Tiotropium Bromide / Olodaterol

Stiolto Respimat Inhaler

Stiolto Respimat is a long-term chronic obstructive pulmonary disease (COPD) treatment. It combines two active ingredients, tiotropium and olodaterol, to help open the airways and improve breathing. The medication is administered through an inhaler, with a recommended dosage of two puffs once daily. Stiolto Respimat is not suitable for sudden breathing problems or asthma and can interact with various medications, requiring careful monitoring. Common side effects include back pain, cough, and cold symptoms. Consult your primary caregiver for personalized advice, especially if you have a history of certain medical conditions or are taking other medications.

Product Overview

Stiolto Respimat inhaler is used for the long-term treatment of chronic obstructive pulmonary disease (COPD). It contains two active ingredients: tiotropium, a long-acting anticholinergic (LAMA), and olodaterol, a long-acting beta2-agonist (LABA). Tiotropium helps to keep the airways open by blocking acetylcholine, a chemical that causes muscle tightening in the lungs, while olodaterol relaxes the airway muscles, allowing for easier airflow.

The medication is delivered through an inhaler, and the usual dosage is two puffs once daily. Each inhalation delivers 2.5 mcg of tiotropium and 2.5 mcg of olodaterol. It’s important to follow your doctor’s instructions on how to use the inhaler and to prepare it correctly for first-time use. Stiolto Respimat is not intended for sudden breathing problems or asthma. It can interact with several other medications, including other LABAs, theophylline, steroids, diuretics, certain antidepressants, heart rhythm drugs, heart rate or blood pressure medications, and urinary incontinence medications. These interactions can reduce the effectiveness of the treatment or increase the risk of side effects.

Common side effects of Stiolto Respimat include back pain, cough, and cold symptoms. Serious side effects may consist of severe allergic reactions, worsening COPD, paradoxical bronchospasm, eye problems, heart problems, urinary retention, high blood sugar levels, low potassium levels, and pneumonia. Before starting Stiolto Respimat, discuss your health history with your doctor, especially if you have asthma, worsening COPD, heart problems, convulsive disorders, thyroid problems, narrow-angle glaucoma, urinary retention, kidney disease, or a history of allergic reactions. Breastfeeding or pregnant women should also consult their doctor. Store Stiolto Respimat at room temperature and dispose of it safely if no longer needed.

Uses of Stiolto Respimat

• It is used for the long-term treatment of COPD (chronic obstructive pulmonary disease).

[Important Warnings: Stiolto Respimat is not intended for sudden breathing problems caused by COPD. It is not approved for treating asthma.]

How to Use Stiolto Respimat?

Dosage

• Stiolto Respimat comes in two pieces:
  • Respimat inhaler device
  • Respimat cartridge that contains the medication (tiotropium & olodaterol)
• If you’re using this inhaler for the first time prior tousing the device, you’ll need to insert the cartridge into the inhaler.
• Each inhalation (puff) delivers 2.5 mcg of olodaterol and 2.5 mcg of tiotropium. Each cartridge contains 60 puffs (30 doses).

Recommended Dosage for Different Patients

Dosage for Chronic Obstructive Pulmonary Disease

• The Typical Dosage: In the treatment of chronic obstructive pulmonary disease (COPD) is 2 puffs taken one time daily.
• 2 puffs deliver a total of 5 mcg of tiotropium & 5 mcg of olodaterol.

[Note: Remember these recommendations may vary depending on person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take It?

• Stiolto Respimat is taken as 2 inhalations (puffs) one time a day. When you first get your prescription, your primary health care giver will explain how to use the inhaler.
• Use Stiolto Respimat according to your healthcare professional’s instructions.
• Stiolto Respimat comes in 2 pieces that you can assemble to deliver the medication:
  • Respimat inhaler device
  • Respimat cartridge containing the medication (tiotropium and olodaterol)

How to Prepare and Use Your Inhaler?

To make sure you receive the correct dose of Stiolto Respimat, it’s crucial to use your inhaler properly. Follow these step-by-step instructions.

Preparing Your Inhaler for First-Time Use

Before using your new Stiolto Respimat inhaler for the first time, you need to insert the cartridge containing the medication. Follow these steps to prepare your inhaler:

• Assemble Your Inhaler:

1. 1. • Ensure you have the inhaler device and the medication cartridge.
      • On the inhaler, there is a green that is closed until you are ready to use it.

