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SEREVENT DISKUS (50MCG/DOSE) is a brand name for Salmeterol, supplied as a powder. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Asthma SEREVENT DISKUS (salmeterol xinafoate) is indicated for the treatment of asthma only as add-on therapy to an inhaled corticosteroid; a long-term asthma control medication; in patients 4 years of age and older with reversible obstructive airway disease, including patients with nocturnal asthma. Corticosteroids…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Asthma Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, increase the risk of asthma-related death (see WARNINGS AND PRECAUTIONS). Because of this risk, use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an inhaled corticosteroid, a long-term asthma control medication, is contraindicated (see CONTRAINDICATIONS).
Use SEREVENT DISKUS only as add-on therapy for patients with asthma who are currently taking but are inadequately controlled on an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals.
If possible without loss of asthma control, discontinue SEREVENT DISKUS and maintain the patient on an inhaled corticosteroid, a long-term asthma control medication. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids (see WARNINGS AND PRECAUTIONS).
Pediatric and Adolescent Patients (4 to 17 years of age):
Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For patients with asthma less than 18 years of age 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 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 (see WARNINGS AND PRECAUTIONS).
At present, there are insufficient clinical data to recommend the use of salmeterol xinafoate in children younger than 4 years of age. Based on available data, no adjustment of salmeterol dosage in pediatric patients is warranted. In adolescents/children the severity of asthma may be variable with age and periodic reassessment should be considered to determine if continued maintenance therapy with SEREVENT DISKUS is still indicated.
SEREVENT DISKUS (salmeterol xinafoate) should not be initiated in patients with significantly worsening or acutely deteriorating asthma, which may be a life-threatening condition (see WARNINGS AND PRECAUTIONS). SEREVENT DISKUS is not a replacement for inhaled or oral corticosteroid therapy; its use is complementary to it.
1 Adverse Reaction Overview As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. e. palpitation; immediate hypersensitivity reactions, including urticaria, rash, bronchospasm, edema, angioedema, and anaphylactic shock or anaphylactic reaction; headache; tremor; nervousness; oropharyngeal irritation, and paradoxical bronchospasm.
There have also been reports of arthralgia and muscle cramps. Page 15 of 49 Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have been reported, usually in susceptible patients. Clinically significant changes in blood glucose and/or serum potassium were seen rarely during clinical studies with long-term administration of SEREVENT at recommended doses.
Asthma Long-acting beta2-adrenergic agonists (LABA), including salmeterol, the active ingredient in SEREVENT DISKUS, increase the risk of asthma-related death. Data from a large, 28-week, placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related death in patients receiving salmeterol.
Post-hoc analysis of the SMART trial data suggests that the risks may be lower in patients who were using inhaled corticosteroids (ICS) at study entry. However, these post-hoc analysis results are not conclusive (see 14 CLINICAL TRIALS: Salmeterol Multi-center Asthma Research Trial (SMART)).
Available data from controlled clinical trials suggest that LABA increase the risk of asthma- related hospitalization in pediatric and adolescent patients (see WARNINGS AND PRECAUTIONS, and 14 CLINICAL TRIALS: Salmeterol Multi-center Asthma Research Trial (SMART)).
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. Page 10 of 49 Use in Asthma Important Information SEREVENT DISKUS (salmeterol xinafoate) should not be initiated in patients with significantly worsening or acutely deteriorating asthma, which may be a life-threatening condition.
Serious acute respiratory events, including fatalities, have been reported worldwide, when SEREVENT has been initiated in this situation. Although it is not possible from these reports to determine whether SEREVENT contributed to these events or simply failed to relieve the deteriorating asthma, the use of SEREVENT DISKUS in this setting is inappropriate.
, unresponsive to usual medications, increasing need for inhaled rapid onset, short duration beta2-agonists, increasing need for systemic corticosteroids, significant increase in symptoms, recent emergency room visits, sudden or progressive deterioration in pulmonary function).
However, they have occurred in a few patients with less severe asthma as well. There are no data demonstrating that SEREVENT DISKUS provides greater efficacy than or additional efficacy to rapid onset, short duration, inhaled beta2-agonists in patients with worsening asthma.
General SEREVENT DISKUS is not a substitute for inhaled or oral corticosteroids All asthma patients should be advised that they must also use corticosteroids if they are taking SEREVENT DISKUS. Corticosteroid therapy should not be stopped or reduced when SEREVENT DISKUS is initiated.
There are no data demonstrating that SEREVENT has a clinical anti-inflammatory effect and could be expected to take the place of, or reduce the dose of, corticosteroids. Asthmatic patients must be warned not to stop or reduce corticosteroid therapy even if they feel better as a result of initiating SEREVENT DISKUS.
