Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs. Do not take more than 1 dose (2 puffs) in 24 hours. Call your doctor at once if you have new or worsening COPD symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 282 mcg tiotropium in 6 healthy volunteers. Gastrointestinal disorders: dry mouth, constipation, oropharyngeal candidiasis, dysphagia, gastroesophageal reflux disease, gingivitis, glossitis, stomatitis, intestinal obstruction including ileus paralytic After 12 weeks, people who took Stiolto Respimat were 60% more likely to report a significant improvement in health-related quality of life than people who took Spiriva. Selected from data included with permission and copyrighted by First Databank, Inc. Discuss the risks and benefits with your doctor. For more information, a video, and images of preparing and using the inhaler, see the drug website. Neither one should be used as rescue medication. You should avoid the regular consumption of large amounts of grapefruits and grapefruit juice while View side-by-side comparisons of medication uses, ratings, cost, side effects and interactions. As with all medications, the cost of Stiolto Respimat can vary. 2.1 Recommended Dosage . 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. The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. People with active COPD symptoms who took Anoro were twice as likely to have a significant improvement in FEV1 than people who took Stiolto Respimat. Talk to your doctor about using this medication safely. Olodaterol was not teratogenic in rats at inhalation doses approximately 2731 times the MRHDID (on an AUC basis at a maternal inhalation dose of 1054 mcg/kg/day). Do not freeze. Store STIOLTO RESPIMAT at room temperature, between 68F to 77F (20C to 25C). Exacerbations of COPD were defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD, with duration of three days or more, requiring a prescription of antibiotics and/or systemic steroids and/or hospitalization. Following oral inhalation, approximately 30% of the drug reaches systemic circulation. 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. The safety profile of STIOLTO RESPIMAT was similar to that of tiotropium 5 mcg inhalation spray and consistent with that documented in the STIOLTO RESPIMAT primary safety database. Avoid getting this medicine in your eyes. STIOLTO RESPIMAT has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Each dose (one dose equals two actuations) from the STIOLTO RESPIMAT inhaler delivers 5 mcg tiotropium and 5 mcg olodaterol in 22.1 mcL from the mouthpiece. Mean post-bronchodilator FEV1 was 1.37 L (GOLD 2 [50%], GOLD 3 [39%], GOLD 4 [11%]). The most common serious adverse reactions were COPD exacerbation and pneumonia. Stiolto Respimat may not be right for you if you have certain medical conditions. Keeping the cap closed, turn the clear base toward the arrows on the label until you hear a click (half a turn). Tiotropium: Co-administration of tiotropium bromide, delivered as a fixed-dose combination with olodaterol, for 21 days had no relevant effect on systemic exposure to olodaterol, and vice versa. In a drug interaction study using the strong dual CYP and P-gp inhibitor ketoconazole, a 1.7-fold increase of olodaterol maximum plasma concentrations and AUC was observed [see Pharmacokinetics (12.3)]. Use with extreme caution. After chronic once-daily inhalation by COPD patients, pharmacokinetic steady state was reached by day 7 with no accumulation thereafter. The renal clearance of tiotropium exceeds the creatinine clearance, indicating secretion into the urine. Olodaterol, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. The effect of tiotropium 5 mcg inhalation spray on exacerbations was evaluated in three 48-week randomized, double-blind, placebo-controlled clinical trials that included COPD exacerbations as the primary endpoint. Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F) [see USP Controlled Room Temperature]. Eye disorders: glaucoma, intraocular pressure increased, vision blurred In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution. (, Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma. Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least 1 time each week. (A generic drug is an exact copy of the active drug in a brand-name medication.). Stiolto Respimat is used once a day to help prevent COPD symptoms on a long-term basis. Did you press the dose-release button when turning the clear base? Be careful not to touch the piercing element. When you get Stiolto Respimat from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. Read and carefully follow any Instructions for Use provided with your medicine. Was the cap open when you turned the clear base? The decrease in serum potassium is usually transient, not requiring supplementation. These medications work by relaxing muscles in the airways to improve breathing. Stiolto Respimat and Anoro are both inhalers. Stiolto Respimat should be used once a day, at the same time each day. Instruct patients that priming STIOLTO RESPIMAT is essential to ensure appropriate content of the medication in each actuation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for STIOLTO RESPIMAT and any potential adverse effects on the breastfed child from STIOLTO RESPIMAT or from the underlying maternal condition. This can increase your risk for side effects. It does not work right away and should not be used to relieve sudden shortness of breath. In the third trial, tiotropium 5 mcg delayed the time to first COPD exacerbation compared to placebo with a hazard ratio of 0.69 (95% CI 0.63, 0.77). Before you use STIOLTO