Azelastine
Generic Name: azelastine
Brand Names:
Azelastine Hydrochloride
11 DESCRIPTION Azelastine HCl nasal spray, 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine HCl, USP occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine.
Overview
11 DESCRIPTION Azelastine HCl nasal spray, 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine HCl, USP occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine.
Uses
1 INDICATIONS AND USAGE Azelastine hydrochloride (HCl) nasal spray, 0.1% is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine HCl nasal spray, 0.1% is an H 1 -receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. (1)
Dosage
2 DOSAGE AND ADMINISTRATION For intranasal use only. (2.3) Seasonal allergic rhinitis: Pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily. (2.1) Adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily. (2.1) Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and adolescents 12 years of age and older. (2.2) Prime azelastine HCl nasal spray, 0.1% before initial use and when it has not been used for 3 or more days. (2.3) 2.1 Seasonal Allergic Rhinitis The recommended dosage of azelastine HCl nasal spray, 0.1% in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily.
Side Effects
6 ADVERSE REACTIONS Use of azelastine HCl nasal spray, 0.1% has been associated with somnolence [see Warnings and Precautions (5.1) ] . The most common adverse reactions (≥2% incidence) are: bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 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.
Interactions
7 DRUG INTERACTIONS 7.1 Central Nervous System Depressants Concurrent use of azelastine HCl nasal spray, 0.1% with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur [see Warnings and Precautions (5.1) ] .
Warnings
5 WARNINGS AND PRECAUTIONS Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine HCl nasal spray, 0.1%. (5.1) Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with azelastine HCl nasal spray, 0.1% because further decreased alertness and impairment of CNS performance may occur. (5.1) 5.1 Somnolence in Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine HCl nasal spray, 0.1% [see Adverse Reactions (6.1) ] . 4 CONTRAINDICATIONS None. None. (4)
Pregnancy
8.1 Pregnancy Risk Summary Limited data from post-marketing experience over decades of use with azelastine HCl nasal spray, 0.1% in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Azelastine HCl nasal spray 0.1%, 137 mcg, is supplied as a 30-mL package (NDC 42291-094-30) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white or clear plastic dust cover.
Frequently Asked Questions
What is Azelastine used for?▼
1 INDICATIONS AND USAGE Azelastine hydrochloride (HCl) nasal spray, 0.1% is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine HCl nasal spray, 0.1% is an H 1 -receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. (1)
What are the side effects of Azelastine?▼
6 ADVERSE REACTIONS Use of azelastine HCl nasal spray, 0.1% has been associated with somnolence [see Warnings and Precautions (5.1) ] . The most common adverse reactions (≥2% incidence) are: bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 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.
Can I take Azelastine during pregnancy?▼
8.1 Pregnancy Risk Summary Limited data from post-marketing experience over decades of use with azelastine HCl nasal spray, 0.1% in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose.
What are the important warnings for Azelastine?▼
5 WARNINGS AND PRECAUTIONS Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine HCl nasal spray, 0.1%. (5.1) Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with azelastine HCl nasal spray, 0.1% because further decreased alertness and impairment of CNS performance may occur. (5.1) 5.1 Somnolence in Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine HCl nasal spray, 0.1% [see Adverse Reactions (6.1) ] . 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.