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Pronunciation |
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(byoo
DES oh
nide) |
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U.S. Brand
Names |
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Pulmicort®
Turbuhaler®; Rhinocort®; Rhinocort®
Aqua™ |
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Generic
Available |
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No |
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Canadian Brand
Names |
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Entocort®;
Pulmicort® |
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Pharmacological Index |
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Corticosteroid, Oral Inhaler; Corticosteroid, Nasal |
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Use |
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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 |
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Pregnancy Risk
Factor |
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C |
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Warnings/Precautions |
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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. |
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Adverse
Reactions |
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>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
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Overdosage/Toxicology |
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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. |
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Drug
Interactions |
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CYP3A3/4 enzyme substrate |
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Mechanism of
Action |
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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 |
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Pharmacodynamics/Kinetics |
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Oral inhalation:
Half-life, plasma: 2-3 hours |
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Usual Dosage |
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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) |
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Mental Health: Effects
on Mental Status |
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May cause nervousness and insomnia |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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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. |
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Patient
Information |
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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. |
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Nursing
Implications |
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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 |
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Dosage Forms |
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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) |
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References |
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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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