Drugplain

ADVAIR DISKUS 500 ug/1

fluticasone propionate and salmeterol · POWDER · A-S Medication Solutions

No Recall HistoryCurrently in Shortage
Plain English

ADVAIR DISKUS is a powder containing fluticasone propionate and salmeterol at 500 ug/1, taken respiratory (inhalation). Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
ADVAIR DISKUS
Generic Name
fluticasone propionate and salmeterol
NDC Code (Product)
50090-4505
Manufacturer
A-S Medication Solutions
Strength
500 ug/1
Dosage Form
POWDER
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA021077
Marketing Start
03/05/2001

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea5,822 reports
drug ineffective4,349 reports
product quality issue2,508 reports
cough2,222 reports
product dose omission issue2,104 reports
pneumonia2,051 reports
drug dose omission1,996 reports
asthma1,902 reports
malaise1,508 reports
wrong technique in device usage process1,472 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma ADVAIR DISKUS is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. ADVAIR DISKUS should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Important Limitation of Use ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm. 1.2 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), includin…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION ADVAIR DISKUS should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. More frequent administration or a greater 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 LABA for any reason. [See Warnings and Precautions ( 5.3 , 5.12 ).] • For oral inhalation only. ( 2 ) • Treatment of asthma in patients aged 12 years and older: 1 inhalation of ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, or ADVAIR DISKUS 500/50 twice daily. Starting dosage is based on asthma severity. ( 2.1 ) • Treatment of asthma in patients aged 4 to 11 years: 1 inhalation of ADVAIR DISKUS 100/50 twice daily. ( 2.1 ) • Maintenance treatment of COPD: 1 inhalation of ADVAIR DISKUS 250/50 twice daily. ( 2.2 ) 2.1 Asthma If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agoni…

Contraindications

4 CONTRAINDICATIONS The use of ADVAIR DISKUS is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see Warnings and Precautions ( 5.2 )] . • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients [see Warnings and Precautions ( 5.11 ), Adverse Reactions ( 6.3 ), Description ( 11 )] . • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. ( 4 ) • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS ADVAIR DISKUS has been used concomitantly with other drugs, including short-acting beta 2 -agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma or COPD without adverse drug reactions [see Clinical Pharmacology ( 12.2 )] . No formal drug interaction trials have been performed with ADVAIR DISKUS. • Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid and cardiovascular effects. ( 7.1 ) • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. ( 7.2 ) • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.3 ) • Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists. ( 7.4 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate and salmeterol, the individual components of ADVAIR DISKUS, are substrates of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazana…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥3%) include: • Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting. ( 6.1 ) • COPD: Pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches, musculoskeletal pain. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience in Asthma Adult and Adolescent Subjects Aged 12 Years and Older The incidence of adverse reactions associated with ADVAIR DISKUS in Table 2 is based upon two 12-week, placebo-controlled, U.S. clinical trials (Trials 1 and 2). A total of 705 adult and adolescent subjects (349 females and 356 males) previously treated with salmeterol or ICS were treated twice daily with ADVAIR DISKUS (100/50- or 250/50-mcg doses), fluticasone propionate inhalation powder (100- or 250-mcg doses), salmeterol inhalation powder 50 mcg, or placebo. The average duration of exposure was 60 to 79 days in the active treatment groups compared with 42 days in the placebo group. Table…

Frequently Asked Questions

What is ADVAIR DISKUS used for?

ADVAIR DISKUS contains fluticasone propionate and salmeterol. It is a powder taken respiratory (inhalation). Consult your doctor for specific uses.

Is ADVAIR DISKUS a controlled substance?

ADVAIR DISKUS is not classified as a controlled substance by the DEA.

What is the generic name for ADVAIR DISKUS?

The generic name for ADVAIR DISKUS is fluticasone propionate and salmeterol. There are 9 other brand versions of fluticasone propionate and salmeterol.

What is the NDC code for ADVAIR DISKUS 500 ug/1?

The NDC (National Drug Code) for ADVAIR DISKUS 500 ug/1 is 50090-4505, listed by A-S Medication Solutions.

Product NDC

50090-4505

Package NDC

50090-4505-0

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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