Spiriva Respimat

What is Spiriva Respimat?

• Spiriva Respimat (tiotropium bromide) is an anticholinergic used in the management of chronic obstructive pulmonary disease (COPD) and asthma.

Tiotropium bromide

What are the uses of this medicine?

Spiriva Respimat (tiotropium bromide) used for:

• The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations.
• The long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.

Limitation of Use:

• Not indicated for relief of acute bronchospasm.

How does this medicine work?

• Tiotropium (tye" oh troe' pee um) is a synthetic quaternary ammonium anticholinergic which inhibits the muscarinic actions of acetylcholine on autonomic nerve endings, decreasing bronchial smooth muscle contractions and alleviating bronchospasm in patients with chronic obstructive pulmonary disease (COPD).
• Tiotropium has potent activity against muscarinic acetylcholine receptors found in bronchial smooth muscle.
• Its quaternary ammonium structure decreases its ability to cross lipid membranes such as the blood brain barrier.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who are:

• Hypersensitivity to tiotropium, ipratropium, or any component of this product.

What drug interactions can this medicine cause?

• Avoid administration of Spiriva Respimat with other anticholinergic-containing drugs.

Is this medicine FDA approved?

• Tiotropium was approved for use in the United States in 2004 for use as a respiratory inhalant as maintenance treatment of bronchospasm associated with chronic bronchitis and emphysema.

How should this medicine be used?

Recommended dosage: Chronic Obstructive Pulmonary Disease:

• The recommended dosage for patients with COPD is 2 inhalations of Spiriva Respimat 2.5 mcg per actuation once-daily; total dose equals 5 mcg of Spiriva Respimat.

Asthma:

• The recommended dosage for patients with asthma is 2 inhalations of Spiriva Respimat 1.25 mcg per actuation once-daily; total dose equals 2.5 mcg of Spiriva Respimat.
• In the treatment of asthma, the maximum benefits in lung function may take up to 4 to 8 weeks of dosing.

Administration:

• Spiriva Respimat must be administered as two inhalations once-daily.
• Do not take more than one dose (2 inhalations) in 24 hours.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation spray: 1.25 mcg or 2.5 mcg tiotropium per actuation with the Spiriva Respimat inhaler. Two actuations equal one dose (2.5 mcg or 5 mcg).

This medicine is available in fallowing brand namesː

• Spiriva Respimat

What side effects can this medication cause?

The most common side effects of this medicine include: In COPD:

• pharyngitis
• cough
• dry mouth
• sinusitis

In Asthma:

• pharyngitis
• headache
• bronchitis
• sinusitis in adults

What special precautions should I follow?

• Do not let the powder from the SPIRIVA capsule get into your eyes. Your vision may get blurry and the pupil in your eye may get larger (dilate). If this happens, call your doctor.
• Spiriva Respimat can cause dizziness and blurred vision. Should you experience these symptoms you should use caution when engaging in activities such as driving a car or operating appliances or other machines.
• Spiriva Respimat is intended as a once-daily maintenance treatment for COPD and should not be used for relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.
• Immediate hypersensitivity reactions, including urticaria, angioedema (including swelling of the lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching, may occur after administration of Spiriva Respimat. Discontinue Spiriva Respimat at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, urticaria, rash, bronchospasm, or anaphylaxis, occur. Use with caution in patients with severe hypersensitivity to milk proteins.
• Inhaled medicines, including Spiriva Respimat, may cause paradoxical bronchospasm. Discontinue Spiriva Respimat and consider other treatments if paradoxical bronchospasm occurs.
• Spiriva Respimat should be used with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs.
• Spiriva Respimat should be used with caution in patients with urinary retention. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if this occurs.
• As a predominantly renally excreted drug, patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) treated with Spiriva Respimat should be monitored closely for anticholinergic side effects.

What to do in case of emergency/overdose?

High doses of tiotropium may lead to anticholinergic signs and symptoms.

Symptoms of overdosage may include:

• Dry mouth/throat
• dry nasal mucosa

Management of overdosage:

• Treatment of overdosage consists of discontinuation of Spiriva Respimat together with institution of appropriate symptomatic and/or supportive therapy.

Can this medicine be used in pregnancy?

• The limited human data with Spiriva Respimat use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes.

Can this medicine be used in children?

• The safety and efficacy of Spiriva Respimat have not been established in pediatric patients less than 6 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• TIOTROPIUM BROMIDE ANHYDROUS

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Distributed by:Boehringer Ingelheim Pharmaceuticals,Inc., Ridgefield, CT 06877 USA

Licensed from:

• Boehringer Ingelheim International GmbH
• SPIRIVA® and RESPIMAT® are registered trademarks of and are used under license from Boehringer Ingelheim International GmbH

What should I know about storage and disposal of this medication?

• Store Spiriva Respimat at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze your Spiriva Respimat cartridge and inhaler.
• If Spiriva Respimat has not been used for more than 3 days, release 1 puff towards the ground.
• If Spiriva Respimat has not been used for more than 21 days, repeat steps 4 to 6 under the "Prepare for first use" until a mist is visible. Then repeat steps 4 to 6 three more times.

• Dailymed label info on Spiriva Respimat
• FDA Spiriva Respimat

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