Stiolto Respimat
- Generic Name: tiotropium bromide and olodaterol
- Brand Name: Stiolto Respimat
- Drug Class: Respiratory Inhalant Combos
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- sinus irritation and sore throat (nasopharyngitis),
- cough,
- back pain,
- dehydration,
- dizziness,
- insomnia,
- glaucoma,
- blurred vision,
- palpitations,
- fast heart rate,
- high blood pressure,
- nosebleed,
- difficulty speaking,
- laryngitis,
- sinus infection,
- dry mouth,
- constipation,
- oral thrush,
- difficulty swallowing,
- gastroesophageal reflux disease (GERD),
- gum disease,
- swollen lips or tongue,
- rash,
- itching,
- hives,
- skin infection,
- dry skin,
- joint pain or swelling,
- urinary retention,
- difficulty urinating, and
- urinary tract infection.
- pounding heartbeats or fluttering in your chest;
- wheezing, choking, or other breathing problems after using this medicine;
- painful or difficult urination, or urinating more often;
- blurred vision, tunnel vision, eye pain, or seeing halos around lights;
- high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or
- low potassium level--leg cramps, constipation, irregular heartbeats, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.
- runny nose;
- cough; or
- back pain.
- Immediate hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
- Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
- Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS]
- Worsening of urinary retention [see WARNINGS AND PRECAUTIONS]
What Is Stiolto Respimat?
Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray is a combination of an anticholinergic and a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
What Are Side Effects of Stiolto Respimat?
Common side effects of Stiolto Respimat include:
Dosage for Stiolto Respimat
The dose of Stiolto Respimat is two inhalations once-daily at the same time of day.
What Drugs, Substances, or Supplements Interact with Stiolto Respimat?
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. Tell your doctor all medications and supplements you use.
Stiolto Respimat During Pregnancy or Breastfeeding
During pregnancy, Stiolto Respimat should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Stiolto Respimat (tiotropium bromide and olodaterol)
SIDE EFFECTS
LABA, such as olodaterol, one of the active components in STIOLTO RESPIMAT, as monotherapy (without an inhaled corticosteroid) for asthma, increase the risk of asthma-related events. STIOLTO RESPIMAT is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS].
The following adverse reactions are described, or described in greater detail, in other sections:
Clinical Trials Experience In Chronic Obstructive Pulmonary Disease
Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidences in the clinical trials of another drug and may not reflect the incidences observed in practice.
The clinical program for STIOLTO RESPIMAT included 7151 subjects with COPD in two 52-week active-controlled trials, one 12-week placebo-controlled trial, three 6-week placebo-controlled cross-over trials, and four additional trials of shorter duration. A total of 1988 subjects received at least 1 dose of STIOLTO RESPIMAT. Adverse reactions observed in the ≤12-week trials were consistent with those observed in the 52-week trials, which formed the primary safety database.
The primary safety database consisted of pooled data from the two 52-week double-blind, active-controlled, parallel group confirmatory clinical trials (Trials 1 and 2). These trials included 5162 adult COPD patients (72.9% males and 27.1% females) 40 years of age and older. Of these patients, 1029 were treated with STIOLTO RESPIMAT once daily. The STIOLTO RESPIMAT group was composed of mostly Caucasians (71.1%) with a mean age of 63.8 years and a mean percent predicted FEV1 at baseline of 43.2%. In these two trials, tiotropium 5 mcg and olodaterol 5 mcg were included as active control arms and no placebo was used.
In these two clinical trials, 74% of patients exposed to STIOLTO RESPIMAT reported an adverse reaction compared to 76.6% and 73.3% in the olodaterol 5 mcg and tiotropium 5 mcg groups, respectively. 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. The adverse reaction most commonly leading to discontinuation was worsening COPD.
The most common serious adverse reactions were COPD exacerbation and pneumonia.
Table 1 shows all adverse drug reactions that occurred with an incidence of >3% in the STIOLTO RESPIMAT treatment group and a higher incidence rate than the active comparator groups listed.
Table 1 : Number and frequency of adverse drug
reactions greater than 3% (and higher than any of the comparators tiotropium
and/or olodaterol) in COPD patients exposed to STIOLTO RESPIMAT: Pooled data
from the two 52-week, double-blind, active-controlled clinical trials in COPD patients
40 years of age and older
| Treatment | STIOLTO RESPIMAT (once daily) | Tiotropium (5 mcg once daily) | Olodaterol (5 mcg once daily) |
| Body system (adverse drug reaction) | n=1029 n (%) |
n=1033 n (%) |
n=1038 n (%) |
| Infections and infestations | |||
| Nasopharyngitis | 128 (12.4) | 121 (11.7) | 131 (12.6) |
| Respiratory, thoracic, and mediastinal disorders | |||
| Cough | 40 (3.9) | 45 (4.4) | 31 (3.0) |
| Musculoskeletal and connective tissue disorders | |||
| Back Pain | 37 (3.6) | 19 (1.8) | 35 (3.4) |
Other adverse drug reactions in patients receiving STIOLTO RESPIMAT that occurred in ≤3% of patients in clinical studies are listed below:
Metabolism and nutrition disorders: dehydration
Nervous system disorders: dizziness, insomnia
Eye disorders: glaucoma, intraocular pressure increased, vision blurred
Cardiac/vascular disorders: atrial fibrillation, palpitations, supraventricular tachycardia, tachycardia, hypertension
Respiratory, thoracic, and mediastinal disorders: epistaxis, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis
Gastrointestinal disorders: dry mouth, constipation, oropharyngeal candidiasis, dysphagia, gastroesophageal reflux disease, gingivitis, glossitis, stomatitis, intestinal obstruction including ileus paralytic
Skin and subcutaneous disorders: rash, pruritus, angioneurotic edema, urticaria, skin infection, and skin ulcer, dry skin, hypersensitivity (including immediate reactions)
Musculoskeletal and connective tissue disorders: arthralgia, joint swelling Renal and urinary disorders: urinary retention, dysuria, and urinary tract infection
COPD Exacerbation Reduction Trial
In a one year trial (Trial 5) of 7880 patients to compare rates of COPD exacerbations, 3939 patients were treated with STIOLTO RESPIMAT and 3941 patients were treated with tiotropium 5 mcg inhalation spray. 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.
Read the entire FDA prescribing information for Stiolto Respimat (tiotropium bromide and olodaterol)
© Stiolto Respimat Patient Information is supplied by Cerner Multum, Inc. and Stiolto Respimat Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
