No data on acute or chronic overdose . In healthy volunteers, intranasal administration of 2 mg fluticasone propionate twice daily for 7 days had no effect on the function of the hypothalamic-pituitary-adrenal system (doses 20 times higher than therapeutic). Use of the drug in doses higher than those recommended for a long period of time can lead to temporary suppression of adrenal function.
In such patients, treatment of fluticasone propionate should be continued at the doses needed to control symptoms; restore adrenal function takes a few days, its monitoring is carried out by measuring the cortisol level in the plasma.
The interaction with other drugs
Because of the very low concentrations of fluticasone propionate in plasma after administration of oxandralone andralone clinically significant interactions are very unlikely.
Ritonavir is able to much increase, the plasma concentration of fluticasone propionate, whereby dramatically reduced levels of cortisol in human serum, there systemic side effects including Cushing’s syndrome and adrenal suppression. Inhibitors enzyme system cytochrome produce negligible (erythromycin) and minor (ketoconazole) increase fluticasone propionate plasma concentrations, which do not entail any significant reduction in serum cortisol concentrations. However, caution should be exercised with the concomitant use inhibitors of cytochrome enzyme system (eg, ketoconazole) and fluticasone propionate in view of a possible rise in the plasma concentration of the latter.
Special instructions and precautions for the use of
drug is indicated only for intranasal use.
Without medical supervision should not be constantly used for more than 6 months.
In the long-term use requires regular monitoring of adrenocortical function.
There are reports of the manifestation of systemic effects when using nasal glucocorticosteroids very high doses for a prolonged time. These effects are much less likely than with oral dosage forms of corticosteroids, and may vary among individual patients and also between different glucocorticosteroids.
Full effect fluticasone propionate nasal spray can occur only after several days of treatment. To achieve maximum therapeutic effect is necessary to adhere to a regular patterns of use.
Care should be taken when transferring patients from systemic glucocorticosteroid therapy for the treatment of nasal spray fluticasone propionate, if there is reason to believe a violation of adrenal function. In most patients, nasal spray fluticasone propionate eliminates the symptoms of seasonal allergic rhinitis, but in some cases, at very high concentrations in the air of allergens, may need additional treatment.
Additional treatment may be required for the relief of ocular manifestations against the background of a successful treatment of seasonal allergic rhinitis.
In the post-registration monitoring reported oxandralone cases the occurrence of systemic effects of corticosteroids, such as Cushing’s syndrome and adrenal suppression, with concomitant use of fluticasone propionate and ritonavir.
Therefore, the simultaneous use of ritonavir and fluticasone propionate should be avoided unless the potential benefit to the patient exceeds the possible risk of systemic corticosteroid side effects.
Effects on ability to drive vehicles, mechanisms
In clinical studies, no data on the effect of the drug on the ability to drive vehicles and other mechanisms, but consider the side effects, which can cause the drug.
Spray nasal dosage 50 .mu.g / dose.
Each vial is provided with a metering device. Per vial and a metering device worn adapter for intranasal administration. The vial is further provided with a cap to protect the adapter from dust.
Each vial with oxandralone a metering device, an adapter and a protective cap (mounted) and instructions for medical use is placed in a cardboard box.