SEREVENT DISKUS is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container and to adrenergic compounds. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Patients with cardiac tachyarrhythmias. SEREVENT DISKUS (salmeterol xinafoate) dry powder for inhalation formulation contains lactose (which contains milk protein) and is therefore contraindicated in patients with an allergy to lactose or milk.
Patients with a history of anaphylactic shock, anaphylactic reaction or angioedema associated with salmeterol xinafoate or any component of this drug. Because of the risk of asthma-related death and hospitalization, use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an inhaled corticosteroid; a long-term asthma control medication; is contraindicated (see WARNINGS AND PRECAUTIONS).
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Salmeterol in Canada.
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Patients must be warned not to stop or reduce anti- inflammatory therapy (see CONTRAINDICATIONS). SEREVENT DISKUS should not be used to treat acute symptoms. It is crucial to inform patients of this and prescribe a rapid onset, short duration beta2-agonist for this purpose.
The need for additional symptomatic bronchodilator therapy is usually reduced with SEREVENT DISKUS (see WARNINGS AND PRECAUTIONS section). Medical attention should be sought if patients find that rapid onset, short duration relief bronchodilator treatment becomes less effective or if they need more inhalations than usual.
Page 8 of 49 Bronchodilators should not be the only or the main treatment in patients with moderate to severe or unstable asthma. Patients with severe asthma require regular medical assessment since death may occur. These patients will require high dose inhaled or oral corticosteroid therapy.
Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under medical supervision. g. salbutamol) when optimum corticosteroid therapy is being used. For full therapeutic benefit, regular usage of SEREVENT DISKUS is recommended in the treatment of reversible airways obstruction.
Chronic Obstructive Pulmonary Disease (COPD) Counselling on smoking cessation should be the first step in treating patients with COPD. Smoking cessation produces symptomatic benefits and has been shown to confer a survival advantage by slowing or stopping the progression of chronic bronchitis and emphysema.
Use with Rapid Onset, Short Duration Bronchodilators:
When beginning treatment with SEREVENT DISKUS, COPD patients should be instructed to use their rapid onset, short duration bronchodilators as determined by their treating physician, at the lowest dose to relieve their symptoms. The regular twice-daily administration of SEREVENT DISKUS should reduce the excessive use of rapid onset, short duration, inhaled bronchodilators.
General Considerations for Asthma and COPD The dosage or frequency of SEREVENT DISKUS administration should not be increased since there may be serious adverse effects associated with excessive dosing. SEREVENT DISKUS should not be used more than twice daily.
Elderly and patients with impaired renal or hepatic function:
There is no need to adjust the dose in the otherwise healthy elderly or in patients with impaired renal function. Because salmeterol is predominantly cleared by hepatic metabolism, patients with hepatic disease should be closely monitored.
2 Recommended Dose and Dosage Adjustment Asthma Maintenance Therapy Patients 4 years of age and older: One blister [50 micrograms of salmeterol (as the xinafoate)] twice daily. COPD One blister [50 micrograms of salmeterol (as the xinafoate)] twice daily.
4 Administration SEREVENT DISKUS is administered by the inhaled route only. 5 Missed Dose If a patient forgets to inhale a dose, instruct the patient to inhale another as soon as they remember unless it is near the time for their next dose.
If so the patient should wait until the next dose and resume the regular dosing schedule. Do not double dose.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Asthma Use in Adolescents and Adults (18 years of age and above) In controlled, multidose clinical trials (treatment period of up to 1 year) involving almost 2000 patients (≥18 years old), the most frequently occurring adverse events were headache, tremor and palpitations (see Table 2 below), which are pharmacologically predictable effects of beta2- adrenoceptor agonists.
Tremor tended to be transient, dose-related and reduced with regular therapy. Headache and palpitations were reported but the incidence was not significantly different from placebo. 1) In a subsequent 24 week controlled clinical trial, 738 patients (≥18 years old) received either salmeterol in combination with beclomethasone dipropionate (BDP) or BDP alone.
A rapid onset, short duration inhaled beta2-adrenergic drug was also provided to all patients for use on Page 16 of 49 an as-needed basis. The incidence of pharmacologically predictable adverse events was similar in all groups except for tremor which was significantly higher in the salmeterol 100 mcg group compared with the other two groups (see Table 3 below).
Table 3 Number (and percentage) of patients with drug-related adverse events Adverse Event Salmeterol 50 mcg bid + BDP* 500 mcg bid n= 243 (%) Salmeterol 100 mcg bid1 + BDP* 500 mcg bid n= 244 (%) BDP* 1000 mcg n= 251 (%) Headache 26 (11) 38 (16) 42 (17) Tremors 6 (2) 19 (8) 2 (<1) Palpitations 4 (2) 6 (2) 4 (2) Tachycardia 4 (2) 5 (2) 2 (<1) BDP* = beclomethasone dipropionate 1 = 100 mcg bid is not a recommended dose Chronic Obstructive Pulmonary Disease (COPD) Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of SEREVENT inhalation aerosol in patients (≥35 years old) with COPD.
