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      Drugs & Diseases

      azelastine/fluticasone intranasal (Rx)

      Brand and Other Names:Dymista
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      Dosing & Uses

      AdultPediatricGeriatric

      Dosing Forms & Strengths

      azelastine/fluticasone

      nasal spray

      • (137mcg/50mcg)/spray

      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

      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

      Next:

      Interactions

      Interaction Checker

      and azelastine/fluticasone intranasal

      No Results

         activity indicator 
        No Interactions Found
        Interactions Found

        Contraindicated

          Serious - Use Alternative

            Significant - Monitor Closely

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                 activity indicator 

                Contraindicated (2)

                • calcium/magnesium/potassium/sodium oxybates

                  azelastine, calcium/magnesium/potassium/sodium oxybates. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration with alcohol or sedative hypnotics are contraindicated because of additive CNS depression.

                • sodium oxybate

                  azelastine, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration with alcohol or sedative hypnotics are contraindicated because of additive CNS depression.

                Serious - Use Alternative (25)

                • atazanavir

                  atazanavir will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • clarithromycin

                  clarithromycin will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • clonidine

                  clonidine, azelastine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Enhanced CNS depressant effects.

                • conivaptan

                  conivaptan will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • darunavir

                  darunavir will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • fedratinib

                  azelastine will increase the level or effect of fedratinib by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of fedratinib (a CYP3A4 and CYP2C19 substrate) with dual CYP3A4 and CYP2C19 inhibitor. Effect of coadministration of a dual CYP3A4 and CYP2C19 inhibitor with fedratinib has not been studied.

                • fosamprenavir

                  fosamprenavir will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • imatinib

                  imatinib will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • indinavir

                  indinavir will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • isoniazid

                  isoniazid will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • itraconazole

                  itraconazole will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • ketoconazole

                  ketoconazole will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • levoketoconazole

                  levoketoconazole will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • lonafarnib

                  azelastine will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

                • lopinavir

                  lopinavir will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • nefazodone

                  nefazodone will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • nelfinavir

                  nelfinavir will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • nicardipine

                  nicardipine will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)

                  ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) will increase the level or effect of fluticasone intranasal by unspecified interaction mechanism. Avoid or Use Alternate Drug. Coadministration may reduce serum cortisol concentrations; alternative corticosteroids should be considered, particularly for long term use.

                • posaconazole

                  posaconazole will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • quinidine

                  quinidine will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • ritonavir

                  ritonavir will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • saquinavir

                  saquinavir will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                • stiripentol

                  stiripentol, azelastine. Either increases effects of the other by sedation. Avoid or Use Alternate Drug. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.

                • tipranavir

                  tipranavir will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Strong CYP3A4 inhibitors may increase systemic corticosteroid adverse effects; monitor for signs/symptoms of high corticosteroid concentrations including Cushing type signs/symptoms.

                Monitor Closely (191)

                • albuterol

                  azelastine increases and albuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • alfentanil

                  azelastine and alfentanil both increase sedation. Use Caution/Monitor.

                • alprazolam

                  azelastine and alprazolam both increase sedation. Use Caution/Monitor.

                • amitriptyline

                  azelastine and amitriptyline both increase sedation. Use Caution/Monitor.

                • amobarbital

                  azelastine and amobarbital both increase sedation. Use Caution/Monitor.

                • amoxapine

                  azelastine and amoxapine both increase sedation. Use Caution/Monitor.

                • apomorphine

                  azelastine and apomorphine both increase sedation. Use Caution/Monitor.

                • arformoterol

                  azelastine increases and arformoterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • aripiprazole

                  azelastine and aripiprazole both increase sedation. Use Caution/Monitor.

                • armodafinil

                  azelastine increases and armodafinil decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • atogepant

                  azelastine will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • avapritinib

                  azelastine will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • axitinib

                  azelastine increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • baclofen

                  azelastine and baclofen both increase sedation. Use Caution/Monitor.

