Drugplain

Fluticasone Propionate and Salmeterol DISKUS 100 ug/1

fluticasone propionate and salmeterol · POWDER · Prasco Laboratories

No Recall HistoryCurrently in Shortage
Plain English

Fluticasone Propionate and Salmeterol DISKUS is a powder containing fluticasone propionate and salmeterol at 100 ug/1, taken respiratory (inhalation). Manufactured by Prasco Laboratories.

Key Facts

Brand Name
Fluticasone Propionate and Salmeterol DISKUS
Generic Name
fluticasone propionate and salmeterol
NDC Code (Product)
66993-584
Manufacturer
Prasco Laboratories
Strength
100 ug/1
Dosage Form
POWDER
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA021077
Marketing Start
02/08/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

product dose omission issue1,556 reports
off label use268 reports
product use issue254 reports
drug ineffective203 reports
dyspnoea181 reports
cough89 reports
wrong technique in product usage process89 reports
accidental underdose85 reports
asthma66 reports
product use in unapproved indication51 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Fluticasone Propionate/Salmeterol 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 Fluticasone Propionate/Salmeterol DISKUS is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Fluticasone Propionate/Salmeterol 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 Fluticasone Propionate/Salmeterol DISKUS is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Fluticasone Propionate/Salmeterol 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 Fluticasone Propionate/Salmeterol DISKUS is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using Fluticasone Propionate/Salmeterol 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 Fluticasone Propionate/Salmeterol DISKUS inhalation powder 100/50 mcg, Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 mcg, and Fluticasone Propionate/Salmeterol DISKUS inhalation powder 500/50 mcg twice daily. Starting dosage is based on asthma severity. ( 2.1 ) Treatment of asthma in patients aged 4 to 11 years: 1 inhalation of Fluticasone P…

Contraindications

4 CONTRAINDICATIONS The use of Fluticasone Propionate/Salmeterol 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 Fluticasone propionate/salmeterol 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 fluticasone propionate/salmeterol 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 Fluticasone Propionate/Salmeterol DISKUS, are substrates…

Adverse Reactions

6 ADVERSE REACTIONS Use of LABA may result in the following: Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] Cardiovascular and central nervous system effects [see Warnings and Precautions ( 5.12 )] Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions ( 5.4 )] Pneumonia in patients with COPD [see Warnings and Precautions ( 5.5 )] Immunosuppression [see Warnings and Precautions ( 5.6 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.8 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.13 )] Growth effects [see Warnings and Precautions ( 5.14 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.15 )] 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. Most common adverse reactions (incidence ≥3%) include: Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral c…

Frequently Asked Questions

What is Fluticasone Propionate and Salmeterol DISKUS used for?

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

Is Fluticasone Propionate and Salmeterol DISKUS a controlled substance?

Fluticasone Propionate and Salmeterol DISKUS is not classified as a controlled substance by the DEA.

What is the generic name for Fluticasone Propionate and Salmeterol DISKUS?

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

What is the NDC code for Fluticasone Propionate and Salmeterol DISKUS 100 ug/1?

The NDC (National Drug Code) for Fluticasone Propionate and Salmeterol DISKUS 100 ug/1 is 66993-584, listed by Prasco Laboratories.

Product NDC

66993-584

Package NDC

66993-584-97

Other Fluticasone Brands

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

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