Serevent Diskus

What Is Serevent Diskus?

Serevent Diskus (salmeterol xinafoate) is a bronchodilator used to prevent asthma attacks. Serevent Diskus will not treat an asthma attack that has already begun. Serevent Diskus is also used to treat chronic obstructive pulmonary disease (COPD) including emphysema and chronic bronchitis.

What Are Side Effects of Serevent Diskus?

Common side effects of Serevent Diskus include:

• hoarseness,
• throat irritation,
• headache,
• rapid heartbeat,
• nervousness,
• dizziness,
• lightheadedness,
• insomnia,
• sweating,
• cough,
• dry mouth/throat,
• upset stomach,
• nausea,
• vomiting, or
• diarrhea.

Many people using Serevent Diskus do not have serious side effects. Seek immediate medical attention if you have rare but very serious side effects of Serevent Diskus including:

• chest pain,
• fast/slow/irregular heartbeat,
• severe dizziness,
• fainting, or
• seizures.

Dosage for Serevent Diskus

Serevent inhalations should not be used more often than prescribed (twice per day) and proper techniques of inhalation closely followed.

What Drugs, Substances, or Supplements Interact with Serevent Diskus?

Serevent may interact with diuretics (water pills), antibiotics, antifungal medications, beta-blockers, antidepressants, HIV or AIDS medications, MAO inhibitors, caffeine, diet medicines, decongestants, aminophylline, theophylline, and others. Tell your doctor all medications you use.

Serevent Diskus During Pregnancy or Breastfeeding

Serevent should be used only when prescribed during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Serevent Diskus (salmeterol xinafoate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Serevent Diskus Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening asthma symptoms, or other breathing problems after using this medicine;
• severe headache, blurred vision, pounding in your neck or ears;
• chest pain, fast or irregular heartbeats;
• tremors, nervousness;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• headache;
• flu symptoms;
• joint or muscle pain;
• throat irritation, cough; or
• stuffy or runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Serevent Diskus (Salmeterol Xinafoate)

 

Serevent Diskus Professional Information

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 Disease^a

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 entire FDA prescribing information for Serevent Diskus (Salmeterol Xinafoate)