                • belladonna and opium

                  azelastine and belladonna and opium both increase sedation. Use Caution/Monitor.

                • benperidol

                  azelastine and benperidol both increase sedation. Use Caution/Monitor.

                • benzphetamine

                  azelastine increases and benzphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • brompheniramine

                  azelastine and brompheniramine both increase sedation. Use Caution/Monitor.

                • buprenorphine

                  azelastine and buprenorphine both increase sedation. Use Caution/Monitor.

                • buprenorphine buccal

                  azelastine and buprenorphine buccal both increase sedation. Use Caution/Monitor.

                • butabarbital

                  azelastine and butabarbital both increase sedation. Use Caution/Monitor.

                • butalbital

                  azelastine and butalbital both increase sedation. Use Caution/Monitor.

                • butorphanol

                  azelastine and butorphanol both increase sedation. Use Caution/Monitor.

                • caffeine

                  azelastine increases and caffeine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • carbinoxamine

                  azelastine and carbinoxamine both increase sedation. Use Caution/Monitor.

                • carisoprodol

                  azelastine and carisoprodol both increase sedation. Use Caution/Monitor.

                • chloral hydrate

                  azelastine and chloral hydrate both increase sedation. Use Caution/Monitor.

                • chlordiazepoxide

                  azelastine and chlordiazepoxide both increase sedation. Use Caution/Monitor.

                • chlorpheniramine

                  azelastine and chlorpheniramine both increase sedation. Use Caution/Monitor.

                • chlorpromazine

                  azelastine and chlorpromazine both increase sedation. Use Caution/Monitor.

                • chlorzoxazone

                  azelastine and chlorzoxazone both increase sedation. Use Caution/Monitor.

                • cimetidine

                  cimetidine increases effects of azelastine by decreasing metabolism. Use Caution/Monitor.

                • cinnarizine

                  azelastine and cinnarizine both increase sedation. Use Caution/Monitor.

                • clemastine

                  azelastine and clemastine both increase sedation. Use Caution/Monitor.

                • clobazam

                  azelastine, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).

                • clomipramine

                  azelastine and clomipramine both increase sedation. Use Caution/Monitor.

                • clonazepam

                  azelastine and clonazepam both increase sedation. Use Caution/Monitor.

                • clorazepate

                  azelastine and clorazepate both increase sedation. Use Caution/Monitor.

                • clozapine

                  azelastine and clozapine both increase sedation. Use Caution/Monitor.

                • codeine

                  azelastine and codeine both increase sedation. Use Caution/Monitor.

                • cyclizine

                  azelastine and cyclizine both increase sedation. Use Caution/Monitor.

                • cyclobenzaprine

                  azelastine and cyclobenzaprine both increase sedation. Use Caution/Monitor.

                • cyproheptadine

                  azelastine and cyproheptadine both increase sedation. Use Caution/Monitor.

                • dantrolene

                  azelastine and dantrolene both increase sedation. Use Caution/Monitor.

                • desipramine

                  azelastine and desipramine both increase sedation. Use Caution/Monitor.

                • dexchlorpheniramine

                  azelastine and dexchlorpheniramine both increase sedation. Use Caution/Monitor.

                • dexfenfluramine

                  azelastine increases and dexfenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • dexmedetomidine

                  azelastine and dexmedetomidine both increase sedation. Use Caution/Monitor.

                • dexmethylphenidate

                  azelastine increases and dexmethylphenidate decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • dextroamphetamine

                  azelastine increases and dextroamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • dextromoramide

                  azelastine and dextromoramide both increase sedation. Use Caution/Monitor.

                • diamorphine

                  azelastine and diamorphine both increase sedation. Use Caution/Monitor.

                • diazepam

                  azelastine and diazepam both increase sedation. Use Caution/Monitor.

                • diethylpropion

                  azelastine increases and diethylpropion decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • difenoxin hcl

                  azelastine and difenoxin hcl both increase sedation. Use Caution/Monitor.

