Fluticasone Propionate and Salmeterol HFA 115 ug/1
fluticasone propionate and salmeterol xinafoate · AEROSOL, METERED · Prasco Laboratories
Fluticasone Propionate and Salmeterol HFA is a aerosol, metered containing fluticasone propionate and salmeterol xinafoate at 115 ug/1, taken respiratory (inhalation). Manufactured by Prasco Laboratories.
Key Facts
- Brand Name
- Fluticasone Propionate and Salmeterol HFA
- Generic Name
- fluticasone propionate and salmeterol xinafoate
- NDC Code (Product)
66993-087- Manufacturer
- Prasco Laboratories
- Strength
- 115 ug/1
- Dosage Form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA021254
- Marketing Start
- 03/01/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA 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). Limitations of Use Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm. Fluticasone Propionate and Salmeterol HFA is a combination of fluticasone propionate, an inhaled corticosteroid, and salmeterol, a long-acting beta 2 ‑adrenergic agonist (LABA), indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. ( 1 ) Limitations of use: Not indicated for relief of acute bronchospasm. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For oral inhalation only. ( 2.1 ) • Adult and adolescent patients aged 12 years and older: 2 inhalations of Fluticasone Propionate and Salmeterol HFA 45 mcg/21 mcg, Fluticasone Propionate and Salmeterol HFA 115 mcg/21 mcg, or Fluticasone Propionate and Salmeterol HFA 230 mcg/21 mcg twice daily. ( 2.2 ) • Starting dosage is based on asthma severity. ( 2.2 ) 2.1 Administration Information Fluticasone Propionate and Salmeterol HFA should be administered by the orally inhaled route only. After inhalation, rinse mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. Priming Prime Fluticasone Propionate and Salmeterol HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray. Avoid spraying in eyes. 2.2 Recommended Dosage Adult and adolescent patients aged 12 years and older: 2 oral inhalations twice daily, approximately 12 hours …
Contraindications
4 CONTRAINDICATIONS Fluticasone Propionate and Salmeterol HFA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . • Hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.11 ), Adverse Reactions ( 6.2 ), Description ( 11 )] . • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4 ) • Hypersensitivity to any ingredient. (4)
Drug Interactions
7 DRUG INTERACTIONS Fluticasone propionate and salmeterol HFA has been used concomitantly with other drugs, including short-acting beta 2 -agonists, methylxanthines, and nasal corticosteroids, commonly used in patients with asthma without adverse drug reactions [see Clinical Pharmacology ( 12.2 )] . No formal drug interaction trials have been performed with fluticasone propionate and salmeterol HFA. • 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 and Salmeterol HFA, are substrates o…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] • Oropharyngeal candidiasis [see Warnings and Precautions ( 5.4 )] • Pneumonia in patients with COPD [see Warnings and Precautions ( 5.5 )] • Immunosuppression and risk of infections [see Warnings and Precautions ( 5.6 )] • Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.8 )] • Cardiovascular and central nervous system effects [see Warnings and Precautions ( 5.12 )] • 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 )] Most common adverse reactions (incidence ≥3%) include: upper respiratory tract infection or inflammation, throat irritation, dysphonia, headache, dizziness, nausea and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are c…
Frequently Asked Questions
What is Fluticasone Propionate and Salmeterol HFA used for?
Fluticasone Propionate and Salmeterol HFA contains fluticasone propionate and salmeterol xinafoate. It is a aerosol, metered taken respiratory (inhalation). Consult your doctor for specific uses.
Is Fluticasone Propionate and Salmeterol HFA a controlled substance?
Fluticasone Propionate and Salmeterol HFA is not classified as a controlled substance by the DEA.
What is the generic name for Fluticasone Propionate and Salmeterol HFA?
The generic name for Fluticasone Propionate and Salmeterol HFA is fluticasone propionate and salmeterol xinafoate. There are 5 other brand versions of fluticasone propionate and salmeterol xinafoate.
What is the NDC code for Fluticasone Propionate and Salmeterol HFA 115 ug/1?
The NDC (National Drug Code) for Fluticasone Propionate and Salmeterol HFA 115 ug/1 is 66993-087, listed by Prasco Laboratories.