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Beconase-AQ

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Beconase-AQ

Beconase-AQ

WARNINGS

The replacement of a systemic corticosteroid with BECONASE AQ Nasal 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 BECONASE AQ Nasal 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.

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, acneiform lesions, cataracts, and cushingoid features. If such changes occur, BECONASE AQ Nasal Spray should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy.

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 children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk 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 intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Avoid spraying in eyes.

PRECAUTIONS

General: Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS: Pediatric Use).

During withdrawal from oral corticosteroids, 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 use of beclomethasone dipropionate.

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 and discontinuation of treatment with BECONASE AQ Nasal Spray.

If persistent nasopharyngeal irritation occurs, it may be an indication for stopping BECONASE AQ Nasal Spray.

Beclomethasone dipropionate is absorbed into the circulation. Use of excessive doses of BECONASE AQ Nasal Spray may suppress HPA function.

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

For BECONASE AQ Nasal Spray to be effective in the treatment of nasal polyps, the spray must be able to enter the nose. Therefore, treatment of nasal polyps with BECONASE AQ Nasal Spray should be considered adjunctive therapy to surgical removal and/or the use of other medications that will permit effective penetration of BECONASE AQ Nasal Spray into the nose. Nasal polyps may recur after any form of treatment.

As with any long-term treatment, patients using BECONASE AQ Nasal Spray 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 nasal 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 Patients

Patients being treated with BECONASE AQ Nasal Spray should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Patients should use BECONASE AQ Nasal Spray at regular intervals since its effectiveness depends on its 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 BECONASE AQ Nasal Spray are fully manifested. One to 2 weeks may pass before full relief is obtained. The patient should contact the physician if symptoms do not improve, if the condition worsens, or if sneezing or nasal irritation occurs.

For the proper use of BECONASE AQ Nasal Spray and to attain maximum improvement, the patient should read and follow carefully the patient's instructions accompanying the product.

Persons who are using immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenicity of beclomethasone dipropionate was evaluated in rats that were exposed for a total of 95 weeks, 13 weeks at inhalation doses up to 0.4 mg/kg and the remaining 82 weeks at combined oral and inhalation doses up to 2.4 mg/kg. There was no evidence of carcinogenicity in this study at the highest dose, approximately 60 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis or approximately 35 times the maximum recommended daily intranasal dose in children on a mg/m2 basis.

Beclomethasone dipropionate did not induce gene mutation in bacterial cells or mammalian Chinese hamster ovary (CHO) cells in vitro. No significant clastogenic effect was seen in cultured CHO cells in vitro or in the mouse micronucleus test in vivo.

In rats, beclomethasone dipropionate caused decreased conception rates at an oral dose of 16 mg/kg (approximately 390 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis). There was no significant effect of beclomethasone dipropionate on fertility in rats at oral doses of 1.6 mg/kg (approximately 40 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis). Inhibition of the estrous cycle in dogs was observed following oral dosing at 0.5 mg/kg (approximately 40 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis). No inhibition of the estrous cycle in dogs was seen following 12 months' exposure at an estimated inhalation dose of 0.33 mg/kg (approximately 25 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis).

Pregnancy

Teratogenic Effects: Pregnancy Category C. Like other corticosteroids, beclomethasone dipropionate was teratogenic and embryocidal in the mouse and rabbit at a subcutaneous dose of 0.1 mg/kg in mice or 0.025 mg/kg in rabbits (approximately equal to the maximum recommended daily intranasal dose in adults on a mg/m2 basis). No teratogenicity or embryocidal effects were seen in rats when exposed to an inhalation dose of 0.1 mg/kg plus oral doses of up to 10 mg/kg per day for a combined dose of 10.1 mg/kg (approximately 240 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis).

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 BECONASE AQ Nasal Spray is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of BECONASE AQ 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 BECONASE AQ Nasal Spray in children below 6 years of age have not been established.

Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including BECONASE AQ Nasal Spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including BECONASE AQ Nasal Spray, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

In a double-blind, controlled trial, 100 children between the ages of 6 and 9½ years with allergic rhinitis were randomized to receive aqueous intranasal beclomethasone dipropionate 168 mcg twice daily or placebo for 1 year. As measured by stadiometry, children who received beclomethasone dipropionate grew more slowly than those who received placebo. A difference in mean change in height was observed within 1 month of drug initiation. At the end of 12 months, the beclomethasone dipropionate-treated group had a growth velocity on average of 4.75 cm/year compared to 6.20 cm/year in the placebo group (p < 0.01). While the placebo group had an expected distribution of growth velocity, approximately 50% of the beclomethasone dipropionate-treated children grew below the 10th percentile.

In children 7.3 years of age, the mean age of children in this study, the range for expected growth velocity is: boys - 3rd percentile = 4.1 cm/year, 50th percentile = 5.8 cm/year, and 97th percentile = 7.5 cm/year; girls - 3rd percentile = 4.3 cm/year, 50th percentile = 5.9 cm/year, and 97th percentile = 7.5 cm/year. The potential reversibility of the reduction in growth velocity was not studied. No significant differences were observed between the 2 groups for mean basal plasma cortisol or ACTH-stimulated plasma cortisol levels.

Geriatric Use

Clinical studies of BECONASE AQ Nasal Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

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