TIOTROPIUM/OLODATEROL - INHALATION

TIOTROPIUM/OLODATEROL - INHALATION

PHONETIC PRONUNCIATION: (TYE-oh-TROE-pee-um/OH-loe-DA-ter-ol)

COMMON BRAND NAME(S): Stiolto Respimat

GENERIC NAME(S): tiotropium bromide/olodaterol HCl

Uses

USES: See also Warning section. This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: tiotropium and olodaterol. Both drugs work by relaxing the muscles around the airways in the lungs so they open up and make breathing easier. Tiotropium belongs to a class of drugs known as anticholinergics, and olodaterol is a LABA medication (see also Warning section). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed.


How to use TIOTROPIUM/OLODATEROL - INHALATION

HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Follow the instructions for priming the inhaler if you are using it for the first time, or if you have not used it for more than 3 days, or for more than 21 days. When priming the inhaler, make sure to spray toward the ground (away from your face) so that you do not get the medication in your eyes. Inhale this medication by mouth as directed by your doctor, usually 2 puffs once daily. Wait at least 1 minute between each inhalation. If you are using other inhalers at the same time, wait at least one minute between the use of each medication. Use this medication regularly to get the most benefit from it. Use it at the same time each day. Do not use it more than one time each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor. Your condition will not improve any faster, and your risk of side effects will increase. Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away. If you have been using a quick-relief inhaler (albuterol, salbutamol) on a regular daily schedule (such as 4 times daily), your doctor will direct you to stop this schedule and only use the quick-relief inhaler as needed for sudden shortness of breath. Consult your doctor for details. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: Nervousness, shaking (tremor), or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: muscle cramps/weakness, increased thirst/urination, difficult/painful urination. Get medical help right away if you have any very serious side effects, including: chest pain, fast/irregular heartbeat, severe dizziness, fainting, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision). Rarely, this medication may cause sudden, severe wheezing/trouble breathing right after you use it. If this happens, use your quick-relief inhaler and get medical help right away. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to tiotropium or olodaterol; or to ipratropium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as chest pain, irregular heartbeat, previous heart attack), high blood pressure, diabetes, kidney disease, personal or family history of glaucoma (angle-closure type), seizures, overactive thyroid, difficulty urinating (such as due to an enlarged prostate). Olodaterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using olodaterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

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Faq for TIOTROPIUM/OLODATEROL - INHALATION

Tiotropium/olodaterol inhalation is used to treat chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Tiotropium/olodaterol inhalation works by relaxing and opening the airways, making it easier to breathe. Tiotropium acts as a bronchodilator, while olodaterol is a long-acting beta2-adrenergic agonist (LABA).

Common side effects of tiotropium/olodaterol inhalation may include dry mouth, sore throat, cough, headache, dizziness, and diarrhea.

Tiotropium/olodaterol inhalation should be used exactly as prescribed by your doctor. Typically, it is used once daily, and the inhaler should be held upright, with a deep breath inhaled after pressing the dose-release button.

Tiotropium/olodaterol inhalation may be used with other medications for COPD, but it is important to consult your doctor or pharmacist to ensure there are no potential drug interactions.

Tiotropium/olodaterol inhalation is not approved for the treatment of asthma. It is specifically indicated for use in COPD.

The effects of tiotropium/olodaterol inhalation can vary from person to person. However, many users may begin experiencing relief within 15 minutes of inhalation, with sustained improvement over time.

Yes, tiotropium/olodaterol inhalation is available as a generic medication. It is sold under the brand name Stiolto Respimat, but the generic version is also available.

Tiotropium/olodaterol inhalation is not approved for use in children. Its safety and effectiveness have not been established in this age group.

Tiotropium/olodaterol inhalation is a combination medication used to treat chronic obstructive pulmonary disease (COPD). It contains two active ingredients, tiotropium and olodaterol, which work together to improve lung function and ease breathing.

The recommended dosage of tiotropium/olodaterol inhalation is one inhalation (two puffs) once daily. It is important to follow the instructions provided by your healthcare provider or read the patient information leaflet for proper usage.

Common side effects of tiotropium/olodaterol inhalation may include dry mouth, throat irritation, cough, headache, and sinus infection. These side effects are usually mild and temporary. However, if you experience any severe or persistent side effects, it is important to contact your healthcare provider.

The safety of tiotropium/olodaterol inhalation in pregnancy and breastfeeding has not been well studied. It is important to consult with your healthcare provider before using this medication if you are pregnant or breastfeeding.

Tiotropium/olodaterol inhalation is not approved for use in children and adolescents below the age of 1

Certain medications, such as anticholinergic drugs, beta-blockers, and diuretics, may interact with tiotropium/olodaterol inhalation. It is important to inform your healthcare provider about all the medications and supplements you are taking to avoid any potential drug interactions.

Tiotropium/olodaterol inhalation should be stored at room temperature (between 68°F to 77°F or 20°C to 25°C) in a dry place. It should be kept away from direct sunlight, heat, and moisture. Always keep the inhaler cap on when not in use.


Warning

WARNING: One ingredient in this product is olodaterol. It belongs to a class of drugs known as long-acting beta agonists (LABAs). Rarely, people with asthma who use LABA medications have had serious (sometimes fatal) asthma-related breathing problems. Tiotropium/olodaterol is not approved to treat asthma.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.