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Indications

Beclometasone 50, 100 & 250 HFA Inhaler is indicated in the prophylactic management of mild, moderate, or severe asthma in adults or children. Beclometasone dipropionate given by inhalation offers preventative treatment for asthma. It provides effective anti-inflammatory action in the lungs with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.

Mild asthma: Patients requiring symptomatic bronchodilator asthma medication on a regular basis.

Moderate asthma: Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone.

Severe asthma: Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms. Many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly, or eliminate, their requirement for oral corticosteroids when they are transferred to high dose inhaled beclometasone dipropionate.

Pharmacology

Beclomethasone dipropionate produces anti-inflammatory and vasoconstrictor effects. The mechanisms responsible for the anti-inflammatory action of beclomethasone dipropionate are unknown. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. The direct relationship of these findings to the effects of beclomethasone dipropionate on allergic rhinitis symptoms is not known.

Biopsies of nasal mucosa obtained during clinical studies showed no histopathologic changes when beclomethasone dipropionate was administered intranasally.

Beclomethasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolyzed via esterase enzymes to its active metabolite beclomethasone-17-monopropionate (B-17-MP), which has high topical anti inflammatory activity.

Dosage

Beclometasone dipropionate Inhaler is for oral inhalation use only. Patients should be given a starting dose of inhaled beclometasone dipropionate appropriate to the severity of their disease. The dose may then be adjusted until control is achieved, or reduced to the minimum effective dose according to individual response.

Adults (including the elderly): The usual starting dose is 200 micrograms twice a day. In more severe cases the starting dose may need to increase to 600 to 800 micrograms per day which may then be reduced when the patient's asthma has stabilised. The total daily dose may be administered as two, three, or four divided doses

Children: 50 to 100 micrograms should be given two, three or four times daily in accordance to the response. Alternatively, 100 micrograms or 200 micrograms twice daily should be given. The usual starting dose is 100 micrograms twice daily. Beclometasone 250 Inhaler is not recommended for children.

Beclometasone 250 HFA Inhaler: The usual starting dose is 200 micrograms twice a day. In more severe cases the starting dose may need to increase to 600 to 800 micrograms per day which may then be reduced when the patient's asthma has stabilised. The total daily dose may be administered as two, three, or four divided doses.

There is no need to increase the dose in patients with hepatic or renal impairment.

Administration

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
  1. Take off the cap.
  2. Shake the inhaler (at least six times) vigorously before each use.
  3. If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
  4. Breathe out as full as comfortably possible & hold the inhaler upright.
  5. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
  6. While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
  7. Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
  8. If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
  9. After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
  10. Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Contraindications

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

Side Effects

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Possible systemic effects include Cushing's syndrome, Cushingoid features, and adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, and glaucoma.

Pregnancy & Lactation

There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation.

The use of beclometasone dipropionate in mothers breast feeding their babies requires that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and baby.

Precautions & Warnings

Patients should be instructed in the proper use of the inhaler, and their technique checked, to ensure that the drug reaches the target areas within the lungs. They should also be made aware that Beclometasone Inhaler has to be used regularly, every day, even when they are asymptomatic, for optimum benefit.

Therapeutic Class

Respiratory corticosteroids

Storage Conditions

The Inhaler should be stored below 30° C, protected from direct sunlight and heat. The canister should not be broken, punctured or burnt, even when apparently empty. Keep away from eyes. Keep out of reach of children.