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Serevent Diskus

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Serevent Diskus

Serevent Diskus

INDICATIONS

Treatment of Asthma

SEREVENT DISKUS (salmeterol xinafoate) 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 patients aged 4 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma. LABA, such as salmeterol, the active ingredient in SEREVENT DISKUS, increase the risk of asthma-related death [see WARNINGS AND PRECAUTIONS]. Use of SEREVENT DISKUS (salmeterol xinafoate) for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated [see CONTRAINDICATIONS]. Use SEREVENT DISKUS (salmeterol xinafoate) 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 SEREVENT DISKUS) 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 SEREVENT DISKUS (salmeterol xinafoate) for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

Pediatric and Adolescent Patients: Available data from controlled clinical trials suggest that LAB A increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LAB A to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and a 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 a 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 a LABA is recommended.

Important Limitation of Use: SEREVENT DISKUS (salmeterol xinafoate) is NOT indicated for the relief of acute bronchospasm.

Prevention of Exercise-Induced Bronchospasm

SEREVENT DISKUS (salmeterol xinafoate) is also indicated for prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. Use of SEREVENT DISKUS (salmeterol xinafoate) as a single agent for the prevention of EIB may be clinically indicated in patients who do not have persistent asthma. In patients with persistent asthma, use of SEREVENT DISKUS (salmeterol xinafoate) for the prevention of EIB may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.

Maintenance Treatment of Chronic Obstructive Pulmonary Disease

SEREVENT DISKUS (salmeterol xinafoate) is indicated for the long-term twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis).

Important Limitation of Use: SEREVENT DISKUS (salmeterol xinafoate) is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

SEREVENT DISKUS (salmeterol xinafoate) should be administered by the orally inhaled route only. For both asthma and COPD, adverse effects are more likely to occur with higher doses of salmeterol, and more frequent administration or administration of a larger number of inhalations (more than 1 inhalation twice daily) is not recommended. Patients using SEREVENT DISKUS (salmeterol xinafoate) should not use additional LAB A for any reason. [See WARNINGS ANDPRECAUTIONS.]

Asthma

LABA, such as salmeterol, the active ingredient in SEREVENT DISKUS (salmeterol xinafoate) , increase the risk of asthma-related death [see WARNINGS ANDPRECAUTIONS.].

Because of this risk, use of SEREVENT DISKUS (salmeterol xinafoate) for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid is contraindicated. Use SEREVENT DISKUS (salmeterol xinafoate) 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 SEREVENT DISKUS (salmeterol xinafoate) ) 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 SEREVENT DISKUS (salmeterol xinafoate) for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

Pediatric and Adolescent Patients: 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 a 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 a 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 a LABA is recommended.

For bronchodilatation and prevention of symptoms of asthma, including the symptoms of nocturnal asthma, the usual dosage for adults and children aged 4 years and older is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart). If a previously effective dosage regimen fails to provide the usual response, medical advice should be sought immediately as this is often a sign of destabilization of asthma. Under these circumstances, the therapeutic regimen should be reevaluated. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Exercise-Induced Bronchospasm

Use of SEREVENT DISKUS (salmeterol xinafoate) as a single agent for the prevention of EIB may be clinically indicated in patients who do not have persistent asthma. In patients with persistent asthma, use of SEREVENT DISKUS (salmeterol xinafoate) for the prevention of EIB may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid. One inhalation of SEREVENT DISKUS (salmeterol xinafoate) at least 30 minutes before exercise has been shown to protect patients against EIB. When used intermittently as needed for prevention of EIB, this protection may last up to 9 hours in adolescents and adults and up to 12 hours in patients aged 4 to 11 years. Additional doses of SEREVENT should not be used for 12 hours after the administration of this drug. Patients who are receiving SEREVENT DISKUS (salmeterol xinafoate) twice daily should not use additional SEREVENT for prevention of EIB.

Chronic Obstructive Pulmonary Disease

For maintenance treatment of bronchospasm associated with COPD (including chronic bronchitis and emphysema), the dosage for adults is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart).

HOW SUPPLIED

Dosage Forms and Strengths

Disposable teal green device with 60 blisters containing salmeterol (50 mcg) as an oral inhalation powder formulation. An institutional pack containing 28 blisters is also available.

SEREVENT DISKUS (salmeterol xinafoate) is supplied as a disposable teal green device containing 60 blisters. The DISKUS inhalation device is packaged within a plastic-coated, moisture-protective foil pouch (NDC 0173-0521-00).

SEREVENT DISKUS (salmeterol xinafoate) is also supplied in an institutional pack of 1 disposable teal green unit containing 28 blisters. The drug product is packaged within a plastic-coated, moisture-protective foil pouch (NDC 0173-0520-00).

Store at controlled room temperature (see USP), 20° to 25°C (68° to 77°F) in a dry place away from direct heat or sunlight. Keep out of reach of children. The DISKUS inhalation device is not reusable. The device should be discarded 6 weeks after removal from the moisture-protective foil pouch or after all blisters have been used (when the dose indicator reads "0"), whichever comes first. Do not attempt to take the DISKUS apart.

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: 12/2010

Last reviewed on RxList: 2/28/2011
This monograph has been modified to include the generic and brand name in many instances.

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