Indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

Alvesco is NOT indicated for the relief of acute bronchospasm.

Alvesco is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Particular care is needed for patients who are transferred from systemically active corticosteroids to ALVESCO because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Transfer of patients from systemic steroid therapy to ALVESCO may unmask allergic conditions previously suppressed by the systemic steroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids.

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ALVESCO routinely (e.g. via stadiometry).

Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported.

Development of localized infections of the mouth and pharynx have been reported.

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of inhaled corticosteroids including ALVESCO. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

There are no adequate and well-controlled studies in pregnant women. Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored Animal studies: fetal loss, reduced fetal weight, cleft palate, skeletal abnormalities including incomplete ossifications, and skin effects.

It is not known if ciclesonide is secreted in human milk. However, other corticosteroids are excreted in human milk. In a study with lactating rats, minimal, but detectable levels of ciclesonide were recovered in milk.

GoToSource

• Use in patients under the age of 12. GoToSource

• Acute bronchospasm. GoToSource

• Hard metal lung disease. GoToSource

• Add-on therapy for small airway inflammation. GoToSource

• Seasonal allergic conjunctivitis. GoToSource

• Reversal of adrenal suppression secondary to the use of fluticasone. GoToSource

• Churg-strauss syndrome. GoToSource

• Allergic rhinitis. GoToSource

• Chronic obstructive pulmonary disease. GoToSource

• Treatment of graft vs host disease. GoToSource

• Eosinophilic esophagitis. GoToSource

Oral candidiasis (yeast infection of mouth and throat), dysphonia (voice disorder) and pharyngitis (inflammation of back of the throat). GoToSource  

Suppression of the hypothalamic-pituitary-adrenal axis, thinning and bruising of the skin, adrenal insufficiency (adrenal glands don’t make enough of certain hormones), cushing syndrome (body produces too much of the hormone cortisol) and osteonecrosis (bone death). GoToSource

Hypercorticism and bronchospasm. GoToSource

Growth suppression, osteoporosis (density and quality of bone are reduced), cataracts and glaucoma. GoToSource

No major injury lawsuits reported.