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Advair Diskus (Fluticasone Propionate / Salmeterol Xinafoate Inhalation) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Asthma

ADVAIR DISKUS is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 4 years of age and older.

Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. ADVAIR DISKUS is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.

ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.

Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis

ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis.

ADVAIR DISKUS 250/50 mcg twice daily is the only approved dosage for the treatment of COPD associated with chronic bronchitis. Higher doses, including ADVAIR DISKUS 500/50, are not recommended (see DOSAGE AND ADMINISTRATION: Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis).

The benefit of treating patients with COPD associated with chronic bronchitis with ADVAIR DISKUS 250/50 for periods longer than 6 months has not been evaluated. Patients who are treated with ADVAIR DISKUS 250/50 for COPD associated with chronic bronchitis for periods longer than 6 months should be reevaluated periodically to assess the continuing benefits and potential risks of treatment.

ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

ADVAIR DISKUS should be administered by the orally inhaled route only (see Instructions for Using ADVAIR DISKUS in the Medication Guide accompanying the product). After inhalation, the patient should rinse the mouth with water without swallowing. ADVAIR DISKUS should not be used for transferring patients from systemic corticosteroid therapy.

Asthma

Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. ADVAIR DISKUS is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.

ADVAIR DISKUS is available in 3 strengths, ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50, containing 100, 250, and 500 mcg of fluticasone propionate, respectively, and 50 mcg of salmeterol per inhalation.

ADVAIR DISKUS should be administered twice daily every day. More frequent administration (more than twice daily) or a higher number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of ADVAIR DISKUS is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. The safety and efficacy of ADVAIR DISKUS when administered in excess of recommended doses have not been established.

If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Patients who are receiving ADVAIR DISKUS twice daily should not use additional salmeterol or other inhaled, long-acting beta2-agonists (e.g., formoterol) for prevention of EIB, or for any other reason.

Adult and Adolescent Patients 12 Years of Age and Older

For patients 12 years of age and older, the dosage is 1 inhalation twice daily (morning and evening, approximately 12 hours apart).

The recommended starting dosages for ADVAIR DISKUS for patients 12 years of age and older are based upon patients’ current asthma therapy.

  • For patients not adequately controlled on an inhaled corticosteroid, Table 7 provides the recommended starting dosage.
  • For patients not currently on inhaled corticosteroids whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, the recommended starting dosage is ADVAIR DISKUS 100/50 or 250/50 twice daily (see INDICATIONS AND USAGE).

The maximum recommended dosage is ADVAIR DISKUS 500/50 twice daily.

For all patients it is desirable to titrate to the lowest effective strength after adequate asthma stability is achieved.

Table 7. Recommended Dosages of ADVAIR DISKUS for Patients With Asthma Aged 12 Years and Older Not Adequately Controlled on Inhaled Corticosteroids

Recommended Strength

and Dosing Schedule

Current Daily Dose of Inhaled Corticosteroid

of ADVAIR DISKUS

Beclomethasone dipropionate

≤160 mcg

100/50 twice daily

HFA inhalation aerosol

320 mcg

250/50 twice daily

640 mcg

500/50 twice daily

Budesonide inhalation aerosol

≤400 mcg

100/50 twice daily

800-1,200 mcg

250/50 twice daily

1,600 mcg*

500/50 twice daily

Flunisolide inhalation aerosol

≤1,000 mcg

100/50 twice daily

1,250-2,000 mcg

250/50 twice daily

Flunisolide HFA inhalation

≤320 mcg

100/50 twice daily

aerosol

640 mcg

250/50 twice daily

Fluticasone propionate HFA

≤176 mcg

100/50 twice daily

inhalation aerosol

440 mcg

250/50 twice daily

660-880 mcg*

500/50 twice daily

Fluticasone propionate

≤200 mcg

100/50 twice daily

inhalation powder

500 mcg

250/50 twice daily

1,000 mcg*

500/50 twice daily

Mometasone furoate

220 mcg

100/50 twice daily

inhalation powder

440 mcg

250/50 twice daily

880 mcg

500/50 twice daily

Triamcinolone acetonide

≤1,000 mcg

100/50 twice daily

inhalation aerosol

1,100-1,600 mcg

250/50 twice daily

* ADVAIR DISKUS should not be used for transferring patients from systemic corticosteroid therapy.

Improvement in asthma control following inhaled administration of ADVAIR DISKUS can occur within 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of ADVAIR DISKUS with a higher strength may provide additional improvement in asthma control.

If a previously effective dosage regimen of ADVAIR DISKUS fails to provide adequateimprovement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options, e.g., replacing the current strength of ADVAIR DISKUS with a higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids, should be considered.

Pediatric Patients

For patients aged 4 to 11 years who are symptomatic on an inhaled corticosteroid the dosage is 1 inhalation of ADVAIR DISKUS 100/50 twice daily (morning and evening, approximately 12 hours apart).

Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis

The dosage for adults is 1 inhalation (250/50 mcg) twice daily (morning and evening, approximately 12 hours apart).

ADVAIR DISKUS 250/50 mcg twice daily is the only approved dosage for the treatment of COPD associated with chronic bronchitis. Higher doses, including ADVAIR DISKUS 500/50, are not recommended, as no additional improvement in lung function was observed in clinical trials and higher doses of corticosteroids increase the risk of systemic effects.

If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Patients who are receiving ADVAIR DISKUS twice daily should not use additional salmeterol or other inhaled, long-acting beta2-agonists (e.g., formoterol) for the maintenance treatment of COPD or for any other reason.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS: Geriatric Use) have been treated with ADVAIR DISKUS, efficacy and safety did not differ from that in younger patients. Based on available data for ADVAIR DISKUS and its active components, no dosage adjustment is recommended.

HOW SUPPLIED

ADVAIR DISKUS 100/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0695-00). ADVAIR DISKUS 100/50 is also supplied in an institutional pack of 1 disposable purple device containing 28 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0695-02).

ADVAIR DISKUS 250/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0696-00). ADVAIR DISKUS 250/50 is also supplied in an institutional pack of 1 disposable purple device containing 28 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0696-02).

ADVAIR DISKUS 500/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0697-00). ADVAIR DISKUS 500/50 is also supplied in an institutional pack of 1 disposable purple device containing 28 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0697-02).

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 1 month 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 device apart.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2006, GlaxoSmithKline. All rights reserved.

September 2006 RL-2332

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