 mcg (1 capsule) once-daily, with the device.

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

No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients. However, patients with moderate to severe renal impairment given Tiotropium capsule should be monitored closely for anticholinergic effects.

Interaction of Topium Rotacap

Interaction studies were performed with Tiotroplum (14.4 mcg intravenous infusion over 15 minutes) and cimetidine 400 mg 3 times a day or ranitidine 300 mg once a day. Simultaneous administration of cimetidine and tiotropium resulted in a 20% increase in AUC at 04 hours, a 28% increase in renal clearance of tiotropium bromide, and no significant changes in Cmax or urinary excretion of 96 hours. Coadministration of Tiotroplum and ranitidine does not affect the pharmacokinetics of Tiotroplum.

Contraindications

Tiotropium is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives e.g. ipratropium or to the excipient lactose.

Side Effects of Topium Rotacap

The side effects of tiotropium include dry mouth, nausea, constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty and headache.

Pregnancy & Lactation

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. It is not known whether tiotropium is excreted in human milk, but because many drugs are excreted in human milk, caution should be exercised if this drug is administered to a nursing woman.

Precautions & Warnings

Patients should be instructed about the proper use of Rotahaler to ensure that drug reaches the target areas of the lung. This drug should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Care should also be taken in patients with moderate to severe renal or hepatic impairment.

Therapeutic Class

Anticholinergic bronchodilators

Storage Conditions

Tiotropium Dry Powder Inhaler capsules must not be swallowed. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from children.

Generic Name of Topium Rotacap

Tiotropium