DOSAGE AND ADMINISTRATION

Inhalation

Adults and children (above 12 years)
The usual dose is 200 µg twice daily. In more severe cases, the dosage may be started at or increased to 600-800 µg per day and subsequently reduced according to the response. The maximum daily dose recommended is 1,600 µg per day. The total dose may be adjusted and administered as recommended by the physician.

Children (6-12 years)
50-100 mcg should be given two, three or four times daily according to the response. Alternatively, 100 µg or 200 µg twice daily may be administered. Patients demonstrating a need for high dose inhaled steroid therapy should start on 1000 µg daily

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Health 2000 Beclomethasone Inhaler 50 mcg Inhaler is indicated for a wide range of patients with bronchial asthma. These include those whose asthma is poorly controlled by bronchodilators alone; those who are inadequately controlled by sodium cromoglycate in addition to bronchodilators; those with severe asthma who are dependent on systemic corticosteroids, or adrenocorticotrophic hormone (ACTH) or its synthetic equivalent. Health 2000 Beclomethasone Inhaler 50 mcg is particularly important for managing asthma in children because good control can be achieved without retardation of growth
Health 2000 Beclomethasone Inhaler 50 mcg Inhaler may be used with a Spacer device in patients who find it difficult to synchronise aerosol actuation with inspiration of breath.
The BabyMask device may be used with Health 2000 Beclomethasone Inhaler 50 mcg Inhaler to facilitate administration to children under 5 years of age.

(iii) DESCRIPTION OF DOSAGE FORM

Beclometasone dipropionate is a synthetic glucocorticoid with a potent anti-inflammatory activity and weak mineralocorticoid activity. Beclometasone dipropionate given by inhalation has a potent antiinflammatory action within the lungs but does not cause adverse systemic glucocorticoid effects at therapeutic doses.

(iv) CONTRAINDICATIONS

Hypersensitivity to the components of the formulation. Special care is necessary in patients with active or quiescent pulmonary tuberculosis.

Warnings and Precautions

Patients should be instructed in the proper use of their device to ensure that the drug reaches the target areas within the lungs. They should also be made aware of the prophylactic nature of therapy with inhaled Beclometasone dipropionate and that it should be taken regularly even when they are asymptomatic. In the majority of patients, no significant adrenal suppression occurs until doses of 1,600 mg per day are exceeded.

PREGNANCY
There is inadequate evidence of safety in human pregnancy. The use of Beclometasone dipro-pionate during pregnancy requires that the possible benefits of the drug be weighed against the possible hazards. It should be noted that the drug has been in widespread use for many years without apparent ill consequences.

NURSING MOTHERS
In the dosages used for direct inhalation, there is low potential for significant levels in breast milk.

WITHDRAWAL OF ORAL STEROID THERAPY
Patients treated with systemic steroids for long periods of time or who have received high doses may have adrenocortical suppression. With these patients adrenocortical function should be monitored regularly and their dose of systemic steroid reduced cautiously. Transferred patients whose adrenocortical function is impaired should carry a warning card indicating that they need supplementary systemic steroid during periods of stress, e.g. surgery, chest infection or worsening asthma attacks. Consideration should be given for administering oral steroids to these patients in an emergency. The dose of inhaled Beclometasone dipropionate should be increased at this time and then reduced to the maintenance level after the systemic steroid has been discontinued.
Replacement of systemic steroid treatment with inhaled Beclometasone dipropionate sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic drug. These allergies should be symptomatically treated with antihistamines and/or topical preparations.

DRUG INTERACTIONS:
Due to very low absorption at therapeutic doses it is unlikely that there would be any important drug interactions. However, in people with hypoprothrombinemia (deficiency of a clotting factor in the blood resulting in an increased tendency to bleed), ASA (e.g. Aspirin ®) should be used cautiously. Use is not recommended in the following situations:
· allergy to Beclometasone dipropionate or any component of the preparation.
· people with tuberculosis
· untreated fungal, bacterial and viral infections
· children under 6 years of age

(v) SIDE EFFECTS

Candidiasis of the mouth and throat (thrush) occurs in some patients, the incidence of which is increased with doses greater than 400 µg of Beclometasone dipropionate per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Some patients may find it helpful to rinse their mouth thoroughly with water after inhalation.
Precaution
The metal canister of Health 2000 Beclomethasone Inhaler 50 mcg Inhaler is pressurised. It should not be broken, punctured or burnt, even when apparently empty.

Storage
Health 2000 Beclomethasone Inhaler 50 mcg Inhaler should be stored in a cool place but should not be refrigerated. The products should be kept out of reach of children.

(vi) TOXIC EFFECTS

MUTAGENICITY
Studies have not been performed to date to evaluate the mutagenic potential of Beclometasone dipropionate.

CARCINOGENICITY
No evidence of carcinogenicity was observed when rats were given the drug for 95 weeks (13 weeks by oral inhalation [up to 0.4 mg/kg daily] and 82 weeks by combined oral and inhalation routes [ up to 2.4 mg/kg daily, about 40 times the maximum recommended human intranasal dosage on a mg/m2 basis] ).

TERATOGENICITY
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/day for combined daily dose of 10.1 mg/kg (approximately 97 times the maximum recommended human daily inhalation dose on mg/m2 basis). There are no adequate and well-controlled studies in pregnant women. Beclometasone dipropionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.