Enrolled patients (3,939 patients receiving STIOLTO RESPIMAT and 3,941 patients receiving tiotropium 5 mcg inhalation spray) had a history of COPD exacerbation in the previous 12 months. Patients treated with STIOLTO RESPIMAT used less rescue medication compared to patients treated with tiotropium 5 mcg and olodaterol 5 mcg. The efficacy of STIOLTO RESPIMAT is based primarily on two 4-week dose-ranging trials in 592 COPD patients and two confirmatory active-controlled 52-week trials (Trials 1 and 2) in 5,162 pin up online casino COPD patients.
- Stiolto Respimat might make it harder to empty your bladder, especially if you already have a blockage or take medicines for overactive bladder.
- 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).
- Increases in leiomyomas and leiomyosarcomas of the female rodent reproductive tract have been similarly demonstrated with other beta2-adrenergic agonist drugs.
- Studies haven’t tested whether Stiolto Respimat is safe or effective in treating asthma.
- Following intravenous administration of 14C-labeled olodaterol, 38% of the radioactive dose was recovered in the urine and 53% was recovered in feces.
Other inhaled medicines, sometimes called rescue inhalers, should be used to treat sudden symptoms. Stiolto Respimat contains two medicines, tiotropium and olodaterol. Stiolto Respimat (tiotropium/olodaterol) is commonly used for chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis.
Some of the pharmacokinetic data described below were obtained with higher doses than recommended for therapy. 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. The precise function of beta2-receptors in the heart is not known, but their presence raises the possibility that even highly selective beta2-agonists may have cardiac effects. Olodaterol is a long-acting beta2-adrenergic agonist (LABA). The bronchodilation following inhalation of tiotropium is predominantly a site-specific effect.
The Stiolto Respimat inhaler is called Stiolto Respimat. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use. Brand-name medications usually cost more than generics. Symbicort is also approved to reduce the number of exacerbations (flare-ups) in COPD and to treat asthma in people ages 6 and older. You may wonder how Stiolto Respimat compares to other medications that are prescribed for similar uses. But Stiolto Respimat contains both a LABA and a long-acting anticholinergic.
The dose of Stiolto Respimat is two inhalations once-daily at the same time of day. If you have asthma, talk with your healthcare provider about which inhalers you need to manage your symptoms. Stiolto Respimat contains a long-acting beta2-agonist (LABA). Following oral inhalation, approximately 30% of the drug reaches systemic circulation. Following oral inhalation, approximately 33% of the drug reaches systemic circulation. Taking more than the recommended dose of Stiolto Respimat can increase your risk for serious side effects.
Patient Counseling Information
If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use see PATIENT INFORMATION. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The STIOLTO RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. Stiolto Respimat may interact with other adrenergic drugs, xanthine derivatives, steroids, diuretics, non-potassium sparing diuretics, MAO inhibitors, tricyclic antidepressants, drugs that prolong QTc intervals, beta-blockers, and other anticholinergics.
Clinical Studies
Stiolto Respimat and Symbicort are both brand-name drugs. Treatment guidelines include both medications as options for COPD maintenance treatment. However, studies have found both Stiolto Respimat and Symbicort to be effective as maintenance treatment for COPD.
STIOLTO RESPIMAT is not meant to relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose. 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. Olodaterol was evaluated in clinical trials for up to one year at doses up to twice the recommended therapeutic dosage.
- No dose adjustment is needed in patients with mild and moderate hepatic impairment.
- Before you use the device for the first time, you’ll need to insert the cartridge into the inhaler.
- Common side effects of Stiolto Respimat are cough, back pain, and stuffy nose.
- Symbicort’s active drugs are a corticosteroid (budesonide) and a LABA (formoterol).
- The proportion of patients who discontinued due to an adverse reaction was 7.4% for STIOLTO RESPIMAT treated patients compared to 9.9% and 9.0% for olodaterol 5 mcg and tiotropium 5 mcg treated patients.
Beta-blockers are medications that treat your heart rate or blood pressure. There are also many combination blood pressure medications that contain a diuretic. There are many combination medications that also contain a corticosteroid.
