FDA warning

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Olodaterol, one of the active drugs in Stiolto, is a long-acting beta2 agonist (LABA). Drugs in the LABA class increase the risk of asthma-related death when used to treat asthma.

Stiolto is not FDA-approved to treat asthma. Clinical trials haven’t tested whether Stiolto is safe and effective in people with asthma.

What is Stiolto?

Stiolto is a brand-name prescription medication. It’s used as a long-term, maintenance (everyday) treatment for chronic obstructive pulmonary disease (COPD). COPD is a group of diseases that include chronic bronchitis and emphysema. Stiolto isn’t meant to be used for asthma.

Stiolto contains two drugs:

  • tiotropium, which belongs to a class of drugs called long-acting anticholinergics (LAMAs)
  • olodaterol, which belongs to a class of drugs called long-acting beta2-agonists (LABAs)

Stiolto comes as an inhaler called Stiolto Respimat. The name of the inhaler device is Respimat.

The usual dose for Stiolto is two inhalations (puffs) once a day. Each puff contains 2.5 mcg of tiotropium and 2.5 mcg of olodaterol. This adds up to a total of 5 mcg of each drug in each dose.

Effectiveness

Stiolto has been found effective as a long-term maintenance treatment for COPD. In clinical studies, Stiolto improved lung function (how well your lungs work) more than tiotropium or olodaterol alone. After 24 weeks of treatment, people who took Stiolto had a greater increase in their FEV1 (forced expiratory volume in one second) than people who took just tiotropium or olodaterol.

The FEV1 value shows how much air you can force from your lungs in one second. An increase in FEV1 value is a sign of better airflow in your lungs.

The Stiolto group FEV1 increased about 1.5 to 2 times more than the FEV1 in the tiotropium or olodaterol groups.

After 12 weeks, people who took Stiolto were 60% more likely to report a significant improvement in health-related quality of life. This was compared to people who took tiotropium.

However, Stiolto didn’t reduce the rate of exacerbations (flare-ups) compared to either tiotropium or olodaterol alone.

Stiolto generic

Stiolto is available only as a brand-name medication. It doesn’t currently have a generic form.

Stiolto contains two active drug ingredients: tiotropium and olodaterol.

Neither of the active drugs in Stiolto are currently available in generic form either.

Stiolto dosage

The following information describes the usual dosage for Stiolto. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Stiolto comes in two pieces:

  • Respimat inhaler device
  • Respimat cartridge that contains the medication (tiotropium and olodaterol)

Before you use the device for the first time, you’ll need to insert the cartridge into the inhaler. (See the “How to use Stiolto” step-by-step instructions below.)

Each inhalation (puff) delivers 2.5 mcg of tiotropium and 2.5 mcg of olodaterol. Each cartridge contains 60 puffs (30 doses).

Dosage for COPD maintenance

The usual dosage for Stiolto in treating chronic obstructive pulmonary disease (COPD) is two puffs taken once a day.

Two puffs deliver a total of 5 mcg of tiotropium and 5 mcg of olodaterol.

What if I miss a dose?

If you miss a dose of Stiolto, take it as soon as you remember. If it’s almost time for your next dose, just take one dose. Don’t take two doses within 24 hours. This can increase your risk for side effects.

Will I need to use this drug long term?

Most likely. Stiolto is meant to be used as long-term maintenance (everyday) treatment for COPD. If you and your doctor decide that Stiolto works for you and is safe, you will likely take it on a long-term basis.

Stiolto side effects

Stiolto can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Stiolto. This list doesn’t include all possible side effects.

For more information on the possible side effects of Stiolto, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Stiolto can include:

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Stiolto aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Severe allergic reactions. Symptoms can include:
    • itchy skin
    • rash
    • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
    • bronchospasm (wheezing or trouble breathing that gets worse)
    • anaphylaxis (allergic reaction that makes it hard to swallow and breathe)
  • Paradoxical bronchospasm. (Paradoxical means unexpected, given the purpose of the drug.) Symptoms can include:
    • coughing
    • trouble breathing that gets worse despite using your inhaler
  • Heart problems. Symptoms can include:
    • fast heart rate
    • increased blood pressure
    • abnormal heart rhythm
    • chest pain
  • New or worsening eye problems, including narrow-angle glaucoma. Symptoms an include:
    • increased pressure in your eyes
    • blurry vision
    • pain in your eyes
    • seeing halos
  • New or worsening urinary problems. Symptoms can include:
    • trouble urinating
    • pain when you urinate
    • urinating more often than normal
    • urinating in a weak stream or drops
  • Low potassium levels, which can cause muscle and heart problems. Symptoms can include:
    • muscle spasms (twitches)
    • muscle weakness
    • abnormal heart rhythm
    • heart palpitations
  • High blood sugar levels, which can be dangerous for people with diabetes. Symptoms can include:
    • excessive thirst
    • urinating more often than normal
    • urinating often at night
    • fatigue
  • Pneumonia.* Symptoms can include:
    • coughing
    • fever
    • shortness of breath
    • chest pain
  • Worsening chronic obstructive pulmonary disease (COPD), including exacerbations (flare-ups).* Symptoms can include:
    • coughing
    • trouble breathing
    • shortness of breath, even when you’re at rest
    • feeling tired
    • confusion
    • coughing up more mucus than usual
    • wheezing more than usual

