Avamys Special Precautions

As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroids are prescribed concurrently.
Local infection: Infection of the nasal airways should be appropriately treated but does not constitute a contraindication to treatment with AVAMYS. After nasal surgery, healing must have occurred before use.
Nasopharyngeal candidiasis can occur in patients treated with intranasal steroids, as a class effect. Special care should be taken when treating patients who may be susceptible to candida infections (e.g. diabetics).
Systemic effects/adrenocortical function: Systemic effects with nasal corticosteroids have been reported, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Intranasal steroid products are designed to deliver drug directly to the nasal mucosa in order to minimise overall systemic glucocorticoid exposure and side effects.
Topical corticosteroids may be absorbed in amounts that can have systemic effects. Use of excessive doses may cause suppression of HPA function, reduction in bone density and retardation of growth rate in adolescents and children.
The lowest dose of AVAMYS that causes suppression of the HPA axis, effects on bone mineral density or growth retardation has not yet been established. However, the systemic bioavailability of fluticasone furoate is low (estimated at 0.50%) when given as AVAMYS and this limits the potential for systemic side effects. Measurement of serum cortisol concentrations in the clinical studies did not suggest any HPA axis suppression with recommended doses.
Ocular effects: As with other intranasal corticosteroids, physicians should be alert for evidence of systemic effects including ocular changes. Rare instances of glaucoma and increased intra-ocular pressure have been reported following administration of intranasal corticosteroids, as a class effect. Therefore, close monitoring is warranted in patients with a history of increased intraocular pressure, glaucoma and/or cataracts.
If a patient presents with a change in vision, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).
Effects on laboratory tests: No data available.
Effects on ability to drive and use machines: Fluticasone furoate is unlikely to produce an effect.
Use in children: Growth retardation has been reported in children receiving some nasal corticosteroids at licensed doses. A reduction in growth velocity has been observed in children treated with fluticasone furoate 110 micrograms daily for one year (see Adverse Reactions and Pharmacology: Pharmacodynamics under Actions). Therefore, children should be maintained on the lowest dose which delivers adequate symptom control (see Dosage & Administration).
The potential growth effects of treatment should be weighed against the clinical benefits and availability of safe and effective non-corticosteroid alternatives.
It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring the patient to a paediatric specialist.
Use in the elderly: No dosage adjustment required (see Pharmacology: Pharmacokinetics: Special patient populations under Actions).