During withdrawal from oral steroids, some patients may experience symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude, and depression).
Rarely, immediate hypersensitivity reactions may occur after the intranasal administration of beclomethasone (see ADVERSE REACTIONS).
Rare instances of nasal septum perforation have been spontaneously reported.
Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of beclamthasone.
In clinical studies with beclomethasone dipropionate administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred only rarely. When such an infection develops, it may require treatment with appropriate local therapy or discontinued use of treatment.
If persistent nasopharyngeal irritation occurs, it may be an indication for stopping beclomethasone dipropionate administered intranasally.
Beclomethasone dipropionate is absorbed into the circulation. Use of excessive doses may suppress HPA function.
This drug should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract; untreated fungal, bacterial, or systemic viral infections; or ocular herpes simplex.
For intranasal forms of beclomethasone dipropionate to be effective in the treatment of nasal polyps, the aerosol or spray must be able to enter the nose. Therefore, treatment of nasal polyps with beclomethasone dipropionate should be considered adjunctive therapy to surgical removal and/or the use of other medications which will permit effective penetration of this drug into the nose. Nasal polyps may recur after any form of treatment.
As with any long-term treatment, patients using intranasal beclomethasone dipropionate over several months or longer should be examined periodically for possible changes in the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or trauma should not use a nasal corticosteroid until healing has occurred.
Although systemic effects have been minimal with recommended doses, this potential increases with excessive doses. Therefore, larger than recommended doses should be avoided.
Information for the Patient
See PATIENT INFORMATION section.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Treatment of rats for a total of 95 weeks, 13 weeks by inhalation and 82 weeks by the oral route, resulted in no evidence of carcinogenic activity. Mutagenic studies have not been performed.
Impairment of fertility, as evidenced by inhibition of the estrous cycle in dogs, was observed following treatment by the oral route. No inhibition of the estrous cycle in dogs was seen following treatment by the inhalation route.
Pregnancy Category C
Teratogenic Effects: Like other corticoids, parenteral (subcutaneous) beclomethasone dipropionate has shown to be teratogenic and embryocidal in the mouse and rabbit when given in doses approximately 10 times the human dose. In these studies beclomethasone was found to produce fetal resorption, cleft palate, agnathia, microstomia, absence of tongue, delayed ossification, and agenesis of the thymus. No teratogenic or embryocidal effects have been seen in the rat when beclomethasone dipropionate was administered by inhalation at 10 times the human dose or orally at 1000 times the human dose. There are no adequate and well-controlled studies in pregnant women. Beclomethasone dipropionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.
It is not known whether beclomethasone dipropionate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when beclomethasone dipropionate nasal spray is administered to a nursing woman.
Nasal Spray: The safety and effectiveness of beclomethasone dipropionate nasal spray have been established in children aged 6 years and above through evidence from extensive clinical use in adult and pediatric patients. The safety and effectiveness of beclomethasone dipropionate nasal spray in children below 6 years of age have not been established.
Glucocorticoids have been shown to cause a reduction in growth velocity in children and teenagers with extended use. If a child or teenager on any glucocorticoid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of glucocorticoids should be considered.
Nasal Inhalation: Safety and effectiveness in children below 6 years of age have not been established.