In clinical trials, SEREVENT was generally well tolerated over chronic dosing periods. The most frequently reported adverse events with SEREVENT 50 mcg twice daily were headache, upper respiratory tract infection and sore throat. Table 4 below includes all events (whether considered drug-related or non-drug-related by the investigator) that occurred at a rate of over 3% in the SEREVENT inhalation aerosol treatment group and were more common in the SEREVENT inhalation aerosol group than in the placebo group.
Table 4 Adverse experience incidence (>3%) in two large 12-week COPD clinical trials Adverse Event SEREVENT 50 mcg bid n= 267 (%) Placebo n= 278 (%) Ipratropium 40 mcg qid n= 271 (%) Ear/Nose/Throat Upper Resp. Tract Infection (URTI) 9 7 9 Sore Throat 8 3 6 Nasal Sinus Infection 4 1 2 Gastrointestinal Diarrhea 5 3 4 Musculoskeletal Back Pain 4 3 3 Neurological Headache 12 10 8 Respiratory Chest Congestion 4 3 3 Page 17 of 49 Common cold, rhinorrhea, bronchitis, cough, exacerbation of chest congestion, chest pain, and dizziness occurred at 3% or more but were equally common on placebo.
Electrocardiographic Monitoring in Patients with COPD Continuous electrocardiographic (Holter) monitoring was performed on 284 patients in two large COPD clinical trials during five 24-hour periods. No significant increase in the incidence of ventricular and supraventricular ectopic events was observed between SEREVENT and placebo.
No cases of sustained ventricular tachycardia were observed. 0%) patients in the placebo, SEREVENT, and […]
Any change in corticosteroid dosage should be made ONLY after clinical evaluation. In the treatment of COPD, the role of inhaled corticosteroid therapy is less well established and SEREVENT DISKUS could be used with or without concomitant corticosteroids.
The use of oral or inhaled corticosteroids should be determined by the treating physician. SEREVENT DISKUS should not be used to treat acute asthma or COPD symptoms It is crucial to inform patients of this and prescribe a rapid onset, short duration, inhaled bronchodilator to relieve acute symptoms.
The use of bronchodilator should be determined by the treating physician. The role of long-acting beta2-agonists in the Management of Asthma and COPD The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.
Sudden or progressive deterioration in asthma control is potentially life-threatening; treatment plan must be re- evaluated, and consideration be given to increasing corticosteroid therapy. In patients at risk, daily peak flow monitoring with precise instructions for acceptable variation limits should be Page 11 of 49 considered.
Increased use of inhaled, rapid onset, short duration beta2-agonists is a marker of destabilization of asthma and requires re-evaluation of the patient and consideration of alternative treatment regimens, especially inhaled or systemic corticosteroids.
Long-acting beta2-agonists are an alternative additional therapy for patients with moderate asthma with unsatisfactory symptom control despite an optimal dose of inhaled steroids particularly when there are nocturnal symptoms. Before introducing long-acting beta2-agonists, adequate education should be provided to the patient on how to use the drug and what to do if asthma flares up.
Long-acting beta2-agonists are an additional therapy for COPD patients requiring long-acting control of symptoms. Use with rapid onset, short duration bronchodilators When asthmatic patients begin treatment with SEREVENT DISKUS, those who have been taking rapid onset, short duration, inhaled beta2-agonists on a regular daily basis should be advised to discontinue their regular daily-dosing regimen and should be clearly instructed to use rapid onset, short duration, inhaled beta2-agonists only for symptomatic relief if they develop asthma symptoms while taking SEREVENT DISKUS.
When beginning treatment with SEREVENT DISKUS, COPD patients should be instructed to use their rapid onset, short duration bronchodilators as determined by their treating physician, at the lowest dose to relieve their symptoms. The regular twice daily administration of SEREVENT DISKUS should reduce the excessive use of rapid onset, short duration inhaled bronchodilators.
Cardiovascular The pharmacological side-effects of beta2-agonist treatment, such as palpitations have been reported, but tend to be transient and to reduce with regular therapy (see ADVERSE REACTIONS). A small increase in QTc interval has been reported at therapeutic doses.
Large doses of inhaled or oral salmeterol (12 to 20 times the recommended dose) have been associated with clinically significant prolongation of the QTc interval, which has the potential for producing ventricular arrhythmias. Fatalities have been reported following excessive use of aerosol preparations containing sympathomimetic amines, the exact cause of which is unknown.
Cardiac arrest was reported in several instances. 17% vs. 308). The […]