Cicloson50 mcg/spray

Cicloson 50 mcg/spray is indicated for treatment to control persistent asthma in adults (18 years and older).

Respiratory corticosteroids

Cicloson 50 mcg/spray is converted by esterases to the pharmacologically active metabolite, desisobutyryl-Cicloson 50 mcg/spray, which has high affinity for the glucocorticoid receptor and exhibits anti-inflammatory activity.

Inhalation/Respiratory: Asthma: Adult: 160 mcg as a single or in 2 divided doses daily, may be reduced to 80 mcg once daily for maintenance. If necessary, may increase up to 320 mcg bid in severe asthma. Child: 12-17 yr Same as adult dose. Nasal: Allergic rhinitis: Adult: Perennial and seasonal allergic rhinitis: 200 mcg daily, given as 2 sprays in each nostril once daily. Child: Perennial allergic rhinitis: ≥12 yr Same as adult dose. Seasonal allergic rhinitis: ≥6 yr Same as adult dose.

Cicloson 50 mcg/spray should preferably be administered in the evening although morning dosing of Cicloson 50 mcg/spray has also been shown to be effective.

Co-administration with a potent inhibitor of the cytochrome P450 3A4 system (e.g. ketoconazole, itraconazole and ritonavir or nelfinavir) should be considered with caution. The risk of clinical adverse effect (eg cushingoid syndrome) cannot be excluded.

Primary treatment of severe acute asthma or status asthmaticus where intensive measures are needed.

Paradoxical bronchospasm, Bad taste, application site reactions, application site dryness, hoarseness, cough after inhalation, rash and eczema.

As with other inhaled glucocorticoids, Cicloson 50 mcg/spray should only be used during pregnancy or lactation if the potential benefit to the mother justifies the potential risk to the mother, foetus or child. The lowest effective dose of Cicloson 50 mcg/spray needed to maintain adequate asthma control should be used.

As with all inhaled corticosteroids, Cicloson 50 mcg/spray should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal, viral, or bacterial infections, and only if these patients are adequately treated. As with all inhaled corticosteroids, Cicloson 50 mcg/spray is not indicated in the treatment of status asthmaticus where intensive measures are required, or to relieve acute asthma symptoms for which an inhaled short-acting bronchodilator is required. Patients should be advised to have such rescue medication available. Patients transferred from oral steroids should be monitored regularly and their dose of systemic steroid reduced cautiously. Treatment with Cicloson 50 mcg/spray should not be stopped abruptly.

The inhaler should be stored below 30°C, protected from direct sunlight and heat. The canister should not be broken, punctured or burnt, even when apparently empty. Keep away from eyes. Keep out of reach of children.

There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment. Patients with severe asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests. Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention must be sought. In this situation, patients should be reassessed and consideration given to the need for increased anti-inflammatory treatment therapy (e.g. higher doses of Cicloson 50 mcg/spray or a course of oral corticosteroids). Severe asthma exacerbations should be managed in the usual way.