• Prepare to Insert the Cartridge:

1. 1. • Hold the inhaler in one hand & press the safety catch with your thumb.
      • With your other hand, pull the clear base off the inhaler. Be careful & don’t touch the piercing element at the bottom. Keep the clear base within reach.

• Insert the Cartridge:

1. 1. • Write the “discard by” date on the inhaler label, which is three months from the insertion date.
      • Insert the cartridge’s narrow end into the inhaler.
      • Place the bottom of the cartridge on a firm surface and press down until it clicks into place.

• Reassemble the Inhaler:

1. 1. • Reattach the clear base to the inhaler until it clicks. Once assembled, do not remove the clear base or the cartridge.

• Prime the Inhaler:

1. 1. • Turn the transparent base in the direction of the arrows on the label, with the cap still closed, until you hear the sound of a click (half a turn).
      • Open the cap fully until it snaps open.
      • Point the inhaler towards the ground and press the dose-release button.
      • Close the cap and check for a visible mist. If no mist is visible, repeat the priming steps (turn, open, press) until you see a mist.

• Final Priming Steps:

1. • Once a mist is visible, repeat the priming process three more times to ensure the inhaler is ready to deliver the correct dose.

After completing these steps, your Stiolto Respimat inhaler is fully prepared and ready for use.

Using Your Inhaler

Once you’ve assembled Stiolto Respimat & it’s ready for use, follow these instructions to take your dose:

Important Notes:

• If it’s been more than 3 days since you used your inhaler, release 1 puff toward the ground before taking your dose.
• If it’s been more than 21 days since you used your inhaler, repeat steps 10 through 15 to prepare the inhaler.

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

Steps to Take Your Dose:

• Keep the cap closed on the inhaler.
• Turn the transparent base toward the arrows on the label until you hear the sound of a click (half a turn).
• Open the cap fully until it snaps completely open.
• Exhale slowly and fully, away from the inhaler, to avoid blowing air into it.
• Without covering the air vents located at the inhaler’s base, place your lips tightly around the mouthpiece.
• Angle the inhaler toward the back of your throat.
• Press the dose-release button while taking a deep, slow breath through your mouth.
• Continue to breathe in steadily and deeply.
• After inhaling, hold your breath for at least ten seconds or as long as it is comfortable for you. This helps the medication to settle in your lungs.
• Repeat all previous steps to administer a total of two puffs as directed by your healthcare provider.
• Close the cap securely after you have taken your dose to keep the inhaler clean and ready for your next use.

Cleaning Your Inhaler

To ensure your inhaler functions properly, clean it at least once a week:

• Wipe the mouthpiece, including the inside, with a damp cloth or tissue.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Stiolto Respimat Work?

Stiolto Respimat contains two active ingredients. First is Tiotropium, which is a long-acting anticholinergic (LAMA). It works by blocking acetylcholine, a chemical messenger that usually signals certain muscles in your lungs to tighten. By preventing this muscle tightening, tiotropium helps keep your airways open, increasing the amount of air you can breathe in and out. Second is Olodaterol, which is a long-acting beta2-agonist (LABA). Olodaterol binds to cells in your airway muscles and relaxes them, opening your airways and allowing air to flow more easily.

Important Safety Information

Side Effects

Common side effects of Stiolto Respimat may include:

• Back pain
• Cough 
• Common cold

Serious side effects of Stiolto Respimat may include:

• Severe allergic reaction
• Worsening chronic obstructive pulmonary disease (COPD), containing flare-ups (exacerbations), signs may include:
  • Wheezing more than usual
  • Trouble breathing
  • Confusion
  • Coughing up more mucus than usual
  • Shortness of breath, even when you’re at rest
  • Coughing
  • Feeling tired
• Paradoxical bronchospasm signs may include:
  • Trouble breathing (getting worse despite using your inhaler)
  • Coughing
• Worsening or new eye problems, including narrow-angle glaucoma, signs may include:
  • Seeing halos
  • Blurry vision
  • Increased pressure in your eyes
  • Pain in your eyes
• Heart problem signs may consist of the following:
  • Increased blood pressure
  • Chest pain
  • Fast heart rate
  • Abnormal heart rhythm
• New or worsening urinary problems signs may consist of:
  • Urinating in a weak stream or drops
  • Urinating more often than normal
  • Pain when you urinate
  • Trouble urinating
• High blood sugar levels in individuals with diabetes which can be dangerous, signs may include:
  • Urinating more often than normal
  • Excessive thirst
  • Fatigue (lack of energy)
  • Urinating often at night
• Low potassium levels that may cause heart and muscle problems, signs may include:
  • Heart palpitations
  • Muscle spasms (twitches)
  • Muscle weakness
  • Abnormal heart rhythm
• Pneumonia, signs may include:
  • Fever
  • Coughing
  • Chest pain
  • Shortness of breath

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

Before taking Stiolto Respimat, discuss your health history with your doctor. Stiolto Respimat may not be suitable for you if you have certain medical conditions, such as:

• Asthma: This inhaler should not be used to treat asthma. This is because it contains olodaterol, a long-acting beta2-agonist (LABA). Using an LABA drug alone (without corticosteroids) over time increases the risk of asthma-related death and may also increase the possibility of hospitalization in children. While Stiolto Respimat does not contain a LABA alone, it is only approved for the treatment of chronic obstructive pulmonary disease (COPD) and not for asthma. Clinical trials have not tested the effectiveness & safety of Stiolto Respimat in people with asthma. If you have asthma, discuss better treatment options with your doctor.
• Worsening COPD: If you have COPD that is suddenly worsening, you should not start using Stiolto Respimat. Clinical trials have not tested the effectiveness & safety of Stiolto Respimat in individuals with rapidly worsening COPD. If your COPD is getting worse quickly, discuss better treatment options with your doctor.
• Heart Problems: Stiolto Respimat may cause serious heart issues, such as an increased heart rate and abnormal heart rhythm. If you have existing heart problems, consult your doctor to determine whether Stiolto Respimat is the right medication for you.
• Convulsive Disorders: This inhaler may worsen certain convulsive disorders, such as seizures. If you have a history of it, discuss it with your doctor whether Stiolto Respimat is appropriate for you.
• Urinary Retention: This medication may cause new or worsening urinary retention (trouble passing urine). If you have a history of kidney, prostate, or bladder problems, discuss with your doctor whether Stiolto Respimat is suitable for you.
• Kidney Disease: The side effects of Stiolto Respimat can be more severe for individuals with kidney disease. If you have a history of kidney disease or kidney problems, consult your doctor to determine if Stiolto Respimat is suitable for you.
• Thyroid Problems: This inhaler can worsen certain thyroid conditions, such as hyperthyroidism. If you have a history of thyroid issues, consult your doctor to determine if Stiolto Respimat is suitable for you.
• Narrow-Angle Glaucoma: This medication may cause worsening or new narrow-angle glaucoma. If you have glaucoma, consult your doctor to determine whether Stiolto Respimat is appropriate for you.
• Allergic Reactions: Stiolto Respimat contains tiotropium, a medication with a chemical structure similar to atropine (Atropen). If you have experienced an allergic reaction to atropine, there is a possibility you might react similarly to Stiolto Respimat. Additionally, it’s important to discuss any past allergic reactions with your doctor, especially if they involve the following medications, as they could indicate a potential risk when using Stiolto Respimat:
  • Ipratropium
  • Olodaterol: Another active ingredient in Stiolto.
  • Tiotropium: One of the main ingredients in Stiolto Respimat.

If you have had allergic reactions to any of these drugs, your doctor may recommend an alternative treatment for you. You should not use Stiolto Respimat if you have known allergies to any of these components.

Precautions

• Alcohol: There is no known interaction between Stiolto Respimat and alcohol. However, research suggests that excessive alcohol consumption over time may weaken your immune system, making it harder to remove bacteria from your lungs. This can result in more frequent or severe infections in individuals with COPD. Discuss your alcohol intake with your doctor. If they recommend reducing or stopping alcohol consumption, they can suggest treatments to help you achieve this.
• Pregnancy: It is not known whether Stiolto Respimat is safe for use during pregnancy. In animal studies when pregnant females were given the drug, it has shown serious to the fetus, but the doses used in these studies were significantly higher than the doses prescribed for humans. Additionally, results from animal studies do not always predict what would happen in humans. If you become pregnant while taking this inhaler, consult your doctor to discuss whether continuing the medication is safe for you.
• Breastfeeding: It is not known whether Stiolto Respimat passes into breast milk in humans. In animal studies, the active drugs in Stiolto Respimat were found in the breast milk of lactating females. However, animal studies do not always predict what will happen in humans. If you are breastfeeding and considering taking Stiolto Respimat, discuss the potential risks and benefits with your doctor.

Contraindications

• Stiolto Respimat contains a long-acting beta2-agonist (LABA). All LABAs are contraindicated for use in people with asthma unless used in combination with an inhaled corticosteroid.
• It is also contraindicated for use in individuals with a history of hypersensitivity to any components of the drug, including tiotropium and olodaterol, or to ipratropium.

