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SPIRIVA® RESPIMAT® 2.5 MCG (TIOTROPIUM BROMIDE) INHALATION SPRAY

 * Home
 * Why RESPIMAT?
 * Efficacy & Evidence
 * How to Use
 * Dosing
 * Safety
 * Savings & Support


CHOOSE INHALEABILITY WITH SPIRIVA RESPIMAT




WHEN PRESCRIBING A LAMA FOR COPD, CHOOSE SPIRIVA RESPIMAT, THE ONLY LAMA
ACTIVELY DELIVERED IN A SOFT MIST FOR EASE OF INHALATION.

 

 
Why RESPIMAT?
With ease of inhalation, your patients don't have to work hard to get their
medication.[1]
Efficacy
SPIRIVA RESPIMAT contains the only LAMA indicated to reduce the risk of
exacerbations in patients with COPD.[1-6]
Savings & Support
Your patients may be eligible to pay as little as $0[*] for SPIRIVA RESPIMAT.

[*]See Terms and Conditions here.

 
 

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INDICATIONS

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are indicated for the
long-term, once-daily, maintenance treatment of bronchospasm associated with
chronic obstructive pulmonary disease (COPD), including chronic bronchitis
and emphysema, and for reducing COPD exacerbations.

SPIRIVA is not indicated for relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

SPIRIVA is contraindicated in patients with a history of hypersensitivity to
tiotropium, ipratropium, or any component of either product. Immediate
hypersensitivity reactions, including angioedema (including swelling of the
lips, tongue, or throat), itching, or rash have been reported.

 


IMPORTANT SAFETY INFORMATION (CONT’D)

SPIRIVA is intended as a once-daily maintenance treatment for COPD 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 attack, a
rapid-acting beta₂-agonist should be used.

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling
of lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may
occur after administration of SPIRIVA. If such a reaction occurs, discontinue
SPIRIVA at once and consider alternative treatments. Given the similar
structural formula of atropine to tiotropium, patients with a history of
hypersensitivity reactions to atropine or its derivatives should be closely
monitored for similar hypersensitivity reactions to SPIRIVA.

SPIRIVA HANDIHALER should be used with caution in patients with severe
hypersensitivity to milk proteins.

Inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If
this occurs, it should be treated with an inhaled short-acting beta₂-agonist,
such as albuterol. Treatment with SPIRIVA should be stopped and other treatments
considered.

SPIRIVA should be used with caution in patients with narrow-angle glaucoma.
Prescribers and patients should be alert for signs and symptoms of acute
narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual
halos or colored images in association with red eyes from conjunctival
congestion and corneal edema). Instruct patients to consult a physician
immediately should any of these signs or symptoms develop.

Since dizziness and blurred vision may occur with the use of SPIRIVA, caution
patients about engaging in activities such as driving a vehicle, or operating
appliances or machinery.

SPIRIVA 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
patients to consult a physician immediately should any of these signs or
symptoms develop.

Patients with moderate to severe renal impairment (creatinine clearance of <60
mL/min) and treated with SPIRIVA should be monitored closely for anticholinergic
side effects.

The most common adverse reactions >3% incidence and higher than placebo with
SPIRIVA RESPIMAT (placebo) in COPD trials were pharyngitis 11.5% (10.1%),
cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with
SPIRIVA HANDIHALER (placebo) in COPD trials were upper respiratory
tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis
9% (7%), non-specific chest pain 7% (5%), urinary tract infection 7% (5%),
dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported
adverse reaction ≥3% incidence and higher than placebo from the 4-year trial
with SPIRIVA HANDIHALER (placebo) not included above were headache 5.7% (4.5%),
depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).

SPIRIVA may interact additively with concomitantly used anticholinergic
medications. Avoid coadministration with other anticholinergic-containing drugs.

SPIRIVA capsules should not be swallowed and should only be inhaled through the
mouth (oral inhalation) using the HANDIHALER device, and the HANDIHALER
device should not be used for administering other medications.

Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause
blurring of vision and pupil dilation.

Please see full Prescribing Information for SPIRIVA RESPIMAT, including
Instructions for Use, and full Prescribing Information for SPIRIVA HANDIHALER,
including Patient Information and Instructions for Use.

CL-SVR-0036 2.8.2016

 
REFERENCES

 1. 1.
    
    SPIRIVA RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer
    Ingelheim Pharmaceuticals, Inc; August 2020.
    
     
 2. 2.
    
    Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium
    Respimat® plus usual therapy in COPD patients. Respir Med.
    2010;104(10):1460-1472.
    
     
 3. 3.
    
    Incruse Ellipta [prescribing information]. Research Triangle Park, NC:
    GlaxoSmithKline; August 2020.
    
     
 4. 4.
    
    Seebri [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals;
    January 2018.
    
     
 5. 5.
    
    Tudorza Pressair [prescribing information]. Wilmington, DE: AstraZeneca
    Pharmaceuticals LP; April 2019.
    
     
 6. 6.
    
    Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
    strategy for the diagnosis, management, and prevention of chronic
    obstructive pulmonary disease.
    https://goldcopd.org/wp-content/uploads/2019/11/GOLD-2020-REPORT-ver1.0wms.pdf.
    Updated November 5, 2019. Accessed April 17, 2020.
    
     
     

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