azelastine (Rx)

Brand and Other Names:Astelin Nasal Spray, Astepro, more...Azelastine HCl, Rhinolast
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

nasal spray

  • 0.1% (137mcg/spray)
  • 0.15% (205.5mcg/spray)
more...

Seasonal Allergic Rhinitis

Astelin 0.1%: 1-2 sprays per nostril q12hr, OR

Astepro 0.15%: 2 sprays per nostril qDay

Perennial Allergic Rhinitis

Astepro 0.15%: 2 sprays per nostril q12hr

Vasomotor Rhinitis

Astelin 0.1%: 2 sprays per nostril q12hr

Administration

Prime with 4 sprays before initial use; if idle for 3 days, reprime with 2 sprays

Dosage Forms & Strengths

nasal spray

  • 0.1% (137mcg/spray)
  • 0.15% (205.5mcg/spray)
more...

Seasonal Allergic Rhinitis

Astelin

  • <6 years: Safety and efficacy not established
  • 6-11 years: 1 spray per nostril q12hr
  • ≥12 years: 1-2 sprays per nostril q12hr

Astepro

  • <2 years: Safety and efficacy not established
  • 2-5 years: 0.1%; 1 spray per nostril q12hr
  • 6-11 years: 0.1% or 0.15%; 1 spray per nostril q12hr
  • ≥12 years
    • 0.1% or 0.15%: 1 or 2 sprays per nostril q12hr, or
    • 0.15%: 2 sprays per nostril qDay

Perennial Allergic Rhinitis

Astepro

  • <6 months: Safety and efficacy not established
  • 6 months through 5 years: 0.1%; 1 spray per nostril q12hr
  • 6-11 years: 0.1% or 0.15%; 1 spray per nostril q12hr
  • ≥12 years: 0.15%; 2 sprays per nostril q12hr

Vasomotor Rhinitis

Astelin

  • <12 years: Safety and efficacy not established
  • ≥12 years: 2 sprays per nostril q12hr

Administration

Prime with 4 sprays before initial use; if idle for 3 days, reprime with 2 sprays

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Interactions

Interaction Checker

and azelastine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Bitter taste (8-19.7%)

            Headache (8-14.8%)

            Somnolence (1-11.5%)

            Cold symptoms/rhinitis (2-17%)

            Cough (11%)

            1-10%

            Nasal burning (4.1%)

            Sneezing (3.1%)

            Dry mouth (2.8%)

            Nausea (2.8%)

            Conjunctivitis (2-5%)

            Asthma (5%)

            Fatigue (2.3%)

            Rhinitis (2.3%)

            Pharyngitis (4%)

            Dizziness (2%)

            Weight increase (2%)

            Myalgia (<2%)

            <1%

            Amenorrhea

            Breast pain

            Constipation

            Contact dermatitis

            Eczema

            Flushing

            Glossitis

            Hyperkinesia

            Hypertension

            Tachycardia

            Vertigo

            Vomiting

            Postmarketing Reports

            Anaphylactoid reaction

            Application site irritation

            Atrial fibrillation

            Chest pain

            Confusion

            Dyspnea

            Facial edema

            Involuntary muscle contractions

            Nasal sores

            Palpitations

            Paresthesia

            Parosmia

            Pruritus

            Rash

            Disturbance or loss of sense of smell and/or taste

            Tolerance

            Urinary retention

            Vision abnormal

            Xerophthalmia

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            Warnings

            Contraindications

            Documented hypersensitivity

            Cautions

            May cause drowsiness

            Caution in narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction

            Avoid concurrent CNS depressants that may add to somnolence

            Caution in premature newborns and neonates  

            Caution in nursing women

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Not known if excreted in breast milk; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            H1-receptor antagonist; inhibits release of histamine and other mediators involved in allergic response; may reduce hyperactivity of airways if used intranasally

            Absorption

            Bioavailability: 40%

            Onset: 1-3 hr

            Duration: 12 hr

            Peak serum time: 2-4 hr

            Distribution

            Protein bound: 88%

            Vd: 14.5 L/kg

            Metabolism

            Metabolized by hepatic P450

            Metabolites: Desmethylazelastine

            Elimination

            Half-life: 22 hr

            Clearance: 0.5 L/hr/kg

            Excretion: Feces (75%)

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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