Dosing & Uses
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
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

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.
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
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
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.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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Formulary
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