                • dimenhydrinate

                  azelastine and dimenhydrinate both increase sedation. Use Caution/Monitor.

                • diphenhydramine

                  azelastine and diphenhydramine both increase sedation. Use Caution/Monitor.

                • diphenoxylate hcl

                  azelastine and diphenoxylate hcl both increase sedation. Use Caution/Monitor.

                • dipipanone

                  azelastine and dipipanone both increase sedation. Use Caution/Monitor.

                • dobutamine

                  azelastine increases and dobutamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • dopamine

                  azelastine increases and dopamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • dopexamine

                  azelastine increases and dopexamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • dosulepin

                  azelastine and dosulepin both increase sedation. Use Caution/Monitor.

                • doxepin

                  azelastine and doxepin both increase sedation. Use Caution/Monitor.

                • doxylamine

                  azelastine and doxylamine both increase sedation. Use Caution/Monitor.

                • droperidol

                  azelastine and droperidol both increase sedation. Use Caution/Monitor.

                • ephedrine

                  azelastine increases and ephedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • epinephrine

                  azelastine increases and epinephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • epinephrine racemic

                  azelastine increases and epinephrine racemic decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • estazolam

                  azelastine and estazolam both increase sedation. Use Caution/Monitor.

                • ethanol

                  azelastine and ethanol both increase sedation. Use Caution/Monitor.

                • etomidate

                  etomidate and azelastine both increase sedation. Use Caution/Monitor.

                • fedratinib

                  fedratinib will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

                • fenfluramine

                  azelastine increases and fenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • finerenone

                  azelastine will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

                • flibanserin

                  azelastine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

                • fluphenazine

                  azelastine and fluphenazine both increase sedation. Use Caution/Monitor.

                • flurazepam

                  azelastine and flurazepam both increase sedation. Use Caution/Monitor.

                • formoterol

                  azelastine increases and formoterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • gotu kola

                  gotu kola increases effects of azelastine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

                • haloperidol

                  azelastine and haloperidol both increase sedation. Use Caution/Monitor.

                • hawthorn

                  hawthorn increases effects of azelastine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

                • hops

                  hops increases effects of azelastine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

                • hyaluronidase

                  azelastine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

                • hydromorphone

                  azelastine and hydromorphone both increase sedation. Use Caution/Monitor.

                • hydroxyzine

                  azelastine and hydroxyzine both increase sedation. Use Caution/Monitor.

                • iloperidone

                  azelastine and iloperidone both increase sedation. Use Caution/Monitor.

                • imipramine

                  azelastine and imipramine both increase sedation. Use Caution/Monitor.

                • isavuconazonium sulfate

                  azelastine will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • isoproterenol

                  azelastine increases and isoproterenol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • ivacaftor

                  azelastine increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

                • kava

                  kava increases effects of azelastine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

                • ketotifen, ophthalmic

                  azelastine and ketotifen, ophthalmic both increase sedation. Use Caution/Monitor.

                • lemborexant

                  azelastine will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

                • letermovir

                  letermovir increases levels of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • levalbuterol

                  azelastine increases and levalbuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • levorphanol

                  azelastine and levorphanol both increase sedation. Use Caution/Monitor.

                • lisdexamfetamine

                  azelastine increases and lisdexamfetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • lofepramine

                  azelastine and lofepramine both increase sedation. Use Caution/Monitor.

                • lofexidine

                  azelastine and lofexidine both increase sedation. Use Caution/Monitor.

                • lomitapide

                  azelastine increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

                • loprazolam

                  azelastine and loprazolam both increase sedation. Use Caution/Monitor.

                • lorazepam

                  azelastine and lorazepam both increase sedation. Use Caution/Monitor.

                • lormetazepam

                  azelastine and lormetazepam both increase sedation. Use Caution/Monitor.

                • loxapine

                  azelastine and loxapine both increase sedation. Use Caution/Monitor.

