Description
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 6 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.
This product is available in the following dosage forms:
- Spray
- Capsule
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled tiotropium to treat asthma in children 6 years of age and older. However, safety and efficacy of inhaled tiotropium have not been established to treat asthma in children younger than 6 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled tiotropium in the elderly.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Potassium Chloride
- Potassium Citrate
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.
- Aclidinium
- Amantadine
- Amifampridine
- Amitriptyline
- Amoxapine
- Atropine
- Belladonna
- Benzhydrocodone
- Benztropine
- Biperiden
- Brompheniramine
- Buprenorphine
- Carbinoxamine
- Carisoprodol
- Chlorpheniramine
- Chlorpromazine
- Clemastine
- Clidinium
- Clomipramine
- Clozapine
- Codeine
- Cyclobenzaprine
- Cyclopentolate
- Cyproheptadine
- Darifenacin
- Desipramine
- Dicyclomine
- Dihydrocodeine
- Dimenhydrinate
- Diphenhydramine
- Donepezil
- Doxepin
- Fentanyl
- Fesoterodine
- Flavoxate
- Fluphenazine
- Glucagon
- Glycopyrrolate
- Glycopyrronium Tosylate
- Homatropine
Other Interactions
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:
- Allergy to milk proteins or
- Difficult urination or
- Enlarged prostate or
- Glaucoma, narrow angle or
- Urinary bladder blockage—Use with caution. May make these conditions worse.
- Kidney disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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®:
- Open the HandiHaler® device and the blister containing the capsule.
- Put one capsule into the HandiHaler® device.
- Press and then release the green piercing button on the side of the HandiHaler® device. Do not press the green button more than once.
- Breathe out fully. Do not breathe into the mouthpiece of the HandiHaler® device.
- Hold the HandiHaler® base, put the mouthpiece between your lips, and close your lips around the mouthpiece.
- Breathe in slowly and deeply through your mouth as you can hear or feel the Spiriva® capsule vibrate. Do not breathe through your nose.
- Hold your breath and remove the mouthpiece from your mouth. Then, breathe normally again.
- After you are finished, open the mouthpiece and remove the used Spiriva® capsule and throw it away. Do not store any used or unused capsule in the HandiHaler® device.
- Rinse the HandiHaler® device with warm water and keep it dry.
To use the Spiriva® Respimat® inhaler:
- Take the inhaler and cartridge out of the carton before you use it for the first time.
- Do not use the inhaler for this medicine with any other medicine.
- Push the narrow end of the cartridge into the inhaler. About 1/8 of an inch will remain visible when the cartridge is correctly inserted.
- Do not turn the clear base before inserting the cartridge.
- Do not remove the cartridge once it has been inserted in the inhaler.
- Flip the aqua cap until it snaps fully open. Turn the clear base in the direction of the black arrows on the label until it clicks (half a turn).
- When you use the inhaler for the first time, or if you have not used it for 3 days or longer, it may not deliver the right amount of medicine with the first puff. Before using the inhaler, prime it by spraying the medicine 3 times into the air away from the face.
- To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
- While pressing down firmly and fully on the dose release button of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
- Repeat these steps for the next puff.
- Close the aqua cap after taking your medicine.
- The inhaler has a window that shows the number of doses that are left. The counter will turn red when the inhaler has few doses left. This will remind you to refill your prescription.
- Clean the inhaler mouthpiece daily with a damp cloth or tissue only, at least once a week.
- Throw away the inhaler after 3 months from its first use.
Dosing
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.
- For asthma:
- For oral inhalation dosage form (spray):
- Adults and children 6 years of age and older—2 puffs once a day. Each puff contains 1.25 microgram (mcg) of tiotropium. Do not take more than 2 puffs in 24 hours.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For oral inhalation dosage form (spray):
- For bronchospasm caused by COPD:
- For oral inhalation dosage form (capsules):
- Adults—2 puffs of the powder from one Spiriva® capsule (18 micrograms [mcg]) inhaled through the HandiHaler® device once a day.
- Children—Use and dose must be determined by your doctor.
- For oral inhalation dosage form (spray):
- Adults—2 puffs once a day. Each puff contains 2.5 microgram (mcg) of tiotropium.
- Children—Use and dose must be determined by your doctor.
- For oral inhalation dosage form (capsules):
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.
Do not use this medicine more than once every 24 hours.
Storage
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.
Precautions
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, 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.
Side Effects
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:
More common
- Arm, back, or jaw pain
- chest pain or discomfort
- chest tightness or heaviness
- fast or irregular heartbeat
- nausea
- sweating
- trouble breathing
Less common
- Cough
- difficulty with swallowing
- dizziness
- hives, itching, or skin rash
- painful blisters on the trunk of body
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tightness in the chest
- unusual tiredness or weakness
Rare
- Fainting
- fast, pounding, or irregular heartbeat or pulse
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
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:
More common
- Acid or sour stomach
- belching
- bladder pain
- bloody or cloudy urine
- body aches or pain
- chest pain
- chills
- congestion
- cough
- difficult, burning, or painful urination
- dry mouth
- dryness of the throat
- ear congestion
- fever
- frequent urge to urinate
- headache
- heartburn
- hoarseness
- indigestion
- loss of voice
- lower back or side pain
- pain or tenderness around the eyes and cheekbones
- runny or stuffy nose
- sneezing
- sore throat
- stomach discomfort, upset, or pain
- tender, swollen glands in the neck
- voice changes
Less common
- Bloody nose
- blurred vision
- bone pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- canker sores
- difficulty having a bowel movement (stool)
- discouragement
- feeling sad or empty
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- irritability
- lack of appetite
- leg pain
- loss of interest or pleasure
- muscle pain
- nausea
- painful or difficult urination
- sore mouth or tongue
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- sweating
- swelling or inflammation of the mouth
- tiredness
- trouble concentrating
- trouble sleeping
- unexplained weight loss
- vomiting
Incidence not known
- Bloating
- change in vision
- diarrhea
- red skin
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.
CON-XXXXXXXX
