See also:
What is the most important information I should know about Airtec-FB DPI?
Do not use Airtec-FB DPI inhalation to treat an asthma attack that has already begun.
Airtec-FB DPI may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using Airtec-FB DPI inhalation.
Asthma is often treated with a combination of different drugs. If you use Airtec-FB DPI inhalation to treat asthma, you must use it together with another asthma control medication. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.
Airtec-FB DPI capsules are for use only in the Airtec-FB DPI device. Use only one capsule at a time. Do not take the capsules by mouth. Never place a capsule in the mouthpiece of the inhaler.
Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.
See also:
What are the possible side effects of Airtec-FB DPI?
Long-acting beta2-adrenergic agonists (LABA), including Airtec-FB DPI, the active ingredient in Airtec-FB DPI, increase the risk of asthma-related death and may increase the risk of asthma-related hospitalizations in pediatric and adolescent patients. Clinical trials with Airtec-FB DPI suggested a higher incidence of serious asthma exacerbations in patients who received Airtec-FB DPI than in those who received placebo.
Adverse reactions common to LABA drugs include: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis, and insomnia.
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 trials.
Asthma
Of the 5824 patients in multiple-dose controlled clinical trials, 1985 were treated with Airtec-FB DPI at the recommended dose of 12 mcg twice daily. The following table shows treatment-emergent adverse reactions where the frequency was greater than or equal to 1% in the Airtec-FB DPI twice daily group and where the rates in the Airtec-FB DPI group exceeded placebo. Three treatment-emergent adverse reactions showed dose ordering among tested doses of 6, 12, and 24 mcg administered twice daily; tremor, dizziness and dysphonia.
Number and Frequency of Treatment-Emergent Adverse Reactions in Patients 5 Years of Age and Older from Multiple-Dose Controlled Clinical Trials
In patients 5-12 years of age, the numbers and percent of patients who reported treatment-emergent adverse reactions were comparable in the 12 mcg twice daily and placebo groups. In general, the pattern of the treatment-emergent adverse reactions observed in children differed from the usual pattern seen in adults. Treatment-emergent adverse reactions that were more frequent in the Airtec-FB DPI group than in the placebo group reflected infection/inflammation (viral infection, rhinitis, tonsillitis, gastroenteritis) or abdominal complaints (abdominal pain, nausea, dyspepsia).
Serious Asthma Exacerbations in Adolescents and Adults 12 Years of Age and Older
In two 12-week controlled trials with combined enrollment of 1095 patients 12 years of age and older, Airtec-FB DPI 12 mcg twice daily was compared to Airtec-FB DPI 24 mcg twice daily, albuterol 180 mcg four times daily, and placebo. Serious asthma exacerbations (acute worsening of asthma resulting in hospitalization) occurred more commonly with Airtec-FB DPI 24 mcg twice daily than with the recommended dose of Airtec-FB DPI 12 mcg twice daily, albuterol, or placebo. The results are shown in the following table.
In a 16-week, randomized, multi-center, double-blind, parallel-group trial, patients who received either 24 mcg twice daily or 12 mcg twice daily doses of Airtec-FB DPI experienced more serious asthma exacerbations than patients who received placebo. The results are shown in the following table.
Serious Asthma Exacerbations in Children 5-11 Years of Age
The safety of Airtec-FB DPI 12 mcg twice daily compared to Airtec-FB DPI 24 mcg twice daily and placebo was investigated in one large, multicenter, randomized, double-blind, 52-week clinical trial in 518 children with asthma (ages 5-12 years) in need of daily bronchodilators and anti-inflammatory treatment. More children who received Airtec-FB DPI 24 mcg twice daily than children who received Airtec-FB DPI 12 mcg twice daily or placebo experienced serious asthma exacerbations, as shown in the next table.
COPDOf the 1634 patients in two pivotal multiple-dose Chronic Obstructive Pulmonary Disease (COPD) controlled trials, 405 were treated with Airtec-FB DPI 12 mcg twice daily. Treatment-emergent adverse reactions reported were similar to those seen in asthmatic patients, but with a higher incidence of COPD-related events in both placebo and Airtec-FB DPI treated patients.
The following table shows treatment-emergent adverse reactions where the frequency was greater than or equal to 1% in the Airtec-FB DPI group and where the rates in the Airtec-FB DPI group exceeded placebo. The two clinical trials included doses of 12 mcg and 24 mcg, administered twice daily. Seven treatment-emergent adverse reactions showed dose ordering among tested doses of 12 and 24 mcg administered twice daily; pharyngitis, fever, muscle cramps, increased sputum, dysphonia, myalgia, and tremor.
Number and Frequency of Treatment-Emergent Adverse Reactions in Adult COPD Patients Treated in Multiple-Dose Controlled Clinical Trials
Overall, the frequency of all cardiovascular treatment-emergent adverse reactions in the two pivotal studies was 6.4% for Airtec-FB DPI 12 mcg twice daily, and 6.0% for placebo. There were no frequently-occurring specific cardiovascular treatment-emergent adverse reactions for Airtec-FB DPI (frequency greater than or equal to 1% and greater than placebo).
