Version May 2024
Allergic rhinitis, perennial: Intranasal: 0.15% solution (Rx or OTC): 2 sprays in each nostril twice daily.
Allergic rhinitis, seasonal: Intranasal:
0.15% solution (Rx or OTC): 1 or 2 sprays in each nostril twice daily or 2 sprays in each nostril once daily.
0.1% solution: 1 or 2 sprays in each nostril twice daily.
Nonallergic rhinitis : Intranasal: 0.1% solution: 2 sprays in each nostril twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Azelastine (nasal): Pediatric drug information")
Allergic rhinitis, perennial: Intranasal:
Infants ≥6 months and Children <6 years: 0.1% solution: 1 spray per nostril twice daily.
Children 6 to <12 years: 0.1% or 0.15% solution: 1 spray per nostril twice daily
Children ≥12 years and Adolescents: 0.15% solution: 2 sprays per nostril twice daily
Allergic rhinitis, seasonal: Intranasal:
Children 2 to <6 years: 0.1% solution: 1 spray per nostril twice daily
Children 6 to <12 years: 0.1% or 0.15% solution: 1 spray per nostril twice daily
Children ≥12 years and Adolescents:
0.1% solution: 1 or 2 sprays per nostril twice daily
0.15% solution: 1 or 2 sprays per nostril twice daily or 2 sprays per nostril once daily
Vasomotor rhinitis: Intranasal: Children ≥12 years and Adolescents: 0.1% solution: 2 sprays per nostril twice daily
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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%, postmarketing, and/or case reports: Altered sense of smell, anaphylactoid reaction, anosmia, application site irritation, atrial fibrillation, blurred vision, chest pain, confusion, drug tolerance, dyspnea, facial edema, increased serum transaminases, insomnia, muscle spasm, nasal sores, palpitations, paresthesia, pruritus, skin rash, urinary retention, visual disturbance, xerophthalmia
There are no contraindications listed in the manufacturer's labeling.
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).
Other warnings/precautions:
• Self-medication (OTC use): When used for self-medication (OTC), do not use if prior allergic reaction to azelastine or any component of the formulation; notify health care provider prior to use if you have had recent nasal ulcers, surgery, or injury that has not healed. Discontinue use and notify health care provider if allergic reaction (eg, skin rash) or severe or frequent nosebleeds occur.
205.5 mcg/spray = 0.15% solution; 137 mcg/spray = 0.1% solution.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Nasal, as hydrochloride:
Astepro: 205.5 mcg/spray (4 mL, 11 mL, 23 mL, 30 mL) [alcohol free, fragrance free, steroid free; contains benzalkonium chloride, edetate (edta) disodium]
AstePro Childrens: 205.5 mcg/spray (4 mL, 11 mL, 23 mL) [alcohol free, fragrance free, steroid free; contains benzalkonium chloride, edetate (edta) disodium]
Generic: 137 mcg/spray (30 mL); 0.1% (30 mL); 0.15% (30 mL)
Yes
Solution (Azelastine HCl Nasal)
0.1% (per mL): $3.51
0.15% (per mL): $1.20 - $4.64
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Intranasal: Before initial use of the nasal spray, the delivery system should be primed with 4 sprays (0.1% solution) or 6 sprays (0.15% solution [Rx or OTC]), 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. Discard bottle after number of sprays have been administered based on the package size (eg, 120 sprays, 200 sprays), even if not completely empty.
For intranasal administration only. Before initial use, the delivery system should be primed until a fine mist appears; when 3 or more days have elapsed since the last use, the pump should be reprimed until a fine mist appears. Blow nose to clear nostrils. Remove the dust cover. Keep head tilted downward when spraying. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. 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.
OTC labeling:
Allergic rhinitis: Temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to hay fever or other upper respiratory allergies in patients ≥6 years of age.
Rx labeling:
Nonallergic rhinitis (azelastine [generic] 0.1% solution): Relief of symptoms of nonallergic rhinitis in adults and adolescents ≥12 years of age.
Perennial allergic rhinitis (0.15% solution): Relief of symptoms of perennial allergic rhinitis in patients ≥6 years of age.
Seasonal allergic rhinitis: Relief of symptoms of seasonal allergic rhinitis in patients ≥6 years of age (0.15% solution) and ≥5 years of age (0.1% solution).
Substrate of CYP1A2 (minor), CYP2C19 (minor), CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
CNS Depressants: Azelastine (Nasal) may enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
An increased risk of adverse pregnancy outcomes has not been observed; however, information related to the use of nasal azelastine in pregnancy is limited. Use of other agents for the treatment of allergic rhinitis in pregnant women may be preferred (BSACI [Scadding 2017]).
It is not known if azelastine is present in breast milk following nasal administration.
The manufacturer recommends that caution be exercised when administering azelastine (nasal) to breastfeeding women; the decision to breastfeed during therapy should consider the risk of infant exposure, benefits of breastfeeding to the infant, and benefits of treatment to the mother.
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
Onset of action: 15 minutes (Dykewicz 2020); maximum effect: 3 hours.
Duration: 12 hours.
Distribution: Vd: 14.5 L/kg.
Protein binding: Azelastine: ~88%; Desmethylazelastine: ~97%.
Metabolism: Hepatic via CYP; active metabolite, desmethylazelastine.
Bioavailability: ~40%
Half-life elimination: Azelastine: 22 hours (0.1% solution), 25 hours (0.15% solution); Desmethylazelastine: 52 hours (0.1% solution), 57 hours (0.15% solution).
Time to peak, serum: 2 to 3 hours (0.1% solution); 4 hours (median; 0.15% solution).
Excretion: Feces (~75%, <10% as unchanged drug).
Clearance: 0.5 L/hour/kg.
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