* It’s not clear whether pneumonia and COPD were caused by Stiolto.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on some of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Stiolto.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Stiolto. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Weight gain (not a side effect)

In clinical studies, Stiolto wasn’t found to cause weight gain.

If you’re concerned about weight changes, talk with your doctor. They can suggest diet and exercise tips that are helpful for people with COPD.

Back pain

Back pain was one of the most commonly reported side effects of Stiolto. In clinical studies, 3.6% of people who took Stiolto had back pain.

If you have back pain while taking Stiolto, talk with your doctor. They can suggest pain relievers that are right for you.

Stiolto cost

As with all medications, the cost of Stiolto can vary. To find current prices for Stiolto in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance coverage and the pharmacy you use.

Financial assistance

If you need financial support to pay for Stiolto, help is available. Boehringer Ingelheim Pharmaceuticals, Inc., the maker of Stiolto, mentions the following options on its website:

  • Stiolto Savings Card
  • Help through the BI Cares Foundation
  • Inside Rx pharmacy discount card

For more information and to find out if you’re eligible for support, call 800-859-2174 or visit the drug website.

How to use Stiolto

You should use Stiolto according to your doctor or healthcare provider’s instructions.

Stiolto is taken as two inhalations (puffs), once a day. When you first get your prescription for Stiolto, your healthcare provider will explain how to use the inhaler.

Stiolto comes in two pieces that you put together to deliver the medication through the inhaler.

If you’re using your inhaler for the first time, see the instructions in the “Preparing your inhaler for first-time use” section below.

If you’ve already prepared your inhaler for the first-time use, see the instructions in the “Using your inhaler” section below.

For more information, a video, and images of preparing and using the inhaler, see the drug website.

How to prepare and use your inhaler

To make sure that you get the proper dose of Stiolto, it’s important to use your inhaler correctly. Read through the step-by-step instructions below.

Preparing your inhaler for first-time use

Before you use a new Stiolto inhaler for the first time, insert the cartridge into the inhaler. The cartridge contains the medication that you’ll breathe in through the inhaler.

The steps below will help you prepare Stiolto for first-time use.

  1. Gather the two pieces you need: the inhaler device and the cartridge.
  2. Keep the green cap on the inhaler until you’re ready to take the dose.
  3. Hold the inhaler in one hand and press the safety catch with your thumb.
  4. Pull the clear base off the inhaler with your other hand. Make sure you don’t touch the piercing element at the bottom of the inhaler. Keep the clear base nearby.
  5. Fill in the “discard by” date on the label. This date is three months from when you first insert the cartridge.
  6. Insert the narrow end of the cartridge into the inhaler.
  7. Place the bottom of the cartridge onto a firm surface.
  8. Press down firmly until the cartridge clicks into place.
  9. Put the clear base back onto the inhaler until it clicks. Don’t remove the clear base or cartridge once you’ve put them together.
  10. Keeping the cap closed, turn the clear base toward the arrows on the label until you hear a click (half a turn).
  11. Open the cap until it snaps open completely.
  12. Point the inhaler toward the ground. Then press the dose-release button.
  13. Close the cap. Look for a mist.
  14. If you don’t see a mist, repeat steps 10 through 12 until you see a mist.
  15. Once you see a mist, repeat steps 10 through 12 three more times. You’re not wasting the drug. This helps prepare the inhaler to deliver the right amount of medication for your dose.
  16. After you finish these steps, your Stiolto inhaler is ready for use.

Using your inhaler

Once you’ve put Stiolto together and it’s ready for use, follow these directions to take your dose.

Note: If it’s been more than three days since you used Stiolto, release one puff toward the ground before you take your dose. See steps 10 through 12 in the “Preparing your inhaler for first-time use” section above.

If it’s been more than 21 days since you used Stiolto, repeat steps 10 through 15 above. This will help prepare the inhaler to deliver your medication.

