Tiotrop Acucap^®

Tiotrop^® Acucap is a preparation ofTiotropium which is a long acting, antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors, M1 to Ms. In the airways, it exhibits pharmacological effects through
inhibition of M3 receptors at the smooth muscle leading to bronchodilation. The bronchodilation following inhalation ofTiotropium is predominantly a site specific effect.

No Data

Tiotrop^® Acucap is indicated for the long term, once daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Adult over 18 years: The recommended dosage is inhalation of the contents of one Tiotrop^® Acucap, once daily, with the Aculizer.

Children: The safety and effectiveness of tiotropium in pediatric patients have not been established.
No dosage adjustment is required for geriatric, hepatically impaired, or renally impaired patients. However, patients with moderate to severe renal impairment given Tiotrop^® Acucap should be monitored closely.

Tiotrop^® Acucap must not be swallowed as the intended effects on the lungs will not be obtained. The contents of the Tiotrop^® Acucap are only for oral inhalation and should only be used with the Aculizer.

Pregnancy
Tiotropium is a pregnancy category C drug. There are no adequate and well controlled studies in pregnant women. Tiotropium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation
Clinical data from nursing women exposed to tiotropium are not available. Based on lactating odent studies, tiotropium is excreted into breast milk. It is not known whether tiotropium is excreted in human milk, but because many drugs are excreted in human milk and given these findings in rats, caution should be exercised if tiotropium is administered to a nursing woman. 

As an anticholinergic drug, tiotropium 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. Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctiva! 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. 

The most commonly reported side effect is 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.

Tiotropium is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, including ipratropium, or to any component of this product.

Tiotropium has been used concomitantly with other drugs commonly used in COPD without increases in adverse drug reactions. These include short acting and long acting sympathomimetic (beta agonists) bronchodilators, methylxanthines, oral and inhaled steroids. However, the co-administration of tiotropium with other anticholinergic containing drugs (e.g., ipratropium) has not been studied and is therefore not recommended.

High doses of tiotropium may lead to anticholinergic signs and symptoms. However, there are no systemic anticholinergic adverse effects following a single inhaled dose of up to 282 mcg tiotropium in 6 healthy volunteers.

No Data

Tiotrop^® Acucap must not be swallowed. It should be used with Aculizer. Remove Acucap from the blister pack just prior to use, as Acucap exposed to moisture may not tear easily. Store in a cool (below 30°C) & dry place. Protect from light. Keep away from the reach of children.

Tiotrop^® Acucap Inhaler: Each Acucap capsule contains Tiotropium Bromide Monohydrate BP 22.5 mcg equivalent to Tiotropium 18 m

Tiotrop^® Acucap Inhaler: Carton of 30 Acucap capsules in blister pack.