Beclomin HFA 250 Inhaler – (250mcg/puff)

Square Pharmaceuticals PLC.

Generic: Beclomethasone Dipropionate

Weight

0.2 kg

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Indication

Asthma, Chronic obstructive pulmonary disease (COPD),

Administration

Prime inhaler (2 actuations into air) before first use and after prolonged idleness (>10 days)

Adult Dose

Management of chronic asthma Adults: 100-400 mcg twice daily. Prophylaxis of asthma Adults: 50-200 mcg twice daily. Increased if necessary to maximum 400 mcg twice daily. When patient’s symptoms remain under satisfactory control, the dose should be titrated to the lowest dose at which effective control of asthma is maintained.

Child Dose

Management of chronic asthma Children over 12 years: 100-400 mcg twice daily. Children (5-12 years): 100-200 mcg twice daily. Maximum 200-400 mcg twice daily. Prophylaxis of asthma Children over 12 years: 50-200 mcg twice daily. Increased if necessary to maximum 400 mcg twice daily. Children (5-12 years): The usual starting dose is 100 mcg twice daily. Depending on the severity of asthma, the daily dose may be increased up to 400 mcg administered in 2-4 divided doses. When patient’s symptoms remain under satisfactory control, the dose should be titrated to the lowest dose at which effective control of asthma is…

Contraindication

Hypersensitivity to any of the ingredients of this preparation contraindicates its use. Child under 6 years not recommended.

Mode of Action

Beclometasone controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes, fibroblasts, reverses capillary permeability and lysosomal stabilisation at the cellular level to prevent or control inflammation.

Precaution

Patients should be instructed to use inhaler properly 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 Beclometasone Dipropionate HFA inhaler and that they should use it regularly, even when they are asymptomatic. Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Beclometasone dipropionate is not suitable for the treatment of an acute asthma attack. Lactation: Potential for excretion into milk; use only if benefits greatly outweigh risks

Side Effect

>10% Pharyngitis (5-27%),Headache (8-25%),URI (5-11%) 1-10% Rhinitis (3-7%),Pain (1-5%),Increased asthma symptoms (2-4%),Dysphonia (1-4%),Sinusitis (3%),Oral symptoms (2-3%),Nausea (1-2%)

Pregnancy Category Note

Pregnancy There are no adequate and well-controlled in pregnant women; there are clinical considerations with use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women; available human data do not establish presence or absence of drug- associated risk to fetus; in animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day); in rats exposed to beclomethasone dipropionate by inhalation, dose-related gross injury to fetal adrenal glands was observed at doses greater than 180…

Interaction

Inhibitors of CYP3A4: potential pharmacokinetic interaction (increased plasma beclomethasone dipropionate concentrations). Inducers of CYP3A4: potential pharmacokinetic interaction (decreased plasma beclomethasone dipropionate concentrations). Antidiabetic agents May increase blood glucose concentrations in patients with diabetes mellitus. NSAIDs Possible increased risk of GI ulcerationa Decreased serum salicylate concentrations. When corticosteroids are discontinued, serum salicylate concentration may increase possibly resulting in salicylate intoxication Vaccines and Toxoids May cause a diminished response to toxoids and live or inactivated vaccines. May potentiate replication of some organisms contained in live, attenuated vaccines. Can aggravate neurologic reactions to some vaccines (supraphysiologic dosages).

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