Tiova Inhaler (Generic Tiotropium Bromide Inhaler)

Tiova Inhaler (Generic Tiotropium Bromide Inhaler)
© The Swiss Pharmacy

Tiova Inhaler (Generic Tiotropium Bromide Inhaler) is used
for the long-term, once-daily, maintenance treatment of
bronchospasm associated with chronic obstructive
pulmonary disease (COPD), and for reducing COPD
exacerbations.
Tiova Inhaler is also used for the long-term, once-daily,
maintenance treatment of asthma in patients 12 years of age
and older with severe asthma who experienced one or
more severe asthma exacerbations in the preceding year.

Tiova Inhaler (Generic
Tiotropium Bromide Inhaler)
is manufactured by Cipla
Limited, India in the strength
of 9 mcg.

Chemical Structure

The active ingredient contained in Tiova Inhaler is
Tiotropium Bromide.
Each actuation of Tiova inhaler delivers Tiotropium
Bromide Monohydrate equivalent to 9 mcg of
Tiotropium.
The dosage form is Inhalation aerosol for
inhalation.

Uses of Tiova 9 mcg Inhaler:
Tiova Inhaler (Generic Tiotropium Bromide Inhaler) is used to treat
lung diseases such as asthma and COPD (bronchitis, emphysema). It
must be used regularly to prevent wheezing and shortness of breath.
It 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 (Asthalin Inhaler), also called Salbutamol in
some countries as prescribed.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html

Uses of Tiova 9 mcg Inhaler:
It helps people who have chronic obstructive pulmonary disease
(COPD) to breathe more easily. COPD is a chronic lung disease that
causes shortness of breath and coughing. The term COPD is
associated with the conditions chronic bronchitis and emphysema. As
COPD is a chronic disease you should use Tiova 9 micrograms
inhaler every day and not only when you have breathing problems or
other symptoms of COPD.
Tiova Inhaler (Generic Tiotropium Bromide Inhaler) 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.

Recommended Adult Dosage
For most Adults patients, the dose of Tiova Inhaler (Generic
Tiotropium Bromide Inhaler) is as given below:
The recommended dosage of Tiotropium Bromide is 2 puffs of Tiova
Inhaler once daily.
Tiova Inhaler may be used with a Zerostat/Zerostat VT Spacer
device in patients who find it difficult to synchronize aerosol
actuation with inspiration of breath.
The recommended dose of Tiova inhaler should not be
exceeded.

Recommended Adult Dosage
Geriatric patients can use Tiotropium Bromide inhaler at the
recommended dose.
Renally impaired patients can use Tiotropium Bromide at the
recommended dose. For patients with moderate to severe
impairment (creatinine clearance 50 ml/min or lower), Tiova
inhaler should be used only if the expected benefit outweighs
the potential risk.
Hepatically impaired patients can use Tiotropium Bromide
inhaler at the recommended dose

Contraindications
➔
Tiova Inhaler is 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 inhaler. In clinical trials with Tiotropium Bromide inhaler
(Tiova Inhaler), immediate hypersensitivity reactions, including
angioedema (including swelling of the lips, tongue, or throat),
itching, or rash have been reported.

Storage Instructions
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 Inhaler (Generic Tiotropium Bromide
Inhaler) 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 Inhaler at
once and consider alternatives if immediate hypersensitivity reactions,
including angioedema, bronchospasm, or anaphylaxis, occur.

Warnings
Paradoxical Bronchospasm: Inhaled medicines, including Tiova Inhaler
(Generic Tiotropium Bromide Inhaler), 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 Inhaler should be stopped and other treatments
considered.
Worsening of Narrow-Angle Glaucoma: Tiova Inhaler 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 Inhaler (Generic
Tiotropium Bromide Inhaler) 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.

Possible Side Effects
The most common Tiotropium Bromide Inhaler (Tiova Inhaler) 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 Inhaler (Tiova Inhaler) 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 Inhaler (Tiova
Inhaler) 5 mcg group at an incidence of 1% to 3% and at a higher
incidence rate on Tiotropium Bromide Inhalation 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 Inhaler (Tiova
Inhaler) 2.5 mcg group at an incidence of 1% to 2% and at a higher
incidence rate on Tiotropium Bromide Inhalation 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.

Tiova Inhaler Overdosage
High doses of Tiotropium Bromide Inhaler (Tiova Inhaler) 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 Inhaler 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
Inhaler is unlikely, since it is not well absorbed systemically.

Tiova Inhaler During Pregnancy
Tiotropium Bromide Inhaler (Tiova Inhaler) 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 Inhaler (Tiova Inhaler) use during pregnancy are
insufficient to inform a drug-associated risk of adverse
pregnancy-related outcomes.
Animal studies do not indicate direct or indirect harmful
effects with respect to reproductive toxicity at clinically
relevant doses.

Tiova Inhaler During Pregnancy
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
Inhaler during pregnancy.

Tiova Inhaler During Breastfeeding
It is unknown whether Tiotropium Bromide is excreted in human
breast milk.
Despite studies in rodents which have demonstrated that
excretion of Tiotropium Bromide in breast milk occurs only in
small amounts, use of Tiova Inhaler is not recommended during
breast-feeding.

Tiova Inhaler (Generic Tiotropium Bromide Inhaler) is
manufactured by Cipla Limited, India.

Tiova Inhaler (Generic Tiotropium Bromide Inhaler)

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