Striverdi Respimat
- Generic Name: olodaterol inhalation spray
- Brand Name: Striverdi Respimat
Striverdi Respimat (Olodaterol Inhalation Spray) side effects drug center
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- upper respiratory tract infection,
- bronchitis,
- urinary tract infection,
- sore throat,
- runny or stuffy nose,
- cough,
- dizziness,
- rash,
- diarrhea,
- back pain,
- joint pain,
- pneumonia,
- constipation, and
- fever.
- 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.
What Is Striverdi Respimat?
Striverdi Respimat (olodaterol) Inhalation Spray is a selective beta2-adrenergic bronchodilator used for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
What Are Side Effects of Striverdi Respimat?
Common side effects of Striverdi Respimat include:
Dosage for Striverdi Respimat
The recommended dose of Striverdi Respimat is two inhalations once-daily at the same time of the day.
What Drugs, Substances, or Supplements Interact with Striverdi Respimat?
Striverdi Respimat may interact with adrenergic drugs, xanthine derivatives, steroids, diuretics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, beta-blockers, and ketoconazole. Tell your doctor all medications and supplements you use.
Striverdi Respimat During Pregnancy or Breastfeeding
During pregnancy, Striverdi Respimat should be used only if prescribed. This drug may pass into breast milk, and its effects on a nursing infant are unknown. Consult your doctor before breastfeeding.
Additional Information
Our Striverdi Respimat (olodaterol) Inhalation Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Striverdi Respimat Consumer Information
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 Striverdi Respimat (Olodaterol Inhalation Spray)
Striverdi Respimat Professional Information
SIDE EFFECTS
Long-acting beta2-adrenergic agonists, such as STRIVERDI RESPIMAT, as monotherapy (without an inhaled corticosteroid) for asthma, increase the risk of asthma-related events. STRIVERDI RESPIMAT is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience In Chronic Obstructive Pulmonary Disease
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The STRIVERDI RESPIMAT clinical development program included seven dose-ranging trials and eight confirmatory trials. Four of the confirmatory trials were 6week cross-over trials and four were 48-week parallel group trials. Adverse reactions observed in the dose-ranging trials and four 6-week cross-over trials were consistent with those observed in the 48-week parallel group trials, which formed the primary safety database.
The primary safety database consisted of pooled data from the four 48-week double-blind, active and placebo-controlled, parallel group confirmatory clinical trials. These trials included 3104 adult COPD patients (77% males and 23% females) 40 years of age and older. Of these patients, 876 and 883 patients were treated with STRIVERDI RESPIMAT 5 mcg and 10 mcg once-daily, respectively. The STRIVERDI RESPIMAT groups were composed of mostly Caucasians (66%) with a mean age of 64 years and a mean percent predicted FEV1 at baseline of 44% for both the 5 mcg and 10 mcg treatment groups. Control arms for comparison included placebo in all four trials plus formoterol 12 mcg in two trials.
In these four clinical trials, seventy-two percent (72%) of patients exposed to any dose of STRIVERDI RESPIMAT reported an adverse reaction compared to 71% in the placebo group. The proportion of patients who discontinued due to an adverse reaction was 7.2% for STRIVERDI RESPIMAT treated patients compared to 8.8% for placebo treated patients. The adverse reaction most commonly leading to discontinuation was worsening COPD. The most common serious adverse reactions were COPD exacerbation, pneumonia, and atrial fibrillation.
Table 1 shows all adverse drug reactions reported by at least 2% of patients (and higher than placebo) who received STRIVERDI RESPIMAT 5 mcg during the 48week trials.
Table 1 : Number and frequency of adverse drug
reactions greater than 2% (and higher than placebo) in COPD patients exposed to
STRIVERDI RESPIMAT 5 mcg: Pooled data from the four 48-week, double-blind,
active-and placebo-controlled clinical trials in COPD patients 40 years of age and
older
Treatment | STRIVERDI 5 mcg once-daily | Placebo |
Body system (adverse drug reaction) | n=876 n (%) | n=885 n (%) |
Infections and infestations | ||
Nasopharyngitis | 99 (11.3) | 68 (7.7) |
Upper Respiratory Tract Infection | 72 (8.2) | 66 (7.5) |
Bronchitis | 41 (4.7) | 32 (3.6) |
Urinary Tract Infection | 22 (2.5) | 9 (1.0) |
Respiratory, thoracic, and mediastinal disorders | ||
Cough | 37 (4.2) | 35 (4.0) |
Nervous system disorders | ||
Dizziness | 20 (2.3) | 19 (2.1) |
Skin and subcutaneous tissue disorders | ||
Rash* | 19 (2.2) | 10 (U) |
Gastrointestinal disorders | ||
Diarrhea | 25 (2.9) | 22 (2.5) |
Musculoskeletal and connective tissue disorders | ||
Back Pain | 31 (3.5) | 24 (2.7) |
Arthralgia | 18 (2.1) | 7 (0.8) |
*Rash includes a grouping of similar terms |
Additional adverse reactions that occurred in greater than 2% (and higher than placebo) of patients exposed to STRIVERDI RESPIMAT 10 mcg were pneumonia, constipation, and pyrexia.
Lung cancers were reported in 6 (0.7%), 3 (0.3%), and 2 (0.2%) patients who received STRIVERDI RESPIMAT 10 mcg, 5 mcg, and placebo, respectively.
Read the entire FDA prescribing information for Striverdi Respimat (Olodaterol Inhalation Spray)
&Copy; Striverdi Respimat Patient Information is supplied by Cerner Multum, Inc. and Striverdi Respimat Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.