Missed Dose

• If you miss a dose of Stiolto Respimat, take it as soon as you remember. 
• If it’s almost time for your next dose, just take one dose and skip the missed one. 
• Do not take two doses within 24 hours, as this can increase your risk of side effects.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

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

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

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Storage

• Store Stiolto Respimat at room temperature. 
• Do not freeze Stiolto Respimat. 
• The medication is effective for three months after you first insert the cartridge into the inhaler.
• If you no longer need to take Stiolto Respimat and have leftover medication, it’s important to dispose of it safely. 
• This helps prevent accidental ingestion by others, including children and pets and protects the environment.
• The FDA website provides several useful tips on medication disposal. 
• You can also ask your pharmacist for information on how to properly dispose of medication.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Stiolto Respimat Interactions

Stiolto Respimat can interact with several other medications. These interactions can lead to various effects. For instance, some interactions might interfere with the effectiveness of the medication, making it less efficient in managing your symptoms. Other interactions can increase the frequency or severity of side effects, potentially causing additional health issues. It is crucial to inform your doctor about all the medications you are taking, including prescription drugs, over-the-counter medications, and supplements, to manage and mitigate potential interactions effectively. Your doctor can help you understand these interactions and adjust your treatment plan as necessary to ensure optimal safety and effectiveness.

Interactions with Other Medications

Below is a list of medications that can interact with Stiolto Respimat. This list does not include all possible drug interactions. Before taking Stiolto Respimat, discuss your current medications with your doctor and pharmacist. Inform them about all the prescription and over-the-counter drugs you take, as well as any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions. If you have questions about how drug interactions may affect you, ask your doctor or pharmacist for more details.

Interactions with Other LABAs: Taking Stiolto Respimat with other long-acting beta2-agonists (LABAs) can increase your risk of serious side effects, including heart problems (such as high blood pressure) and even death. This risk arises because Stiolto Respimat already contains a LABA as one of its active ingredients, leading to excessive exposure to LABAs if combined with others.

Examples of other LABAs include:

• Arformoterol (Brovana)
• Formoterol (Perforomist, Foradil)
• Salmeterol (Serevent)
• Indacaterol (Arcapta)
• Olodaterol (Striverdi)

To avoid these interactions, inform your doctor about all the chronic obstructive pulmonary disease (COPD) medications you are taking. They will ensure you are not taking more than one type of LABA.

Interactions with Theophylline: Taking Stiolto Respimat with theophylline (Theo-24, Theocron) can increase your risk of hypokalemia (low potassium levels). This condition can lead to serious heart problems such as heart palpitations (the feeling of skipped or extra heartbeats) and muscle issues such as spasms (twitches).

If you need to take Stiolto Respimat with theophylline, your doctor may monitor your potassium levels to manage and mitigate these risks.

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

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

• Prednisone (Rayos)
• Hydrocortisone (Cortef)
• Mometasone (Asmanex, Elocon)
• Methylprednisolone (Medrol, Solu-Medrol)
• Dexamethasone (Dextenza)

Many combination medications also contain a corticosteroid. If you need to take Stiolto Respimat with a steroid, your doctor may monitor your potassium levels to manage and mitigate these risks.

Interactions with Diuretics: Taking Stiolto Respimat with a diuretic (often called a water pill) can increase your risk of hypokalemia (low potassium levels). Diuretics can also interact and cause abnormal heart rhythms (heartbeats that are too fast, too slow, or uneven). This can lead to serious heart problems, such as heart palpitations (the feeling of skipped or extra heartbeats), and muscle problems, such as spasms (twitches).

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

• Hydrochlorothiazide (Microzide)
• Chlorthalidone
• Furosemide (Lasix)
• Torsemide

Many combination blood pressure medications also contain a diuretic. If you need to take Stiolto Respimat with a diuretic, your doctor may monitor your potassium levels to manage and mitigate these risks.

Interactions with Certain Antidepressants: Taking Stiolto Respimat with certain antidepressants can increase your risk of abnormal heart rhythms (a heartbeat that is too fast, too slow, or uneven). This can lead to serious and potentially fatal heart problems, such as increased blood pressure. Examples of antidepressants that can increase the risk of heart problems if taken with Stiolto Respimat include:

• Amitriptyline
• Desipramine (Norpramin)
• Imipramine (Tofranil)
• Doxepin (Silenor)
• Nortriptyline
• Selegiline (Emsam, Zelapar)
• Phenelzine (Nardil)
• Isocarboxazid (Marplan)

If you are taking an antidepressant, be sure to inform your doctor. They may recommend a different antidepressant that does not interact with Stiolto Respimat.

