Beclomethasone

Registered South African indications:

• Asthma

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Abrupt withdrawal
• Inhaler preparation not indicated for the relief of acute bronchospasm
• Cataract
• Glaucoma
• History of pathological visual disturbance
• Past paradoxical bronchospasm experience with inhaled corticosteroids
• Active or latent pulmonary tuberculosis
• Prolonged use of high doses
• Patients who have received systemic steroids for long periods of time or at high doses or both when being transferred to inhaled steroid therapy
• Stress
• Elective surgery

Forms avail. in SA and covered in this monograph: inh

Asthma

• Inhaled (inh): 200-400μg, 6-12hrly; Max: 1000μg/24hr

Rinse mouth after inhalation

Inhaled steroid treatment should not be stopped abruptly

Taper oral corticosteroids gradually, after the introduction of  inhaler therapy when switching from systemic to inhaled therapy

To be effective, inhaled beclometasone must be used on a regular basis even when patients are asymptomatic

Paed. forms avail. in SA and covered in this monograph: inh

Asthma

• Inhaled (inh): 50-100μg, 6-12hrly; Max: 500μg/24hr

Rinse mouth after inhalation

Inhaled steroid treatment should not be stopped abruptly

Taper oral corticosteroids gradually, after the introduction of  inhaler therapy when switching from systemic to inhaled therapy

To be effective, inhaled beclometasone must be used on a regular basis even when patients are asymptomatic

Pregnancy

• Caution
• There is no experience of the use of beclometasone in pregnancy in humans. It should not be used in pregnancy unless the expected benefits to the mother are thought to outweigh any potential risks to the foetus or neonate
• There is inadequate evidence of the safety of beclometasone in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may, therefore, be a risk of such effects in the human foetus. It should be noted, however, that the foetal changes in animals occur after relatively high systemic exposure. Beclometasone is delivered directly to the lungs by the inhaled route and so avoids the high level of exposure that occurs when corticosteroids are given by systemic routes

Breastfeeding

• Caution
• No specific studies examining the transfer of beclometasone dipropionate into the milk of lactating animals have been performed. It is reasonable to assume that beclometasone dipropionate is secreted in milk, but at the dosages used for direct inhalation there is low potential for significant levels in breast milk
• There is no experience with or evidence of safety of propellant HFA-134a in breastfeeding women. However, studies of the effect of HFA-134a on reproductive function and embryofetal development in animals have revealed no clinically relevant adverse effects

Fertility

• There is no data from the use of beclometasone dipropionate on human fertility

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Vertigo
• Tremor
• Psychomotor hyperactivity
• Sleep disorders
• Anxiety
• Depression
• Aggression
• Behavioural changes

Respiratory Disorders

• Hoarseness
• Pharyngitis
• Cough
• Increased asthma symptoms
• Paradoxical bronchospasm

Gastrointestinal disorders

• Nausea
• Oral candidiasis

Endocrine and metabolic disorders

• Adrenal suppression
• Growth retardation (in children and adolescents)
• Bone density decreased
• Cushing's syndrome
• Cushingoid features

Musculoskeletal Disorders

• Decrease bone mineral density
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Rash
• Pruritus
• Erythema
• Purpura

Immune, Blood and Lymphatic System Disorders

• Allergic reactions 
• Angioedema in eyes, throat, lips and face

Sensory Disorders

• Cataract
• Glaucoma
• Tinnitus
• Taste disturbances
• Blurred vision
• Central serous retinopathy

• Disulfiram
• Metronidazole
• CYP3A4 inhibitors
• Ritonavir
• Cobicistat

None routine. Specific cases may require

• Height
• FEV1
• Peak flow
• Lung function tests
• Bone mineral density

Beclometasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes to the active metabolite beclometasone 17-monohydrate, which is a potent topical anti-inflammatory agent. Inhaled beclometasone dipropionate is well established in the management of asthma. It is a synthetic glucocorticoid and exerts a topical, anti-inflammatory effect on the lungs, with fewer systemic effects than oral corticosteroids.

Inhaler 50μg

• Beceze 50 CFC Free (Biotech)
• Beclate 50 Hfa (Cipla)

Inhaler 100μg

• Beceze 100 CFC Free (Biotech)
• Beclate 100 Hfa (Cipla)

Inhaler 200μg

• Beclate 200 Hfa (Cipla)

Also available in the following forms: Cream and nasal spray.