Adult Dosing
Seasonal allergic rhinitis
Note:
- For intranasal use only
- Prime the spray before initial use by releasing 6 sprays or until a fine mist appears; when it has not been used for 14 or more days, reprime with 1 spray
Pediatric Dosing
- Safety and effectiveness in pediatric patients <12 yrs have not been established
Seasonal allergic rhinitis
Children 
12 yrs
Note:
- For intranasal use only
- Prime the spray before initial use by releasing 6 sprays or until a fine mist appears; when it has not been used for 14 or more days, reprime with 1 spray
[Outline]
See Supplemental Patient Information
- Somnolence has been reported in patients using azelastine nasal spray; advise patients not to engage in hazardous tasks requiring mental alertness and motor coordination such as operating machinery or driving a motor vehicle following administration of the spray
- Avoid concomitant use of azelastine/fluticasone nasal spray with alcohol or other CNS depressants because additional impairment of CNS performance may occur
- Nasal ulceration and nasal septal perforation have been associated with intranasal use of corticosteroids
- Therapy should not be used in patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma until healing has occurred due to the inhibitory effect of corticosteroids on wound healing
- Localized infections of the nose and pharynx with Candida albicans may develop with the use of fluticasone intranasally. If such infection occurs, provide appropriate local therapy and discontinue azelastine/fluticasone until the infection has been adequately controlled
- Regularly monitor for the evidence of Candida infection or other signs of adverse effects on the nasal mucosa if this product is used for several months or longer
- Long-term use of nasal and inhaled corticosteroids may cause glaucoma and/or cataracts. Closely monitor patients with a vision change or with a history of elevated IOP, glaucoma, and/or cataracts
- Corticosteroids may suppress the immune system and thus increase the susceptibility to infections such as chickenpox and measles, which can have a more serious or even fatal course in susceptible children or adults using corticosteroids. Particular care should be taken to avoid exposure in such individuals who have not had these diseases or been properly immunized
- If exposed to chickenpox, provide prophylaxis with varicella zoster immune globulin (VZIG); if exposed to measles, give prophylaxis with pooled intramuscular immunoglobulin (IG). Consider treatment with antiviral agents if chickenpox develops
- Higher than recommended doses of intranasal steroids may cause signs or symptoms of hypercorticism and/or suppression of HPA axis function. Withdraw gradually to discontinue
- Risk of hypercorticism and/or HPA axis suppression may increase with concomitant use of intranasal corticosteroids with other inhaled corticosteroids
- Replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and patients may experience withdrawal symptoms. Carefully monitor for acute adrenal insufficiency in response to stress during replacement
- In patients having 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
- Ritonavir and other strong CYP3A4 inhibitors may markedly increase plasma concentration of fluticasone propionate, resulting in significantly reduced serum cortisol concentrations. Concomitant use with ritonavir should be avoided unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects
- Reduced growth velocity may occur when intranasal corticosteroids are administered to pediatric patients; regularly monitor growth of pediatric patients receiving therapy
Cautions: Use cautiously in
- Untreated local or systemic infection
- Active or quiescent tuberculous infections of the respiratory tract
- Systemic viral or parasitic infections
- Ocular herpes simplex
- Co-administration with potent CYP3A4 inhibitors
- Increased intraocular pressure
- Recurrent epistaxis
- Elderly patients
- Lactation
Supplemental Patient Information
- Advise patients to refrain from performing hazardous tasks such as driving a vehicle or operating heavy machinery after receiving azelastine/fluticasone nasal spay
- Instruct patients to prime the pump until a fine mist appears before initial use and when 14 or more days have elapsed since the last use
- Advise patients to avoid spraying into their eyes or mouth
- Instruct patients to avoid concomitant use with alcohol or other CNS depressants
Pregnancy Category:C
Breastfeeding: Limited information indicates that small occasional doses of azelastine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use of the nasal spray may cause drowsiness in the infants or decrease the milk supply, especially in combination with pseudoephedrine. Non-sedating oral antihistamines are preferred alternatives. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 08 may 2012). It is not known if azelastine/fluticasone is excreted in breastmilk. Manufacturer advises caution.
US Trade Name(s)
US Availability
Dymista (azelastine/fluticasone)
- Nasal spray: 137 mcg/50 mcg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]