A helpful tool for remembering how to take your daily Stiolto dose is TOP: Turn. Open. Press.

Now you’re ready to take your dose of Stiolto.

  1. Keeping the cap closed, turn the clear base toward the arrows on the labels until it clicks (half a turn).
  2. Open the cap until it snaps completely open.
  3. Breathe out slowly and fully.
  4. Without covering the air vents on the inhaler, close your lips around the mouthpiece.
  5. Point the inhaler toward the back of your throat.
  6. While taking a slow, deep breath, press the dose-release button and keep breathing in.
  7. Hold your breath for 10 seconds or for as long as is comfortable for you.
  8. Repeat these steps for a total of two puffs.
  9. Close the cap until you take your next dose.

Cleaning your inhaler

It’s important to keep your inhaler device clean. At least once a week, wipe the mouthpiece (including the inside of it) with a damp cloth or tissue.

When to get a new Stiolto inhaler

A dose indicator on the inhaler tells you about how much medication is left in the device. When the indicator enters the red area, you have about a week’s worth of doses left in the inhaler. That’s about 14 puffs. This is a good time to get a new inhaler from your pharmacy so there are no breaks in your treatment.

When to use

Stiolto should be used once a day, at the same time each day. Take both puffs together, one after the other. Keep in mind that you can’t simply press the dose-release button twice to get both puffs together. For each puff, you’ll have to follow the steps in the “Using your inhaler” section above.

You can use Stiolto at any time of the day.

Medication reminders can help make sure that you don’t miss a dose.

Stiolto uses

The Food and Drug Administration (FDA) approves prescription drugs such as Stiolto to treat certain conditions.

Stiolto for COPD

Stiolto is FDA-approved as a long-term, maintenance (everyday) treatment for chronic obstructive pulmonary disease (COPD). This includes maintenance treatment for chronic bronchitis and emphysema.

COPD is a group of conditions, including chronic bronchitis and emphysema, that slowly destroy the small air sacs in your lungs. These conditions make it harder for you to breathe air out of your lungs.

COPD has no cure. Treatment guidelines recommend maintenance treatment to:

  • reduce how often you have COPD symptoms and how severe they are
  • reduce how often you have exacerbations (flare-ups)
  • improve your overall lung function (how well your lungs work) and health status

In clinical studies of people with COPD, Stiolto improved lung function (how well lungs work) more than the drug’s active ingredients (tiotropium or olodaterol) alone.

In the studies, improvement in lung function was measured using FEV1 (forced expiratory volume in one second). This is how much air you can force out of your lungs in one second. Higher FEV1 values are a sign of better airflow control.

After 24 weeks of treatment, FEV1 improved more in people who took Stiolto than in people who took tiotropium or olodaterol. Similar results were found after a year of treatment with Stiolto.

People who took Stiolto also had a better health-related quality of life than people who took tiotropium.

However, Stiolto didn’t reduce how many moderate to severe exacerbations (flare-ups) people had in one year, compared to tiotropium alone.

Stiolto for other conditions

You may wonder whether Stiolto is used for other conditions.

Stiolto for asthma (not an appropriate use)

Stiolto should only be used to treat COPD.

Stiolto isn’t FDA-approved to treat asthma. Studies haven’t tested whether the drug is safe or effective in treating asthma.

Olodaterol, one of the active drugs in Stiolto, belongs to a drug class called long-acting beta2-agonists (LABAs). Unless a LABA is used with an inhaled corticosteroid (ICS), taking a LABA to treat asthma increases the risk of asthma-related death. Stiolto doesn’t contain an ICS.

Because of the increased risk of asthma-related death, medications that contain a LABA without an ICS are required by the FDA to have a boxed warning on their labels. Boxed warnings are the strongest warnings that the FDA requires. They are meant to educate healthcare providers and patients about dangerous effects that can occur with a drug.

Stiolto has a boxed warning for olodaterol that describes the increased risk of asthma-related death.

Alternatives to Stiolto

Other drugs are available that can treat your chronic obstructive pulmonary disease (COPD). Some may be better suited for you than others. If you’re interested in finding an alternative to Stiolto, talk with your doctor to learn more about other medications that may work well for you.

Examples of other inhaler medications that are FDA-approved for long-term COPD maintenance (everyday) treatment are listed below. This list doesn’t include all available alternatives.

