Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery or nasal trauma should not use a nasal corticosteroid until healing has occurred.
The full benefit of DALMAN AQ Nasal Spray therapy may not be achieved until treatment has been administered for several days.
Although systemic effects have been minimal with recommended doses of DALMAN AQ Nasal Spray, potential risk increases with larger doses.
Although DALMAN AQ Nasal Spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate appropriate additional therapy.
Care must be taken while transferring patients from systemic steroid treatment to DALMAN AQ Nasal Spray if there is any reason to suppose that their adrenal function is impaired.
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, e.g. joint and/or muscular pain and depression.
In those 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. The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.
May cause suppression of HPA axis, particularly in younger children or in patients receiving high doses for prolonged periods. Fluticasone may cause less HPA axis suppression than therapeutically equivalent oral doses of prednisone. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving 20 mg per day of prednisone (or equivalent) may be more susceptible.
To minimize the systemic effects of orally-inhaled and intranasal corticosteroids, each patient should be titrated to the lowest effective dose.
May suppress the immune system; patients may be more susceptible to infection. Use with caution, if at all, in patients with systemic infections, active or quiescent tuberculosis infection, or ocular herpes simplex. Avoid exposure to chickenpox and measles.
How the dose, route, and duration of corticosteroid administration effect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the 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. If chickenpox develops, treatment with antiviral agents may be considered.
Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Rare cases of vasculitis (Churg-Strauss syndrome) or other eosinophilic conditions can occur.
Fluticasone must not be inhaled in acute bronchospasm Status asthmaticus.
May also cause suppression of HPA axis, especially when used on large areas of the body, denuded areas, for prolonged periods of time or with an occlusive dressing.
Avoid spray to the eyes.
Effect on Driving or Machinery Operation: Any effect has not been observed.
Use in Children: Controlled clinical studies have shown that orally-inhaled or intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients.
Pediatric patients may be more susceptible to systemic toxicity. Safety and efficacy in pediatric patients < 3 months of age have not been established.