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Serevent Diskus

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Serevent Diskus

Serevent Diskus

SIDE EFFECTS

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 trial that compared the safety of salmeterol or placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. 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, Clinical Studies].

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.

Clinical Trials Experience In Asthma

Adult and Adolescent Subjects Aged 12 Years and Older

Two multicenter, 12-week, placebo-controlled clinical trials evaluated twice-daily doses of SEREVENT DISKUS in subjects aged 12 years and older with asthma. Table 1 reports the incidence of adverse reactions in these 2 trials.

Table 1: Adverse Reactions With SEREVENT DISKUS With ≥ 3 Incidence and More Common Than Placebo in Adult and Adolescent Subjects With Asthma

Adverse Event Percent of Subjects
Placebo
(n = 152)
SEREVENT DISKUS 50 mcg Twice Daily
(n = 149)
Albuterol Inhalation Aerosol 180 mcg 4 Times Daily
(n = 150)
Ear, nose, and throat
  Nasal/sinus congestion, pallor 6 9 8
  Rhinitis 4 5 4
Neurological
  Headache 9 13 12
Respiratory
  Asthma 1 3 < 1
  Tracheitis/bronchitis 4 7 3
  Influenza 2 5 5

Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of ≥ 3% in the group treated with SEREVENT DISKUS and were more common than in the placebo group.

Pharyngitis, sinusitis, upper respiratory tract infection, and cough occurred at ≥ 3% but were more common in the placebo group. However, throat irritation has been described at rates exceeding that of placebo in other controlled clinical trials.

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with SEREVENT DISKUS compared with subjects treated with placebo include the following: contact dermatitis, eczema, localized aches and pains, nausea, oral mucosal abnormality, pain in joint, paresthesia, pyrexia of unknown origin, sinus headache, and sleep disturbance.

Pediatric Subjects Aged 4 to 11 Years

Two multicenter, 12-week, controlled trials have evaluated twice-daily doses of SEREVENT DISKUS in subjects aged 4 to 11 years with asthma. Table 2 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving SEREVENT DISKUS and were more common than in the placebo group.

Table 2: Adverse Reaction Incidence in Two 12-Week Pediatric Clinical Trials in Subjects With Asthma

Adverse Event Percent of Subjects
Placebo
(n = 215)
SEREVENT DISKUS 50 mcg Twice Daily
(n = 211)
Albuterol Inhalation Aerosol 200 mcg 4 Times Daily
(n = 115)
Ear, nose, and throat
  Ear signs and symptoms 3 4 9
  Pharyngitis 3 6 3
Neurological
  Headache 14 17 20
Respiratory
  Asthma 2 4 < 1
Skin
  Skin rashes 3 4 2
  Urticaria 0 3 2

The following events were reported at an incidence of greater than 1% in the salmeterol group and with a higher incidence than in the albuterol and placebo groups: gastrointestinal signs and symptoms, lower respiratory signs and symptoms, photodermatitis, and arthralgia and articular rheumatism.

In clinical trials evaluating concurrent therapy of salmeterol with inhaled corticosteroids, adverse events were consistent with those previously reported for salmeterol, or with events that would be expected with the use of inhaled corticosteroids.

Laboratory Test Abnormalities

Elevation of hepatic enzymes was reported in > 1% of subjects in clinical trials. The elevations were transient and did not lead to discontinuation from the trials. In addition, there were no clinically relevant changes noted in glucose or potassium.

Clinical Trials Experience In Chronic Obstructive Pulmonary Disease

Two multicenter, 24-week, placebo-controlled US trials evaluated twice-daily doses of SEREVENT DISKUS in subjects with COPD. For presentation (Table 3), the placebo data from a third trial, identical in design, subject entrance criteria, and overall conduct but comparing fluticasone propionate with placebo, were integrated with the placebo data from these 2 trials (total N = 341 for salmeterol and 576 for placebo).