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Airtec-FB DPI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In extensive worldwide marketing experience with Airtec-FB DPI, serious exacerbations of asthma, including some that have been fatal, have been reported. While most of these cases have been in patients with severe or acutely deteriorating asthma, a few have occurred in patients with less severe asthma. It is not possible to determine from these individual case reports whether Airtec-FB DPI contributed to the events.
Immune system disorders: rare reports of anaphylactic reactions, including severe hypotension and angioedema
Metabolism and nutrition disorders: Hypokalemia, hyperglycemia
Respiratory, thoracic and mediastinal disorders: Cough
Skin and subcutaneous tissue disorders: Rash
Cardiac disorders: Angina pectoris, cardiac arrhythmias, e.g., atrial fibrillation, ventricular extrasystoles, tachyarrhythmia
Investigations: Electrocardiogram QT prolonged, blood pressure increased (including hypertension)
Airtec-FB DPI CERTIHALER (Airtec-FB DPI fumarate inhalation powder) is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airway disease. Long-acting beta-adrenergic agonists (LABA), such as Airtec-FB DPI, the active ingredient in Airtec-FB DPI CERTIHALER (Airtec-FB DPI fumarate inhalation powder), increase the risk of asthma-related death. Use of Airtec-FB DPI CERTIHALER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use Airtec-FB DPI CERTIHALER (Airtec-FB DPI fumarate inhalation powder) only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue Airtec-FB DPI CERTIHALER (Airtec-FB DPI fumarate inhalation powder) ) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Airtec-FB DPI CERTIHALER (Airtec-FB DPI fumarate inhalation powder) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
Pediatric and Adolescent PatientsAvailable data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.
Airtec-FB DPI is used together with other medicines (such as inhaled corticosteroids) to treat asthma and prevent bronchospasm in patients with asthma. When used regularly every day, inhaled Airtec-FB DPI decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.
Airtec-FB DPI is also used to treat symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Airtec-FB DPI belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.
Airtec-FB DPI is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm or EIB).
Airtec-FB DPI is available only with your doctor's prescription.
Airtec-FB DPI is a derivative of theophylline which shares bronchodilator properties. Airtec-FB DPI is used in asthma, chronic obstructive pulmonary disease, and in the management of cerebrovascular insufficiency, sickle cell disease, and diabetic neuropathy. Long-term enprofylline administration may be associated with elevation in liver enzyme levels and unpredictable blood levels.
Use Airtec-FB DPI solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Airtec-FB DPI solution.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Airtec-FB DPI is used for treatment of wheezing, shortness of breath and breathing difficulties caused by asthma or chronic obstructive pulmonary disorder (COPD) It is also used to treat bronchospasm (constriction of air passages) in people with night time asthma.
The recommended dose of Airtec-FB DPI (Airtec-FB DPI fumarate) Inhalation Solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended.
Airtec-FB DPI Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of Airtec-FB DPI Inhalation Solution have been established in clinical trials when administered using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) and the PRONEB® Ultra compressor. The safety and efficacy of Airtec-FB DPI Inhalation Solution delivered from non-compressor based nebulizer systems have not been established.
Airtec-FB DPI Inhalation Solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE. Contents of any partially used container should be discarded.
If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered.
The drug compatibility (physical and chemical), efficacy, and safety of Airtec-FB DPI Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
How suppliedDosage Forms And StrengthsAirtec-FB DPI (Airtec-FB DPI fumarate) Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each vial contains Formoterol fumarate dihydrate, USP equivalent to 20 mcg/2 mL of Airtec-FB DPI fumarate.
Airtec-FB DPI (Airtec-FB DPI fumarate) Inhalation Solution is supplied as a 2 mL sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and supplied in cartons as listed below.
Carton of 30 individually wrapped unit dose vials, NDC 49502-605-30
Carton of 60 individually wrapped unit dose vials, NDC 49502-605-61
Storage And HandlingPrior to dispensing to the patient: Store in a refrigerator, 2°C to 8°C (36°F to 46°F)
After dispensing to the patient: Store at 2°C to 25°C (36°F to 77°F) for up to 3 months. Protect pouch from heat.
Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505. Manufactured by: The Ritedose Corporation, Columbia, SC 29203. Revised: March 2013
See also:
What other drugs will affect Airtec-FB DPI?
If additional adrenergic drugs are to be administered by any route, they should be used with caution because the pharmacologically predictable sympathetic effects of Airtec-FB DPI may be potentiated.
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists.
The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonist with non-potassium sparing diuretics.
Airtec-FB DPI, as with other beta-agonists, should be administered with extreme caution to patients being treated with monamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.
Beta-adrenergic receptor antagonists (beta-blockers) and Airtec-FB DPI may inhibit the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta-agonists, such as Airtec-FB DPI, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