How to prepare and use your inhaler
The maximum mean (one-sided 95% upper confidence bound) difference in QTcI from placebo after baseline correction was 2.5 (5.6) ms, 6.1 (9.2) ms, 7.5 (10.7) ms, and 8.5 (11.6) ms following doses of 10, 20, 30, and 50 mcg, respectively. Relative to placebo, the maximum mean change from baseline in study-specific QTc interval was 3.2 msec and 0.8 msec for tiotropium inhalation powder 18 mcg and 54 mcg, respectively. In vitro studies have shown that olodaterol has 241-fold greater agonist activity at beta2-adrenoceptors compared to beta-adrenoceptors and 2,299-fold greater agonist activity compared to beta3-adrenoceptors. The compound exerts its pharmacological effects by binding and activation of beta2-adrenoceptors after topical administration by inhalation.
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). Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to STIOLTO RESPIMAT. When prescribing STIOLTO RESPIMAT, the healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient on how it should be used. STIOLTO RESPIMAT should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.
FDA Drug Information
Because of the potential for beta-agonist interference with uterine contractility, use of STIOLTO RESPIMAT during labor should be restricted to those patients in whom the benefits clearly outweigh the risks. There are no adequate and well-controlled human studies that have investigated the effects of STIOLTO RESPIMAT on preterm labor or labor at term. Olodaterol produced increased frequency of micronuclei in rats after intravenous doses. STIOLTO RESPIMAT patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then to repeat the process three more times.
Stiolto Respimat dosage
It is important for patients to understand how to correctly administer STIOLTO RESPIMAT inhalation spray using the STIOLTO RESPIMAT inhaler. Patients who have been taking inhaled, short-acting beta2-agonists on a regular basis should be instructed to discontinue the regular use of these products and use them only for the symptomatic relief of acute symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist such as albuterol.
Intravenously administered tiotropium bromide is mainly excreted unchanged in urine (74%). Total clearance was 880 mL/min after an intravenous dose in young healthy volunteers. Of the six metabolites identified, only the unconjugated demethylation product binds to beta2-receptors.
Drug-drug interaction studies were carried out using fluconazole as a model inhibitor of CYP 2C9 and ketoconazole as a potent P-gp (and CYP3A4, 2C8, 2C9) inhibitor. An interaction study with tiotropium (14.4 mcg intravenous infusion over 15 minutes) and cimetidine 400 mg three times daily or ranitidine 300 mg once-daily was conducted. More than 90% of the dose was excreted within 6 and 5 days following intravenous and oral administration, respectively. This metabolite, however, is not detectable in plasma after chronic inhalation of the recommended therapeutic dose.
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol see WARNINGS AND PRECAUTIONS. Tiotropium has been used concomitantly with short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators, methylxanthines, and oral and inhaled steroids, without increases in adverse reactions. These trials included 5,162 adult COPD patients (72.9% males and 27.1% females) 40 years of age and older.
Stiolto Respimat and Symbicort have different FDA-approved uses, but they’re both used as maintenance (everyday) treatment for COPD. Therefore, the two medications can cause some similar and some different side effects. Stiolto Respimat and Symbicort are both FDA-approved as maintenance (everyday) treatment for chronic obstructive pulmonary disease (COPD). And it’s only approved for maintenance (everyday) treatment of COPD. Due to the increased risk of asthma-related death, medications that only contain a LABA are required to have a boxed warning. Using a LABA on its own, without an inhaled corticosteroid, for asthma treatment can increase the risk of asthma-related death.
Does Stiolto Respimat interact with foods or drinks?
Of these patients, 1,029 were treated with STIOLTO RESPIMAT once daily. 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 total of 1,988 subjects received at least 1 dose of STIOLTO RESPIMAT. After assembly, the STIOLTO RESPIMAT inhaler should be discarded at the latest 3 months after first use or when the locking mechanism is engaged, whichever comes first. When the labeled number of actuations has been dispensed from the inhaler, the RESPIMAT locking mechanism will be engaged and no more actuations can be dispensed.
Can I use Stiolto Respimat as a rescue drug?
Based on animal studies, olodaterol was not teratogenic when administered to pregnant rats or rabbits during organogenesis at inhalation doses of approximately 2,731 or 1,353 times the MRHDID (on an AUC basis), in rats or rabbits, respectively (see Data). Olodaterol did not impair male or female fertility in rats at inhalation doses up to 3,068 mcg/kg/day (approximately 2,322 times the RHDID on an AUC basis). Lifetime treatment of female mice induced leiomyomas and leiomyosarcomas of the uterus at doses ≥76.9 mcg/kg/day (approximately 106-fold the RHDID on an AUC basis).