Flutic AZ

Somnolence: in clinical studies, the occurrence of somnolence has been reported in some patients taking FLUTIC AZ. The overall incidence of somnolence was much lower than that reported for oral antihistamines.

Local effetcs: instances of nasal ulceration and nasal septal perforation have been reported in patients following the intranasal application of corticosteroids. There were no instances of nasal ulceration or nasal septal perforation observed in clinical studies with innovator. Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, surgical operation, or injury to the nose or mouth should not use FLUTIC AZ until healing has occurred.

Glaucoma or cataracts: visual disturbance may be reported with systemic and topical corticosteroid use.

Hypothalamic-pituitary-adrenal (HPA) axis effects: Systemic effects such as HPA axis suppression, reduction of bone density, and retardation of growth rate in children may occur with intranasal steroids, particularly at high doses prescribed for prolonged periods of time.

Respiratory conditions: In patients who have tuberculosis or untreated infection of the respiratory tract, the possible benefits of the treatment with FLUTIC AZ should be weighed against possible risk.

Use of cytochrome P450 3A4 inhibitors: care should be taken when coadministering known, strong CYP3A4 inhibitors, e.g., ritonavir and ketoconazole, as there is potential for increased systemic exposure to fluticasone propionate

Effect on growth: retardation of growth rate in children may occur with intranasal steroids, particularly at high doses prescribed for prolonged periods of time.

Use in children and adolescents: safety and effectiveness of FLUTIC AZ in pediatric patients below the age of 12 years have not been established.

Carcinogenicity: no studies of carcinogenicity were conducted with FLUTIC AZ; however, studies are available for the individual active components, azelastine and fluticasone propionate.

Genotoxicity: no studies of genotoxicity were conducted with FLUTIC AZ; however, studies are available for the individual active components, azelastine and fluticasone propionate.

Fertility: no studies on impairment of fertility were conducted with FLUTIC AZ.

Pregnancy: kategory B3. There is no or insufficient evidence of safety of azelastine or fluticasone propionate in human pregnancy.

Lactation: it is not known whether FLUTIC AZ is excreted in human breast milk.

Effects on driver and operating machines: due to the potential occurrence of somnolence, patients using FLUTIC AZ should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of FLUTIC AZ until they know how they react to the nasal spray.