Formulary
Beclometasone dipropionate: Indications, Dosing, Side Effects and Interactions
Beclometasone dipropionate clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 10 min read
Beclometasone dipropionate: Indications, Dosing, Side Effects and Interactions
Beclometasone dipropionate clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Prophylaxis of asthma**
- **Child** (By Inhalation Of Aerosol): 100 micrograms twice daily; increased if necessary up to 400 micrograms daily in 2-4 divided doses.
- **Adult** (By Inhalation Of Aerosol): 200 micrograms twice daily; increased if necessary up to 2 mg daily in 2-4 divided doses.
**Severe inflammatory skin disorders such as eczemas unresponsive to less potent corticosteroids,Psoriasis**
- **Child** (To The Skin): Apply 1-2 times a day, to be applied thinly.
- **Adult** (To The Skin): Apply 1-2 times a day, to be applied thinly.
**Adjunct to aminosalicylates in acute mild to moderate ulcerative colitis**
- **Adult** (By Mouth): 5 mg once daily maximum duration of treatment of 4 weeks, dose to be taken in the morning.
**Prophylaxis of asthma for beclometasone dipropionate**
- **Child 5-11 years** (By inhalation of powder): 100-200 micrograms twice daily, dose to be adjusted as necessary.
- **Child 12-17 years** (By inhalation of powder): 200-400 micrograms twice daily; increased if necessary up to 800 micrograms twice daily, dose to be adjusted as necessary.
**Prophylaxis and treatment of allergic and vasomotor rhinitis for beclometasone dipropionate**
- **Child 6-17 years** (By intranasal administration): 100 micrograms twice daily, dose to be administered into each nostril, reduced to 50 micrograms twice daily, dose to be administered into each nostril, dose to be reduced when symptoms controlled.
**Severe inflammatory skin disorders such as eczemas unresponsive to less potent corticosteroids, Psoriasis for beclometasone dipropionate**
- **Child** (To the skin): Apply 1-2 times a day, to be applied thinly.
**Prophylaxis of asthma for Clenil Modulite**
- **Child 2-11 years** (By inhalation of aerosol): 100-200 micrograms twice daily.
- **Child 12-17 years** (By inhalation of aerosol): 200-400 micrograms twice daily; increased if necessary up to 1 mg twice daily.
**Prophylaxis of asthma for Qvar preparations**
- **Child 5-11 years** (By inhalation of aerosol): 50-100 micrograms twice daily, using Autohaler or MDI device.
- **Child 12-17 years** (By inhalation of aerosol): 50-200 micrograms twice daily, using Autohaler, MDI, or Easi-Breathe device; increased if necessary up to 400 micrograms twice daily.
**Prophylaxis of asthma for Soprobec**
- **Child** (By inhalation of aerosol): 100 micrograms twice daily; increased if necessary up to 400 micrograms daily in 2-4 divided doses.
Cautions
For all corticosteroids (intranasal) Avoid after nasal surgery (until healing has occurred); avoid in pulmonary tuberculosis; avoid in the presence of untreated nasal infections; patients transferred from systemic corticosteroids may experience exacerbation of some symptoms Cautions, further information Systemic absorption Systemic absorption may follow nasal administration particularly if high doses are used or if treatment is prolonged; therefore also consider the cautions and side-effects of systemic corticosteroids. The risk of systemic effects may be greater with nasal drops than with nasal sprays; drops are administered incorrectly more often than sprays. Cautions For all corticosteroids (systemic) Congestive heart failure; diabetes mellitus (including a family history of); diverticular disease (increased risk of diverticular perforation); diverticulitis; epilepsy; glaucoma (including a family history of or susceptibility to); history of steroid myopathy; history of tuberculosis or X-ray changes (frequent monitoring required); hypertension; hypothyroidism; infection (particularly untreated); long-term use; myasthenia gravis; ocular herpes simplex (risk of corneal perforation); osteoporosis (in children); osteoporosis (postmenopausal women and the elderly at risk) (in adults); peptic ulcer; psychiatric reactions; recent intestinal anastomoses; recent myocardial infarction (rupture reported); severe affective disorders (particularly if history of steroid-induced psychosis); thromboembolic disorders; ulcerative colitis Cautions, further information With intra-articular use or intradermal use or intralesional use: For further information on cautions associated with intra-articular, intradermal, and intralesional preparations, consult product literature. Elderly In adults: Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: if used instead of inhaled corticosteroids for maintenance therapy in moderate to severe COPD (unnecessary exposure to long-term side-effects) as long-term (longer than 3 months) monotherapy for rheumatoid arthritis (risk of side-effects) for treatment of osteoarthritis other than for periodic intra-articular injections for monoarticular pain (risk of side-effects) with concurrent