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

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Interactions

Interaction Checker

and azelastine/fluticasone intranasal

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            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 (24)

            • 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.

            • 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

              ombitasvir/paritaprevir/ritonavir & dasabuvir 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 (188)

            • 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.

            • 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.

            • 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.

            • 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 (7)

            • 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.

            • 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

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            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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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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.