Long-acting beta2-agonists (LABAs):

  • arformoterol (Brovana)
  • formoterol (Perforomist, Foradil)
  • olodaterol (Striverdi)
  • salmeterol (Serevent)

Long-acting anticholinergics (LAMAs):

  • tiotropium (Spiriva)
  • umeclidinium (Incruse)

Combination medications:

  • umeclidinium/vilanterol (Anoro)
  • budesonide/formoterol (Symbicort)
  • fluticasone/salmeterol (Advair)
  • fluticasone/vilanterol (Breo)

Stiolto vs. Anoro

You may wonder how Stiolto compares to other medications that are prescribed for similar uses. Here we look at how Stiolto and Anoro are alike and different.

Uses

Stiolto and Anoro are both FDA-approved for as use as long-term maintenance (everyday) treatment of chronic obstructive pulmonary disease (COPD). COPD includes chronic bronchitis and emphysema.

Neither drug should be used as rescue medication for COPD or as treatment for asthma.

Drug forms and administration

Stiolto and Anoro are both inhalers.

Stiolto contains the drugs tiotropium and olodaterol. Anoro contains the drugs umeclidinium and vilanterol.

Both drugs contain a long-acting beta2-agonist (LABA) and a long-acting anticholinergic (LAMA).

The Stiolto inhaler is called Stiolto Respimat. The Anoro inhaler is called Anoro Ellipta. Respimat and Ellipta are the names of the inhaler devices.

You take Stiolto as two inhalations (puffs), once a day. You take Anoro as one puff a day.

Side effects and risks

Stiolto and Anoro both contain a LABA and a LAMA. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Stiolto, with Anoro, or with both drugs (when taken individually).

  • Can occur with Stiolto:
    • common cold
    • cough
    • back pain
  • Can occur with Anoro:
    • diarrhea
    • leg or arm pain
    • muscle spasms (twitches)
    • neck pain
  • Can occur with both Stiolto and Anoro:

Serious side effects

These lists contain examples of serious side effects that can occur with Stiolto, with Anoro, or with both drugs (when taken individually).

  • Can occur with Stiolto:
    • COPD exacerbation (flare-ups)
    • pneumonia
  • Can occur with Anoro:
    • severe allergic reaction in people who are allergic to milk
  • Can occur with both Stiolto and Anoro:
    • severe allergic reaction
    • paradoxical bronchospasm (wheezing or trouble breathing that gets worse right after using your inhaler)
    • heart problems, such as fast heart rate
    • new or worsening eye problems, such as narrow-angle glaucoma
    • new or worsening urinary problems, such as trouble urinating or pain when you urinate
    • low potassium levels
    • high blood sugar levels

Effectiveness

Stiolto and Anoro are both used as a long-term maintenance treatment for COPD.

The use of Stiolto and Anoro as COPD maintenance treatment has been directly compared in a clinical study.

In this study, Stiolto was compared to Anoro in people with moderate COPD. The study tested the drugs’ effects on FEV1 (forced expiratory volume in one second). FEV1 shows how much air you can force out of your lungs in one second. Higher FEV1 values are a sign of better COPD symptom control.

People who took Anoro were twice as likely to have a significant improvement in FEV1 compared to people who took Stiolto.

Similar results were also seen in an analysis that compared Stiolto and Anoro in people who had never taken COPD maintenance treatment before. In this analysis, 60% of people who took Anoro for eight weeks had a significant improvement in FEV1. This was compared to 42% of people who took Stiolto.

Another analysis found a greater improvement in FEV1 in people who took Anoro. This was whether the people used their rescue inhaler often or rarely at the beginning of the study.

In treatment guidelines, both medications are maintenance treatment options for COPD.

Costs

Stiolto and Anoro are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Anoro generally costs more than Stiolto. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

Stiolto vs. Symbicort

You may wonder how Stiolto compares to other medications that are prescribed for similar uses. Here we look at how Stiolto and Symbicort are alike and different.

Uses

Stiolto and Symbicort are both FDA-approved as maintenance (everyday) treatment for chronic obstructive pulmonary disease (COPD). COPD includes chronic bronchitis and emphysema.

Symbicort is only approved for COPD maintenance in one strength: Symbicort 160/4.5.

Symbicort is also approved to reduce the number of exacerbations (flare-ups) in COPD and to treat asthma in people ages 6 and older.

Neither drug should be used as rescue medication.

Drug forms and administration

Stiolto and Symbicort are both inhalers.

Stiolto contains two active drugs: tiotropium and olodaterol. Symbicort also contains two drugs: formoterol and budesonide.

Stiolto’s active drugs are a long-acting anticholinergic (tiotropium) and a long-acting beta2-agonist (LABA) (olodaterol).

Symbicort’s active drugs are a corticosteroid (budesonide) and a LABA (formoterol).

Stiolto is taken as two inhalations (puffs), once a day. Symbicort is taken as two puffs, twice a day.