                • loxapine inhaled

                  azelastine and loxapine inhaled both increase sedation. Use Caution/Monitor.

                • lurasidone

                  lurasidone, azelastine. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

                • maprotiline

                  azelastine and maprotiline both increase sedation. Use Caution/Monitor.

                • marijuana

                  azelastine and marijuana both increase sedation. Use Caution/Monitor.

                • mavacamten

                  azelastine will increase the level or effect of mavacamten by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Inititiation of weak CYP2C19 inhibitors may require decreased mavacamten dose.

                • melatonin

                  azelastine and melatonin both increase sedation. Use Caution/Monitor.

                • meperidine

                  azelastine and meperidine both increase sedation. Use Caution/Monitor.

                • meprobamate

                  azelastine and meprobamate both increase sedation. Use Caution/Monitor.

                • metaproterenol

                  azelastine increases and metaproterenol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • metaxalone

                  azelastine and metaxalone both increase sedation. Use Caution/Monitor.

                • methadone

                  azelastine and methadone both increase sedation. Use Caution/Monitor.

                • methamphetamine

                  azelastine increases and methamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • methocarbamol

                  azelastine and methocarbamol both increase sedation. Use Caution/Monitor.

                • methylenedioxymethamphetamine

                  azelastine increases and methylenedioxymethamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • midazolam

                  azelastine and midazolam both increase sedation. Use Caution/Monitor.

                • midazolam intranasal

                  azelastine will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

                • midodrine

                  azelastine increases and midodrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • mirtazapine

                  azelastine and mirtazapine both increase sedation. Use Caution/Monitor.

                • modafinil

                  azelastine increases and modafinil decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • morphine

                  azelastine and morphine both increase sedation. Use Caution/Monitor.

                • motherwort

                  azelastine and motherwort both increase sedation. Use Caution/Monitor.

                • moxonidine

                  azelastine and moxonidine both increase sedation. Use Caution/Monitor.

                • nabilone

                  azelastine and nabilone both increase sedation. Use Caution/Monitor.

                • nalbuphine

                  azelastine and nalbuphine both increase sedation. Use Caution/Monitor.

                • norepinephrine

                  azelastine increases and norepinephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • nortriptyline

                  azelastine and nortriptyline both increase sedation. Use Caution/Monitor.

                • olanzapine

                  azelastine and olanzapine both increase sedation. Use Caution/Monitor.

                • opium tincture

                  azelastine and opium tincture both increase sedation. Use Caution/Monitor.

                • orphenadrine

                  azelastine and orphenadrine both increase sedation. Use Caution/Monitor.

                • oxazepam

                  azelastine and oxazepam both increase sedation. Use Caution/Monitor.

                • oxycodone

                  azelastine and oxycodone both increase sedation. Use Caution/Monitor.

                • oxymetazoline intranasal

                  oxymetazoline intranasal, azelastine. Other (see comment). Modify Therapy/Monitor Closely. Comment: Oxymetazoline has been known to slow the rate, but not affect the extent of absorption of concomitantly administered intranasal products. Do not administer other intranasal products with oxymetazoline intranasal.

                • oxymorphone

                  azelastine and oxymorphone both increase sedation. Use Caution/Monitor.

                • paliperidone

                  azelastine and paliperidone both increase sedation. Use Caution/Monitor.

                • papaveretum

                  azelastine and papaveretum both increase sedation. Use Caution/Monitor.

                • papaverine

                  azelastine and papaverine both increase sedation. Use Caution/Monitor.

                • passion flower

                  passion flower increases effects of azelastine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

                • pentazocine

                  azelastine and pentazocine both increase sedation. Use Caution/Monitor.

                • pentobarbital

                  azelastine and pentobarbital both increase sedation. Use Caution/Monitor.

                • perphenazine

                  azelastine and perphenazine both increase sedation. Use Caution/Monitor.

