Spiriva

Generic Name: tiotropium (Inhalation, oral/nebulization route)

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 Spiriva

Tiotropium is a medicine used to treat bronchospasm (wheezing or difficulty in breathing) that is associated with Chronic Obstructive Pulmonary Disease. Chronic obstructive pulmonary disease is a long-term lung disease. It is also called COPD. COPD also includes breathing problems like chronic bronchitis (swelling of the airways or tubes leading to the lungs) and emphysema (damage to the air sacs in the lungs).

Tiotropium is a bronchodilator. A bronchodilator is a medicine that opens up narrowed breathing passages. It is taken by inhalation (an inhaler) to help decrease coughing, wheezing, shortness of breath, and troubled breathing by increasing the flow of air into the lungs

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

Before Using Spiriva

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

Studies on this medicine have only been done in adult patients, and there is no specific information comparing the use of tiotropium in children with use in other age groups. The disease that this medicine treats does not normally occur in children.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Difficulty urinating (bladder problems) or
• Narrow angle glaucoma (eye condition) or
• Enlarged prostate — this medicine can make these conditions worse

Proper Use of Spiriva

Inhaled tiotropium is used with a special inhaler (HandiHaler) and usually comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. There are four main steps to take your medicine. Open the blister and the HandiHaler device, insert the tiotropium capsule, press the HandiHaler button and inhale your medication. Ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

The HandiHaler is an inhalation device (inhaler) that has been specially designed for use with tiotropium capsules for inhalation. The HandiHaler must not be used to take other medicines.

Capsules should always be stored in sealed blisters and only removed immediately before use. The blister strip should be carefully opened to expose only one capsule at a time. Open the blister foil as far as the STOP line to remove only one capsule at a time. The medicine should be used immediately after the packaging over an individual capsule is opened, or else it may not be as effective as it should be. After using the first capsule, the 2 remaining capsules should be used over the next 2 consecutive days. Capsules should always be stored in the blister and only removed immediately before use. Capsules that are accidently exposed to air and that are not intended for immediate use should be discarded.

Inhaled tiotropium is a once daily maintenance medicine that opens narrowed airways and keeps them open for 24 hours. This medicine should not be used for immediate relief of breathing problems, such as a rescue medication.

Tiotropium capsules are to be used for oral inhalation only. The capsules should not be swallowed.

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 inhalation dosage form (capsules):
  • For bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD)
    • Adults— 1 capsule (18 micrograms [mcg]) inhaled once daily; capsules should only be used with the HandiHaler inhalation device (inhaler)
    • 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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using Spiriva

Care must be taken not to allow powder from the capsules to get into your eyes. If the powder does get into your eye it can cause blurring of vision and pupil dilation (decreasing pupil size).

If symptoms of eye pain, eye discomfort, blurred vision, visual halos, or colored images in association with red eyes occur, contact a physician immediately.

It is very important that your doctor check you at regular visits.

Spiriva 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:

• Arm, back or jaw pain
• chest pain or discomfort
• chest tightness or heaviness
• fast or irregular heartbeat
• nausea
• shortness of breath
• sweating

• Cough
• difficulty swallowing
• dizziness
• hives
• itching
• painful blisters on trunk of body
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• skin rash
• tightness in chest
• unusual tiredness or weakness
• wheezing

• Fainting
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, 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:

• 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 in breathing
• dry mouth
• dryness of throat
• ear congestion
• fever
• frequent urge to urinate
• headache
• heartburn
• hoarseness
• indigestion
• loss of voice
• lower back or side pain
• nasal congestion
• pain or tenderness around eyes and cheekbones
• runny nose
• sneezing
• sore throat
• stomach discomfort, upset or pain
• stuffy nose
• tender, swollen glands in neck
• trouble in swallowing
• troubled breathing
• unusual tiredness or weakness
• voice changes

• Abdominal 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
• fatigue
• 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 lips or tongue or inside the mouth
• sweating
• swelling
• swelling or inflammation of the mouth
• tiredness
• troubled breathing
• trouble concentrating
• trouble sleeping
• unexplained weight loss
• vomiting
• white patches in mouth and/or on tongue

• Painful or difficult urination

• Hives or welts
• irregular heartbeat
• itching
• itching skin
• redness of skin
• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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