Description

PRESENTATION

TropexTM ConviCap: Each capsule contains Tiotropium Bromide Monohydrate BP equivalent to 18 µg of Tiotropium.

DESCRIPTION

Tiotropium is a long-acting, specific antimuscarinic agent, in clinical medicine often called an anticholinergic. It has a similar

affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, inhibition of M3- receptors at the smooth muscle

results in relaxation. The high potency and slow receptor dissociation found its clinical correlate in significant and long-acting

bronchodilation in patients with COPD.

INDICATIONS

Tiotropium is indicated for the long term once daily maintenance treatment of bronchospasm and dyspnoea associated with chronic

obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tiotropium reduces the frequency of

exacerbations and improves exercise tolerance and health-related quality of life.

DOSAGE & ADMINISTRATION

The recommended dosage of Tiotropium is inhalation of the contents of one capsule once daily with the ConviHaler device at the

same time of day.

SIDE EFFECTS

Inhaled medicines may cause inhalation-induced bronchospasm, dehydration, dry mouth, constipation, dizziness, insomnia, skin and

subcutaneous tissue disorders and immune system disorders

PRECAUTIONS

Tiotropium, as a once daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of

bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of Tiotropium inhalation

powder. As with other anticholinergic drugs, Tiotropium should be used with caution in patients with narrow-angle glaucoma,

prostatic hyperplasia or bladder-neck obstruction.

USE IN PREGNANCY & LACTATION

Pregnancy: There is a limited amount of data from the use of Tiotropium in pregnant women. Animal studies do not indicate direct

or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses.

Lactation: Clinical data from nursing women exposed to Tiotropium are not available. Based on lactating rodent studies, a small

amount of Tiotropium is excreted in milk. Therefore, Tiotropium should not be used in nursing women unless the expected benefit

outweighs any possible risk to the unborn child or the infant.

DRUG INTERACTION

Although no formal drug interaction studies have been performed, Tiotropium inhalation powder has been used concomitantly with

other drugs, commonly used in the treatment of COPD, including sympathomimetic bronchodilators, methylxanthines, oral and inhaled

steroids without clinical evidence of drug interactions.

OVER DOSE

High doses of Tiotropium may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse

effects following a single inhaled dose of up to 282 micrograms Tiotropium in healthy volunteers.

STORAGE

Storage: 1) Store below 25ºC but do not freeze. 2) Store in cool and dry place, protected from light.

COMMERCIAL PACK

Tropex ConviCap: Each box contains 5 alu-alu blister strips of 6 capsules.