XHANCE 93 ug/1

fluticasone propionate · SPRAY, METERED · Paratek Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

XHANCE is a spray, metered containing fluticasone propionate at 93 ug/1, taken nasal. Manufactured by Paratek Pharmaceuticals, Inc..

Key Facts

Brand Name: XHANCE
Generic Name: fluticasone propionate
NDC Code (Product): 71715-003
Manufacturer: Paratek Pharmaceuticals, Inc.
Strength: 93 ug/1
Dosage Form: SPRAY, METERED
Route: NASAL
Marketing Status
Application #: NDA209022
Marketing Start: 01/12/2026

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective2,422 reports

dyspnoea2,418 reports

headache2,351 reports

fatigue2,130 reports

off label use1,930 reports

pain1,840 reports

nausea1,836 reports

cough1,753 reports

asthma1,650 reports

diarrhoea1,585 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE XHANCE is a corticosteroid indicated for the treatment of: Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. ( 1.1 ) Chronic rhinosinusitis without nasal polyps (CRSsNP) in adults. ( 1.2 ) 1.1 Chronic Rhinosinusitis with Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. 1.2 Chronic Rhinosinusitis without Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Recommended Dosage : 186 mcg (1 spray per nostril) or 372 mcg (2 sprays per nostril) twice daily. ( 2.1 ) For nasal use only. Shake before use. Prime before initial use. ( 2.2 ) XHANCE is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of XHANCE is 186 mcg (1 spray per nostril) or 372 mcg (2 sprays per nostril) twice daily (total daily dose of 372 mcg or 744 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril twice daily (total daily dose of 744 mcg). Patients should use XHANCE at regular intervals since its effectiveness depends on regular use. Individual patients will experience a variable time to onset and different degrees of symptom relief. The safety and efficacy of XHANCE when administered in excess of recommended doses have not been established. 2.2 Administration Information Shake XHANCE before each use. Administer XHANCE by the nasal route only. Avoid spraying directly on the nasal septum. Priming Before initial use, prime XHANCE by first gently shaking and then pressing the bottl…

Contraindications

4 CONTRAINDICATIONS XHANCE is contraindicated in patients with hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.3 ) and Description ( 11 )] . Hypersensitivity to any ingredient in XHANCE. ( 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, voriconazole) with XHANCE 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 with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Ketoconazole Coadministration of orally …

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Local Nasal Adverse Reactions: [see Warnings and Precautions ( 5.1 )] Glaucoma and Cataracts [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions including Anaphylaxis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Immunosuppression and Risk of Infection [see Warnings and Precautions ( 5.4 )] Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] Reduction in Bone Mineral Density [see Warnings and Precautions ( 5.7 )] Effect on Growth [see Warnings and Precautions ( 5.8 )] CRSwNP: The most common adverse reactions (incidence ≥ 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. ( 6.1 ) CRSsNP: The most common adverse reactions (incidence ≥ 3%) are epistaxis, headache, and nasopharyngitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-678-6673 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience B…

Frequently Asked Questions

What is XHANCE used for?

XHANCE contains fluticasone propionate. It is a spray, metered taken nasal. Consult your doctor for specific uses.

Is XHANCE a controlled substance?

XHANCE is not classified as a controlled substance by the DEA.

What is the generic name for XHANCE?

The generic name for XHANCE is fluticasone propionate. There are 12 other brand versions of fluticasone propionate.

What is the NDC code for XHANCE 93 ug/1?

The NDC (National Drug Code) for XHANCE 93 ug/1 is 71715-003, listed by Paratek Pharmaceuticals, Inc..

Product NDC

71715-003

Package NDC

71715-003-31

Other Fluticasone Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)