DYMISTA 137 ug/1
Azelastine Hydrochloride and Fluticasone Propionate · SPRAY, METERED · Viatris Specialty LLC
DYMISTA is a spray, metered containing azelastine hydrochloride and fluticasone propionate at 137 ug/1, taken nasal. Manufactured by Viatris Specialty LLC.
Key Facts
- Brand Name
- DYMISTA
- Generic Name
- Azelastine Hydrochloride and Fluticasone Propionate
- NDC Code (Product)
0037-0245- Manufacturer
- Viatris Specialty LLC
- Strength
- 137 ug/1
- Dosage Form
- SPRAY, METERED
- Route
- NASAL
- Marketing Status
- Application #
- NDA202236
- Marketing Start
- 10/01/2016
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 DYMISTA is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. DYMISTA contains an H 1 -receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Recommended dosage: 1 spray per nostril twice daily ( 2.1 ) • For nasal use only. ( 2.2 ) • Prime before initial use and when it has not been used for 14 or more days. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of DYMISTA is 1 spray (137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate) in each nostril twice daily. 2.2 Important Administration Instructions • Administer DYMISTA by the nasal route only. • Shake the bottle gently before each use. • Avoid spraying DYMISTA into the eyes. If sprayed in the eyes, flush eyes with water for at least 10 minutes. Priming Prime DYMISTA before initial use by releasing 6 sprays or until a fine mist appears. Repriming (as needed) When DYMISTA has not been used for 14 or more days, reprime with 1 spray or until a fine mist appears.
Contraindications
4 CONTRAINDICATIONS DYMISTA is contraindicated in patients with hypersensitivity to azelastine hydrochloride, fluticasone propionate, or to any other ingredients of DYMISTA. Reactions have included anaphylaxis [see Adverse Reactions (6.2) ] . Hypersensitivity to azelastine hydrochloride, fluticasone propionate, or to any ingredients of DYMISTA. Reactions have included anaphylaxis. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug interaction studies have been performed with DYMISTA. The drug interactions of the combination are expected to reflect those of the individual components. • Potent inhibitors of cytochrome P450 (CYP) 3A4: May increase blood levels of fluticasone propionate. • Ritonavir: Coadministration is not recommended. ( 5.6 , 7.2 ) • Other potent CYP3A4 inhibitors, such as ketoconazole: use caution with coadministration. ( 5.6 , 7.2 ) 7.1 Central Nervous System Depressants Concurrent use of DYMISTA with alcohol or other central nervous system depressants should be avoided because somnolence and impairment of central nervous system performance may occur [see Warnings and Precautions (5.1) ] . 7.2 Cytochrome P450 3A4 Ritonavir (a strong CYP3A4 inhibitor) significantly increased plasma fluticasone propionate exposure following administration of fluticasone propionate aqueous nasal spray, 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 and ritonavir, resulting in systemic …
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Somnolence [see Warnings and Precautions (5.1) ] • Local nasal effects, including epistaxis, nasal ulceration, nasal septal perforation, impaired wound healing, and Candida albicans infection [see Warnings and Precautions (5.2) ] • Glaucoma and Cataracts [see Warnings and Precautions (5.3) ] • Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4) ] • Hypercorticism and Adrenal Suppression, including growth reduction [see Warnings and Precautions (5.5 and 5.7) , Use in Specific Populations (8.4) ] The most common adverse reactions (≥2% incidence) are: dysgeusia, epistaxis, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-888-939-6478 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 clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Adults and Adolescents 12 Year…
Frequently Asked Questions
What is DYMISTA used for?
DYMISTA contains Azelastine Hydrochloride and Fluticasone Propionate. It is a spray, metered taken nasal. Consult your doctor for specific uses.
Is DYMISTA a controlled substance?
DYMISTA is not classified as a controlled substance by the DEA.
What is the generic name for DYMISTA?
The generic name for DYMISTA is Azelastine Hydrochloride and Fluticasone Propionate. There are 3 other brand versions of Azelastine Hydrochloride and Fluticasone Propionate.
What is the NDC code for DYMISTA 137 ug/1?
The NDC (National Drug Code) for DYMISTA 137 ug/1 is 0037-0245, listed by Viatris Specialty LLC.