Side effects and risks

Stiolto and Symbicort both contain a LABA. They also contain a different second drug. Therefore, the two medications can cause some similar and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Stiolto, with Symbicort, or with both drugs (when taken individually).

  • Can occur with Stiolto:
    • constipation
  • Can occur with Symbicort:
    • fungal infection in mouth
  • Can occur with both Stiolto and Symbicort:
    • back pain
    • upper respiratory infections, such as bronchitis, the common cold, or sinus infections
    • cough

Serious side effects

These lists contain examples of serious side effects that can occur with Stiolto, with Symbicort, or with both drugs (when taken individually).

  • Can occur with Stiolto:
    • new or worsening urinary problems, such as trouble urinating or pain when you urinate
    • worsening COPD
  • Can occur with Symbicort:
    • weakened immune system (your body can’t fight infections as well)
    • adrenal gland problems, such as Addison’s disease
    • decreased bone density
    • inflammation (swelling) of the blood vessels
    • delayed growth in children
  • Can occur with both Stiolto and Symbicort:
    • severe allergic reactions
    • pneumonia
    • paradoxical bronchospasm (wheezing or trouble breathing that gets worse right after using your inhaler)
    • heart problems, such as fast heart rate
    • new or worsening eye problems, such as narrow-angle glaucoma
    • low potassium levels
    • high blood sugar levels

Effectiveness

Stiolto and Symbicort have different FDA-approved uses, but they’re both used as maintenance (everyday) treatment for COPD.

These drugs haven’t been directly compared in clinical studies. However, studies have found both Stiolto and Symbicort to be effective as maintenance treatment for COPD.

Treatment guidelines include both medications as options for COPD maintenance treatment.

Costs

Stiolto and Symbicort are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Stiolto may cost more than Symbicort. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

Stiolto use with other drugs

Your doctor may prescribe other drugs to be taken with Stiolto.

Most commonly, your doctor will prescribe a rescue medication for you to keep on hand at all times. Rescue medications are short-acting bronchodilators. You use them when you need quick relief from COPD symptoms.

Examples of short-acting bronchodilators that are used as rescue medication include:

  • albuterol (ProAir HFA, Proventil HFA, Ventolin HFA)
  • levalbuterol (Xopenex, Xopenex HFA)

These medications quickly relax the muscles in your airways and relieve shortness of breath. You’re not meant to use short-acting bronchodilators on a routine basis.

Stiolto and alcohol

There’s no known interaction between Stiolto and alcohol.

However, research suggests that drinking too much alcohol over time can make it harder for your immune system to remove bacteria from your lungs. This can lead to more frequent or worse infections in people with chronic obstructive pulmonary disease (COPD).

Talk with your doctor about how much alcohol you drink. If they want you to cut back or stop drinking, they can suggest treatments that may help.

Stiolto interactions

Stiolto can interact with several other medications.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Stiolto and other medications

Below is a list of medications that can interact with Stiolto. This list doesn’t contain all drugs that may interact with Stiolto.

Before taking Stiolto, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Stiolto and other LABAs

Taking Stiolto with other long-acting beta2-agonists (LABAs) can increase your risk for serious side effects, including heart problems (such as high blood pressure) and even death. This can happen because Stiolto already contains a LABA as an active drug. So your body would be exposed to too much of the LABAs.

Examples of other LABAs include:

  • arformoterol (Brovana)
  • formoterol (Perforomist, Foradil)
  • salmeterol (Serevent)
  • indacaterol (Arcapta)
  • olodaterol (Striverdi)

To avoid these interactions, tell your doctor about all chronic obstructive pulmonary disease (COPD) medications you take. They’ll make sure that you’re not taking more than one type of LABA.

Stiolto and theophylline

Taking Stiolto with theophylline (Theo-24, Theocron) can increase your risk for hypokalemia (low potassium levels). This can lead to serious heart problems such as heart palpitations (the feeling of skipped or extra heartbeats). It can also lead to muscle problems such as spasms (twitches).

If you need to take Stiolto with theophylline, your doctor may monitor your potassium levels.

Stiolto and steroids

Taking Stiolto with steroids, such as corticosteroids, can increase your risk for hypokalemia (low potassium levels). This can lead to serious heart problems such as heart palpitations (the feeling of skipped or extra heartbeats). It can also lead to muscle problems such as spasms (twitches).

Examples of steroids that can lower potassium levels if taken with Stiolto include:

  • prednisone (Rayos)
  • hydrocortisone (Cortef)
  • mometasone (Asmanex, Elocon)
  • methylprednisolone (Medrol, Solu-Medrol)
  • dexamethasone (Dextenza)

There are many combination medications that also contain a corticosteroid.

