TIOVA ROTACAPS
Composition
Tiova Rotacaps
Each rotacap contains tiotropium bromide monohydrate equivalent
to tiotropium 18 mcg
Description
Tiotropium bromide is a long-acting, specific,
muscarinic receptor antagonist, in clinical medicine often
called an anticholinergic. By binding to the muscarinic
receptors in the bronchial smooth musculature, tiotropium
bromide inhibits the cholinergic (bronchoconstrictive) effects
of acetylcholine, released from parasympathetic nerve endings.
The long duration is probably due to the very slow dissociation
from the M3 receptor, exhibiting a significantly longer
dissociation half-life than ipratropium.
Indications
Tiotropium bromide is indicated in the maintenance treatment
of chronic obstructive pulmonary disease (COPD).
Dosage and administration
The recommended dosage of tiotropium bromide is the inhalation
of the contents of one rotacap once daily.
Tiotropium bromide should only be inhaled with the Rotahaler
device.
The recommended dose should not be exceeded.
Tiotropium bromide rotacaps must not be swallowed.
Special populations
Renally impaired patients can use tiotropium bromide at
the recommended dose. For patients with moderate to severe
impairment (creatinine clearance < - 50 ml/min see warnings
and precautions).
Hepatically-impaired patients can use tiotropium bromide
at the recommended dose.
Paediatric patients: Safety and effectiveness of tiotropium
bromide inhalation powder in paediatric patients have not
been established and therefore it should not be used in
patients under 18 years of age.
Contraindications
Tiotropium bromide inhalation powder is contraindicated
in patients with hypersensitivity to tiotropium bromide,
atropine or its derivatives, e.g. ipratropium or oxitropium
or to the excipient lactose monohydrate.
Warnings and precautions
Tiotropium bromide, 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 bromide inhalation powder.
As with other anticholinergic drugs, tiotropium bromide
should be used with caution in patients with narrow-angle
glaucoma, prostatic hyperplasia or bladder-neck obstruction.
Inhaled medicines may cause inhalation-induced bronchospasm.
As plasma concentration increases with decreased renal function
in patients with moderate to severe renal impairment (creatinine
clearance < - 50 ml/min) tiotropium bromide should be
used only if the expected benefit outweighs the potential
risk. There is no long-term experience in patients with
severe renal impairment. Patients should be cautioned to
avoid getting the drug powder into their eyes. They should
be advised that this may result in precipitation or worsening
of narrow-angle glaucoma, eye pain or discomfort, temporary
blurring of vision, visual halos or coloured images in association
with red eyes from conjunctival and corneal congestion.
Patients should stop using tiotropium bromide and consult
a physician immediately when signs and symptoms of narrow-angle
glaucoma appear.
Dry mouth, which has been observed with anti-cholinergic
treatment, may in the long- term be associated with dental
caries. Tiotropium bromide should not be used more frequently
than once daily.
Drug interactions
Although no formal drug interaction studies have been performed,
tiotropium bromide inhalation powder has been used concomitantly
with other drugs without adverse drug reactions. These include
sympathomimetic bronchodilators, methylxanthines, oral and
inhaled steroids, commonly used in the treatment of COPD.
The co-administration of tiotropium bromide
with other anticholinergic-containing drugs has not been
studied and is therefore not recommended.
Pregnancy and lactation
For tiotropium bromide, no clinical data on exposed pregnancies
are available. Studies in animals have shown reproductive
toxicity associated with maternal toxicity. Clinical data
from nursing women exposed to tiotropium bromide are not
available. Based on lactating rodent studies, a small amount
of tiotropium bromide is excreted in milk. Therefore, tiotropium
bromide should not be used in pregnant or nursing women
unless the expected benefit outweighs any possible risk
to the unborn child or the infant.
Effects on ability
to drive and use machines
No studies on the effects on the ability to drive and use
machines have been performed. However, on the basis of the
pharmacodynamic and reported undesirable effects profiles
at the recommended dose, there is no evidence of any potential
influence on the ability to drive and use machines. What
about the effect of blurring of vision?
Adverse events
Several organ systems and functions are under control of
the parasympathetic nervous system and thus can be affected
by anticholinergic agents. Possible adverse events attributable
to systemic anticholinergic effects include dry mouth, dry
throat, increased heart rate, blurred vision, glaucoma,
urinary difficulty, urinary retention, and constipation.
In addition, local upper airway irritant phenomena were
observed in patients receiving tiotropium bromide. An increased
incidence of dry mouth and constipation may occur with increasing
age.
The most common anticholinergic adverse reaction reported
by COPD patients was dry mouth, which was mild in the majority
of cases. In general, dry mouth had an onset between three
and five weeks, which resolved while patients continued
to receive tiotropium bromide. Discontinuation rates due
to dry mouth were 0.3% (3 of 906 patients) of the treated
patients from the one-year studies. Isolated adverse reactions
occurring in single cases reported as severe and consistent
with anticholinergic effects in the one-year trials included
constipation and urinary retention. Urinary retention was
limited to elderly men with predisposing factors, (e.g.
prostatic hyperplasia). Isolated adverse reactions of supraventricular
tachycardia and atrial fibrillation were reported in association
with the use of tiotropium bromide, usually in susceptible
patients.
Overdose
High doses of tiotropium bromide may lead to anticholinergic
signs and symptoms (see adverse events). However, there
were no systemic anticholinergic adverse effects following
a single inhaled dose of up to 340 micrograms tiotropium
bromide in healthy volunteers. Additionally, no relevant
adverse effects, beyond dry mouth, were observed following
seven-day dosing of up to 170 micrograms tiotropium bromide
in healthy volunteers. In a multiple-dose study in COPD
patients with a maximum daily dose of 43 micrograms tiotropium
bromide over four weeks, no significant undesirable effect
has been observed. Acute intoxication by inadvertent oral
ingestion of tiotropium bromide capsules is unlikely due
to low oral bioavailability.
Presentation
TIOVA Rotacaps……………………
Container of 15 Rotacaps
