Inhaled corticosteroid (prodrug) Pregnancy: There are no adequate and well-controlled studies in pregnant women. In animal studies glucocorticoids have been shown to induce malformations, which is not likely to be relevant for humans at recommended inhalation doses. As with other glucocorticoids, ciclesonide should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus, and the lowest effective dose needed to maintain adequate asthma control should be used. Infants born of mothers who received corticosteroids during pregnancy are to be observed carefully for hypoadrenalism. Breast-feeding: it is unknown whether inhaled ciclesonide is excreted in human breast milk; administration to breast-feeding women should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Ciclesonide

Brand names: Alvesco

Ciclesonide is an inhaled corticosteroid prodrug used for the regular preventive treatment of asthma.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Adults and adolescents (asthma): 160 micrograms once daily by inhalation, which leads to asthma control in the majority of patients

Route: Inhalation use only (pressurised metered-dose inhaler; source product Alvesco 160 mcg Inhaler). Can be used with the AeroChamber Plus spacer device where the patient finds it difficult to press the inhaler and breathe in at the same time.

Frequency: Once daily, preferably in the evening (morning dosing has also been shown to be effective; the final decision is at the physician's discretion)

Max: Up to 640 micrograms per day, given as 320 micrograms twice daily, in patients with severe asthma and while reducing or discontinuing oral corticosteroids

PRIOR HOLD RESOLVED: the earlier draft had no eMC arm at all and was built on the US openFDA label for OMNARIS NASAL SPRAY (intranasal, allergic rhinitis), which wrongly replaced the inhaled asthma ceiling of 640 mcg/day with an intranasal ceiling of 200 mcg/day. The bundle has since been re-fetched and now carries the correct UK SPC for 'Alvesco 160 mcg Inhaler' (medicines.org.uk/emc/product/13890/smpc); all figures above are from that SPC. TITRATION: patients should be given a dose appropriate to the severity of their disease. Symptoms start to improve within 24 hours of treatment. Once control is achieved, the dose should be individualised and titrated to the minimum dose needed to maintain good asthma control; dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients. Patients with severe asthma are at risk of acute attacks and should have regular assessments of asthma control including pulmonary function tests. Increasing use of short-acting bronchodilators indicates deterioration of asthma control and should prompt reassessment and consideration of increased anti-inflammatory therapy (a higher dose for a short period, or a course of oral corticosteroids). NOT FOR ACUTE USE: as with all inhaled corticosteroids, Alvesco is not indicated in status asthmaticus or other acute episodes of asthma requiring intensive measures, and is not designed to relieve acute asthma symptoms — an inhaled short-acting bronchodilator is required and patients should be advised to have such rescue medication available. ELDERLY AND RENAL OR HEPATIC IMPAIRMENT: no need to adjust the dose in elderly patients or those with hepatic or renal impairment (section 4.2); however there are no data in severe hepatic impairment, where increased exposure is expected and patients should be monitored for potential systemic effects (section 4.4). PAEDIATRIC: the safety and efficacy of Alvesco in children aged under 12 years have not yet been established and no sufficient data are available — no paediatric dose is stated, hence paedDose is null. It is recommended that the height of children and adolescents receiving prolonged inhaled corticosteroid treatment is regularly monitored; if growth is slowed, therapy should be reviewed with the aim of reducing the dose to the lowest that maintains effective control, and referral to a paediatric respiratory specialist considered. ADRENAL: patients transferred from oral steroids remain at risk of impaired adrenal reserve for a considerable time and may require specialised advice to determine the extent of adrenal impairment before elective procedures. FORMULATION NOTE: the openFDA arm of this bundle is OMNARIS Nasal Spray (2 sprays per nostril once daily, 200 mcg/day, for allergic rhinitis) — a different formulation, route and indication. It must not be used as a cross-check for inhaled asthma dosing. eMC sections 4.4 and 4.5 were truncated or not captured at the source-fetch limit.

Dose adjustments

Renal

There is no need to adjust the dose in patients with renal impairment (section 4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to ciclesonide or to any of the excipients

Side effects

Oral fungal infections, headache, nausea, vomiting, abdominal pain and dyspepsia (uncommon; similar or lower incidence than placebo for the starred items)
Dysphonia, cough after inhalation and paradoxical bronchospasm (uncommon) — paradoxical bronchospasm may occur immediately after dosing and, in severe cases, withdrawal should be considered
Bad taste, application site reactions and application site dryness (rare)
Eczema and rash, hypertension, palpitations (uncommon); angioedema and hypersensitivity (rare)
Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression and behavioural changes, predominantly in children (frequency unknown); blurred vision (frequency unknown)
Systemic effects of inhaled corticosteroids, particularly at high doses for prolonged periods: Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma

Interactions

Ketoconazole (a potent CYP3A4 inhibitor) — co-administration with orally inhaled ciclesonide increased the exposure (AUC) of des-ciclesonide approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged (US labelling section 7)
Erythromycin (a moderate CYP3A4 inhibitor) — had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin following oral inhalation of ciclesonide (US labelling section 7)
NOTE: eMC section 4.5 was not captured in this bundle; both items above come from the US prescribing information and should be checked against the UK SPC

Clinical monograph

How it works

It is activated by esterases in the airways to its active metabolite, which binds glucocorticoid receptors to reduce airway inflammation while limiting systemic and oropharyngeal exposure.

Prescribing in practice

It is a preventer for regular use and does not relieve acute bronchospasm, so a reliever inhaler remains necessary.
As with all inhaled corticosteroids, sustained high exposure can produce systemic corticosteroid effects.
Correct inhaler technique should be confirmed to ensure effective lung deposition.

Monitoring

Monitor asthma control, inhaler technique and, in children, growth during continued therapy.

Counselling the patient

Use every day as a preventer, even when symptom-free.
Keep a reliever inhaler for sudden breathlessness.
Local airway activation means mouth thrush is less common, but rinsing remains good practice.

Evidence & guidelines

Inhaled corticosteroids including ciclesonide are supported as maintenance asthma therapy in national asthma guidance.

Reference: SmPC Alvesco; BTS/SIGN Asthma 158 (2019); GINA 2024; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways