Beconase Aq (Beclomethasone Dipropionate)

BECONASE Aq®

Glaxo Wellcome

Beclomethasone Dipropionate

Corticosteroid for Nasal Use

Action And Clinical Pharmacology: Beclomethasone dipropionate is a potent anti-inflammatory steroid with strong topical and weak systemic activity. When inhaled intranasally at therapeutic doses, it has a direct anti-inflammatory action within the nasal mucosa, the mechanism of which is not yet completely defined. The minute amount absorbed in therapeutic doses has not been shown to exert any apparent clinical systemic effects.

Indications And Clinical Uses: Treatment of perennial and seasonal allergic rhinitis, poorly responsive to conventional treatment. Beclomethasone dipropionate can significantly delay the recurrence of nasal polyps in those patients who have undergone nasal polypectomy. In those patients in whom polyps do recur, beclomethasone dipropionate nasal spray can prevent their increase in size.

Contra-Indications: Active or quiescent tuberculosis of the respiratory tract or untreated fungal, bacterial and viral infections.

Patients with a history of hypersensitivity to any of the ingredients of these preparations.

Manufacturers’ Warnings In Clinical States: Careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids. Transfer to beclomethasone dipropionate nasal spray may cause withdrawal symptoms e.g. joint and/or muscular pain, lassitude and depression. In severe cases, adrenal insufficiency may occur necessitating the temporary resumption of systemic steroids. This is particularly important in those patients who have associated asthma or other clinical conditions, in whom too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol beclomethasone dipropionate. Therefore, systemic corticosteroid therapy should be withdrawn gradually.

If recommended doses of intranasal beclomethasone dipropionate are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic therapies, systemic effects may occur, including reduction in growth velocity and symptoms of hypercorticism, including very rare cases of menstrual irregularities, acneiform lesions, cataracts, and cushingoid features. If such changes occur, beclomethasone dipropionate should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy.

Pregnancy and Lactation: Glucocorticoids are known teratogens in rodent species and beclomethasone dipropionate is no exception. Teratogenicity studies were performed in the mouse and rabbit using beclomethasone dipropionate administered by the inhaled or oral route. At high dose levels of beclomethasone dipropionate fetuses were growth retarded and had cleft palate.

The safety of beclomethasone dipropionate nasal spray in human pregnancy and lactation has not been established. Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

Precautions: Beclomethasone dipropionate nasal spray is absorbed into the circulation. Use of excessive doses of beclomethasone dipropionate may suppress hypothalamic-pituitary-adrenal function. Therefore, larger than recommended doses should be avoided. Systemic effects have been minimal with recommended doses. Treatment should not be stopped abruptly but tapered off gradually.

Patients should be advised that beclomethasone dipropionate nasal spray must be used at regular intervals to be therapeutically effective. The patient should take the medication as directed, and the prescribed dosage should not be increased. For proper dosage and administration of the drug and to attain maximum improvement, the patient must be instructed by the physician or other health care professional in the correct use of this preparation. The physician should also advise the patient to read and follow the accompanying Information for the Patient insert carefully. The patient should contact the physician if the symptoms do not improve, or if the condition worsens, or if sneezing or nasal irritation occurs. An abnormally heavy challenge of summer allergens may, in certain instances, necessitate appropriate additional therapy, particularly to control eye symptoms. These patients should also be instructed to inform subsequent physicians of the prior use of corticosteroids.

Rare instances of increased intraocular pressure have been reported following intranasal application of aerosolised corticosteroids. Rare instances of nasal septum perforation have been spontaneously reported.

Steroid Replacement by Beconase Aq: The replacement of systemic steroids with beclomethasone dipropionate nasal spray has to be gradual and carefully supervised by the physician. During withdrawal from oral steroids, some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude and depression. The guidelines under Dosage should be followed in all such cases.

During periods of stress or during a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to immediately resume systemic steroids in dosages that were previously effective and to contact their physicians for further instructions. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack. To assess the risk of adrenal insufficiency in emergency situations, routine tests of adrenal cortical function, including measurement of early morning and evening cortisol levels, should be performed periodically in all patients. An early morning resting cortisol level may be accepted as normal only if it falls at or near the normal mean level.

