Tiotropium and olodaterol (Inhalation)

Tiotropium and olodaterol combination is used for long-term maintenance treatment in patients with chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis or emphysema.

Olodaterol and tiotropium are 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 (an inhaler) and will increase the flow of air into 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. Blood and urine tests may be needed to check for side effects.

Tell your doctor if you are using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor's instructions on how to take your medicine.

This medicine should not be used if you are having a severe asthma or COPD attack, or if symptoms of an asthma or COPD attack have already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, inform your doctor immediately.

Talk to your doctor or seek medical care right away if:

• Your symptoms do not improve after using this medicine or if they worsen.
• Your short-acting inhaler does not seem to work as well as it used to and you need it more often than normal.
• You have a significant decrease in your peak flow when measured as directed by your doctor.

This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid. Talk to your doctor if you have concerns about this.

This medicine may cause allergic reactions, including anaphylaxis and angioedema. Contact 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 genitals 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 right away if you have coughing or difficulty breathing after using this medicine.

This medicine may cause heart or blood vessel problems, including heart rhythm issues. Contact your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain.

Contact your doctor right away if you notice any changes to your eyes, such as eye pain, discomfort, blurred vision, visual halos, or colored images with red eyes while using this medicine. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

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

Hypokalemia (low potassium in the blood) may occur while using this medicine. Contact your doctor right away if you have more than one of the following symptoms: convulsions, decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, contact your doctor.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine versus the benefits it will provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine the effects of inhaled tiotropium and olodaterol combination in children. Safety and effectiveness have not been established for this age group.

Geriatric

Studies so far have not shown any specific problems that would limit the use of inhaled tiotropium and olodaterol combination in older adults.

Breast Feeding

There are no sufficient studies in women to assess the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together, even if an interaction might happen. In these cases, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions are highlighted for their potential significance and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe 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 how often you use one or both of the medicines.

• Acebutolol
• Aclidinium
• Amantadine
• Amifampridine
• Amitriptyline
• Amoxapine
• Arotinolol
• Atenolol
• Atropine
• Befunolol
• Belladonna
• Benztropine
• Betaxolol
• Bevantolol
• Biperiden
• Bisoprolol
• Bopindolol
• Brompheniramine
• Bucindolol
• Bupranolol
• Buprenorphine
• Carbinoxamine
• Carisoprodol
• Carteolol
• Carvedilol
• Celiprolol
• Chlorpheniramine
• Chlorpromazine
• Clemastine
• Clidinium
• Clomipramine
• Clozapine
• Codeine
• Cyclobenzaprine
• Cyclopentolate
• Cyproheptadine
• Darifenacin
• Desipramine
• Dicyclomine
• Dilevalol
• Dimenhydrinate
• Diphenhydramine
• Donepezil
• Doxepin
• Esmolol
• Fesoterodine
• Flavoxate
• Fluphenazine
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Homatropine
• Hydroxyzine
• Hyoscyamine
• Imipramine
• Ipratropium
• Labetalol
• Landiolol
• Levobunolol
• Loxapine
• Meclizine
• Mepenzolate
• Mepindolol
• Methacholine
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nortriptyline
• Olanzapine
• Orphenadrine
• Oxitropium Bromide
• Oxprenolol
• Oxybutynin
• Oxycodone
• Paroxetine
• Penbutolol
• Perphenazine
• Pimozide
• Pindolol
• Pipenzolate Bromide
• Pirenzepine
• Practolol
• Prochlorperazine
• Procyclidine
• Promethazine
• Propantheline
• Propiverine
• Propranolol
• Protriptyline
• Quetiapine
• Revefenacin
• Scopolamine
• Solifenacin
• Sotalol
• Stramonium
• Talinolol
• Tapentadol
• Terodiline
• Tertatolol
• Thioridazine
• Thiothixene
• Timolol
• Tiotropium
• Tizanidine
• Tolterodine
• Trifluoperazine
• Trihexyphenidyl
• Trimipramine
• Tropicamide
• Trospium
• Umeclidinium

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Other medical issues may affect your ability to use this medicine. Make sure to inform your doctor about any other medical problems you have, especially:

• Asthma—Use is not recommended in patients with this condition without an inhaled steroid.

• Diabetes or
• Difficult urination or
• Enlarged prostate or
• Glaucoma, narrow angle or
• Heart or blood vessel disease (e.g., coronary insufficiency, obstructive cardiomyopathy) or
• Heart rhythm problems (e.g., arrhythmia, QT prolongation) or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Hypokalemia (low potassium levels in the blood) or
• Seizures or
• Thyroid problems (e.g., thyrotoxicosis) 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 body removes the medicine more slowly.

• Liver disease, severe—Use has not been studied in patients with this condition.

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

• Chest pain
• chills
• cough
• fever
• sneezing
• sore throat
• trouble breathing
• tightness in the chest

Less common

• Bladder pain
• blindness
• bloody or cloudy urine
• blurred vision
• confusion
• decrease in the frequency of urination
• decreased vision
• difficult, burning, or painful urination
• difficulty in passing urine (dribbling)
• dizziness
• dry mouth
• eye pain or discomfort
• fainting
• fast or irregular heartbeat
• frequent urge to urinate
• headache
• hives, itching, or rash
• hoarseness
• increase in heart rate
• irritation
• joint pain, stiffness, or swelling
• lightheadedness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lower back or side pain
• nausea
• nervousness
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid breathing
• redness of the skin
• slow or fast heartbeat
• sunken eyes
• swelling of the eyelids, face, lips, hands, or feet
• tearing
• thirst
• troubled swallowing
• unusual tiredness or weakness
• visual halos or colored images
• vomiting
• wrinkled skin

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:

Less common

• Back pain
• bleeding gums
• bloody nose
• creamy white, curd-like patches in the mouth or throat
• difficulty having a bowel movement
• difficulty with moving
• dry skin
• heartburn
• irritation in the mouth
• mouth ulcers
• muscle pain or stiffness
• pain in the joints
• pain or tenderness around the eyes and cheekbones
• pain when eating or swallowing
• redness and swelling of the gums
• redness, swelling, or soreness of the tongue
• stuffy or runny nose
• swelling or inflammation of the mouth
• trouble sleeping
• voice changes

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.

• Stiolto Respimat

Available Dosage Forms:

• Spray

Therapeutic Class: Bronchodilator

Pharmacologic Class: Tiotropium

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 breathing problems.

This medicine is used with a special inhaler and usually comes with a patient information leaflet and patient instructions. Read the instructions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

Use this medicine at the same time each day to prevent COPD attacks.

Do not stop using this medicine or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

When you use the inhaler for the first time, or if you have not used it for more than 3 days, it may not deliver the right amount of medicine with the first puff. Before using the inhaler or if you have not used it for more than 21 days, prime it by spraying the medicine towards the ground until a visible cloud appears, then repeat it three times. If you have not used it for more than 3 days, spray the medicine into the air away from the face once.

To use the 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 green 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).
• Prime the inhaler before use by releasing a test spray until you see a mist, then repeat 3 more times.
• 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 without covering the air vents. 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.
• Hold your breath for about 10 seconds or for as long as you can, then breathe out. Repeat these steps for the next puff.
• Close the green cap after taking your medicine.
• Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least once a week.

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 (spray):For maintenance treatment of COPD, chronic bronchitis, or emphysema: Adults—Two puffs once a day. Do not use more than 2 puffs every 24 hours. 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.

Throw away the inhaler 3 months after its first use or when the inhaler is locked.