Interactions with Certain Heart Rhythm Drugs: Taking Stiolto Respimat with certain drugs that affect your heart rate can increase your risk of abnormal heart rhythms (a heartbeat that’s too fast, too slow, or uneven). This can lead to 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 Respimat include:

• Amiodarone (Pacerone, Nexterone)
• Dronedarone (Multaq)
• Dofetilide (Tikosyn)
• Sotalol (Betapace, Sorine, Sotylize)

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

Interactions with Certain Heart Rate or Blood Pressure Medications: Beta-blockers are medications used to treat heart rate or blood pressure. Taking Stiolto Respimat with certain beta-blockers can prevent Stiolto Respimat from working effectively in your body. This can make Stiolto Respimat less effective and may 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 Respimat should not 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.

Interactions with Certain Urinary Incontinence Medications: Anticholinergics are medications used to treat urinary incontinence (loss of bladder control) and can also treat COPD when taken in an inhaler. This includes tiotropium, one of the active drugs in Stiolto Respimat. Taking Stiolto Respimat with other anticholinergics can increase your risk of serious side effects, such as eye problems (like 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 Respimat include:

• Oxybutynin (Ditropan XL)
• Tolterodine (Detrol)
• Darifenacin (Enablex)
• Solifenacin (VESIcare)
• Fesoterodine (Toviaz)

If you need to take Stiolto Respimat and a urinary incontinence medication, your doctor will monitor you closely for increased side effects, such as eye problems or trouble urinating. They may also recommend a different COPD or urinary incontinence medication to better suit your needs.

[Note: This isn’t a complete list, and there could be other drugs that interact with Stiolto Respimat. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re you’re taking.]

Stiolto Respimat Alternatives

• Stiolto Respimat (olodaterol/tiotropium)
• Serevent (salmeterol)
• Bevespi Aerosphere (formoterol/glycopyrrolate)
• Anoro Ellipta (Vilanterol/Umeclidinium)
• Advair Diskus (salmeterol/Fluticasone)
• Symbicort (formoterol/budesonide)
• Dulera (formoterol/mometasone)
• Atrovent HFA (ipratropium)
• Breo Ellipta (Vilanterol/Fluticasone)
• Tudorza Pressair (aclidinium)
• Lonhala Magnair (glycopyrrolate)
• Seebri Neohaler (glycopyrrolate)
• Spiriva (tiotropium)
• Daliresp (roflumilast)
• Incruse Ellipta (Umeclidinium)
• Theochron (Theophylline)
• Perforomist (formoterol)
• Foradil (formoterol)
• Arcapta (indacaterol)
• Serevent (salmeterol)
• Striverdi (olodaterol)
• Flovent HFA (Fluticasone)
• Asmanex Twisthaler (mometasone)
• Alvesco (ciclesonide)
• Pulmicort Flexhaler (budesonide)
• Singulair (montelukast)
• Qvar RediHaler (beclomethasone)
• Accolate (zafirlukast)
• Theo-24 (Theophylline)
• Zyflo (zileuton)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

How long does it take to work?

Stiolto Respimat starts working within minutes of taking your dose. However, it is not intended to be used as a rescue medication during emergency situations for sudden breathing problems.

Should I rinse my mouth after using Stiolto Respimat?

You can rinse your mouth after using Stiolto Respimat, but it’s not necessary. Some COPD inhalers contain steroids, which can cause mouth and throat infections if you don’t rinse your mouth afterwards. Stiolto Respimat doesn’t contain a steroid and shouldn’t cause an infection. However, if you prefer, you can rinse your mouth after using it.

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

You might need to continue using oxygen if your doctor has prescribed it for you. Your doctor will monitor your lung function and COPD symptoms while you take Stiolto Respimat. Based on the results, you and your doctor can decide whether you still need oxygen therapy. Do not make any changes to your treatment routine unless your doctor advises you to do so.

When to get a new Stiolto Respimat inhaler?

A dose indicator on the inhaler tells you approximately 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, which is approximately 14 puffs. This is a good time to get a new inhaler from your pharmacy to ensure there are no breaks in your treatment.

When to use this inhaler?

Stiolto Respimat 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 simultaneously. You can use Stiolto Respimat at any time of the day, as there is no recommended best time to take this medication.

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