Ciclesonide

Registered South African indications:

• Asthma

Contraindication

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Severe hepatic impairment
• Active or latent pulmonary tuberculosis
• fungal, viral or bacterial infections
• Status asthmaticus
• Acute asthma  
• Children and adolescents
• Impaired adrenal reserve
• Recent long-term systemic corticosteroid treatment
• Adrenocortical suppression
• Adrenal hypercorticism
• Bronchospasm
• Glaucoma
• Cataracts

Form avail. in SA and covered in this monograph: inh

Asthma

• Inhaled (inh): 80-320μg, 12-24hrly; Max: 320μg/24hrs

See additional prescribing points

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

Asthma

Younger than 12 years

• Not established for use

Older than 12 years

• See adult dosage

Pregnancy 

• Caution
• There are no adequate and well-controlled studies in pregnant women. In animal studies, glucocorticoids have been shown to induce malformations. This is not likely to be relevant for humans given 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 foetus. The lowest effective dose of ciclesonide 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

Breastfeeding 

• Caution
• It is unknown whether inhaled ciclesonide is excreted in human breast milk. Administration of ciclesonide to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child

Renal Impairment 

• No dose adjustment recommended

Hepatic Impairment 

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; 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 (predominantly in children)
• Dysgeusia

Cardiovascular Disorders

• Palpitations
• Hypertension

Respiratory Disorders

• Dysphonia
• Cough
• Paradoxical bronchospasm
• Pharyngitis
• Epistaxis
• Nasopharyngitis
• Sinusitis
• Nasal dryness
• Pharyngolaryngeal pain
• Rhinorrheoea
• Nasal septum disorder
• Throat irritation

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Dyspepsia
• Dry mouth

Skin and Subcutaneous Tissue Disorders

• Eczema
• Rash

Immune, Blood and Lymphatic System Disorders

• Angioedema
• Hypersensitivity
• Oral fungal infections
• Upper respiratory tract infections
• Influenza
• Candidiasis

Sensory Disorders

• Taste disturbance 

• CYP3A4 inhibitors

None routine. Specific cases may require

• Height monitoring in children
• Opthalmic examination

More than 320ug is regarded as high dose inhaled corticosteroids. High dose inhaled corticosteroids are only recommended when the patient has uncontrolled asthma on medium dose inhaled corticosteroids/long-acting beta-2 agonists combination and all confounding factors have been addressed. In this case, high dose corticosteroids should only be given for 3-6 months and its use reviewed. Doses higher than 320ug hold a higher risk of systemic adverse effects with minimal additional improvement in symptoms and pulmonary function.

Ciclesonide exhibits low binding affinity to the glucocorticoid-receptor. In the lungs it is enzymatically converted to the principal metabolite, which has pronounced anti-inflammatory activity.

Inhaler 80μg

• Alvesco 80 (Acino Pharma (Pty) Ltd) originator
• Ciclovent 80 (Cipla)

Inhaler 160μg 

• Ciclovent 160 (Cipla)
• Alvesco 160 (Acino Pharma (Pty) Ltd) originator

Also available in the following form: Nasal spray