NSAIDs without proton pump inhibitor prophylaxis (increased risk of peptic ulcer disease) Cautions For all corticosteroids (topical) Avoid prolonged use (particularly on the face); cautions applicable to systemic corticosteroids may also apply if absorption occurs following topical and local use; dermatoses of infancy, including nappy rash (extreme caution required-treatment should be limited to 5-7 days) (in children); infection; keep away from eyes; use potent or very potent topical corticosteroids under specialist supervision (in children); use potent or very potent topical corticosteroids under specialist supervision in psoriasis (can result in rebound relapse, development of generalised pustular psoriasis, and local and systemic toxicity) (in adults)
Contraindications
For all corticosteroids (systemic) Avoid live virus vaccines in those receiving immunosuppressive doses (serum antibody response diminished); systemic infection (unless specific therapy given) Contra-indications, further information With intra-articular use or intradermal use or intralesional use: For further information on contra-indications associated with intra-articular, intradermal and intralesional preparations, consult product literature. Contra-indications For all corticosteroids (topical) Acne; perioral dermatitis; potent corticosteroids in widespread plaque psoriasis; rosacea; untreated bacterial, fungal or viral skin lesions
Side effects
For all corticosteroids (inhaled) Common or very common Headache; oral candidiasis; pneumonia (in patients with COPD); taste altered; voice alteration Uncommon Bronchospasm paradoxical; cataract; vision blurred Rare or very rare Adrenal suppression; anxiety; behaviour abnormal; glaucoma; growth retardation (in children); sleep disorder Side-effects, further information Systemic absorption may follow inhaled administration particularly if high doses are used or if treatment is prolonged. Therefore also consider the side-effects of systemic corticosteroids. Candidiasis The risk of oral candidiasis can be reduced by using a spacer device with the corticosteroid inhaler; rinsing the mouth with water after inhalation of a dose may also be helpful. An anti-fungal oral suspension or oral gel can be used to treat oral candidiasis without discontinuing corticosteroid therapy. Paradoxical bronchospasm The potential for paradoxical bronchospasm (calling for discontinuation and alternative therapy) should be borne in mind. Mild bronchospasm may be prevented by inhalation of a short-acting beta2 agonist beforehand (or by transfer from an aerosol inhalation to a dry powder inhalation). Side-effects For all corticosteroids (intranasal) Common or very common Altered smell sensation; epistaxis; headache; nasal complaints; taste altered; throat irritation Rare or very rare Glaucoma; nasal septum perforation (more common following nasal surgery); vision blurred Side-effects, further information Systemic absorption may follow nasal administration particularly if high doses are used or if treatment is prolonged. Therefore also consider the side-effects of systemic corticosteroids. Side-effects For all corticosteroids (systemic) Common or very common Anxiety; appetite increased; behaviour abnormal; cataract subcapsular; cognitive impairment; Cushing's syndrome; electrolyte imbalance; fluid retention; gastrointestinal discomfort; headache; healing impaired; hirsutism; hypertension; increased risk of infection; menstrual cycle irregularities; mood altered; nausea; osteoporosis; peptic ulcer; psychotic disorder; skin reactions; sleep disorder; vision blurred; weight increased Uncommon Adrenal suppression; alkalosis hypokalaemic; bone fractures; diabetic control impaired; glaucoma; haemorrhage; heart failure; hyperhidrosis; leucocytosis; myopathy; osteonecrosis; pancreatitis; papilloedema; seizure; thromboembolism; tuberculosis reactivation; vertigo Rare or very rare Tendon rupture Frequency not known Chorioretinopathy; eye disorders; growth retardation (very common in children); intracranial pressure increased with papilloedema (usually after withdrawal) Side-effects, further information Adrenal suppression During prolonged therapy with corticosteroids, particularly with systemic use, adrenal atrophy develops and can persist for years after stopping. Abrupt withdrawal after a prolonged period can lead to acute adrenal insufficiency, hypotension, or death. To compensate for a diminished adrenocortical response caused by prolonged corticosteroid treatment, any significant intercurrent illness, trauma, or surgical procedure requires a temporary increase in corticosteroid dose, or if already stopped, a temporary reintroduction of corticosteroid treatment. For vamorolone, there is no evidence on the effects of increasing the dose, and temporary supplementation with hydrocortisone is advised. Infections Prolonged courses of corticosteroids increase susceptibility to infections and severity of infections; clinical presentation of infections may also be atypical. Serious infections e.g. septicaemia and tuberculosis may reach an advanced stage before being recognised, and amoebiasis or strongyloidiasis may be activated or exacerbated (exclude before initiating a corticosteroid in those at risk or with suggestive symptoms). Fungal or viral ocular infections may also be exacerbated. Chickenpox Unless they have had chickenpox, patients receiving oral or parenteral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature. Passive immunisation with varicella-zoster immunoglobulin is needed for exposed non-immune patients receiving systemic corticosteroids or for those who have used them within the previous 3 months. