CONTRAINDICATIONS
Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
WARNINGS
The replacement of a systemic corticosteroid with beclomethasone dipropionate nasal
inhaler or spray can be accompanied by signs of adrenal insufficiency.
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.
PRECAUTIONS
General
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
Patients being treated with beclomethasone dipropionate should receive the following
information and instructions. This information is intended to aid in the safe and effective
use of this medication. It is not a disclosure of all possible adverse or intended effects.
Patients should use beclomethasone dipropionate at regular intervals since its
effectiveness depends on their regular use. The patient should take the medication as
directed. It is not acutely effective, and the prescribed dosage should not be increased.
Instead, nasal vasoconstrictors or oral antihistamines may be needed until the effects of
this drug are fully manifested. One to 2 weeks may pass before relief is obtained. The
patient should contact the doctor if symptoms do not improve, or if the condition
worsens, or if sneezing or nasal irritation occurs. For the proper use of this unit and to
attain maximum improvement, the patient should read and follow carefully the
accompanying patient's instructions.
Persons who are on immunosuppressant doses of corticosteroids should be warned to
avoid exposure to chickenpox or measles and, if exposed, medical advice should be
sought without delay.
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.
Nursing Mothers
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.
Pediatric Use
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.