Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder)

Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder)
© The Swiss Pharmacy

Tiova Rotacaps (Generic Tiotropium Bromide
Inhalation Powder) are used for the long-term, once-
daily, maintenance treatment of bronchospasm
associated with chronic obstructive pulmonary
disease (COPD), including chronic bronchitis and
emphysema.
Tiova Rotacaps are indicated to reduce
exacerbations in COPD patients.

Tiova Rotacaps
(Tiotropium Bromide
Inhalation Powder) are
manufactured by Cipla
Limited, India in the
strength of 18 mcg.
They are available in a
bottle containing 30
rotacaps (Capsules
containing dry inhalation
powder).

Chemical Structure

The active ingredient present in Tiova rotacaps
is Tiotropium Bromide.
Each Tiova rotacap contains 18 mcg of Tiotropium
(as Tiotropium Bromide Monohydrate).
The dosage form is dry powder for inhalation.

Uses of Tiova 18 mcg Rotacaps:
Tiova 18 mcg Rotacaps (Generic Tiotropium Bromide Inhalation
Powder) are used to treat chronic obstructive pulmonary disease
(COPD). COPD is a lung disease that also includes chronic bronchitis
(swelling of the tubes leading to the lungs) and emphysema (damage
to the air sacs in the lungs). It is also used as maintenance treatment
for asthma in adults and children 6 years of age and older.
Tiotropium belongs to the family of medicines known as
bronchodilators. Bronchodilators are breathed in through the mouth
to help open up the bronchial tubes (air passages) in the lungs. It is
taken by inhalation (an inhaler) and will increase the flow of air to the
lungs.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html

How Does Tiova (Generic Tiotropium Bromide
Inhalation Powder) Work?:
Tiova (Generic Tiotropium Bromide Rotacaps) works by relaxing the
muscles around the airways so that they open up and you can
breathe more easily. Tiotropium belongs to a class of drugs known as
anticholinergics. Controlling symptoms of breathing problems can
decrease time lost from work or school.
This medication must be used regularly to be effective. It does not
work right away and should not be used to relieve sudden breathing
problems. If wheezing or sudden shortness of breath occurs, use your
quick-relief inhaler such as Albuterol Inhaler (Asthalin Inhaler), also
called Salbutamol.

Recommended Adult Dosage
For most Adults (Including the Elderly) patients, the dose of
Tiova Rotacaps (Tiotropium Bromide Inhalation Powder) is as given
below:
The recommended dosage is inhalation of the contents of one
capsule once daily with the Cipla Rotahaler (HandiHaler device) at the
same time of day. More frequent administration or a greater number
of inhalations is not recommended.
No dosage adjustment is required for geriatric, hepatically-impaired,
or renally-impaired patients. However, patients with moderate to
severe renal impairment, who are being treated with Tiova 18
microgram Rotacaps, should be monitored closely.

Recommended Adult Dosage
Tiotropium Bromide Capsules (Tiova Rotacaps) are only for
inhalation and not for oral intake.
Tiotropium Bromide Capsules must not be swallowed.
Tiotropium Bromide Capsules should only be inhaled with
the Cipla Rotahaler/HandiHaler device.
There is no relevant use in the paediatric population
(below 18 years) in the indication.

Cipla Rotahaler
Tiova Rotacaps are used in a plastic device called a
Rotahaler. When used in your Cipla Rotahaler (Generic
HandiHaler device), your Tiova Rotacaps provide a
measured amount of medicine for you to breathe into your
lungs.
Your Tiova Rotacaps help you to breathe more easily.

Cipla Rotahaler
1.Hold the Rotahaler vertically and position the two halves of the Rotahaler such that
the fin is not directly below the rotacap hole.
2.Remove the rotacap from its bottle and insert it into the rotacap hole with its
transparent end facing downwards
3.Hold the mouth piece firmly with one hand and rotate the base
4.Breathe out fully and place the mouthpiece of the Rotahaler between your teeth.
5.Close your lips tightly around it & tilt your head slightly backward & breathe in
through the mouth rapidly & deeply.
6.Hold your breath for 10 seconds or for as long as you are comfortable and then
breathe out normally. In case some powder remains repeat step 4.
7.Open the Rotahaler and dispose the empty capsule.
8.You can continue to use your Rotahaler daily for up to 6 months. Then discard it
and replace with a new one.

Contraindications
➔
Tiova Rotacaps are contraindicated in patients with a known
hypersensitivity to Tiotropium Bromide, or to Atropine or its
derivatives, e.g. Ipratropium or Oxitropium or any component of
Tiova rotacaps. In clinical trials with Tiotropium Bromide
Capsules (Tiova Rotacaps), immediate hypersensitivity reactions,
including angioedema (including swelling of the lips, tongue, or
throat), itching, or rash have been reported.

Storage Instructions
Tiova Rotacaps (Generic Tiotropium Bromide
Inhalation Powder) have to be stored at controlled
room temperature i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15° to 30°C (59° to
86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
Not for Acute Use: Use of Tiova Rotacaps (Tiotropium Bromide
Inhalation Powder) is intended as a once-daily maintenance treatment
for COPD and asthma and should not be used for the relief of acute
symptoms, i.e., as rescue therapy for the treatment of acute episodes
of bronchospasm. In the event of an acute attack, a rapid-acting beta2-
agonist should be used.
Immediate Hypersensitivity Reactions: Discontinue Tiova Rotacaps at
once and consider alternatives if immediate hypersensitivity reactions,
including angioedema, bronchospasm, or anaphylaxis, occur.

