tiotropium Inhalation, oral/nebulization

tye-oh-TROE-pee-um

Commonly used brand name(s)

In the U.S.

• Spiriva

Available Dosage Forms:

• Capsule

Therapeutic Class: Bronchodilator

Pharmacologic Class: Antimuscarinic

Uses For tiotropium

Tiotropium is used to treat bronchospasm or wheezing caused by 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).

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.

tiotropium is available only with your doctor's prescription.

Before Using tiotropium

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 tiotropium, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tiotropium 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 have not been performed on the relationship of age to the effects of inhaled tiotropium in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled tiotropium in the elderly.

Pregnancy

	Pregnancy Category	Explanation
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.

Breast Feeding

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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 tiotropium. 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—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of tiotropium

Use tiotropium 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 tiotropium without telling your doctor. To do so may increase the chance of having breathing problems.

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.

tiotropium 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.

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:

• 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.

Dosing

The dose of tiotropium 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 tiotropium. 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 oral inhalation dosage form (capsules):
  
  • For bronchospasm caused by COPD:
    
    • Adults—Two 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.
    
    
  
  

Missed Dose

If you miss a dose of tiotropium, 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 tiotropium 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 While Using tiotropium

It is very important that your doctor check your progress closely while you are using tiotropium to see if it is working properly and to help reduce any unwanted effects.

tiotropium 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. Stop using the medicine and check with your doctor right away if you develop a skin rash, itching, shortness of breath, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs after using tiotropium.

tiotropium may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using tiotropium and check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using tiotropium.

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 tiotropium. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

tiotropium 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.

tiotropium 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


• shortness of breath


• sweating

Less common

• Cough


• difficulty with swallowing


• dizziness


• hives


• itching


• painful blisters on the trunk of body


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Rare

• Fainting


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• palpitations


• pounding, or irregular heartbeat or pulse

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


• difficulty with breathing


• 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


• trouble with swallowing


• troubled breathing


• unusual tiredness or weakness


• voice changes

Less common

• Abdominal or stomach pain


• bloody nose


• blurred vision


• 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


• large amount of cholesterol in the blood


• leg pain


• loss of interest or pleasure


• muscle pain


• nausea


• painful or difficult urination


• skeletal pain


• sore mouth or tongue


• sores, ulcers, or white spots on the lips or tongue or inside the mouth


• sweating


• swelling


• swelling or inflammation of the mouth


• tiredness


• trouble concentrating


• trouble sleeping


• troubled breathing


• unexplained weight loss


• vomiting


• white patches in the mouth and/or on the tongue

Incidence not known

• Bloating


• change in vision


• constipation


• diarrhea


• itching or 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.

See also: tiotropium Inhalation,/nebulization side effects (in more detail)

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More tiotropium Inhalation, oral/nebulization resources

• Tiotropium Inhalation, oral/nebulization Side Effects (in more detail)
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• Tiotropium Inhalation, oral/nebulization Drug Interactions
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