                • phendimetrazine

                  azelastine increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • phenobarbital

                  azelastine and phenobarbital both increase sedation. Use Caution/Monitor.

                • phentermine

                  azelastine increases and phentermine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • phenylephrine

                  azelastine increases and phenylephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • phenylephrine PO

                  azelastine increases and phenylephrine PO decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

                • pholcodine

                  azelastine and pholcodine both increase sedation. Use Caution/Monitor.

                • pimozide

                  azelastine and pimozide both increase sedation. Use Caution/Monitor.

                • pirbuterol

                  azelastine increases and pirbuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • primidone

                  azelastine and primidone both increase sedation. Use Caution/Monitor.

                • prochlorperazine

                  azelastine and prochlorperazine both increase sedation. Use Caution/Monitor.

                • promethazine

                  azelastine and promethazine both increase sedation. Use Caution/Monitor.

                • propylhexedrine

                  azelastine increases and propylhexedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • protriptyline

                  azelastine and protriptyline both increase sedation. Use Caution/Monitor.

                • quazepam

                  azelastine and quazepam both increase sedation. Use Caution/Monitor.

                • quetiapine

                  azelastine and quetiapine both increase sedation. Use Caution/Monitor.

                • ramelteon

                  azelastine and ramelteon both increase sedation. Use Caution/Monitor.

                • ribociclib

                  ribociclib will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • risperidone

                  azelastine and risperidone both increase sedation. Use Caution/Monitor.

                • rucaparib

                  rucaparib will increase the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

                • salmeterol

                  azelastine increases and salmeterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • scullcap

                  azelastine and scullcap both increase sedation. Use Caution/Monitor.

                • secobarbital

                  azelastine and secobarbital both increase sedation. Use Caution/Monitor.

                • shepherd's purse

                  azelastine and shepherd's purse both increase sedation. Use Caution/Monitor.

                • stiripentol

                  stiripentol, fluticasone intranasal. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

                • sufentanil

                  azelastine and sufentanil both increase sedation. Use Caution/Monitor.

                • tapentadol

                  azelastine and tapentadol both increase sedation. Use Caution/Monitor.

                • tazemetostat

                  azelastine will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                  tazemetostat will decrease the level or effect of fluticasone intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • temazepam

                  azelastine and temazepam both increase sedation. Use Caution/Monitor.

                • terbutaline

                  azelastine increases and terbutaline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • thioridazine

                  azelastine and thioridazine both increase sedation. Use Caution/Monitor.

                • thiothixene

                  azelastine and thiothixene both increase sedation. Use Caution/Monitor.

                • tinidazole

                  azelastine will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • topiramate

                  azelastine and topiramate both increase sedation. Modify Therapy/Monitor Closely.

                • tramadol

                  azelastine and tramadol both increase sedation. Use Caution/Monitor.

                • trazodone

                  azelastine and trazodone both increase sedation. Use Caution/Monitor.

                • triazolam

                  azelastine and triazolam both increase sedation. Use Caution/Monitor.

                • triclofos

                  azelastine and triclofos both increase sedation. Use Caution/Monitor.

                • trifluoperazine

                  azelastine and trifluoperazine both increase sedation. Use Caution/Monitor.

                • trimipramine

                  azelastine and trimipramine both increase sedation. Use Caution/Monitor.

                • triprolidine

                  azelastine and triprolidine both increase sedation. Use Caution/Monitor.

                • valerian

                  valerian increases effects of azelastine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

                • xylometazoline

                  azelastine increases and xylometazoline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • yohimbine

                  azelastine increases and yohimbine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • ziconotide

                  azelastine and ziconotide both increase sedation. Use Caution/Monitor.

                • ziprasidone

                  azelastine and ziprasidone both increase sedation. Use Caution/Monitor.

                • zotepine

                  azelastine and zotepine both increase sedation. Use Caution/Monitor.

