Ciclesonide

Registered South African indications:

• Allergic rhinitis

Contraindication

• Hypersensitivity to the active ingredient or any of its excipients
• Active pulmonary tuberculosis

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Nasal septal ulcers  
• Nasal surgery  
• Nasal trauma  
• Glaucoma
• Cataracts
• Previous prolonged treatment with systemic corticosteroids
• Immunosuppression
• Untreated local or systemic infections
• Ocular herpes simplex

Forms avail. in SA and covered in this monograph: nas

Seasonal and perennial allergic rhinitis 

• Nasal (nas): 100μg per nostril, dly; Max: 200μg/24hrs

Paed. forms avail. in SA and covered in this monograph: nas

Perennial allergic rhinitis 

Younger than 12 years

• Not established for use

Older than 12 years

• See adult dosage

Seasonal allergic rhinitis

Younger than 6 years

• Not established for use

Older than 6 years

• See adult dosage

Pregnancy 

• Caution
• In animal studies, glucocorticoids have been shown to induce malformations. As with other glucocorticoids, ciclesonide should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the foetus. The lowest effective dose of ciclesonide needed to treat allergic rhinitis should be used

Breastfeeding 

• Caution
• It is known that systemic corticosteroids are secreted into breast milk, however, the extent of absorption and excretion into human breast milk following nasal inhalation is unknown. Caution is recommended when administrating intranasal ciclesonide to women who are breastfeeding and should only be considered if the expected benefit to the mother is greater than any possible risk to the child

Renal Impairment 

• Caution; no dose adjustment recommended

Hepatic Impairment 

• No dose adjustment recommended

Elderly 

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache 
• Psychomotor hyperactivity
• Sleep disorders
• Anxiety
• Depression
• Aggression
• Behavioural changes 
• Dysgeusia

Cardiovascular Disorders

• Palpitations
• Hypertension

Respiratory Disorders

• Dysphonia
• Cough 
• Paradoxical bronchospasm
• Pharyngitis
• Epistaxis
• Nasopharyngitis
• Sinusitis
• Nasal dryness
• Pharyngolaryngeal pain
• Rhinorrhoea
• Nasal septum disorder
• Throat irritation
• Upper respiratory tract infections
• Influenza

Gastrointestinal Disorders

• Nausea and vomiting
• Bad taste
• Abdominal pain
• Dyspepsia
• Dry mouth
• Oral fungal infections

Skin and Subcutaneous Tissue Disorders

• Eczema
• Rash
• Application site reactions
• Application site dryness

Immune, Blood and Lymphatic System Disorders

• Angioedema
• Hypersensitivity
• Candidiasis

• CYP3A4 inhibitors

None routine. Specific cases may require

• Height (children)
• Ophthalmic examination

Ciclesonide exhibits low binding affinity to the glucocorticoid-receptor. Once orally or intranasally inhaled, ciclesonide is enzymatically converted in the lungs to the principal metabolite (C21-des-methylpropionyl-ciclesonide) which has pronounced anti-inflammatory activity and is thus considered as the active metabolite. 

Nasal spray (per spray) 50μg

• Omnair ( Acino Pharma) originator

Also available in the following form: Inhaler.