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and dosage may need to be increased. Measles Patients taking corticosteroids should be advised to take particular care to avoid exposure to measles and to seek immediate medical advice if exposure occurs. Prophylaxis with intramuscular normal immunoglobulin may be needed. Psychiatric reactions Systemic corticosteroids, particularly in high doses, are linked to psychiatric reactions including euphoria, insomnia, irritability, mood lability, suicidal thoughts, psychotic reactions, and behavioural disturbances. These reactions frequently subside on reducing the dose or discontinuing the corticosteroid but they may also require specific management. Patients should be advised to seek medical advice if psychiatric symptoms (especially depression and suicidal thoughts) occur and they should also be alert to the rare possibility of such reactions during withdrawal of corticosteroid treatment. Systemic corticosteroids should be prescribed with care in those predisposed to psychiatric reactions, including those who have previously suffered corticosteroid-induced psychosis, or who have a personal or family history of psychiatric disorders. When used by eye (topical) Vision disorders can occur with use of topical (eye) corticosteroids. Consider seeking specialist advice to evaluate cause if vision blurred or other vision disorder occurs. Side-effects For all corticosteroids (topical) Common or very common Skin reactions; telangiectasia Rare or very rare Adrenal suppression; hypertrichosis; skin depigmentation (may be reversible) Frequency not known Local reaction; vasodilation Side-effects, further information Side-effects applicable to systemic corticosteroids may also apply if absorption occurs following topical and local use. In order to minimise the side-effects of a topical corticosteroid, it is important to apply it thinly to affected areas only, no more frequently than twice daily, and to use the least potent formulation which is fully effective. Side-effects For beclometasone dipropionate Common or very common When used by inhalation Throat irritation Uncommon With oral use Constipation; idiopathic intracranial hypertension; muscle cramps Rare or very rare When used by inhalation Wheezing Frequency not known With topical use Vision blurred
Pregnancy
For all corticosteroids (inhaled) Inhaled drugs for asthma can be taken as normal during pregnancy. Pregnancy For all corticosteroids (systemic) The benefit of treatment with corticosteroids during pregnancy outweighs the risk. Corticosteroid cover is required during labour. Following a review of the data on the safety of systemic corticosteroids used in pregnancy and breast-feeding the CSM (May 1998) concluded that corticosteroids vary in their ability to cross the placenta but there is no convincing evidence that systemic corticosteroids increase the incidence of congenital abnormalities such as cleft palate or lip. When administration is prolonged or repeated during pregnancy, systemic corticosteroids increase the risk of intra-uterine growth restriction; there is no evidence of intra-uterine growth restriction following short-term treatment (e.g. prophylactic treatment for neonatal respiratory distress syndrome). Any adrenal suppression in the neonate following prenatal exposure usually resolves spontaneously after birth and is rarely clinically important. Monitoring in pregnancy Pregnant women with pre-eclampsia or fluid retention should be monitored closely when given systemic corticosteroids.
Breast feeding
For all corticosteroids (inhaled) Inhaled corticosteroids for asthma can be taken as normal during breast-feeding. Breast feeding For all corticosteroids (systemic) The benefit of treatment with corticosteroids during breast-feeding outweighs the risk.
Hepatic impairment
For all corticosteroids (systemic) In general, manufacturers advise caution (risk of increased exposure). Hepatic impairment For beclometasone dipropionate With oral use in adults: Manufacturer advises avoid in severe impairment (no information available).
Renal impairment
For all corticosteroids (systemic) In general, manufacturers advise caution.
Medicinal forms
Tablet,Powder,Spray,Cream,Ointment
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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