DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

 
 



INDICATIONS AND USAGE

Maintenance Treatment of Asthma

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

Important Limitations of Use:

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

Maintenance Treatment of Chronic Obstructive Pulmonary Disease

ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated.

Important Limitations of Use: ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

ADVAIR DISKUS should be administered twice daily every day by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing [see Patient Counseling Information].

More frequent administration 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. Patients using ADVAIR DISKUS should not use additional long-acting beta2-agonists for any reason. [See Warnings and Precautions (5.3, 5.12).]

Asthma

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

Adult and Adolescent Patients Aged 12 Years and Older

For patients aged 12 years 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 aged 12 years and older are based upon patients’ asthma severity. For patients not currently on inhaled corticosteroids whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, or patients inadequately controlled on an inhaled corticosteroid, the recommended starting dosage is ADVAIR DISKUS 100/50 or 250/50 twice daily.

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.

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 adequate improvement 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, initiating oral corticosteroids) should be considered.

Pediatric Patients Aged 4 to 11 Years

For patients with asthma 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

The recommended dosage for patients with COPD is 1 inhalation of ADVAIR DISKUS 250/50 twice daily (morning and evening, approximately 12 hours apart).

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

DOSAGE FORMS AND STRENGTHS

Disposable purple device with 60 blisters containing a combination of fluticasone propionate (100, 250, or 500 mcg) and salmeterol (50 mcg) as an oral inhalation powder formulation. An institutional pack containing 14 blisters is also available.

HOW SUPPLIED/STORAGE AND HANDLING

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. ADVAIR DISKUS 100/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch.

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 68258-3031-1). ADVAIR DISKUS 250/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch.

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. ADVAIR DISKUS 500/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch.

They are supplied by Dispensing Solutions Inc. as follows:

NDC Strength Quantity/Form Source NDC
68258-3031-1 50 ug / 250 ug 60 BLISTER 0173-0696-00

This product was Manufactured By:

GlaxoSmithKline
Research Triangle Park, NC 27709

And Relabeled By:

Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States

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 overwrap 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.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015