Version July 2025
Dosage guidance:
Dosage form information: Nasal spray available in a 0.15% solution which delivers 205.5 mcg azelastine hydrochloride/spray (generic prescription, OTC: Astepro, Children's Astepro), and a 0.1% solution which delivers 137 mcg azelastine hydrochloride/spray (generic prescription). Dosing varies based on product, indication, and age.
Allergic rhinitis, perennial:
Infants ≥6 months and Children <6 years: Limited data available: 0.1% solution (137 mcg/spray): Intranasal: 1 spray per nostril twice daily (Ref).
Children 6 to <12 years: 0.15% solution (205.5 mcg/spray): Intranasal: 1 spray per nostril twice daily.
Children ≥12 years and Adolescents: 0.15% solution (205.5 mcg/spray): Intranasal: 2 sprays per nostril twice daily.
Allergic rhinitis, seasonal:
Children 2 to <5 years: Limited data available: 0.1% solution (137 mcg/spray): Intranasal: 1 spray per nostril twice daily (Ref).
Children 5 to <12 years: Note: Dosing varies based on product strength and patient age.
Children 5 to <12 years: 0.1% solution (137 mcg/spray): Intranasal: 1 spray per nostril twice daily.
Children 6 to <12 years: 0.15% solution (205.5 mcg/spray): Intranasal: 1 spray per nostril twice daily.
Children ≥12 years and Adolescents:
0.1% solution (137 mcg/spray): Intranasal: 1 or 2 sprays per nostril twice daily.
0.15% solution (205.5 mcg/spray): Intranasal: 1 or 2 sprays per nostril twice daily or 2 sprays per nostril once daily.
Vasomotor rhinitis:
Children ≥12 years and Adolescents: 0.1% solution (137 mcg/spray): Intranasal: 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.
(For additional information see "Azelastine (nasal): Drug information")
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Contact dermatitis (infants, children: ≥2%)
Gastrointestinal: Bitter taste (adolescents, adults: 4% to 7%), dysgeusia (children: 2% to 4%), vomiting (infants, children: ≥2%)
Nervous system: Drowsiness (adolescents, adults: 1% to 2%), fatigue (adolescents, adults: 2%), headache (adolescents, adults: 1% to 3%)
Otic: Otitis media (infants, children: ≥2%)
Respiratory: Cough (infants, children: ≥2%), epistaxis (children, adolescents, adults: 2% to 5%), nasal discomfort (children, adolescents, adults: ≤4%), nasal mucosa ulcer (adolescents, adults: 2%), oropharyngeal pain (infants, children: ≥2%), sinusitis (adolescents, adults: >5%), sneezing (children, adolescents, adults: 1% to 3%), sore nose (infants, children: ≥2%), upper respiratory tract infection (children: 3%)
Miscellaneous: Fever (infants, children: ≥2%)
Frequency not defined: Respiratory: Nasopharyngitis
Postmarketing (any population):
Cardiovascular: Atrial fibrillation, chest pain, hypertension, palpitations, tachycardia
Dermatologic: Pruritus, skin rash
Gastrointestinal: Abdominal pain, ageusia, nausea, unusual taste (sweet taste)
Genitourinary: Urinary retention
Hypersensitivity: Facial edema, nonimmune anaphylaxis
Local: Application-site irritation
Nervous system: Altered sense of smell, anosmia, confusion, dizziness, insomnia, nervousness, paresthesia
Neuromuscular & skeletal: Muscle spasm
Ophthalmic: Blurred vision, dry eye syndrome
Respiratory: Burning sensation of the nose, dyspnea, throat irritation
Miscellaneous: Drug tolerance
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. [DSC] = Discontinued product
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 Allergy: 205.5 mcg/spray (23 mL) [alcohol free, fragrance free, steroid free; contains benzalkonium chloride, edetate (edta) disodium]
AstePro Childrens: 205.5 mcg/spray (4 mL [DSC], 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 [DSC])
Yes
Solution (Astepro Allergy Nasal)
205.5 mcg/spray (per mL): $0.78
Solution (Azelastine HCl Nasal)
0.1% (per mL): $3.51
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: For intranasal administration only.
Priming the device: Before initial use, the delivery system should be primed until a fine mist appears; the number of sprays to prime depends on product strength: the 0.1% solution (137 mcg/spray) is primed with 4 sprays and the 0.15% solution (205.5 mcg/spray) is primed with 6 sprays, or until a fine mist appears. If 3 or more days have elapsed since the last use, the pump should be reprimed with 2 sprays or until a fine mist appears.
Administration process: 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. Do not tilt head back after administration. Discard bottle after number of sprays have been administered based on the package size (eg, 120 sprays, 200 sprays), even if not completely empty.
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.
Store upright at 20°C to 25°C (68°F to 77°F); protect from freezing.
Prescription products:
0.1% solution: Treatment of the symptoms of seasonal allergic rhinitis (FDA approved in ages ≥5 years and adults); treatment of the symptoms of vasomotor rhinitis (FDA approved in ages ≥12 years and adults).
0.15% solution: Treatment of the symptoms of perennial allergic rhinitis and seasonal allergic rhinitis (FDA approved in ages ≥6 years and adults).
OTC products: Temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to hay fever or other upper respiratory allergies (OTC products: FDA approved in ages ≥6 years and adults).
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
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 drug interactions program
CNS Depressants: Azelastine (Nasal) may increase CNS depressant effects of CNS Depressants. Risk X: Avoid
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]).
Sedation, epistaxis, systemic anticholinergic effects.
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.
