Beclomethasone

Registered South African indications:

• Allergic rhinitis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Children < 12 years

Cautions

• Pregnancy
• Breastfeeding
• Prolonged use 
• Cataract
• Glaucoma
• Active or latent pulmonary tuberculosis 5
• Infections of the nasal passages and paranasal sinuses
• Bleeding tendency  
• Recurrent epistaxis
• Unhealed nasal lesions

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

Seasonal allergic rhinitis

• Nasal (nas): 50-100μg per nostril, 6-12hrly; Max: 200μg/24hrs per nostril

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

Seasonal allergic rhinitis

Younger than 12 years

• Not established for use

Older than 12 years

• See adult dosage

Pregnancy

• Caution
• There is inadequate evidence of safety 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 very small 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. Beclomethasone nasal sprays deliver beclometasone dipropionate directly to the nasal mucosa and so minimises systemic exposure
  The use of beclometasone dipropionate should be avoided during pregnancy unless thought essential

Breastfeeding

• Caution
• No specific studies examining the transference of beclometasone dipropionate into the milk of breastfeeding animals have been performed. It is reasonable to assume that beclometasone dipropionate is secreted in milk but at the dosages used for direct intranasal administration there is low potential for significant levels in breast milk. The use of beclometasone dipropionate in mothers breastfeeding their babies requires that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and baby

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
• Epistaxis
• Nasal dryness 
• Nasal irritation 
• Throat dryness 
• Throat irritation 
• Nasal septum perforation 

Gastrointestinal Disorders

• Taste disturbances
• Nausea

Endocrine and Metabolic Disorders

• Adrenal suppression
• Growth retardation (in children)
• Decreased bone density 

Musculoskeletal Disorders

• Decreased 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 
• Unpleasant smell (nasal spray)
• Tinnitis

CYP3A4 inhibitors

None routine. Specific cases may require

• Height monitoring

Beclometasone crosses cell membranes and binds with high affinity to specific cytoplasmic receptors. The result includes inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of the inflammatory response, suppression of humoural immune responses, and reduction in oedema and scar tissue. The anti-inflammatory actions of glucocorticoids are thought to involve phospholipase A2 inhibitory proteins, called lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

Nasal spray (per spray) 50μg

• Beclate Aquanase (Cipla)
• Clenil Aquanase (Sandoz)

Nasal spray (per spray) 100μg

• Ventnaze Aquanase (Pharmacare)

Also available in the following forms: Cream and inhaler.