Tiotropium is used to treat chronic obstructive pulmonary disease (COPD). COPD is a lung disease that also includes chronic bronchitis (swelling of the tubes leading to the lungs) and emphysema (damage to the air sacs in the lungs). It is also used as maintenance treatment for asthma in adults and children 12 years of age and older.
Tiotropium belongs to the family of medicines known as bronchodilators. Bronchodilators are breathed in through the mouth to help open up the bronchial tubes (air passages) in the lungs. It is taken by inhalation (an inhaler) and will increase the flow of air to the lungs.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled tiotropium to treat asthma in children 12 years of age and older. However, safety and efficacy of inhaled tiotropium have not been established in children younger than 12 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled tiotropium in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance of having breathing problems.
This medicine usually comes with patient instructions. Read them carefully before using the medicine. If you do not understand the instructions or have questions about using the inhaler, talk to your doctor.
Use this medicine at the same time each day.
Spiriva® capsules should only be used with the HandiHaler® device. Do not swallow the capsule. Spiriva® capsules should only be inhaled through your mouth (oral inhalation). Do not use the HandiHaler® device with any other medicine.
Do not allow the powder from the capsules to get in your eyes. If the powder does get in your eyes, it may cause blurred vision and pupil dilation (increased pupil size). If this happens, call your doctor right away.
To use the Spiriva® HandiHaler®:
To use the Spiriva® Respimat® inhaler:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
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.
Do not use this medicine more than once every 24 hours.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Leave the capsules in the blister pack until you are ready to use the medicine. Only open one blister at a time when you are ready to remove a capsule and put it in the HandiHaler® device. Once you have opened a blister, use the capsule right away. After using the first capsule, the 2 remaining capsules should be used over the next 2 consecutive days. Capsules that are accidently exposed to air and not intended for immediate use should be discarded.
It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to help reduce any unwanted effects.
This medicine will not stop bronchospasm that has already started. Your doctor will give you another medicine to use in case of an acute attack.
Tiotropium may cause allergic reactions, including anaphylaxis and angioedema. Check with your doctor right away if you develop a skin rash, itching, shortness of breath, trouble breathing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs after using this medicine.
This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.
Check with your doctor right away if you have any changes to your eyes, such as eye pain, eye discomfort, blurred vision, visual halos, or colored images with red eyes while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Check with your doctor right away if you have decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine, or painful urination.
This medicine may cause dizziness or blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are dizzy or not able to see well.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.
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.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.