If you need to take Stiolto with a steroid, your doctor may monitor your potassium levels.

Stiolto and diuretics

Taking Stiolto with a diuretic (often called a water pill) can increase your risk for hypokalemia (low potassium levels). Diuretics may also interact and cause an abnormal heart rhythm (a heartbeat that’s too fast, too slow, or uneven). This can lead to serious heart problems such as heart palpitations (the feeling of skipped or extra heartbeats). It can also lead to muscle problems such as spasms (twitches).

Examples of diuretics that can lower potassium levels if taken with Stiolto include:

  • hydrochlorothiazide (Microzide)
  • chlorthalidone
  • furosemide (Lasix)
  • torsemide (Demadex)

There are also many combination blood pressure medications that contain a diuretic.

If you need to take Stiolto with a diuretic, your doctor may monitor your potassium levels.

Stiolto and certain antidepressants

Taking Stiolto with certain antidepressants can increase your risk for abnormal heart rhythms (a heartbeat that’s too fast, too slow, or uneven). This can lead to serious, potentially fatal, heart problems such as increased blood pressure.

Examples of certain antidepressants that can increase the risk of heart problems if taken with Stiolto include:

  • amitriptyline
  • desipramine (Norpramin)
  • imipramine (Tofranil)
  • doxepin (Silenor)
  • nortriptyline
  • selegiline (Emsam, Zelapar)
  • phenelzine (Nardil)
  • isocarboxazid (Marplan)

If you’re taking an antidepressant, be sure to tell your doctor. They may recommend a different antidepressant that won’t interact with Stiolto.

Stiolto and certain heart rhythm drugs

Taking Stiolto with certain drugs that affect your heart rate can increase your risk for an abnormal heart rhythm (a heartbeat that’s too fast, too slow, or uneven). This can increase your risk for serious, potentially fatal, heart problems such as ventricular arrhythmia (a heart rhythm disorder).

Examples of drugs that can increase the risk of abnormal heart rhythms if taken with Stiolto include:

  • amiodarone (Pacerone, Nexterone)
  • dronedarone (Multaq)
  • dofetilide (Tikosyn)
  • sotalol (Betapace, Sorine, Sotylize)

If you need to take Stiolto with one of these heart rhythm drugs, your doctor will monitor your heart function closely.

Stiolto and certain heart rate or blood pressure medications

Beta-blockers are medications that treat your heart rate or blood pressure. Taking Stiolto with certain beta-blockers can prevent Stiolto from working in your body. This can make Stiolto less effective. It can also cause your airway muscles to tighten severely.

Examples of beta-blockers include:

  • metoprolol (Lopressor, Toprol XL)
  • carvedilol (Coreg)
  • atenolol (Tenormin)
  • propranolol (Inderal, Innopran XL)

Stiolto shouldn’t be prescribed with a beta-blocker unless there’s an emergency situation, such as a heart attack. Talk with your doctor if you have any concerns.

Stiolto with certain urinary incontinence medications

Anticholinergics are medications that treat urinary incontinence (loss of bladder control). Anticholinergics can also treat COPD when they are taken in an inhaler. This includes tiotropium, one of the active drugs in Stiolto.

Taking Stiolto with other anticholinergics can increase your risk for serious side effects. Some of these side effects include eye problems, such as glaucoma, or urinary problems, such as trouble urinating.

Examples of urinary incontinence drugs that can increase the risk of side effects if taken with Stiolto include:

  • oxybutynin (Ditropan XL)
  • tolterodine (Detrol)
  • darifenacin (Enablex)
  • solifenacin (VESIcare)
  • fesoterodine (Toviaz)

If you need to take Stiolto and a urinary incontinence medication such as the ones listed above, your doctor will monitor you closely. They’ll keep an eye out for increased side effects, such as eye problems or trouble urinating. They may also recommend a different COPD or urinary incontinence drug for you.

How Stiolto works

Chronic obstructive pulmonary disease (COPD) is a group of lung diseases that damage your lungs over time. Most people with COPD have emphysema or chronic bronchitis, or both.

Emphysema damages the small air sacs in your lungs. Chronic bronchitis causes the lining of your airways to swell. As a result, mucus builds up in your bronchial tubes (the tubes that take air to and from your lungs). Both diseases make it hard for your body to bring in oxygen and remove carbon dioxide.

One of the active drugs in Stiolto is tiotropium, a long-acting anticholinergic (LAMA). The drug blocks the action of a chemical messenger called acetylcholine. Acetylcholine normally tells certain muscles, such as those in your lungs, to tighten. Tiotropium helps prevent those muscles from tightening, which helps keep your airways open. This increases how much air you can breathe in and out.