Warnings
Paradoxical Bronchospasm: Inhaled medicines, including Tiova
Rotacaps (Tiotropium Bromide Inhalation Powder), may cause
paradoxical bronchospasm. If this occurs, it should be treated
immediately with an inhaled short-acting beta2-agonist such as
Albuterol Inhaler. Treatment with Tiova Rotacaps should be stopped
and other treatments considered.
Worsening of Narrow-Angle Glaucoma: Tiova Rotacaps should be
used with caution in patients with narrow-angle glaucoma. Worsening
of narrow-angle glaucoma may occur. Use with caution in patients with
narrow-angle glaucoma and instruct patients to consult a physician
immediately if this occurs.

Warnings
Worsening of Urinary Retention: Tiova Rotacaps should be used with
caution in patients with urinary retention. Prescribers and patients
should be alert for signs and symptoms of urinary retention (e.g.,
difficulty passing urine, painful urination), especially in patients with
prostatic hyperplasia or bladder-neck obstruction. Instruct patient to
consult a physician immediately if this occurs.
Tiova 18 microgram is not recommended for children and adolescents
under 18 years

Possible Side Effects
The most common Tiotropium Bromide Inhalation Powder (Tiova
Rotacaps) side effects in patients with COPD with an incidence rate
of greater than 3% in the placebo-controlled trials with treatment
durations of between 4 and 48 weeks were pharyngitis, cough, dry
mouth, and sinusitis.
The most common Tiotropium Bromide Inhalation Powder (Tiova
Rotacaps) side effects in patients with Asthma with an incidence rate
of greater than 2% in the placebo-controlled trials with treatment
durations of between 12 and 52 weeks) were pharyngitis, sinusitis,
bronchitis, and headache in adults.

Clinical Trials Experience in Chronic Obstructive Pulmonary Disease:
Other reactions that occurred in the Tiotropium Bromide Inhalation Powder
(Tiova Rotacaps) 5 mcg group at an incidence of 1% to 3% and at a higher
incidence rate on Tiotropium Bromide Inhalation Powder 5 mcg than on
placebo included: Cardiac disorders: palpitations; Gastrointestinal
disorders: constipation; gastroesophageal reflux disease; oropharyngeal
candidiasis; Nervous system disorders: dizziness; Respiratory system
disorders (Upper): dysphonia; Skin and subcutaneous tissue disorders:
pruritus, rash; Renal and urinary disorders: urinary tract infection.

Clinical Trials Experience in Asthma:
Other reactions that occurred in the Tiotropium Bromide Inhalation Powder
(Tiova Rotacaps) 2.5 mcg group at an incidence of 1% to 2% and at a higher
incidence rate on Tiotropium Bromide Inhalation Powder 2.5 mcg than on
placebo included: Nervous system disorders: dizziness; Gastrointestinal
disorders: oropharyngeal, candidiasis, diarrhea; Respiratory system
disorders (Upper): cough, rhinitis allergic; Renal and urinary disorders:
urinary tract infection; General disorders and administration site conditions:
pyrexia; and Vascular disorders: hypertension.

Overdosage
High doses of Tiotropium Bromide Inhalation Powder (Tiova Rotacaps) may
lead to anticholinergic signs and symptoms. However, there were no systemic
anticholinergic adverse effects following a single inhaled dose of up to 340
mcg of Tiotropium Bromide Inhalation Powder in healthy volunteers.
Additionally, no relevant adverse effects, beyond dry mouth, were observed
following a 7-day dosing of up to 170 mcg of Tiotropium Bromide in healthy
volunteers. In a multiple-dose study in COPD patients with a maximum daily
dose of 43 mcg of tiotropium bromide over 4 weeks, no significant
undesirable effect has been observed.
Acute intoxication by inadvertent oral ingestion of Tiotropium Bromide
Rotacaps is unlikely, since it is not well absorbed systemically.

Tiova Rotacaps During Pregnancy
Tiotropium Bromide Inhalation Powder (Tiova Rotacaps) has been classified
by the US FDA as Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women. The
limited human data with Tiotropium Bromide Inhalation Powder (Tiova
Rotacaps) use during pregnancy are insufficient to inform a drug-associated
risk of adverse pregnancy-related outcomes. Based on animal reproduction
studies, no structural abnormalities were observed when Tiotropium Bromide
was administered by inhalation to pregnant rats and rabbits during the period
of organogenesis at doses 790 and 8 times, respectively, the maximum
recommended human daily inhalation dose (MRHDID). Increased post-
implantation loss was observed in rats and rabbits administered tiotropium at
maternally toxic doses 430 times and 40 times the MRHDID, respectively. As a
precautionary measure, it is preferable to avoid the use of Tiova Rotacaps
during pregnancy.

Tiova Rotacaps (Tiotropium Bromide Inhalation
Powder) are manufactured by Cipla Limited, India.

Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder)

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