RESPIMAT, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, Read the step-by-step instructions for using STIOLTO RESPIMAT at the end of this Patient Information leaflet, Do not use STIOLTO RESPIMAT more often than prescribed. Results demonstrated improvement in trough FEV1 for the combination when compared to olodaterol alone. Two actuations equal one dose. Boehringer Ingelheim Pharmaceuticals, Inc., the maker of Stiolto Respimat, mentions the following options on its website: For more information and to find out if youre eligible for support, call 800-859-2174 or visit the drug manufacturers website. The expected signs and symptoms with overdosage of olodaterol are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., myocardial ischemia, angina pectoris, hypertension or hypotension, tachycardia, arrhythmias, palpitations, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis. It is not known if STIOLTO RESPIMAT is safe and effective in children. These drugs represent 2 different classes of medication (an anticholinergic and a beta-agonist) that have different effects on clinical and physiological indices. (Rescue medications are used for sudden breathing problems.). The recommended dose of STIOLTO RESPIMAT is two inhalations once-daily at the same time of the day. Consult your pharmacist or local waste disposal company. (Rescue medications are used for sudden breathing problems.). Your doctor may prescribe other drugs to be taken with Stiolto Respimat. This was assessed by how often people had to use their rescue inhaler while they were also using Anoro. | Jun. Concomitant short-acting beta, Do not exceed the recommended dose. You should use Stiolto Respimat according to your doctor or healthcare professionals instructions. at a higher dose than prescribed for you, or. Following intravenous administration of [14C]-labeled olodaterol, 38% of the radioactive dose was recovered in the urine and 53% was recovered in feces. To view a report comparing 3 (or more) medications, please sign in or create an account. In COPD patients with severe renal impairment (CLCR <30 mL/min), a single intravenous administration of tiotropium bromide resulted in 94% higher AUC0-4 and 52% higher Cmax compared to COPD patients with normal renal function. The light green-colored cap and the written information on the label of the gray inhaler body indicate that it is labeled for use with the STIOLTO RESPIMAT cartridge. People with chronic obstructive pulmonary disease (COPD) might find it helpful to adopt the tripod position when they are finding it difficult to. The difference in trough FEV1 for the tiotropium/olodaterol doses of 5/2, 5/5, and 5/10 mcg once daily from tiotropium 5 mcg were 0.024 L (95% CI -0.029, 0.076), 0.033 L (-0.019, 0.085), and 0.057 L (0.004, 0.110), respectively. WHEN YOU PICK UP YOUR MEDICATION, ASK YOUR PHARMACIST TO DEMONSTRATE PREPARING AND USING YOUR INHALER Was 21.99. Do not spray STIOLTO RESPIMAT in your eyes. (, Life-threatening paradoxical bronchospasm can occur. Do not use more than once in a 24-hour period. Immediate hypersensitivity reactions, including urticaria, angioedema (including swelling of the lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of STIOLTO RESPIMAT. People with asthma using long-acting inhaled beta agonists (such as olodaterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems. Do not get this medicine in your eyes. Also tell them about any vitamins, herbs, and supplements you use. STIOLTO RESPIMAT, as with other drugs containing beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. These highlights do not include all the information needed to use STIOLTO RESPIMAT safely and effectively. Taking Stiolto Respimat with certain antidepressants can increase your risk for abnormal heart rhythms (a heartbeat thats too fast, too slow, or uneven). In 2 separate embryo-fetal development studies, pregnant rats and rabbits received tiotropium during the period of organogenesis at doses up to approximately 790 and 8 times the MRHDID, respectively (on a mcg/m2 basis at inhalation doses of 1471 and 7 mcg/kg/day in rats and rabbits, respectively). Following inhaled administration of therapeutic doses of tiotropium to steady-state to patients with COPD, mild renal impairment (creatinine clearance 60 - <90 mL/min) resulted in 23% higher AUC0-6,ss and 17% higher Cmax,ss values. It isnt known whether Stiolto Respimat passes into breast milk in humans. No. No study adequate to determine whether the rate of asthma-related death is increased in patients treated with STIOLTO RESPIMAT has been conducted. 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). You should always have a rescue inhaler with you, even if you take Stiolto Respimat every day. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Keep your STIOLTO RESPIMAT inhaler, cartridge, and all medicines out of the reach of children. Therefore, avoid co-administration of STIOLTO RESPIMAT with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions (5.8, 5.9) and Adverse Reactions (6)]. (, Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or sensitivity to sympathomimetic drugs. Do not turn the clear base before inserting the cartridge. Increased post-implantation loss was observed in rats and rabbits administered tiotropium at maternally toxic doses 430 times and 40 times the MRHDID, respectively [see Data]. The drug substance tiotropium bromide monohydrate is chemically described as (1, 2, 4, 5, 7)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. Acetylcholine normally tells certain muscles, such as those in your lungs, to tighten. Use with caution. For more information about STIOLTO RESPIMAT, including current prescribing information, a video demonstration or a Quick Start Guide on how to use STIOLTO RESPIMAT, go to www.STIOLTO.com, scan the code, or call 1-800-542-6257. Enrolled patients (3939 patients receiving STIOLTO RESPIMAT and 3941 patients receiving tiotropium 5 mcg inhalation spray) had a history of COPD exacerbation in the previous 12 months. Note: Neither Stiolto Respimat nor Symbicort should be used as a rescue medication for COPD or as a treatment for asthma. