Azelastine-Fluticasone Intranasal

Azelastine-Fluticasone Intranasal is a combination medication used to treat the symptoms of Seasonal Allergic Rhinitis. 

• Azelastine-Fluticasone Intranasal is available under the following different brand names: Dymista

Common side effects of Azelastine-Fluticasone Intranasal include:

• Changes in taste,
• Headache,
• Nosebleeds,
• Sores or white patches inside or around the nose,
• Slow wound healing, and
• Nasal candida albicans infection

Serious side effects of Azelastine-Fluticasone Intranasal include:

• Changes in taste,
• Nosebleeds, and
• Headache

Rare side effects of Azelastine-Fluticasone Intranasal include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Azelastine/fluticasone

Nasal spray

• (137 mcg/50 mcg)/spray

Seasonal Allergic Rhinitis

Adult dosage

• 1 spray per nostril two times a day

Pediatric dosage

• Children below 6 years: Safety and efficacy not established
• Children above 6 years: 1 spray per nostril two times a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Azelastine-Fluticasone Intranasal has severe interactions with the following drugs
  • calcium/magnesium/potassium/sodium oxybates
  • sodium oxybate
• Azelastine-Fluticasone Intranasal has serious interactions with at least 25 other drugs.
• Azelastine-Fluticasone Intranasal has moderate interactions with at least 191 other drugs.
• Azelastine-Fluticasone Intranasal has minor interactions with the following drugs
  • ashwagandha
  • brimonidine
  • eucalyptus
  • nettle
  • ruxolitinib
  • ruxolitinib topical
  • sage
  • Siberian ginseng

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Azelastine-Fluticasone Intranasal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Azelastine-Fluticasone Intranasal?”

Cautions

• For intranasal use only
  • Avoid spraying directly into eyes; if the 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 the drug
  • May cause glaucoma or cataractsNasal and inhaled corticosteroids may result in the 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 the 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 the 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 the risk of developing a disseminated infection is not known; the contribution of the 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 the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the 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 the 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, .g, 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 cytochromes 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 the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects; use caution with the 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 and Lactation

• 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
• Lactation
  • There are no available data on the presence of azelastine hydrochloride or fluticasone propionate in human milk, its effects on breastfed infants, 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 infants from therapy or from an underlying maternal condition