Tiotropium bromide and olodaterol

Tiotropium bromide/olodaterol is a prescription medication used to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

It is a single product containing two medications: tiotropium and olodaterol. Tiotropium belongs to a group of drugs called bronchodilators. It works by relaxing and opening the air passages to the lungs to make breathing easier. Olodaterol belongs to a group of drugs called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe. Tiotropium bromide/olodaterol helps the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

This medication comes as an inhalation spray and is taken usually once a day.

Common side effects of this medication include runny nose, cough, and back pain. 

Tiotropium bromide/olodaterol is a prescription medication used to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tiotropium bromide and olodaterol may be found in some form under the following brand names:

• Stiolto Respimat

Serious side effects have been reported with tiotropium bromide/olodaterol. See the "Drug Precautions" sections.

Common side effects include:

• runny nose
• cough
• back pain
• dizziness
• difficulty falling or staying asleep
• blurred vision
• glaucoma
• dry mouth
• constipation
• rash
• dry skin
• urinary retention

This is not a complete list of tiotropium bromide/olodaterol side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Anticholinergics (including atropine, ipratropium, aclidinium, umeclidinium or another tiotropium-containing product such as Spiriva Respimat or Spiriva HandiHaler)
• Beta blockers such as metoprolol, carvedilol, bisoprolol, betaxolol, nebivolol, and propranolol
• Monoamine oxidase inhibitors such as isocarboxazid, phenelzine, tranylcypromine, selegiline, and rasagiline
• Diuretics such as furosemide, bumetanide, torsemide, hydrochlorothiazide, chlorothiazide, and chlorthalidone
• Tricyclic Antidepressants such as trimipramine, amitriptyline, nortriptyline, protriptyline, and clomipramine
• QT Prolonging medications such as: certain anti-arrhythmia medications (including procainamide, sotalol, quinidine, dofetilide, amiodarone, ibutilide), fluoroquinolone antibiotics (including levofloxacin, ciprofloxacin, gatifloxacin, moxifloxacin), macrolide antibiotics (including clarithromycin, erythromycin), azole antifungals (including ketoconazole, itraconazole), antidepressants (including amitriptyline, desipramine, imipramine, doxepin, fluoxetine, sertraline, venlafaxine), antipsychotics (including haloperidol, droperidol, quetiapine, thioridazine, ziprasidone), and other medications (including sumatriptan, zolmitriptan, dolasetron, and methadone)

This is not a complete list of tiotropium bromide/olodaterol drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with tiotropium bromide/olodaterol including the following:

• sudden shortness of breath that may be life-threatening
• serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
• heart problems including fast or irregular heartbeat, palpitations, chest pain, increased blood pressure
• new or worsening eye problems including acute narrow-angle glaucoma. Symptoms of acute narrow-angle glaucoma include eye pain or discomfort, blurred vision, seeing halos or colored images around lights, and red eyes. Call your healthcare provider right away if you have any of these symptoms. Use caution as some of these eye problems can affect your ability to drive and operate appliances and machinery.
• new or worsening urinary retention. Symptoms of urinary retention may include difficulty urinating, painful urination, urinating frequently, or urinating in a weak stream or drips. Call your healthcare provider right away if you have any of these symptoms.
• low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
• high blood sugar

Call your healthcare provider or get emergency medical care right away if:

• your breathing problems worsen with tiotropium bromide/olodaterol
• you need to use your rescue medicine more often than usual
• your rescue inhaler medicine does not work as well for you at relieving your symptoms 

Do not take tiotropium bromide/olodaterol if you:

• have asthma.
• are allergic to tiotropium, ipratropium, olodaterol 

Tiotropium bromide/olodaterol should not be used in children. It is not known if tiotropium bromide/olodaterol is safe and effective in children.

Before using tiotropium bromide/olodaterol tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to tiotropium bromide/olodaterol or any of its ingredients, any other medicines, or food products.
• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have eye problems, such as glaucoma. This medication can make your glaucoma worse.
• have prostate or bladder problems, or problems passing urine. This medication can make these problems worse.
• have any other medical conditions
• are pregnant or planning to become pregnant. It is not known if this medication can harm your unborn baby.
• are breastfeeding. It is not known if tiotropium bromide/olodaterol passes into your breast milk and if it can harm your baby.

Tell your doctor about all the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan on becoming pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories-A,B,C,D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tiotropium bromide/olodaterol falls into category C. There are no well-controlled studies that have been done in pregnant women. This medication should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if tiotropium bromide/olodaterolcrosses into human milk. Because many medications can cross into human milk and because of the possibility of serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using tiotropium bromide/olodaterol.

Use tiotropium bromide/olodaterol exactly as prescribed.

This medication comes as an inhalation spray. It is usually taken once daily at the same time of the day.

Do not spray this medication in your eyes.

Always use the new tiotropium bromide/olodaterol inhaler that is provided with each new prescription.

Tiotropium bromide/olodaterol does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have one prescribed for you.

Do not stop using tiotropium bromide/olodaterol or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of this medication at the same time. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Stiolto Respimat (tiotropium & olodaterol) is two inhalations once-daily at the same time of the day. Do not use this medication more than two inhalations every 24 hours.

If you use too much tiotropium bromide/olodaterol, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze your cartridge or respimat inhaler.
• Keep tiotropium bromide/olodaterol and all medicines out of the reach of children.

Tiotropium bromide/olodaterol is not for use to treat sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

It is not known if tiotropium bromide/olodaterol is safe and effective in people with asthma.

Tiotropium bromide/olodaterol should not be used in children. It is not known if this medication is safe and effective in children.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) such as olodaterol, one of the active ingredients in Stiolto Respimat, increase the risk of asthma-related death. Data from a large, placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) with placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of all LABA, including olodaterol, one of the active ingredients in Stiolto Respimat. The safety and efficacy of Stiolto Respimat in patients with asthma have not been established. Stiolto Respimat is not indicated for the treatment of asthma.