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The effect of tiotropium dry powder for inhalation on QT interval was also evaluated in a randomized, placebo- and positive-controlled crossover study in 53 healthy volunteers. Increased cAMP levels cause relaxation of airway smooth muscles. Spiriva contains one active drug: tiotropium. Copyright 1996-2023 Cerner Multum, Inc. DOWNLOAD THE QUICK START GUIDE An easy, step-by-step guide on how to prepare and use the RESPIMAT inhaler Download It Now 2. Since dizziness and blurred vision may occur with the use of STIOLTO RESPIMAT, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=01e15aee-40e0-23f3-537f-c96dd63e2cb1, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. The medication is good for three months after you first put the cartridge in the inhaler. Do not start, stop, or change the dosage of any medicines without your doctor's approval. The STIOLTO RESPIMAT inhaler is a cylindrical shaped plastic inhalation device with a gray colored body and a clear base. Now youre ready to take your dose of Stiolto Respimat. Ankylosing Spondylitis Pain: Fact or Fiction, chronic obstructive pulmonary disease (COPD), FEV1 (forced expiratory volume in one second), Stiolto Respimat expiration, storage, and disposal, Professional information for Stiolto Respimat, How people with type 2 diabetes may benefit from afternoon exercise, Medicare reimbursements differ between simple and complex cataract surgeries, Chronic insomnia may increase stroke risk. The terminal half-life is approximately 25 hours in COPD patients. If you are a consumer or patient please visit All rights reserved. Tiotropium is a long-acting muscarinic antagonist (LAMA) that prevents your airways from tightening and helps them stay open.. Olodaterol is a long-acting beta-2 adrenergic agonist (LABA) that helps relax the muscles in your airways . Acute symptoms should be treated with an inhaled, short-acting beta2-agonist such as albuterol. Stiolto Respima containes a combination of olodaterol and tiotropium. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well. sudden shortness of breath can happen immediately after using STIOLTO RESPIMAT. These lists contain examples of serious side effects that can occur with Stiolto Respimat, with Anoro, or with both drugs (when taken individually). STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). These drugs are different from steroids, which work by reducing inflammation (swelling). If youre interested in finding an alternative to Stiolto Respimat, talk with your doctor to learn more about other medications that may work well for you. After inhalation of the solution by patients with COPD, urinary excretion is 18.6% (0.932 mcg) of the dose, the remainder being mainly non-absorbed drug in the gut that is eliminated via the feces. Olodaterol is a LABA, which opens airways in your lungs. Many people using this medication do not have serious side effects. STIOLTO RESPIMAT- tiotropium bromide and olodaterol spray, metered, 0597-0155-28, Adverse reactions observed in the 12-week trials were consistent with those observed in the 52-week trials, which formed the primary safety database. A study in subjects with severe hepatic impairment was not performed [see Clinical Pharmacology (12.3)]. Repeat Turn, Open, Press (TOP) 3 times after inserting the cartridge as shown in steps 4 to 6 under "Prepare for first use". Co-administration of tiotropium with ranitidine did not affect the pharmacokinetics of tiotropium. Its an inhalation spray thats used as a long-term maintenance (everyday) treatment for chronic obstructive pulmonary disease (COPD). Keep out of reach of children. Some may be better suited for you than others. In preclinical in vitro as well as in vivo studies, prevention of methacholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. But its not known for sure how many people had an allergic reaction to Stiolto Respimat during clinical studies. You should always consult your doctor or another healthcare professional before taking any medication. However, research suggests that drinking too much alcohol over time can make it harder for your immune system to remove bacteria from your lungs. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away. The difference in trough FEV1 for the tiotropium bromide/olodaterol doses of 1.25/5, 2.5/5, and 5/5 mcg once daily from olodaterol 5 mcg were 0.054 L (95% CI 0.016, 0.092), 0.065 L (0.027, 0.103), and 0.084 L (0.046, 0.122), respectively. Call your doctor for medical advice about side effects. Difficulty passing urine and dysuria may be symptoms of new or worsening prostatic hyperplasia or bladder outlet obstruction. Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose. To help prevent COPD symptoms happen immediately after using STIOLTO RESPIMAT every day prevent COPD symptoms a... When turning the clear base any medicines without your doctor about using this medication safely 68F to 77F 20C... Dose ( 2 puffs ) in 24 hours lasted longer than 24 hours muscles, such as albuterol different on... Shaped plastic inhalation device with a gray colored body and a beta-agonist ) that different. 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