Tiotropium and olodaterol (Inhalation route)
tye-oh-TROE-pee-um BROE-mide, oh-loe-DA-ter-ol
- Stiolto Respimat
Use of long-acting beta 2-adrenergic agonists (LABAs), including olodaterol, increases the risk of asthma-related death. A large, placebo-controlled study showed an increase in asthma-related deaths in patients taking salmeterol added to usual asthma therapy. This finding is considered a class effect of LABAs, including olodaterol. The safety and efficacy of tiotropium bromide/olodaterol in patients with asthma have not been established. Tiotropium bromide/olodaterol is not indicated for the treatment of asthma .
Uses of This Medicine:
Tiotropium and olodaterol combination is used as a maintenance treatment to treat air flow blockage in chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and 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 to the lungs.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
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.
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.
|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.|
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.
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 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.
- Oxitropium Bromide
- Pipenzolate Bromide
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.
- 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
- Hyperthyroidism (overactive thyroid) or
- Hypokalemia (low potassium levels in the blood) or
- Seizures 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.
Proper Use of This Medicine:
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 for breathing problems.
This medicine is used with a special inhaler and usually comes with patient directions or a Medication Guide. 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 doctor or pharmacist to show you what to do.
Use this medicine at the same time each day.
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 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 three times into the air away from the face.
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 3 test sprays.
- 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 green cap after taking your medicine.
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:
- 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:
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.
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.
Precautions While Using This Medicine:
It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to help reduce any unwanted effects.
This medicine should not be used if you are having a severe asthma or COPD attack, or if symptoms of a 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 cause allergic reactions, including anaphylaxis and angioedema. 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 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, difficulty breathing, shortness of breath, or wheezing after using this medicine.
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 you to have your eyes 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, shortness of breath, 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 for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.
Side Effects of This Medicine:
- Less common or rare
- Bladder pain
- bloody or cloudy urine
- blurred vision
- decrease in the frequency of urination
- decrease in urine volume
- decreased urination
- decreased vision
- difficult, burning, or painful urination
- difficulty in passing urine (dribbling)
- dry mouth
- eye pain
- fast or irregular heartbeat
- frequent urge to urinate
- hives, itching, or rash
- increase in heart rate
- joint pain, stiffness, or swelling
- lower back or side pain
- nausea or vomiting
- pounding in the ears
- rapid breathing
- redness of the skin
- slow or fast heartbeat
- sunken eyes
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- troubled breathing or swallowing
- unusual tiredness or weakness
- wrinkled skin
- Incidence not known
- eye pain or discomfort
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- visual halos or colored images
- More common
- Muscle aches
- sore throat
- stuffy or runny nose
- Less common
- Back pain
- Less common or rare
- Bleeding gums
- bloody nose
- creamy white, curd-like patches in the mouth or throat
- difficulty having a bowel movement (stool)
- difficulty with moving
- dry skin
- 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
- swelling or inflammation of the mouth
- trouble sleeping
- voice changes
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:
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:
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.
Last Updated: 9/15/2016