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Look Up > Drugs > Budesonide
Budesonide
Pronunciation
U.S. Brand Names
Generic Available
Canadian Brand Names
Pharmacological Index
Use
Pregnancy Risk Factor
Warnings/Precautions
Adverse Reactions
Overdosage/Toxicology
Drug Interactions
Mechanism of Action
Pharmacodynamics/Kinetics
Usual Dosage
Mental Health: Effects on Mental Status
Mental Health: Effects on Psychiatric Treatment
Dental Health: Local Anesthetic/Vasoconstrictor Precautions
Dental Health: Effects on Dental Treatment
Patient Information
Nursing Implications
Dosage Forms
References

Pronunciation
(byoo DES oh nide)

U.S. Brand Names
Pulmicort® Turbuhaler®; Rhinocort®; Rhinocort® Aqua™

Generic Available

No


Canadian Brand Names
Entocort®; Pulmicort®

Pharmacological Index

Corticosteroid, Oral Inhaler; Corticosteroid, Nasal


Use

Intranasal: Children and Adults: Management of symptoms of seasonal or perennial rhinitis

Oral inhalation: Maintenance and prophylactic treatment of asthma; includes patients who require corticosteroids and those who may benefit from systemic dose reduction/elimination


Pregnancy Risk Factor

C


Warnings/Precautions

Controlled clinical studies have shown that inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. Growth velocity provides a means of comparing the rate of growth among children of the same age.

FDA's Pulmonary and Allergy Drugs and Metabolic and Endocrine Drugs advisory committees discussed this issue at a July 1998 meeting. They recommended that the agency develop class-wide labeling to inform healthcare providers so they would understand this potential side effect and monitor growth routinely in pediatric patients who are treated with inhaled corticosteroids, intranasal corticosteroids or both.

Long-term effects of this reduction in growth velocity on final adult height are unknown. Likewise, it also has not yet been determined whether patients' growth will "catch up" if treatment in discontinued. Drug manufacturers will continue to monitor these drugs to learn more about long-term effects. Children are prescribed inhaled corticosteroids to treat asthma. Intranasal corticosteroids are generally used to prevent and treat allergy-related nasal symptoms.

Patients are advised not to stop using their inhaled or intranasal corticosteroids without first speaking to their healthcare providers about the benefits of these drugs compared to their risks.


Adverse Reactions

>10%:

Cardiovascular: Pounding heartbeat

Central nervous system: Nervousness, headache, dizziness

Dermatologic: Itching, rash

Gastrointestinal: GI irritation, bitter taste, oral candidiasis

Respiratory: Coughing, upper respiratory tract infection, bronchitis, hoarseness

Miscellaneous: Increased susceptibility to infections, diaphoresis

1% to 10%:

Central nervous system: Insomnia, psychic changes

Dermatologic: Acne, urticaria

Endocrine & metabolic: Menstrual problems

Gastrointestinal: Anorexia, increase in appetite, xerostomia, dry throat, loss of taste perception

Ocular: Cataracts

Respiratory: Epistaxis

Miscellaneous: Loss of smell

<1%: Abdominal fullness, bronchospasm, shortness of breath


Overdosage/Toxicology

Symptoms of overdose include irritation and burning of the nasal mucosa, sneezing, intranasal and pharyngeal Candida infections, nasal ulceration, epistaxis, rhinorrhea, nasal stuffiness, headache. When consumed in excessive quantities, systemic hypercorticism and adrenal suppression may occur, in those cases discontinuation and withdrawal of the corticosteroid should be done judiciously.