Studies in asthmatic patients have shown that the combined administration of alternate-day prednisone systemic treatment and orally inhaled beclomethasone dipropionate increases the likelihood of hypothalamic-pituitary-adrenal suppression compared to a therapeutic dose of either drug alone. Therefore, beclomethasone dipropionate nasal spray should be used with caution in patients already on an alternate day prednisone regimen for any disease.

Long-Term Effects: The long-term effects of beclomethasone dipropionate in human subjects have not been established. In particular, the local effects of the agent on the developmental or immunologic processes of the respiratory passageways are still unknown. During long-term therapy, pituitary-adrenal function and hematological status should be periodically assessed. In addition, as with any long-term treatment with a topical steroid, patients using beclomethasone dipropionate nasal spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. The possibility of atrophic rhinitis should be kept in mind.

Effect on Infections: Patients 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. 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 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 i.v. immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

Corticosteroids may mask some signs of infection and new infections may appear. A decreased resistance to localized infections has been observed during corticosteroid therapy. The possibility of nasal, prenasal or pharyngeal candidiasis should be kept in mind. If any infection occurs during therapy, it requires appropriate treatment and/or discontinuance of beclomethasone dipropionate nasal spray, depending on the severity of the infection.

Inhibitory Effect on Wound Healing: 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.

Hypothyroidism and Cirrhosis: There may be enhanced systemic effects of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Corticosteroids and ASA: ASA should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Pregnancy and Lactation: The safety of beclomethasone dipropionate nasal spray in pregnancy and in lactation has not been established. Unnecessary administration of drugs during the first trimester of pregnancy is undesirable.

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

Glucocorticoids are secreted in human milk. It is not known whether beclomethasone dipropionate is secreted in human milk, but it is suspected to be likely.

The use of beclomethasone dipropionate in pregnancy, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother, and embryo or fetus. Infants born of mothers who have received substantial dosages of corticosteroids during pregnancy should be carefully observed for hypoadrenalism.

Teratogenic Effects: Glucocorticoids are known teratogens in rodent species and beclomethasone dipropionate is no exception.

Teratogenicity studies have been carried out by the inhaled and oral routes in mice, rats and rabbits. In mice and rabbits beclomethasone dipropionate showed effects at high dose levels typical of a potent corticosteroid, e.g. fetal growth retardation and cleft palate. Similarly, in rats beclomethasone dipropionate induced early embryonic death and fetal growth retardation at very high dose levels; however, no fetus with cleft palate was detected. Well controlled trials relating to fetal risk in humans are not available.

Adverse Reactions: General: In general, inhaled corticosteroid therapy may be associated with dose dependent increases in the incidence of ocular complications, suppression of HPA axis responsiveness to stress, and inhibition of growth velocity in children.

Glaucoma may be exacerbated by inhaled corticosteroid treatment for asthma or rhinitis. In patients with established glaucoma who require long-term inhaled corticosteroid treatment, it is prudent to measure intraocular pressure before commencing the inhaled corticosteroid and to monitor it subsequently. In patients without established glaucoma, but with a potential for developing intraocular hypertension (e.g., the elderly), intraocular pressure should be monitored at appropriate intervals.

In elderly patients treated with inhaled corticosteroids, the prevalence of posterior subscapular and nuclear cataracts is probably low but increased in relation to the daily and cumulative lifetime dose. Cofactors such as smoking, ultraviolet B exposure, or diabetes may increase the risk. Children may be less susceptible.

A reduction in growth velocity in children or teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment. Physicians should closely follow the growth of adolescents taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression if any adolescent’s growth appears slowed.

Nasopharyngeal Effect: In general, side effects have been primarily associated with the nasal mucous membranes and are consistent with what one would expect from applying a topical medication to an already inflamed membrane.

Sensations of irritation and burning in the nose following the use of beclomethasone dipropionate nasal spray have been reported. Occasional sneezing attacks have occurred immediately following the use of intranasal beclomethasone dipropionate.

Other adverse nasopharyngeal effects of beclomethasone dipropionate use include nasal dryness or crusting and transient episodes of bloody discharge from the nose. Extremely rare instances of ulceration of the nasal mucosa and of nasal septum perforation have been reported following intranasal application of aerosol and aqueous corticosteroids. Localized infections of the nose and pharynx with C. albicans have occurred rarely (see Precautions, Effect on Infection). If persistent nasopharyngeal irritation occurs, it may be an indication for stopping beclomethasone dipropionate nasal spray.

