Chemical formula: C₂₈H₃₇ClO₇ Molecular mass: 521.042 g/mol PubChem compound: 21700
Beclometasone interacts in the following cases:
Beclometasone should be used with caution in patients with gastro-duodenal ulcer.
Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.
Beclometasone should be used with caution in patients with diabetes mellitus.
Beclometasone should be used with caution in patients with cataract.
Beclometasone should be used with caution in patients with hypoadrenalism.
Beclometasone should be used with caution in patients with glaucoma.
Beclometasone should be used with caution in patients with serious arterial hypertension.
Beclometasone should be used with caution in patients with osteoporosis.
There is no experience of the use of this product 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 fetus or neonate.
There is inadequate evidence of safety of beclometasone in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may therefore, be a risk of such effects in the human fetus. It should be noted, however, that the fetal 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.
There is no experience with or evidence of safety of propellant HFA-134a in human pregnancy. However, studies of the effect of HFA-134a on reproductive function and embryofetal development in animals have revealed no clinically relevant adverse effects.
There is no experience of the use of this product in lactation in humans. It should not be used in lactation unless the expected benefits to the mother are thought to outweigh any potential risks to the fetus or neonate.
No specific studies examining the transfer of beclometasone into the milk of lactating animals have been performed. It is reasonable to assume that beclometasone 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 human lactation.
None reported.
h2 ®. Respiratory administration
Adverse events are listed below by system class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (≤1/10,000), unknown (frequency cannot be estimated from the available data).
Very Common: Oral candidiasis (of the mouth and throat)
Hypersensitivity reaction with the following manifestations:
Uncommon: Rash, urticaria, pruritus, erythema
Very Rare: Oedema of the eyes, face, lips and throat
Very Rare: Adrenal suppression*, growth retardation* (in children and adolescents), bone density decreased*
Unknown: Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural disorders (predominantly in children)
Unknown: Headache
Very Rare: Cataract*, glaucoma*
Unknown: Vision, blurred
Common: Hoarseness, throat irritation
Very Rare: Paradoxial bronchospasm, wheezing, dyspnoea, cough
Unknown: Nausea
* Systemic reactions are a possible response to inhaled corticosteroids, especially when a high dose is prescribed for a prolonged time.
As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing, shortness of breath and cough after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. Beclometasone Modulite should be discontinued immediately, the patient assessed and, if necessary, alternative therapy instituted.
Candidiasis of the mouth and throat occurs in some patients, the incidence increasing with doses greater than 400 micrograms beclometasone dipropionate per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Patients may find it helpful to rinse their mouth thoroughly with water after inhalation. Symptomatic oral candidiasis can be treated with topical antifungal therapy while continuing with beclometasone.
Hoarseness or throat irritation may occur in some patients. These patients should be advised to rinse the mouth out with water immediately after inhalation. Use of the Volumatic spacer device may be considered.
h2 ®. Nasal administration
A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely.
As with other inhalation therapy, paradoxical bronchospasm may occur after dosing. Immediate treatment with a short-acting bronchodilator should be initiated, beclometasone should be discontinued immediately and an alternative prophylactic treatment introduced.
Systemic effects of inhaled corticosteroids may occur, particularly with high doses prescribed for prolonged periods. These include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density and the occurrence of cataract and glaucoma.
Commonly, when taking beclometasone, hoarseness and candidiasis of the throat and mouth may occur. To reduce the risk of hoarseness and candida infection, patients are advised to rinse their mouth after using their inhaler.
Based on the MedDra system organ class and frequencies, adverse events are listed below according to the following frequency estimate: very common (≥1/10); common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Common: Candidiasis in mouth and throat
Rare: Allergic reactions, angioedema in eyes, throat, lips and face
Very rare: Adrenal suppression*, growth retardation* (in children and adolescents), bone density decreased*
Unknown: Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (predominantly in children)
Uncommon: Headache, vertigo, tremor
Uncommon: Vision, blurred
Very rare: Cataract*, glaucoma*
Not known: Central serous retinopathy
Common: Hoarseness, pharyngitis
Uncommon: Cough, increased asthma symptoms
Rare: Paradoxical bronchospasm
Common: Taste disturbances
Uncommon: Nausea
Uncommon: Urticaria, rash, pruritus, erythema, purpura
Very rare: Decrease bone mineral density
* Systemic reactions are a possible response to inhaled corticosteroids, especially when a high dose is prescribed for a prolonged time.
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