Tiotropium inhalation

Tiotropium inhalation is a bronchodilator that helps prevent bronchospasm (narrowing of the airways in the lungs) in adults with COPD (chronic obstructive pulmonary disease), which includes bronchitis and emphysema.

Tiotropium inhalation is also used to prevent asthma attacks in adults and children who are at least 6 years old.

Tiotropium inhalation may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Tiotropium inhalation is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Tiotropium inhalation powder comes in capsules that are for use only with a special inhaler device (Spiriva HandiHaler). Do not take the capsule by mouth.

Tiotropium inhalation aerosol is a cartridge that is inserted into a special inhaler device (Spiriva Respimat). Turning the base of the Respimat device until it clicks will release the medicine into the inhaler chamber.

Any child using tiotropium inhalation should be supervised by an adult while using this medicine.

You may need frequent lung function tests.

Store this medicine at room temperature away from moisture and heat. Do not freeze.

Do not remove a tiotropium capsule from its blister pack until you are ready to place the capsule into the HandiHaler and use the device.

A tiotropium capsule is meant to be used only in the HandiHaler device. Do not swallow the capsule. Use only one capsule at a time.

You should not use tiotropium inhalation if you are allergic to tiotropium or ipratropium (Atrovent, Combivent, DuoNeb).

Tell your doctor if you have ever had:

• narrow-angle glaucoma;
• kidney disease;
• a milk allergy; or
• an enlarged prostate or urination problems.

Tell your doctor if you are pregnant. It is not known whether tiotropium will harm an unborn baby. However, having uncontrolled asthma during pregnancy may cause premature birth, a low birth weight baby, or complications such as eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Tiotropium inhalation is not approved for use by anyone younger than 6 years old.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tiotropium inhalation may cause serious side effects. Call your doctor right away if you experience:

• wheezing, choking, or other breathing problems after using tiotropium inhalation;
• blurred vision, eye pain or redness, seeing halos around lights;
• sores or white patches in your mouth, on your lips, or on your tongue;
• pain or burning when you urinate; or
• little or no urinating.

Common side effects of tiotropium inhalation may include:

• dry mouth;
• blurred vision;
• constipation, painful urination;
• upset stomach;
• chest pain, fast heart rate; or
• cold symptoms such as stuffy or runny nose, sinus pain, sore throat.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

Tiotropium inhalation powder, hard capsule:-18 mcg (2 inhalations) orally once a day using the HandiHaler deviceTiotropium, solution for inhalation:-5 mcg (2 inhalations) orally once a dayUses: Long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema; to reduce exacerbations in COPD patients

Usual Adult Dose for Asthma -- Maintenance:

-2.5 mcg (2 inhalations of 1.25 mcg) orally once a dayComments:-The maximum benefits in lung function may take up to 4 to 8 weeks of dosing.Use: Long-term maintenance treatment of asthma

Usual Pediatric Dose for Asthma -- Maintenance:

6 years or older:-2.5 mcg (2 inhalations of 1.25 mcg) orally once a dayComments:-The maximum benefits in lung function may take up to 4 to 8 weeks of dosing.Use: Long-term maintenance treatment of asthma

Use the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not use two doses at once.

Do not use more than two times in a 24-hour period.

Get your prescription refilled before you completely run out of medicine.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Symptoms of an overdose may include dry mouth, red eyes, constipation, stomach pain, and confusion or drowsiness.

Do not get the powder from a tiotropium capsule in your eyes. If this occurs, call your doctor.

Do not drive or engage in hazardous activities until you understand how tiotropium inhalation will affect you. Your reactions could be impaired.

Tell your doctor about all the other medicines you are taking, especially:

• medicine for depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (like Benadryl);
• medicine for Parkinson's disease;
• medicine for stomach problems, motion sickness, or irritable bowel syndrome;
• medicine for overactive bladder; or
• bronchodilator asthma medication.

This list is not complete. Other drugs may affect tiotropium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.