Beclomethasone Dipropionate inhaler is indicated for the preventive (prophylactic) management of asthma of varying severity (mild, moderate, and severe) in both adults and children. It provides effective anti-inflammatory control in the airways with fewer systemic side effects compared to oral corticosteroids.

Mild asthma: Patients who require regular use of bronchodilators for symptom relief.

Moderate asthma: Patients with unstable or progressively worsening asthma despite preventive therapy or bronchodilator use alone.

Severe asthma: Patients with severe chronic asthma or those dependent on systemic corticosteroids for symptom control. In many cases, switching to high-dose inhaled beclomethasone may significantly reduce or eliminate the need for oral corticosteroids.

Beclomethasone dipropionate exhibits potent anti-inflammatory and vasoconstrictive effects. Although the exact mechanism is not fully understood, corticosteroids are known to influence various inflammatory cells such as mast cells, eosinophils, neutrophils, macrophages, and lymphocytes, as well as inflammatory mediators including histamine, leukotrienes, cytokines, and eicosanoids.

It is a prodrug with low affinity for glucocorticoid receptors. After administration, it is rapidly converted by esterase enzymes into its active metabolite, beclomethasone-17-monopropionate (B-17-MP), which has strong local anti-inflammatory activity in the lungs.

Clinical studies have shown no significant histopathological changes in nasal mucosa following intranasal administration.

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):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• 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.
• Breathe out as full as comfortably possible & hold the inhaler upright.
• Place the actuator into mouth between the teeth and close lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
• Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
• 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.
• After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
• 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.

Beclomethasone dipropionate inhaler is contraindicated in patients with known hypersensitivity to any of its components. Caution is required in patients with active or latent pulmonary tuberculosis.

Systemic effects of inhaled corticosteroids may occur, particularly with high doses or prolonged use. These may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract, and glaucoma.

There is limited evidence regarding the safety of beclomethasone during pregnancy. Animal studies have shown that corticosteroids may cause fetal abnormalities such as cleft palate and intrauterine growth retardation.

Use during breastfeeding should be considered only when the expected therapeutic benefit outweighs the potential risks to both mother and infant.

Patients should be instructed on the correct inhaler technique to ensure optimal delivery of the medication to the lungs. Regular monitoring of inhalation technique is recommended. Patients should also be advised to use the inhaler consistently every day, even in the absence of symptoms, to achieve maximum therapeutic benefit.

Respiratory corticosteroids.

Store below 30°C, protected from direct sunlight and heat. Do not puncture, break, or burn the canister, even when empty. Avoid contact with eyes. Keep out of reach of children.