Tiotropium bromide

What is Tiotropium bromide?

• Tiotropium bromide (Spiriva Handihaler) is an anticholinergic used in the management of chronic obstructive pulmonary disease (COPD).

Tiotropium bromide

What are the uses of this medicine?

• Tiotropium bromide (Spiriva Handihaler) is a prescription medicine used each day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
• Tiotropium bromide (Spiriva Handihaler) helps make your lungs work better for 24 hours. Spiriva Handihaler relaxes your airways and helps keep them open. You may start to feel like it is easier to breathe on the first day, but it may take longer for you to feel the full effects of the medicine. Spiriva Handihaler works best and may help make it easier to breathe when you use it every day.
• It reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations). A COPD exacerbation is defined as an increase or new onset of more than one COPD symptom such as cough, mucus, shortness of breath, and wheezing that requires medicine beyond your rescue medicine.

Chronic Obstructive Pulmonary Disease:

• COPD is a serious lung disease that includes chronic bronchitis, emphysema, or both.
• Most COPD is caused by smoking.
• When you have COPD, your airways become narrow.
• So, air moves out of your lungs more slowly.
• This makes it hard to breathe.

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 have:

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

What drug interactions can this medicine cause?

• Avoid administration of Spiriva Handihaler with other anticholinergic-containing drugs including ipratropium.

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:

• Two inhalations of the powder contents of a single Spiriva capsule (18 mcg) once daily.

Administration:

• Use Spiriva Handihaler one time every day.
• Do not swallow Spiriva capsules.
• Only use Spiriva capsules with the Handihaler device.
• Do not use the Handihaler device to take any other medicine.
• Spiriva Handihaler comes as a powder in a Spiriva capsule that fits the Handihaler device. Each Spiriva capsule, containing only a small amount of Spiriva powder, is one full dose of medicine.
• Separate one blister from the blister card. Then take out one of the Spiriva capsules from the blister package right before you use it.
• After the capsule is pierced, take a complete dose of Spiriva Handihaler by breathing in the powder by mouth two times, using the Handihaler device (take 2 inhalations from one Spiriva capsule).
• Throw away any Spiriva capsule that is not used right away after it is taken out of the blister package. Do not leave the Spiriva capsules open to air; they may not work as well.
• If you miss a dose, take it as soon as you remember. Do not use Spiriva Handihaler more than one time every 24 hours.
• If you use more than your prescribed dose of Spiriva Handihaler, call your doctor or a poison control center.

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

This medicine is available in fallowing doasage form:

• As Inhalation powder: Spiriva capsules contain 18 mcg tiotropium powder for use with Handihaler device.

This medicine is available in fallowing brand namesː

• Spiriva Handihaler

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory tract infection
• dry mouth
• sinus infection
• sore throat
• non-specific chest pain
• urinary tract infection
• indigestion
• runny nose
• constipation
• increased heart rate
• blurred vision

Spiriva Handihaler can cause serious side effects, including:

• Allergic reaction
• bronchospasm
• acute narrow-angle glaucoma
• New or worsened urinary retention

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 Handihaler 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 Handihaler 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 Handihaler. Discontinue Spiriva Handihaler 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 Handihaler, may cause paradoxical bronchospasm. Discontinue Spiriva Handihaler and consider other treatments if paradoxical bronchospasm occurs.
• Spiriva Handihaler should be used with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs.
• Spiriva Handihaler 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 Handihaler should be monitored closely for anticholinergic side effects.
• Tiotropium has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

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

Symptoms of overdosage may include:

• bilateral conjunctivitis
• dry mouth
• altered mental status
• tremors
• abdominal pain
• severe constipation

Management of overdosage:

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

Can this medicine be used in pregnancy?

• The limited human data with Spiriva Handihaler use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes.
• It is not known if Spiriva Handihaler could harm your unborn baby.

Can this medicine be used in children?

• Spiriva Handihaler is not indicated for use in children.
• The safety and effectiveness of Spiriva Handihaler in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tiotropium
• Inactive ingredient: lactose monohydrate

Who manufactures and distributes this medicine?

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

Licensed from:

• Boehringer Ingelheim International GmbH

• Spiriva® and Handihaler® 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?

• Do not store Spiriva capsules in the Handihaler device.
• Store Spiriva capsules in the sealed blister package at room temperature 68°F to 77°F (20°C to 25°C).
• Keep Spiriva capsules away from heat and cold (do not freeze).
• Store Spiriva capsules in a dry place. Throw away any unused Spiriva capsules that have been open to air.

• Dailymed label info on Tiotropium bromide
• FDA Tiotropium bromide

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