Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Long-acting beta 2 -adrenergic agonists, such as arformoterol tartrate inhalation solution, as monotherapy (without inhaled corticosteroids) for asthma increase the risk of asthma-related events.
Arformoterol tartrate inhalation solution is not indicated for the treatment of asthma [see Warnings and Precautions (5.1 )].
Most common adverse reactions (≥2% incidence and more common than placebo) are pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder.
( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC.
at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Beta 2 -Agonist Adverse Reaction Profile Adverse reactions to arformoterol tartrate inhalation solution are expected to be similar in nature to other beta 2 -adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.
6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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.
Adults with COPD in Short-Term Trials (12 weeks) The safety data described below for adults ≥35 years of age are based on 2 clinical trials of 12 weeks.
In the 2 trials of 12 weeks duration, 1456 patients (860 males and 596 females, ages 34 to 89 years old) with COPD were treated with arformoterol tartrate inhalation solution 15 mcg twice daily, 25 mcg twice daily, 50 mcg once daily, salmeterol 42 mcg twice daily, or placebo.
The racial/ethnic distribution in these two trials included 1383 Caucasians, 49 Blacks, 10 Asians, and 10 Hispanics, and 4 patients classified as Other.
5 WARNINGS AND PRECAUTIONS • LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events.
( 5.1 ) • Do not initiate arformoterol tartrate inhalation solution in acutely deteriorating patients.
( 5.2 ) • Do not use for relief of acute symptoms.
Concomitant short-acting beta 2 -agonists can be used as needed for acute relief.
( 5.2 ) • Do not exceed the recommended dose.
Like all medications, Arformoterol Tartrate Inhalation can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: