Tiotropium (Inhalation)

Tiotropium is used to treat chronic obstructive pulmonary disease (COPD). COPD is a lung disease that 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 a maintenance treatment for asthma in adults and children 6 years of age and older.

Tiotropium is part of a group of medicines called bronchodilators. Bronchodilators are inhaled through the mouth to help open up the bronchial tubes (air passages) in the lungs. It is taken by inhalation (using an inhaler) and will increase the flow of air to the lungs.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your progress closely while you are using this medicine to ensure it is working properly and to help minimize any unwanted effects.

This medicine will not stop bronchospasm that has already started. Your doctor will provide you with another medicine to use in case of an acute attack.

Tiotropium may cause allergic reactions, including anaphylaxis and angioedema. Contact your doctor immediately 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 could worsen. Paradoxical bronchospasm may be life-threatening. Contact your doctor immediately if you experience coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Contact your doctor immediately if you notice any changes to your eyes, such as eye pain, eye discomfort, blurred vision, visual halos, or colored images with red eyes while using this medicine. Your doctor may refer you to an ophthalmologist (eye doctor) for an eye exam.

Contact your doctor immediately if you experience a decrease in urine volume, a decrease in the frequency of urination, difficulty passing urine, or painful urination.

This medicine may cause dizziness or blurred vision. Avoid driving, using machines, or any other activities that could be dangerous if you feel dizzy or cannot 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, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to the benefits it can provide.

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your healthcare professional about 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

Studies have not shown any specific problems that would limit the use of inhaled tiotropium for treating asthma in children aged 6 years and older. However, the safety and effectiveness of inhaled tiotropium for treating asthma in children younger than 6 years old have not been established.

Geriatric

Studies have not shown any specific problems that would limit the use of inhaled tiotropium in older adults.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should not be used together at all, other times two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected because of their potential importance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Aclidinium
• Amantadine
• Amifampridine
• Amitriptyline
• Amoxapine
• Atropine
• Belladonna
• Benztropine
• Biperiden
• Brompheniramine
• Buprenorphine
• Carbinoxamine
• Carisoprodol
• Chlorpheniramine
• Chlorpromazine
• Clemastine
• Clidinium
• Clomipramine
• Clozapine
• Codeine
• Cyclobenzaprine
• Cyclopentolate
• Cyproheptadine
• Darifenacin
• Desipramine
• Dicyclomine
• Dimenhydrinate
• Diphenhydramine
• Donepezil
• Doxepin
• Fesoterodine
• Flavoxate
• Fluphenazine
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Homatropine
• Hydroxyzine
• Hyoscyamine
• Imipramine
• Ipratropium
• Loxapine
• Meclizine
• Mepenzolate
• Methacholine
• Nortriptyline
• Olanzapine
• Orphenadrine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Paroxetine
• Perphenazine
• Pimozide
• Pipenzolate Bromide
• Pirenzepine
• Prochlorperazine
• Procyclidine
• Promethazine
• Propantheline
• Propiverine
• Protriptyline
• Quetiapine
• Revefenacin
• Scopolamine
• Solifenacin
• Stramonium
• Tapentadol
• Terodiline
• Thioridazine
• Thiothixene
• Tiotropium
• Tizanidine
• Tolterodine
• Trifluoperazine
• Trihexyphenidyl
• Trimipramine
• Tropicamide
• Trospium
• Umeclidinium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to milk proteins or
• Difficulty urinating or
• Enlarged prostate or
• Glaucoma, narrow angle or
• Urinary bladder blockage—Use with caution. May worsen these conditions.

• Kidney disease, moderate to severe—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

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 the 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.

In the U.S.

• Spiriva
• Spiriva Respimat

Available Dosage Forms:

• Spray
• Capsule

Therapeutic Class: Bronchodilator

Pharmacologic Class: Antimuscarinic

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 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.

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.

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• How to use an inhaler: step-by-step for every type