AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE 137 ug/1
azelastine hydrochloride, fluticasone propionate · SPRAY, METERED · Bryant Ranch Prepack
Azelastine hydrochloride and fluticasone propionate is a nasal spray that combines an antihistamine and a corticosteroid to treat nasal allergy symptoms. It is a prescription medication used to help reduce congestion, sneezing, itching, and other allergy-related nasal symptoms.
Key Facts
- Brand Name
- AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
- Generic Name
- azelastine hydrochloride, fluticasone propionate
- NDC Code (Product)
72162-1388- Manufacturer
- Bryant Ranch Prepack
- Strength
- 137 ug/1
- Dosage Form
- SPRAY, METERED
- Route
- NASAL
- Marketing Status
- Application #
- ANDA208111
- Marketing Start
- 03/01/2021
Recall History
Mylan Pharmaceuticals Inc.
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Mylan Pharmaceuticals Inc.
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. Azelastine hydrochloride and fluticasone propionate nasal spray 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 azelastine hydrochloride and fluticasone propionate nasal spray 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 azelastine hydrochloride and fluticasone propionate nasal spray by the nasal route only. Shake the bottle gently before each use. Avoid spraying azelastine hydrochloride and fluticasone propionate nasal spray into the eyes. If sprayed in the eyes, flush eyes with water for at least 10 minutes. Priming Prime azelastine hydrochloride and fluticasone propionate nasal spray before initial use by releasing 6 sprays or until a fine mist appears. Repriming (as needed) When azelastine hydrochloride and fluticasone propionate nasal spray has not been used for 14 or more days, reprime with 1 spray or until a fine mist appears.
Contraindications
4 CONTRAINDICATIONS Azelastine hydrochloride and fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to azelastine hydrochloride, fluticasone propionate, or to any other ingredients of azelastine hydrochloride and fluticasone propionate nasal spray. Reactions have included anaphylaxis [see Adverse Reactions ( 6.2 )] . Hypersensitivity to azelastine hydrochloride, fluticasone propionate, or to any ingredients of azelastine hydrochloride and fluticasone propionate nasal spray. Reactions have included anaphylaxis. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug interaction studies have been performed with azelastine hydrochloride and fluticasone propionate nasal spray. 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 azelastine hydrochloride and fluticasone propionate nasal spray 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 signific…
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 Teva at 1-888-838-2872 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 Years of Age and Older The safety data d…
Frequently Asked Questions
What is AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE used for?
Azelastine hydrochloride and fluticasone propionate is a nasal spray that combines an antihistamine and a corticosteroid to treat nasal allergy symptoms. It is a prescription medication used to help reduce congestion, sneezing, itching, and other allergy-related nasal symptoms.
Is AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE a controlled substance?
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE is not classified as a controlled substance by the DEA.
What is the generic name for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE?
The generic name for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE is azelastine hydrochloride, fluticasone propionate. There are no other listed brand versions of azelastine hydrochloride, fluticasone propionate.
What is the NDC code for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE 137 ug/1?
The NDC (National Drug Code) for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE 137 ug/1 is 72162-1388, listed by Bryant Ranch Prepack.
Other AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)