The other active drug in Stiolto is olodaterol, a long-acting beta2-agonist (LABA). Olodaterol attaches to cells in your airway muscles and relaxes those muscles. This opens your airways and lets air flow in and out more easily.

How long does it take to work?

Stiolto will start working within minutes of when you take your dose. However, it doesn’t work as rescue medication during emergency situations.

Stiolto and pregnancy

It’s not known whether Stiolto is safe for humans to take during pregnancy. Studies in animals did show harm to the fetus when the mother received the drug. However, the doses used in animal studies were many times higher than what humans would take. Also, animal studies don’t always predict what would happen in humans.

If you become pregnant while taking Stiolto, talk with your doctor about whether continuing the medication is safe for you.

Stiolto and breastfeeding

It isn’t known whether Stiolto passes into breast milk in humans. In animal studies, the active drugs in Stiolto were found in breast milk. However, animal studies may not predict what will happen in humans.

If you’re breastfeeding your child and considering taking Stiolto, talk with your doctor about the potential risks and benefits.

Common questions about Stiolto

Here are answers to some frequently asked questions about Stiolto.

How is Stiolto different from Spiriva?

Stiolto contains two active drugs: olodaterol and tiotropium. Spiriva contains one active drug: tiotropium.

Olodaterol is a long-acting beta2-agonist (LABA), which opens airways in your lungs. Tiotropium is a long-acting anticholinergic (LAMA), which relaxes airway muscles in your lungs.

Stiolto works to treat chronic obstructive pulmonary disease (COPD) symptoms by opening up your airways in two different ways. Spiriva works in only one of these ways to open up your airways.

Both drugs are used as long-term maintenance (everyday) treatment of COPD and are taken once a day. Neither one should be used as rescue medication.

Spiriva is also used as maintenance treatment for asthma in people ages 6 and older. But Stiolto shouldn’t be used to treat asthma. This is because one of its drugs, olodaterol, increases the risk of asthma-related death.

In clinical studies, Stiolto improved certain aspects of lung function (how well lungs work) better than Spiriva. After 24 weeks, FEV1 (forced expiratory volume in one second) improved more in people who took Stiolto than in people who took Spiriva. FEV1 shows how much air you can force out of your lungs in one second.

After 12 weeks, people who took Stiolto were 60% more likely to report a significant improvement in health-related quality of life than people who took Spiriva. However, there was no difference in the rates of exacerbations (flare-ups) each year for Stiolto and Spiriva.

A safety analysis of three year-long studies looked at both Stiolto and Spiriva. The analysis found that the two drugs caused similar common and serious side effects.

Does Stiolto contain a steroid?

No. Stiolto doesn’t contain a steroid.

Stiolto contains two bronchodilators:

  • a long-acting beta2-agonist (olodaterol)
  • a long-acting anticholinergic (tiotropium)

Bronchodilators relax muscles that line the airways in your lungs to help you breathe easier. These drugs are different from steroids, which work by reducing inflammation (swelling).

Can I use Stiolto as a rescue drug?

No. Stiolto isn’t meant to be used as a rescue drug.

Stiolto is used once a day to help prevent COPD symptoms on a long-term basis. It doesn’t work as quickly as rescue medications and shouldn’t be used in emergency situations.

You should always have a rescue inhaler with you, even if you take Stiolto every day.

Should I rinse my mouth after using Stiolto?

You can, but you don’t have to.

Some COPD inhalers contain a steroid, which can cause mouth and throat infections if you don’t rinse your mouth afterward.

Stiolto doesn’t contain a steroid and shouldn’t cause an infection. However, you can rinse your mouth after using Stiolto if you prefer.

Do I need to keep using oxygen if I take Stiolto?

You might. If your doctor prescribes oxygen for you, you should continue to take it. Your doctor will monitor your lung function (how well your lungs work) and COPD symptoms while you take Stiolto. The results will help you and your doctor decide whether you still need oxygen therapy. Don’t make any changes to your treatment routine unless your doctor advises you to.

Stiolto warnings

This drug comes with several warnings.

FDA warning: Asthma-related death

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Stiolto contains olodaterol, which is a long-acting beta2-agonist (LABA). Drugs in the LABA class increase the risk of asthma-related death. Stiolto isn’t approved to treat asthma. Clinical trials haven’t tested whether Stiolto is safe and effective in people with asthma.

