INFORMATION FOR HEALTH PROFESSIONALS
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
Aldecin Aqueous Nasal Pump Spray is a metered-dose manual pump spray unit containing a microcrystalline suspension of beclomethasone dipropionate.
Inactive Ingredients: microcrystalline cellulose, carmellose sodium, glycerol, propylene glycol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride and purified water.
Each metered dose (actuation) provides 50mcg of beclomethasone dipropionate per inhalation with a specially designed nasal adaptor. Each bottle of Aldecin Aqueous Nasal Pump Spray will provide at least 200 metered doses.
Beclomethasone dipropionate, a synthetic halogenated corticosteroid, demonstrates anti-inflammatory properties in the respiratory tract.
When given by nasal inhalation, Aldecin is deposited primarily in the nasal passages. A portion of the drug is swallowed. Complete data on the rate and extent of absorption are not available.
In vitro studies have shown that lung slices can rapidly metabolise beclomethasone dipropionate to beclomethasone 17-monopropionate and, more slowly, to free beclomethasone (which has very weak anti-inflammatory activity). It is probable that gut esterases hydrolyse swallowed beclomethasone in the same manner. The principal route of excretion of the drug and its metabolites is in the faeces.
Prophylaxis and treatment of allergic rhinitis
Do not exceed the recommended dosage. Shake well before use.
The usual dose for patients of any age group (adults or children 3 to 12 years) is 1 actuation (50mcg) into each nostril four times daily. However, two puffs in each nostril (one to upper cavity, one to lower cavity) twice daily may also give satisfactory results. Subsequently, dosage may be modified according to patient response. The maximum recommended dosage for intranasal use for adults is 10 actuations per day and for children 3 to 12 years, 4 to 6 actuations per day.
The therapeutic effects of Aldecin aqueous nasal pump spray, unlike decongestants, are not immediate. Relief from symptoms of rhinitis usually becomes apparent within a few days after the start of therapy but may take as long as two weeks. Aldecin aqueous nasal spray should not be continued beyond three weeks in the absence of significant symptomatic improvement.
The proper use and operation of the pump spray unit should be understood clearly by the patient. Physicians should emphasise to patients the need for regular use of Aldecin Aqueous Nasal Pump Spray. It is imperative that the nasal passages be clear before using Aldecin Aqueous Nasal Pump Spray. This may be done simply by blowing the nose or by taking, when necessary, other appropriate measures as prescribed by the physician.
Aldecin Aqueous Nasal Pump Spray may be used concomitantly with beclomethasone dipropionate inhaler in a total combined daily dose up to 1mg in adults and 0.5mg in children.
Since HPA axis suppression may be present in patients receiving long-term systemic corticosteroid or corticotropin (ACTH) administration, special care should be taken in transferring these patients to Aldecin Aqueous Nasal Pump Spray. Such suppression has been known to last for up to 12 months. During the first week, Aldecin Aqueous Nasal Pump Spray should be administered along with the patient's maintenance dose of systemic corticosteroid. Subsequently, Aldecin Aqueous Nasal Pump Spray therapy should be maintained while the systemic corticosteroid is reduced gradually to a minimal dosage at a rate not to exceed 0.1mg of beclomethasone (or its equivalent) at intervals of one or two weeks. With ACTH-dependent patients, the transfer should be made by similarly reducing the ACTH dosage accordingly. The importance of a slow rate of withdrawal cannot be overemphasised.
Such patients should be watched carefully for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid dose should be boosted temporarily and subsequent withdrawal should continue more slowly.
Patients with known hypersensitivity to the drug or to any of the inactive ingredients. Severe nasal infection, especially candidiasis. Persons with haemorrhagic diatheses or with a history of recurrent nasal bleeding.
Aldecin Nasal Spray should not be used in the presence of untreated localised infection involving the nasal mucosa.
Aldecin Aqueous Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
Care must be given to patients who are transferred from long-term administration of systemically active corticosteroids to Aldecin Aqueous Nasal Pump Spray. After systemic corticosteroid withdrawal in patients who have received long-term corticosteroid therapy, a number of months is required for recovery of HPA axis function. During this period of HPA axis suppression, patients may exhibit signs and symptoms of adrenal insufficiency. In such situations, systemic administration of corticosteroids should be resumed and other modes of therapy and appropriate measures should be instituted.
During the transfer from systemic corticosteroids to Aldecin Aqueous Nasal Pump Spray, some patients may experience symptoms of systemically active corticosteroid withdrawal, despite relief from nasal symptoms and will require encouragement to continue Aldecin Aqueous Nasal Pump Spray therapy. Such transfer may also unmask pre-existing allergic conditions previously suppressed by systemic corticosteroid therapy.
If recommended doses of intranasal beclomethasone are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent or current systemic corticosteroid therapy, symptoms of hypercorticism may occur including very rare cases of menstrual irregularities, acneiform lesions and cushingoid features. If such changes occur, Aldecin Aqueous Nasal Pump Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.
Aldecin Aqueous Nasal Pump Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
As with any long-term treatment, patients using Aldecin Aqueous Nasal Pump Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localized fungal infection of the nose and pharynx develops, it may require appropriate treatment or discontinuance of therapy with Aldecin Aqueous Nasal Spray. Persistence of nasopharyngeal irritation may be an indication for discontinuing Aldecin Aqueous Nasal Spray.
Beclomethasone dipropionate is absorbed into the circulation. Although systemic effects have been minimal with recommended doses, this potential increases with excessive doses. Use of excessive doses of Aldecin Aqueous Nasal Spray may suppress HPA function.
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.
Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (eg chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs. This is of particular importance in children.
Beclomethasone dipropionate should be used in pregnant women or women of childbearing age only if the potential benefit justifies the potential risk to the mother or fetus. Infants born of mothers who received corticosteroids during pregnancy should be carefully observed for hypoadrenalism.
Beclomethasone dipropionate should be used in breastfeeding mothers only if the potential benefit justifies the potential risk to the infant. If a decision is taken to administer Aldecin Aqueous Nasal Pump Spray to the breastfeeding mother, caution should be exercised.
The most common adverse reaction reported with Aldecin Aqueous Solution has been nasopharyngeal irritation. Transient episodes of sneezing, headache, nausea, light-headedness, nasal stuffiness, nosebleeds, rhinorrhea and tearing eyes have been reported rarely. Also, rare instances of immediate or delayed hypersensitivity reactions including urticaria, angioedema, rash and bronchospasm may occur after the intranasal administration of beclomethasone dipropionate.
Localized infections of the nose and pharynx with Candida albicans have occurred rarely.
Extremely rare instances of wheezing, nasal septum perforation and increased intraocular pressure have been reported following the administration of aerosolised corticosteroids.
No data available
When Aldecin Aqueous Nasal Pump Spray is used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur. If such symptoms occur, the dosage should be decreased slowly in accordance with accepted procedures for discontinuing oral corticosteroid therapy.
The oral LD50 of beclomethasone dipropionate is greater than 1g/kg in rodents.
Store below 30°C. Shake well before use.
Pharmacist-only medicine
200 metered doses. 50mcg beclomethasone dipropionate in each actuation.
Nil
Schering-Plough Pty. Ltd.,
54 Carbine Road
Mt Wellington
Auckland
NEW ZEALAND
18 July 1996