Becovent HFA

Asthma, Chronic obstructive pulmonary disease (COPD),

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

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.

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 maintained.

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

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.

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

>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 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 times the MRHDID, but there was no evidence of external or skeletal malformations or embryo lethality at inhalation doses up to 440 times the MRHDID The risk of complications to mother and developing fetus from inadequate control of asthma must be balanced against risks from exposure to beclomethasone dipropionate Labor or delivery There are no specific human data regarding any adverse effects of inhaled beclomethasone dipropionate on labor and delivery Fertility Impairment of fertility was observed in rats and dogs at oral doses corresponding to 250 and 25 times the MRHDID for adults on a mg/ m² basis, respectively Lactation There are no data available on presence in human milk, effects on breastfed child, or on milk production; however, other inhaled corticosteroids have been detected in human milk The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from beclomethasone dipropionate or from underlying maternal condition

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).