Drug Interactions

CYP3A3/4 enzyme substrate


Mechanism of Action

Controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes, fibroblasts, reverses capillary permeability, and lysosomal stabilization at the cellular level to prevent or control inflammation


Pharmacodynamics/Kinetics

Oral inhalation:

Half-life, plasma: 2-3 hours


Usual Dosage

Children <6 years: Not recommended

Aerosol inhalation: Children greater than or equal to 6 years and Adults:

Rhinocort®: Nasal: Initial: 8 sprays (4 sprays/nostril) per day (256 mcg/day), given as either 2 sprays in each nostril in the morning and evening or as 4 sprays in each nostril in the morning; after symptoms decrease (usually by 3-7 days), reduce dose slowly every 2-4 weeks to the smallest amount needed to control symptoms

Rhinocort® Aqua™: 64 mcg/day as a single 32 mcg spray in each nostril. Some patients who do not achieve adequate control may benefit from increased dosage. A reduced dosage may be effective after initial control is achieved.

Maximum dose: Children <12 years: 129 mcg/day; Adults: 256 mcg/day

Oral inhalation:

Children greater than or equal to 6 years:

Previous therapy of bronchodilators alone: 200 mcg twice initially which may be increased up to 400 mcg twice daily

Previous therapy of inhaled corticosteroids: 200 mcg twice initially which may be increased up to 400 mcg twice daily

Previous therapy of oral corticosteroids: The highest recommended dose in children is 400 mcg twice daily

Adults:

Previous therapy of bronchodilators alone: 200-400 mcg twice initially which may be increased up to 400 mcg twice daily

Previous therapy of inhaled corticosteroids: 200-400 mcg twice initially which may be increased up to 800 mcg twice daily

Previous therapy of oral corticosteroids: 400-800 mcg twice daily which may be increased up to 800 mcg twice daily

NIH Guidelines (NIH, 1997) (give in divided doses twice daily):

Children:

"Low" dose: 100-200 mcg/day

"Medium" dose: 200-400 mcg/day (1-2 inhalations/day)

"High" dose: >400 mcg/day (>2 inhalation/day)

Adults:

"Low" dose: 200-400 mcg/day (1-2 inhalations/day)

"Medium" dose: 400-600 mcg/day (2-3 inhalations/day)

"High" dose: >600 mcg/day (>3 inhalation/day)


Mental Health: Effects on Mental Status

May cause nervousness and insomnia


Mental Health: Effects on Psychiatric Treatment

None reported


Dental Health: Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions


Dental Health: Effects on Dental Treatment

Localized infections with Candida albicans or Aspergillus niger have occurred frequently in the mouth and pharynx with repetitive use of oral inhaler of beclomethasone. Positive cultures for oral Candida may be present in up to 75% of patients. These infections may require treatment with appropriate antifungal therapy or discontinuance of treatment with beclomethasone inhaler.


Patient Information

Use as directed; do not increase dosage or discontinue abruptly without consulting prescriber. It may take several days for you to realize full effects of treatment. If you are also using an inhaled bronchodilator, wait 10 minutes before using this steroid aerosol. You may experience dizziness, anxiety, or blurred vision (rise slowly from sitting or lying position and use caution when driving or engaging in tasks requiring alertness until response to drug is known); or taste disturbance or aftertaste (frequent mouth care and mouth rinses may help). Report pounding heartbeat or chest pain; acute nervousness or inability to sleep; severe sneezing or nosebleed; difficulty breathing, sore throat, hoarseness, or bronchitis; respiratory difficulty or bronchospasms; disturbed menstrual pattern; vision changes; loss of taste or smell perception; or worsening of condition or lack of improvement. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.


Nursing Implications

Inhaler should be shaken well immediately prior to use; while activating inhaler, deep breathe for 3-5 seconds, hold breath for ~10 seconds and allow greater than or equal to 1 minute between inhalations


Dosage Forms

Aerosol: 50 mcg released per actuation to deliver ~32 mcg to patient via nasal adapter [200 metered doses] (7 g)

Rhinocort® Aqua™: 32 mcg (60, 120 metered sprays); 64 mcg (120 metered sprays)

Turbuhaler: ~160 mcg delivered (200 mcg released) with each actuation (200 doses/inhaler)


References

Expert Panel Report 2, "Guidelines for the Diagnosis and Management of Asthma," Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 94-4051, April, 1997.


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