Generic Name: Spiriva
What is Spiriva?
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However, neither the FDA nor Merck recommended that patients stop taking Singulair, a drug that has proven very effective against seasonal allergies and asthma. The FDA announcement falls in line with a new focus on suicide and drug use, according to reporting in the New York Times. Since January, makers of drugs for depression, obesity and epilepsy have been asked to include data on suicide in their clinical trial reports.
But the FDA does not anticipate completing the review evaluation for Singulair for at least nine months. Following the updates, the Merck label for Singulair currently reads: "The following additional adverse reactions have been reported in post-marketing use: Psychiatric disorders: agitation including aggressive behavior, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior including suicidetremor.
What Would You Do. Doctors Not Concerned by US FDA Probing Safety of Merck's Singulair By RADHA CHITALE Email Star 0 Shares Email The Food and Drug Administration FDA announced an investigation Wednesday examining a link between suicide and Merck's popular allergy and asthma drug, Singulair.
Jump to navigationThe popular asthma and allergy medication Singulair is being investigated by government officials for a possible link to suicide. Food and Drug Administration announced in March 2008 that it had launched the probe after receiving reports involving Singulair and side effects including behavior and mood swings and suicidal thoughts.
It also received reports of actual suicides but did not release the number or other detailed information. The FDA said it was also reviewing reports of behavioral changes related to the similar drugs Accolate, made by AstraZeneca, and Zyflo, a product of Critical Therapeutics Inc. If you or someone you know used Singulair or one of these other medications and suffered an injurious side effect or committed suicide, you may want to contact a Singulair attorney.
The FDA said its investigation of Singulair, a leukotriene receptor antagonist, would take up to nine months to complete.
How should I take Spiriva?
These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine a component of aspartame0. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment.
SINGULAIR has been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. Cumulatively, 569 patients were treated with SINGULAIR for at least 6 months, 480 for one year, and 49 for two years in clinical trials.
With prolonged treatment, the adverse experience profile did not significantly change.
What should I avoid while taking Spiriva?
If you are taking Singulair montelukast to treat asthma, continue to take or use all other medications that your doctor has prescribed to treat your asthma. Do not stop taking any of your medications or change the doses of any of your medications unless your doctor tells you that you should. If your asthma is made worse by aspirin, do not take aspirin or other nonsteroidal anti-inflammatory drugs NSAIDs during your treatment with Singulair montelukast.
Singulair montelukast controls the symptoms of asthma and allergic rhinitis but does not cure these conditions. Continue to take Singulair montelukast even if you feel well. Do not stop taking Singulair montelukast without talking to your doctor. Skip the missed dose and continue your regular dosing schedule.
Spiriva side effects
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Common Spiriva ide effects may include:
Adults and Adolescents 15 Years of Age and Older with AsthmaClinical trials in adults and adolescents 15 years of age and older demonstrated there is no additional clinical benefit to montelukast doses above 10 mg once daily.
The elimination of montelukast was slightly prolonged compared with that in healthy subjects mean half-life, 7.
How to tell if the drug is working You should notice a decrease in how frequent or severe your asthma attacks are.
If you take corticosteroids, you can take these drugs together.
You can take this drug in combination with corticosteroids. This drug may increase your risk of mental health problems. Symptoms can include agitation, aggressive behavior, hostility, anxiousness, depression, or confusion. They can also include vivid dreams, hallucinations, trouble sleeping, irritability, or suicidal thoughts or actions. If you or your child is taking this drug, watch for these symptoms.
Where can I get more information?
OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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