"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...
(Generic versions may still be available.)
- Patient Information:
Details with Side Effects
Careful attention must be given when patients previously treated for prolonged periods with systemic corticosteroids are transferred to beclomethasone dipropionate nasal inhaler or spray. This is particularly important in those patients who have associated asthma or other clinical conditions where too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
Studies have shown that combined administration of alternate-day prednisone systemic treatment and orally inhaled beclomethasone dipropionate increases the likelihood of HPA suppression compared to a therapeutic dose of either one alone. Therefore, nasal forms of beclomethasone dipropionate should be used with caution in patients already on alternate day prednisone regimens for any disease.
If recommended doses of intranasal beclomethasone are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic steroid therapy, symptoms of hypercorticism may occur, including very rare cases of menstrual irregularities, acneform lesions, cataracts, and cushingoid features. If such changes occur, this drug should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy.
Persons who are on 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 nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure of these infectious agents. How the dose, route, and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk of developing a more severe infection is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscualr immunoglobulin (IG), may be indicated. (See the respective product information for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
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.
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.
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.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Beconase Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Allergies & Asthma
Improve treatments & prevent attacks.