Fluticasone Propionate spray, metered 50 ug/1

Fluticasone Propionate · SPRAY, METERED · Chartwell RX, LLC

No Recall HistoryCurrently in Shortage

Plain English

Fluticasone Propionate spray, metered is a spray, metered containing fluticasone propionate at 50 ug/1, taken nasal. Manufactured by Chartwell RX, LLC.

Key Facts

Brand Name: Fluticasone Propionate spray, metered
Generic Name: Fluticasone Propionate
NDC Code (Product): 62135-810
Manufacturer: Chartwell RX, LLC
Strength: 50 ug/1
Dosage Form: SPRAY, METERED
Route: NASAL
Marketing Status
Application #: ANDA078492
Marketing Start: 01/09/2012

Recall History

No Recall History

Side Effects Reported to FDA

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

dyspnoea2,347 reports

drug ineffective2,307 reports

headache2,191 reports

fatigue2,062 reports

off label use1,831 reports

pain1,814 reports

nausea1,787 reports

cough1,666 reports

asthma1,610 reports

diarrhoea1,558 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older. Fluticasone propionate nasal spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administer fluticasone propionate nasal spray by the intranasal route only. Prime fluticasone propionate nasal spray before using for the first time or after a period of non-use (1 week or more) by shaking the contents well and releasing 6 sprays into the air away from the face. Shake fluticasone propionate nasal spray gently before each use. Patients should use fluticasone propionate nasal spray at regular intervals since its effectiveness depends on its regular use. Maximum effect may take several days and individual patients will experience a variable time to onset and different degree of symptom relief. For intranasal use only. Recommended starting dosages: Adults: 2 sprays per nostril once daily (200 mcg per day). ( 2.1 ) Adolescents and children aged 4 years and older: 1 spray per nostril once daily (100 mcg per day). ( 2.2 ) 2.1 Adults The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able…

Contraindications

4 CONTRAINDICATIONS Fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3) , Description (11) ]. Hypersensitivity to any ingredient. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, nefazodone, voriconazole) with fluticasone propionate nasal spray is not recommended because increased systemic corticosteroid adverse effects may occur. Ritonavir A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology (12.3) ]. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate products, including fluticasone propionate nasal spray, with ritonavir, resulting in systemic corticosteroid effects including…

Adverse Reactions

6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing [see Warnings and Precautions (5.1) ] Glaucoma and cataracts [see Warnings and Precautions (5.2) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.5) ] Effect on growth [see Warnings and Precautions (5.7) ] The most common adverse reactions (>3%) are headache, pharyngitis, epistaxis, nasal burning/nasal irritation, nausea/vomiting, asthma symptoms, and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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. In controlled US clinical trials, more than 3,300 subjects with allergic and nonallergic rhinitis received treatment with …

Frequently Asked Questions

What is Fluticasone Propionate spray, metered used for?

Fluticasone Propionate spray, metered contains Fluticasone Propionate. It is a spray, metered taken nasal. Consult your doctor for specific uses.

Is Fluticasone Propionate spray, metered a controlled substance?

Fluticasone Propionate spray, metered is not classified as a controlled substance by the DEA.

What is the generic name for Fluticasone Propionate spray, metered?

The generic name for Fluticasone Propionate spray, metered is Fluticasone Propionate. There are 12 other brand versions of Fluticasone Propionate.

What is the NDC code for Fluticasone Propionate spray, metered 50 ug/1?

The NDC (National Drug Code) for Fluticasone Propionate spray, metered 50 ug/1 is 62135-810, listed by Chartwell RX, LLC.

Product NDC

62135-810

Package NDC

62135-810-61

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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