(a ZEL as teen)
Perennial allergic rhinitis (Astepro 0.1% and 0.15% solution only): Relief of symptoms of perennial allergic rhinitis in adults and pediatric patients ≥6 months.
Seasonal allergic rhinitis: Relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients ≥2 years (Astepro 0.1% and 0.15% solution) and ≥5 years (azelastine [generic] 0.1% solution).
Vasomotor rhinitis (azelastine [generic] 0.1% solution): Relief of symptoms of vasomotor rhinitis in adults and adolescents ≥12 years.
There are no contraindications listed in the manufacturers labeling.
Perennial allergic rhinitis: Intranasal: Astepro (0.15% solution): Two sprays in each nostril twice daily.
Seasonal allergic rhinitis: Intranasal:
Astepro (0.1% or 0.15% solution): One or two sprays (0.1% solution) in each nostril twice daily or two sprays (0.15% solution) in each nostril once daily
Azelastine [generic] 0.1% solution: One or two sprays in each nostril twice daily
Vasomotor rhinitis: Intranasal: Azelastine [generic] 0.1% solution: Two sprays in each nostril twice daily.
Refer to adult dosing.
Perennial allergic rhinitis: Intranasal: Astepro:
Infants ≥6 months and Children ≤5 years: 0.1% solution: One spray in each nostril twice daily.
Children 6 to <12 years: 0.1% or 0.15% solution: One spray in each nostril twice daily.
Children ≥12 years and Adolescents: Refer to adult dosing.
Seasonal allergic rhinitis: Intranasal:
Astepro:
Children 2 to 5 years: 0.1% solution: One spray in each nostril twice daily.
Children 6 to <12 years: 0.1% or 0.15% solution: One spray in each nostril twice daily.
Children ≥12 years and Adolescents: Refer to adult dosing.
Azelastine [generic] 0.1% solution:
Children ≥5 to 11 years: One spray in each nostril twice daily.
Children ≥12 years and Adolescents: Refer to adult dosing.
Vasomotor rhinitis: Intranasal: Azelastine [generic] 0.1% solution: Children ≥12 years and Adolescents: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer 's labeling.
There are no dosage adjustments provided in the manufacturer 's labeling.
Intranasal: Before initial use of the nasal spray, the delivery system should be primed with 4 sprays (azelastine [generic] 0.1% solution) or 6 sprays (Astepro), or until a fine mist appears. If 3 or more days have elapsed since last use, the delivery system should be reprimed with 2 sprays or until a fine mist appears. Blow nose to clear nostrils. Keep head tilted downward when spraying. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. Aim the spray tip toward the back of nose. Breathe in through nose. While inhaling, press pump to release spray. Alternate sprays between nostrils. After each use, wipe the spray tip with a clean tissue or cloth. Avoid spraying in eyes or mouth. Do not tilt head back after use.
Store upright at 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F); protect from freezing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Nasal, as hydrochloride:
Astelin: 137 mcg/spray (30 mL [DSC]) [contains benzalkonium chloride, edetate disodium]
Astepro: 0.15% (30 mL) [contains benzalkonium chloride, edetate disodium]
Generic: 0.1% (30 mL); 0.15% (30 mL)
Alcohol (Ethyl): May enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination
CNS Depressants: May enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination
Adverse reactions may be dose-, indication-, or product-dependent:
>10%:
Central nervous system: Bitter taste (4% to 20%), headache (1% to 15%), drowsiness ( ≤12%)
Infection: Cold symptoms (children ≤17%)
Respiratory: Rhinitis (exacerbation; ≤17%), cough (children: 11%; infants and children: ≥2%)
2% to 10%:
Central nervous system: Dysesthesia (8%), dizziness (2%), fatigue (2%)
Dermatologic: Contact dermatitis
Endocrine & metabolic: Weight gain (2%)
Gastrointestinal: Dysgeusia (children: 2% to 4%), nausea (3%), xerostomia (3%), vomiting
Infection: Upper respiratory tract infection (children: ≥2% to 3%)
Neuromuscular & skeletal: Myalgia ( ≤2%)
Ophthalmic: Conjunctivitis (<2% to 5%)
Otic: Otitis media (infants & children: ≥2%)
Respiratory: Epistaxis (2% to 7%), asthma (5%), sinusitis (3% to >5%), burning sensation of the nose (4%), pharyngitis (4%), nasal discomfort ( ≤4%), sneezing (1% to 3%), sore nose (infants and children: ≥2%), nasal mucosa ulcer ( ≤2%), pharyngolaryngeal pain
Miscellaneous: Fever
<2%:
Cardiovascular: Flushing, hypertension, tachycardia
Central nervous system: Abnormality in thinking, anxiety, depersonalization, depression, hypoesthesia, malaise, nervousness, sleep disorder, vertigo
Dermatologic: Eczema, folliculitis, furunculosis
Endocrine & metabolic: Albuminuria, amenorrhea
Gastrointestinal: Abdominal pain, ageusia, aphthous stomatitis, constipation, diarrhea, gastroenteritis, glossitis, increased appetite, toothache
Genitourinary: Hematuria, mastalgia
Hepatic: Increased serum ALT
Hypersensitivity: Hypersensitivity reaction
Infection: Herpes simplex infection, viral infection
Neuromuscular & skeletal: Back pain, dislocation of temporomandibular joint, hyperkinesia, limb pain, rheumatoid arthritis
Ophthalmic: Eye pain, watery eyes
Renal: Polyuria
Respiratory: Bronchitis, bronchospasm, laryngitis, nasal congestion, paranasal sinus hypersecretion, paroxysmal nocturnal dyspnea, postnasal drip, sore throat
Miscellaneous: Laceration
<1% (Limited to important or life-threatening): Altered sense of smell, anaphylactoid reaction, anosmia, atrial fibrillation, chest pain, confusion, drug tolerance, increased serum transaminases, insomnia, muscle spasm, urinary retention, xerophthalmia
Concerns related to adverse effects:
- CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
C
Adverse events have been observed in some animal reproduction studies. Azelastine is systemically absorbed following nasal inhalation and may have side effects similar to other antihistamines. However, data related to the use of azelastine in pregnancy is limited; if treatment for rhinitis in a pregnant woman is needed, other agents are preferred (Wallace 2008).
Competes with histamine for H1-receptor sites on effector cells and inhibits the release of histamine and other mediators involved in the allergic response; when used intranasally, reduces hyper-reactivity of the airways; increases the motility of bronchial epithelial cilia, improving mucociliary transport
Vd: 14.5 L/kg
Hepatic via CYP; active metabolite, desmethylazelastine
Feces (75%, <10% as unchanged drug)
Clearance: 0.5 L/hour/kg
30 minutes (Wallace 2008); maximum effect: 3 hours
2 to 3 hours (Azelastine [generic] 0.1% solution); 3 to 4 hours (Astepro)
12 hours
Azelastine: 22 hours (0.1% solution), 25 hours (0.15% solution); Desmethylazelastine: 52 hours (0.1% solution), 57 hours (0.15% solution)
Azelastine: ~88%; Desmethylazelastine: ~97%
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience fatigue, headache, cough, rhinitis, rhinorrhea, pharyngitis, nose pain, burning, loss of strength and energy, nausea, vomiting, dry mouth, dizziness, weight gain, sneezing, or change in taste. Have patient report immediately to prescriber shortness of breath, severe nose irritation, ear pain, or nose bleeds (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.