Other Effects: Other less frequent adverse effects associated with beclomethasone dipropionate include: sore throat, cough, headache, rhinorrhea, nasal stuffiness, tearing eyes, dizziness, nausea, lightheadedness, lethargy and stomach pains. Rare cases of wheezing, cataracts, raised intraocular pressure or glaucoma in association with intranasal formulations of beclomethasone dipropionate have been reported. Reports of dryness and irritation of the throat, and unpleasant taste and smell have been received. There are rare reports of loss of taste and smell. Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash, pruritus, erythema, edema of the eyes, face, lips and throat and bronchospasm, have been reported after the use of beclomethasone dipropionate oral or intranasal inhalers.

When patients are transferred to beclomethasone dipropionate nasal spray from a systemic steroid, allergic conditions such as asthma, conjunctivitis or eczema may be unmasked.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: When used at excessive dosages (above 600 µg or 12 applications/day), systemic steroid effects such as hypercorticism and adrenal suppression, may appear. Decreasing the dose will abolish these side effects.

The restoration of hypothalamic-pituitary-axis may be slow; during periods of pronounced physical stress (i.e., severe infections, trauma, surgery) a supplement with systemic steroids may be advisable.

Dosage And Administration: The safety and efficacy of the nasal spray in children under 6 years of age have not been established.

For administration by the intranasal route only.

The usual dosage for patients who have received no previous systemic steroid is 2 applications (100 µg) into each nostril twice daily. A dosage regimen of 1 application into each nostril 3 or 4 times daily may be preferred. When administered as 2 applications into each nostril, the first puff should be directed at the upper and the second at the lower part of the nasal cavity. Maximum daily dosage should not exceed 12 applications (600 µg) in adults and 8 applications (400 µg) in children.

When Beconase Aq is used concurrently with Beclovent, the combined total daily dosage should not exceed the maximum daily recommended dosage of beclomethasone dipropionate (1 000 µg in adults). Since the effectiveness of beclomethasone dipropionate nasal spray depends on its regular use, patients must be instructed to take the nasal inhalations at regular intervals and not as with other nasal sprays, as they feel necessary.

Patients should be instructed on the correct method of use, which is to blow the nose, then insert the nozzle firmly into the nostril, compress the opposite nostril and actuate the spray while inspiring through the nose, with the mouth closed (see Information for the Patient).

In order to ensure cooperation and continuation of treatment, patients must be advised that the therapeutic effects are not immediate and that some days may elapse before improvement is noted. Beclomethasone dipropionate nasal spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement.

In the presence of excessive nasal mucus secretion or edema of the nasal mucosa, the drug may fail to reach the site of action. In such cases, it is advisable to use a nasal vasoconstrictor for 2 to 3 days prior to beclomethasone dipropionate nasal spray.

Careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids when these patients are transferred to beclomethasone dipropionate nasal spray. Initially, the corticosteroid nasal spray and the systemic corticosteroid must be given concomitantly, while the dose of the latter is gradually decreased. In adults, the usual rate of withdrawal of the systemic corticosteroid is the equivalent of 1 mg of the daily dose of prednisone (or equivalent) at no less than weekly intervals if the patient is under close supervision. In children over 6 years of age, the rate of withdrawal is 1 mg of the daily dose of prednisone (or equivalent), every 8 days under close supervision. If continuous supervision is not feasible, the withdrawal of the systemic steroid should be slower, approximately 1 mg of prednisone (or equivalent) every 10 days and every 20 days, in adults and in children, respectively. A slow rate of withdrawal cannot be overemphasized. If withdrawal symptoms appear, the previous dose of the systemic steroid should be resumed for a week before a further decrease is attempted.

Availability And Storage: Each spray of aqueous suspension delivered by the nasal applicator contains: beclomethasone dipropionate 50 µg. Nonmedicinal ingredients: avicel, benzalkonium chloride, dextrose, phenylethyl alcohol, polysorbate 80 and purified water. Glass bottles of 200 doses fitted with a metered atomizing pump and a nasal applicator. Protect from light. Do not refrigerate. Store between 15 and 30°C. Discard 3 months after first use.

BECONASE Aq ® Glaxo Wellcome Beclomethasone Dipropionate Corticosteroid for Nasal Use

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