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Spiriva®
Brand Name: Spiriva®
Active Ingredient:   Tiotropium bromide
Strength(s): 18 mcg
Dosage Form(s):   Capsule
Company Name:    Boehringer Ingelheim Pharmaceuticals, Inc.
Availability:         Prescription only
*Dated Approved by FDA:  January 30, 2004
*Approval by FDA does not mean that the drug is available for consumers at this time.


What is Spiriva used for?     

Spiriva HandiHaler is used for the treatment of breathing problems in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Spiriva is a maintenance bronchodilator. It helps to keep narrowed airways open.   Spiriva does not treat sudden episodes of breathing problems (bronchospasm).

 Special Warnings with Spiriva:

·       Do not use Spiriva to treat sudden episodes of breathing problems.

·       Serious allergic reactions such as itching, rash, swelling of the lips, tongue, or throat (trouble swallowing) may occur after taking Spiriva.  Stop taking Spiriva and get emergency help right away if you get any of these symptoms.

·       Spiriva may cause breathing problems (paradoxical bronchospasm).  Stop taking Spiriva and call your doctor right away if this happens.

General Precautions with Spiriva:

·       Spiriva capsules are used only with the HandiHaler device. Do not use the Handihaler device to take other medicines. 

·       Do not swallow Spiriva capsules.  The powder in the capsules is inhaled using the Handihaler device.

·       Store Spiriva capsules in the sealed blister strip until ready to use.  Only open the blister strip enough to remove one Spiriva capsule.  Spiriva capsules must be used right away when removed from the blister strip or they may not work as well.  Throw away Spiriva capsules that are exposed to air and not used right away.

·       Do not get Spiriva powder in your eyes.  It can affect your vision for awhile.

Who should not use Spiriva?

Do not use Spiriva if you:

·       are allergic to atropine or any medicine that contains atropine.

·       are allergic to any of the ingredients in Spiriva.

What should I tell my health care provider?

Tell your health care provider if you:

·       have or had glaucoma, prostate problems, or bladder blockages

·       have or had kidney problems

·       are trying to become pregnant, are already pregnant, or are breast-feeding

·       are allergic to Spiriva or to medicines that contain atropine

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.    Spiriva may interact with some other medicines used for COPD. 

What are some possible side effects of Spiriva? (This list is NOT a complete list of side effects reported with Spiriva.  Your health care provider can discuss with you a more complete list of side effects.) 

Serious side effects include (see General Precautions with Spiriva):

·       serious allergic reactions

·       breathing problems (paradoxical bronchospasm)

·       worsening of symptoms in people with narrow-angle glaucoma, enlarged prostates, and bladder blockages

Some common side effects with Spiriva include:

·       dry mouth

·       constipation

·       increased heart rate

·       blurred vision

·       glaucoma

·       problems with urination

For more detailed information about Spiriva, ask your health care provider or pharmacist.

Posted 4/2/04

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**This information came from an FDA consumer information site**
**This information is not updated - Check for updates at the FDA site**


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