azelastine/fluticasone intranasal (Rx)

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Brand and Other Names:Dymista

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

azelastine/fluticasone

nasal spray

  • (137mcg/50mcg)/spray
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Seasonal Allergic Rhinitis

1 spray per nostril BID

Administration

Administer by intranasal route only

Shake bottle gently prior to each use

Prime the bottle before initial use by releasing 6 sprays or more until a fine mist sprays

Reprime the bottle if unused for >14 days by spraying once or more until fine mist appears

Dosage Forms & Strengths

azelastine/fluticasone

nasal spray

  • (137mcg/50mcg)/spray
more...

Seasonal Allergic Rhinitis

<6 years: Safety and efficacy not established

≥6 years: 1 spray per nostril BID

Administration

Administer by intranasal route only

Shake bottle gently prior to each use

Prime the bottle before initial use by releasing 6 sprays or more until a fine mist sprays

Reprime the bottle if unused for >14 days by spraying once or more until fine mist appears

Seasonal allergic rhinitis: Clinical trials did not include sufficient numbers of patients older than 65 years to determine whether they respond differently from younger patients

Initiate at low end of dosing range and exercise caution

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Interactions

Interaction Checker

and azelastine/fluticasone intranasal

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Dysgeusia (4%)

            Headache (2%)

            Epistaxis (2%)

            Frequency Not Defined

            Somnolence

            Nasal effects (eg, nasal ulceration, nasal septal perforation)

            Impaired wound healing

            Candida albicans infection

            Glaucoma

            Cataracts

            Immunosuppression

            Hypothalamic-pituitary-adrenal (HPA) axis suppression

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            Warnings

            Contraindications

            None

            Cautions

            For intranasal use only

            Avoid spraying directly into eyes; if drug is sprayed into eyes, flush with water for a minimum of 10 minutes

            May cause somnolence; avoid operating heavy machinery or engaging in tasks that require mental alertness and coordination

            Do not use with history of recent nasal ulcers, nasal surgery, or any nasal trauma

            May cause glaucoma or cataracts

            As corticosteroids may cause immunosuppression, patients should notify healthcare providers if they experience any symptoms of tuberculosis, viral, bacterial, fungal or parasitic infections or ocular herpes simplex

            Due to the potential reduction in growth velocity in children, patients must be monitored routinely

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown whether distributed in breast milk, exercise 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.

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            Pharmacology

            Mechanism of Action

            Azelastine: Phthalazinones derivative; elicits histamine H1-receptor antagonist activity; major metabolite (desmethylazelastine) also exhibits histamine H1-receptor antagonist activity

            Fluticasone: Corticosteroid possessing anti-inflammatory activity; exact mechanism of action unknown, but shown to exhibit anti-inflammatory effect on multiple cells (eg, neutrophils, eosinophils, macrophages, mast cells, lymphocytes) and mediators (eg, histamine, leukotrienes, cytokines and eicosanoids)

            Absorption

            Bioavailability: azelastine (40%); fluticasone (44-61% higher than fluticasone alone)

            Peak Plasma Time: azelastine (0.5 hr); fluticasone (1 hr)

            Peak Plasma Concentration: azelastine (194.5 pg/mL); fluticasone 10.3 pg/mL

            AUC: azelastine (4217 pg/mL•hr); fluticasone (97.7 pg/mL•hr)

            Distribution

            Protein Bound: azelastine hydrochloride (88%), desmethylazelastine (97%)

            Vd: azelastine (14.5 L/kg)

            Metabolism

            Metabolism: azelastine (CYP450 enzyme system [specific enzyme unknown]), fluticasone (CYP3A4)

            Elimination

            Half-life: azelastine (25 hours), fluticasone (7.8 hours)

            Excretion: azelastine (feces 75%); fluticasone (urine <5%, feces >95%)

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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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