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Qvar RediHaler

Generic Name: Beclomethasone Dipropionate HFA
Drug Category: Corticosteroid
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 4 years old for a maximum duration of 1 year.

Approved Uses

Indicated in the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. 

QVAR REDIHALER is not indicated for the relief of acute bronchospasm.

QVAR REDIHALER is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

The maximum recommended dosage for patients 12 years of age and older is 320 mcg twice daily.

The maximum recommended dosage for patients 4 to 11 years of age is 80 mcg twice daily.

The maximum number of inhalations should not exceed 8 per day.

As with any inhaled corticosteroid, physicians are advised to titrate the dose of QVAR REDIHALER downward over time to the lowest level that maintains proper asthma control. This is particularly important in children since a controlled study has shown that beclomethasone dipropionate has the potential to affect growth in children.

Particular care is needed in patients who are transferred from systemically active corticosteroids to QVAR REDIHALER because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Transfer of patients from systemic corticosteroid therapy to QVAR REDIHALER may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

Orally inhaled corticosteroids, including QVAR REDIHALER, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving QVAR routinely (e.g., via stadiometry).

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term administration of inhaled corticosteroids.

Aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported (primarily in children).

Localized infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving QVAR REDIHALER.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune patients on corticosteroids. In such patients who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure.

Inhaled corticosteroids may produce inhalation-induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when beclomethasone dipropionate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of QVAR REDIHALER should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

There are no adequate and well-controlled studies with QVAR REDIHALER or beclomethasone dipropionate in pregnant women. Animal studies: adverse developmental effects including injury to fetal adrenal glands.

Corticosteroids are secreted in human milk. Caution should be exercised when QVAR REDIHALER  is administered to a nursing mother.

GoToSource

Off-label Uses

• Use in patients under the age of 4. GoToSource 

• Chronic obstructive pulmonary disease. GoToSource

• Cystic fibrosis. GoToSource

Adverse Events

Pulmonary eosinophilia (respiratory disorder). GoToSource

Growth suppression in children. GoToSource

Posterior subcapsular cataracts, ocular hypertension and glaucoma. GoToSource

Reduction of bone mineral density. GoToSource

Allergic contact dermatitis. GoToSource

Paradoxical bronchospasm. GoToSource 

Adrenal insufficiency (adrenal glands do not make enough of the hormone cortisol). GoToSource

Oropharyngeal candidiasis (yeast infection of mouth and throat). GoToSource 

Central serous chorioretinopathy (fluid builds up under the retina). GoToSource

Non-vertebral fractures. GoToSource

Litigation

Lawsuits filed for central serous chorioretinopathy. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated April 25, 2024