Other warnings

Before taking Stiolto, talk with your doctor about your health history. Stiolto may not be right for you if you have certain medical conditions. These include:

  • Asthma. Stiolto shouldn’t be used to treat asthma. If you have asthma, talk with your doctor about better treatment options for you.
  • Heart problems. Stiolto can cause serious heart problems, including increased heart rate and abnormal heart rhythm. If you have heart problems, talk with your doctor about whether Stiolto is right for you.
  • Convulsive disorders. Stiolto may worsen certain convulsive disorders, such as seizures. If you have a history of seizures, talk with your doctor about whether Stiolto is right for you.
  • Thyroid problems. Stiolto may worsen certain thyroid conditions. If you have a history of hyperthyroidism, talk with your doctor about whether Stiolto is right for you.
  • Narrow-angle glaucoma. Stiolto can cause new or worsening narrow-angle glaucoma. If you have glaucoma, talk with your doctor about whether Stiolto is right for you.
  • Urinary retention. Stiolto can cause new or worsening urinary retention (trouble passing urine). If you have a history of kidney problems, prostate problems, or bladder problems, talk with your doctor about whether Stiolto is right for you.
  • Kidney disease. Stiolto’s side effects can be worse for people with kidney disease. If you have a history of kidney disease or kidney problems, talk with your doctor about whether Stiolto is right for you.
  • Allergic drug reactions. One of the active drugs in Stiolto, tiotropium, has a similar chemical makeup to the drug atropine (Atropen). If you’ve had an allergic reaction to atropine in the past, you may also have a reaction to Stiolto. In addition, if you have a history of allergic reactions to any of the following drugs, your doctor can recommend a different drug for you. You shouldn’t take Stiolto if you’ve had an allergic reaction to any of these drugs in the past:
    • tiotropium, one of the active drugs in Stiolto
    • ipratropium, a drug that’s similar to tiotropium
    • olodaterol, one of the active drugs in Stiolto

Note: For more information about the potential negative effects of Stiolto, see the “Stiolto side effects” section above.

Stiolto overdose

Taking more than the recommended dose of Stiolto can increase your risk for serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

  • dry mouth and throat
  • dry nasal passages (dry nose)
  • chest pain
  • rapid heart rate
  • high blood pressure
  • dizziness
  • nervousness
  • headache
  • serious heart problems, such as heart attack

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Stiolto expiration, storage, and disposal

When you get Stiolto from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Store Stiolto at room temperature. Don’t freeze Stiolto. The medication is good for three months after you first put the cartridge in the inhaler.

Disposal

If you no longer need to take Stiolto and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of medication.

Professional information for Stiolto

The following information is provided for clinicians and other healthcare professionals.

Indications

Stiolto is FDA-approved as long-term, once daily maintenance treatment for chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

It’s not indicated to treat asthma or acute deteriorations of COPD.

Mechanism of action

Stiolto contains tiotropium, a long-acting anticholinergic, and olodaterol, a long-acting beta2-agonist (LABA). Tiotropium causes bronchodilation through antagonism at M3 muscarinic receptors on smooth muscles. Olodaterol causes bronchodilation through activation of airway beta2-adrenoreceptors, which increases cyclic-3′,5′ adenosine monophosphate (cAMP). Increased cAMP levels cause relaxation of airway smooth muscles.

Pharmacokinetics and metabolism

Tiotropium

Following oral inhalation, approximately 33% of the drug reaches systemic circulation. Maximum concentration is reached in five to seven minutes. Tiotropium is 72% plasma protein-bound. Most of the drug is excreted in the urine unchanged. CYP2D6 and CYP3A4 may play small role in metabolism of approximately 25% of the drug. The terminal half-life is approximately 25 hours in COPD patients. Steady-state concentrations are reached by day seven.

Olodaterol

Following oral inhalation, approximately 30% of the drug reaches systemic circulation. Maximum concentration is reached within 10 to 20 minutes. Olodaterol is approximately 60% plasma protein-bound. Metabolism occurs primarily by glucuronidation and O-demethylation. Most of the drug and its metabolites (84%) is excreted in feces. The effective half-life is 7.5 hours in COPD patients. Steady-state concentrations are reached after eight days.

Contraindications

Stiolto contains a LABA. All LABAs are contraindicated for use in people with asthma, without concomitant use of long-term asthma control medication.

Stiolto is also contraindicated for use in people with a history of hypersensitivity to any components of the drug, including tiotropium and olodaterol, or to ipratropium.

Storage

Stiolto should be stored at room temperature (77*F/25*C). Do not freeze.

Respimat should be discarded three months after assembly, or when the locking mechanism is engaged (indicating that all actuations have been dispensed), whichever comes first.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.