Azelastine Hydrochloride, Fluticasone Propionate
Generic Name: azelastine hydrochloride, fluticasone propionate
Brand Names:
Azelastine Hydrochloride And Fluticasone Propionate
11 DESCRIPTION Azelastine hydrochloride and fluticasone propionate nasal spray is formulated as a white, uniform metered-spray suspension for nasal administration. It is a fixed dose combination product containing an antihistamine (H 1 receptor antagonist) and a corticosteroid as active ingredients. Azelastine hydrochloride active ingredient occurs as a white, odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37.
Overview
11 DESCRIPTION Azelastine hydrochloride and fluticasone propionate nasal spray is formulated as a white, uniform metered-spray suspension for nasal administration. It is a fixed dose combination product containing an antihistamine (H 1 receptor antagonist) and a corticosteroid as active ingredients. Azelastine hydrochloride active ingredient occurs as a white, odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37.
Uses
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
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.
Side Effects
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.
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.
Warnings
5 WARNINGS AND PRECAUTIONS • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine hydrochloride and fluticasone propionate nasal spray. ( 5.1 ) • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with azelastine hydrochloride and fluticasone propionate nasal spray because further decreased alertness and impairment of CNS performance may occur. ( 5.1 ) • Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection: Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Limited data from postmarketing experience with azelastine hydrochloride and fluticasone propionate nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. The individual components of azelastine hydrochloride and fluticasone propionate nasal spray have been marketed for decades.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray How Supplied: Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, 137 mcg/50 mcg is supplied as an amber glass bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump with a white nasal adapter and clear plastic dust cap.
Frequently Asked Questions
What is Azelastine Hydrochloride, Fluticasone Propionate used for?▼
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 )
What are the side effects of Azelastine Hydrochloride, Fluticasone Propionate?▼
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.
Can I take Azelastine Hydrochloride, Fluticasone Propionate during pregnancy?▼
8.1 Pregnancy Risk Summary Limited data from postmarketing experience with azelastine hydrochloride and fluticasone propionate nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. The individual components of azelastine hydrochloride and fluticasone propionate nasal spray have been marketed for decades.
What are the important warnings for Azelastine Hydrochloride, Fluticasone Propionate?▼
5 WARNINGS AND PRECAUTIONS • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine hydrochloride and fluticasone propionate nasal spray. ( 5.1 ) • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with azelastine hydrochloride and fluticasone propionate nasal spray because further decreased alertness and impairment of CNS performance may occur. ( 5.1 ) • Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection: Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.