Dymista Nasal Spray (Made in Thailand)

Seasonal Allergic Rhinitis

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

Nasal Spray Seasonal allergic rhinitis The recommended dosage is 1 spray each nostril twice daily.

Nasal Spray Seasonal Allergic Rhinitis <6 years: Safety and efficacy not established >6 years: 1 each nostril twice daily.

There is no known contraindication.

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)

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 Do not use with history of recent nasal ulcers, nasal surgery, or any nasal trauma May cause glaucoma or cataracts 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 Due to the potential reduction in growth velocity in children, patients must be monitored routinely Lactation: Unknown whether distributed in breast milk, exercise caution

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,Hypothalamic-pituitary-adrenal (HPA) axis suppression

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

Additive effects with CNS depressants and ethanol. Increased plasma concentration w/ potent CYP3A4 inhibitors (e.g. ritonavir).