Table 3: Adverse Reactions With SEREVENT DISKUS With ≥ 3% Incidence in US Controlled Clinical Trials in Subjeci ts With Chronic Obstructive Pulmonary Diseasea

Adverse Event Percent of Patients
Placebo
(n = 576)
SEREVENT DISKUS 50 mcg Twice Daily
(n = 341)
Cardiovascular
Hypertension 2 4
Ear, nose, and throat
Throat irritation 6 7
Nasal congestion/blockage 3 4
Sinusitis 2 4
Ear signs and symptoms 1 3
Gastrointestinal
Nausea and vomiting 3 3
Lower respiratory
Cough 4 5
Rhinitis 2 4
Viral respiratory infection 4 5
Musculoskeletal
Musculoskeletal pain 10 12
Muscle cramps and spasms 1 3
Neurological
Headache 11 14
Dizziness 2 4
Average duration of exposure (days) 128.9 138.5
a Table 3 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving SEREVENT DISKUS and were more common in the group receiving SEREVENT DISKUS than in the placebo group.

Additional Adverse Reactions

Other adverse reactions occurring in the group receiving SEREVENT DISKUS that occurred at a frequency of ≥ 1% and were more common than in the placebo group were as follows: anxiety; arthralgia and articular rheumatism; bone and skeletal pain; candidiasis mouth/throat; dental discomfort and pain; dyspeptic symptoms; edema and swelling; gastrointestinal infections; hyperglycemia; hyposalivation; keratitis and conjunctivitis; lower respiratory signs and symptoms; migraines; muscle pain; muscle stiffness, tightness, and rigidity; musculoskeletal inflammation; pain; and skin rashes.

Adverse reactions to salmeterol are similar in nature to those seen with other selective beta2-adrenoceptor agonists, e.g., tachycardia; palpitations; immediate hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm; headache; tremor; nervousness; and paradoxical bronchospasm.

Laboratory Abnormalities

There were no clinically relevant changes in these trials. Specifically, no changes in potassium were noted.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of salmeterol. 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. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to salmeterol or a combination of these factors.

In extensive US and worldwide postmarketing experience with salmeterol, serious exacerbations of asthma, including some that have been fatal, have been reported. In most cases, these have occurred in patients with severe asthma and/or in some patients in whom asthma has been acutely deteriorating [see WARNINGS AND PRECAUTIONS], but they have also occurred in a few patients with less severe asthma. It was not possible from these reports to determine whether salmeterol contributed to these events.

Cardiovascular

Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) and anaphylaxis.

Non-Site Specific

Very rare anaphylactic reaction in patients with severe milk protein allergy.

Respiratory

Reports of upper airway symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking; oropharyngeal irritation.

Read the Serevent Diskus (salmeterol xinafoate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Inhibitors Of Cytochrome P450 3A4

Salmeterol is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with SEREVENT DISKUS is not recommended because increasedcardiovascular adverse effects may occur.

In a drug interaction trial in 20 healthy subjects, coadministration of inhaled salmeterol (50 mcg twice daily) and oral ketoconazole (400 mg once daily) for 7 days resulted in greater systemic exposure to salmeterol (AUC increased 16-fold and Cmax increased 1.4-fold). Three (3) subjects were withdrawn due to beta2-agonist side effects (2 with prolonged QTc and 1 with palpitations and sinus tachycardia). Although there was no statistical effect on the mean QTc, coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration compared with salmeterol and placebo administration.

Monoamine Oxidase Inhibitors And Tricyclic Antidepressants

SEREVENT DISKUS should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol on the vascular system may be potentiated by these agents.

Beta-Adrenergic Receptor Blocking Agents

Beta-blockers not only block the pulmonary effect of beta-agonists, such as SEREVENT DISKUS, but may also produce severe bronchospasm in patients with asthma or COPD. Therefore, patients with asthma or COPD should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of betaadrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.

Non-Potassium-Sparing Diuretics

The ECG changes and/or hypokalemia that may result from the administration of nonpotassium- sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by betaagonists, 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 SEREVENT DISKUS with non-potassium-sparing diuretics.

Read the Serevent Diskus Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/29/2014
This monograph has been modified to include the generic and brand name in many instances.

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