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|Tiotropium Inhalation-Local

TIOTROPIUM (Inhalation-Local)

Some commonly used brand names are:

In the U.S.—

• Spiriva HandiHaler

In Canada—

• Spiriva

Category

• Bronchodilator

Description

Tiotropium (ty-OH-tro-pee-um) is a medicine used to treat bronchospasm (wheezing or difficulty in breathing) that is associated with Chronic Obstructive Pulmonary Disease. Chronic obstructive pulmonary disease is a long-term lung disease. It is also called COPD. COPD also includes breathing problems like chronic bronchitis (swelling of the airways or tubes leading to the lungs) and emphysema (damage to the air sacs in the lungs).

Tiotropium is a bronchodilator. A bronchodilator is a medicine that opens up narrowed breathing passages. It is taken by inhalation (an inhaler) to help decrease coughing, wheezing, shortness of breath, and troubled breathing by increasing the flow of air into the lungs

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Inhalation
• Capsule for inhalation (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tiotropium, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tiotropium, ipratropium, atropine, or inhaled lactose. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—This medicine has not been studied in pregnant women. Before taking this medicine, be sure your doctor knows if you are pregnant or planning to become pregnant.

Breast-feeding—It is not known whether inhaled tiotropium passes into breast milk. Mothers who are taking this medicine and wish to breast feed should discuss this with their doctor.

Children—Studies on this medicine have only been done in adult patients, and there is no specific information comparing the use of tiotropium in children with use in other age groups. The disease that this medicine treats does not normally occur in children.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using tiotropium, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Ipratropium (e.g., Atrovent) — using these medicines at the same time has not been studied and is not recommended

Other medical problems—The presence of other medical problems may affect the use of tiotropium. Make sure you tell your doctor if you have any other medical problems, especially:

• Difficulty urinating (bladder problems) or
• Narrow angle glaucoma (eye condition) or
• Enlarged prostate — this medicine can make these conditions worse

Proper Use of This Medicine

Inhaled tiotropium is used with a special inhaler (HandiHaler) and usually comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. There are four main steps to take your medicine. Open the blister and the HandiHaler device, insert the tiotropium capsule, press the HandiHaler button and inhale your medication. Ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

The HandiHaler is an inhalation device (inhaler) that has been specially designed for use with tiotropium capsules for inhalation. The HandiHaler must not be used to take other medicines.

Capsules should always be stored in sealed blisters and only removed immediately before use. The blister strip should be carefully opened to expose only one capsule at a time. Open the blister foil as far as the STOP line to remove only one capsule at a time. The medicine should be used immediately after the packaging over an individual capsule is opened, or else it may not be as effective as it should be. After using the first capsule, the 2 remaining capsules should be used over the next 2 consecutive days. Capsules should always be stored in the blister and only removed immediately before use. Capsules that are accidently exposed to air and that are not intended for immediate use should be discarded.

Inhaled tiotropium is a once daily maintenance medicine that opens narrowed airways and keeps them open for 24 hours. This medicine should not be used for immediate relief of breathing problems, such as a rescue medication.

Tiotropium capsules are to be used for oral inhalation only. The capsules should not be swallowed.

Dosing— Follow your doctor"s orders or the directions on the label . Use this medicine exactly as prescribed by your doctor. Do not use more of it than prescribed by your doctor.

• For inhalation dosage form (capsules):
  • For bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD)
    • Adults— 1 capsule (18 micrograms [mcg]) inhaled once daily; capsules should only be used with the HandiHaler inhalation device (inhaler)
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.
• Do not store capsules in the HandiHaler.

Precautions While Using This Medicine

Care must be taken not to allow powder from the capsules to get into your eyes. If the powder does get into your eye it can cause blurring of vision and pupil dilation (decreasing pupil size).

If symptoms of eye pain, eye discomfort, blurred vision, visual halos, or colored images in association with red eyes occur, contact a physician immediately.

It is very important that your doctor check you at regular visits.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 04/08/2004

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