Description
Tiotropium and olodaterol combination is used as long-term maintenance treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis or emphysema.
Olodaterol and 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 into the lungs.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Spray
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 have not been performed on the relationship of age to the effects of inhaled tiotropium and olodaterol combination 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 and olodaterol combination 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.
- Acebutolol
- Aclidinium
- Amantadine
- Amifampridine
- Amitriptyline
- Amoxapine
- Arotinolol
- Atenolol
- Atropine
- Befunolol
- Belladonna
- Benzhydrocodone
- 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
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:
- 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 (eg, coronary insufficiency, obstructive cardiomyopathy) or
- Heart rhythm problems (eg, 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 (eg, thyrotoxicosis) 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.
- Liver disease, severe—Use has not been studied in patients with this condition.
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 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.
- For maintenance treatment of COPD, chronic bronchitis, or emphysema:
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.
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. Blood and urine tests may be needed to check for unwanted effects.
Tell your doctor if you are also 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 you should 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 has 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, tell your doctor right away.
Talk with your doctor or get medical care right away if:
- Your symptoms do not improve after using this medicine or if they become worse.
- 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 big 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 medicine. Talk to your doctor if you have concerns about this.
This medicine 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 genitals 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 or difficulty breathing after using this medicine.
This medicine may cause heart or blood vessel problems, including heart rhythm problems. Check with 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.
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 your eyes be 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.
Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with 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, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, 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
- 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.
DRG-20146778