                Minor (8)

                • ashwagandha

                  ashwagandha increases effects of azelastine by pharmacodynamic synergism. Minor/Significance Unknown. May enhance CNS depression.

                • brimonidine

                  brimonidine increases effects of azelastine by pharmacodynamic synergism. Minor/Significance Unknown. Increased CNS depression.

                • eucalyptus

                  azelastine and eucalyptus both increase sedation. Minor/Significance Unknown.

                • nettle

                  nettle increases effects of azelastine by pharmacodynamic synergism. Minor/Significance Unknown. (High dose nettle; theoretical interaction) May enhance CNS depression.

                • ruxolitinib

                  azelastine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

                • ruxolitinib topical

                  azelastine will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

                • sage

                  azelastine and sage both increase sedation. Minor/Significance Unknown.

                • Siberian ginseng

                  Siberian ginseng increases effects of azelastine by pharmacodynamic synergism. Minor/Significance Unknown. May enhance CNS depression.

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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 and risk of infections

                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; caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of drug

                May cause glaucoma or cataractsNasal and inhaled corticosteroids may result in development of glaucoma and/or cataracts; close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts

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

                Nasal effects

                • Epistaxis reported; nasal ulceration and nasal septal perforation reported in patients following nasal application of corticosteroids
                • Because of inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should avoid use until healing has occurred
                • Development of localized infections of the nose and pharynx with Candida albicans has occurred; when such an infection develops, it may require treatment with appropriate local therapy and discontinuation of therapy; patients receiving therapy over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on nasal mucosa

                Immunosuppression

                • 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
                • Persons who are using corticosteroids, that suppress the immune system are more susceptible to infections than healthy individuals; chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids; in children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure
                • How the dose, route, and duration of corticosteroid administration affect risk of developing a disseminated infection is not known; the contribution of underlying disease and/or prior corticosteroid treatment to risk is also not known; if exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated; if exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see respective prescribing Information for VZIG and IG); if chickenpox develops, treatment with antiviral agents may be considered
                • Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of potential for worsening of these infections

                Adrenal suppression and hypercorticism

                • When nasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear; if such changes occur, the dosage should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy
                • The concomitant use of nasal corticosteroids with other inhaled corticosteroids could increase risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis
                • The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of withdrawal, eg, joint and/or muscular pain, lassitude, and depression
                • Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress
                • In patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms

                Drug interaction overview

                • Ritonavir and other strong cytochrome P450 3A4 (CYP3A4) inhibitors can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations; during postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression; therefore, coadministration with ritonavir is not recommended unless potential benefit to patient outweighs risk of systemic corticosteroid side effects; use caution with coadministration of other potent CYP3A4 inhibitors, such as ketoconazole
                • Avoid concurrent use with alcohol or other central nervous system depressants; additional reductions in alertness and additional impairment of central nervous system performance may occur from interaction
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                Pregnancy & Lactation

                Pregnancy

                Limited data from postmarketing experience over decades of use in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes

                Animal data

                • Animal reproduction studies with combination product are not available; however, studies are available with its individual components, azelastine hydrochloride and fluticasone propionate
                • In animal reproduction studies with azelastine, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose; oral administration to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than maximum recommended human daily intranasal dose of 1.096 mg; relevance of these findings in animals to pregnant women considered questionable based upon high animal to human dose multiple
                • In animal reproduction studies, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m2 basis; teratogenicity, characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the MRHDID of 200 mcg on a mcg/m2 basis; experience with corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans

                Lactation

                There are no available data on presence of azelastine hydrochloride or fluticasone propionate in human milk, effects on breastfed infant, or on milk production; breastfed infants should be monitored for signs of milk rejection during combination treatment by lactating women; fluticasone propionate is present in rat milk

                Other corticosteroids have been detected in human milk; however, fluticasone propionate concentrations in plasma after intranasal therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for combination treatment and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

                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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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                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.

                View explanations for tiers and restrictions
                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
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.
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