Presentation: Alvesco® 160 Inhaler and Alvesco® 80 Inhaler: Each actuation (delivered dose from the mouthpiece) delivers a pressurised inhalation solution containing either 160 micrograms or 80 micrograms of the active ingredient ciclesonide. The inhalation solution also contains Norflurane (HFA-134a) and Ethanol, anhydrous.
Indications: Alvesco® is indicated for treatment to control persistent asthma in adults and adolescents (12 years and older).
Dosage and administration: Alvesco® is for inhalation use only. For adults and adolescents, the recommended dose of Alvesco® is 160 micrograms once daily. A higher dose of 640 micrograms daily may be used for a short period, see section 5.1 of the full Summary of Product Characteristics. Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients. Alvesco® should preferably be administered in the evening although morning dosing of Alvesco® has also been shown to be effective. There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment.
Contra-indications: Hypersensitivity to ciclesonide or any of the excipients.
Special warnings and precautions for use: As with all inhaled corticosteroids, Alvesco® 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, Alvesco® 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.
Systemic Effects: Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, decrease in bone mineral density, cataract, glaucoma and growth retardation in adolescents. Regular monitoring of the height of adolescents receiving prolonged treatment is recommended. If growth is slowed, the dose should be reduced to that which maintains effective asthma control. Patients with severe hepatic impairment should be monitored for potential systemic effects.
Interactions: 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.
Side effects: Very rare: angioedema. Please refer to full Summary of Product Characteristics for information on uncommon side effects.
Pregnancy and lactation: As with other inhaled glucocorticoids, ciclesonide should only be used during pregnancy or lactation if the potential benefit to the mother justifies the potential risk to the foetus or child. The lowest effective dose of ciclesonide needed to maintain adequate asthma control should be used.
Basic NHS Price (applicable to UK only):
Product Licence Number: Alvesco® 160 Inhaler PL 31752/0006, Alvesco® 80 Inhaler PL 31752/0005 Legal Category: POM
Alvesco® is a registered trademark of Nycomed GmbH, Germany.
Further information is available from Nycomed UK Ltd, Three Globeside Business Park, Fieldhouse Lane, Marlow, Bucks SL7 1HZ Telephone 01628 646400.
For Alvesco prescribing information please refer to full Summary of Product Characteristics
Disclaimer: For exclusive use at EPG Asthma Knowledge Centre, July 2008. Local regulation may apply. Please check your local SmPC.