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Pronunciation |
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(floo
NIS oh
lide) |
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U.S. Brand
Names |
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AeroBid®-M Oral Aerosol Inhaler;
AeroBid® Oral Aerosol Inhaler; Nasalide® Nasal Aerosol;
Nasarel® Nasal
Spray |
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Generic
Available |
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No |
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Canadian Brand
Names |
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Bronalide®; Rhinalar®;
Rhinaris®-F; Syn-Flunisolide |
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Pharmacological Index |
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Corticosteroid, Oral Inhaler; Corticosteroid, Nasal |
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Use |
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Steroid-dependent asthma; nasal solution is used for seasonal or perennial
rhinitis |
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Pregnancy Risk
Factor |
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C |
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Pregnancy/Breast-Feeding
Implications |
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Clinical effects on the fetus: No data on crossing the placenta or effects on
the fetus
Breast-feeding/lactation: No data on crossing into breast milk or effects on
the infant |
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Contraindications |
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Known hypersensitivity to flunisolide, acute status asthmaticus; viral,
tuberculosis, fungal or bacterial respiratory infections, or infections of nasal
mucosa |
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Warnings/Precautions |
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Use with caution in patients with hypothyroidism, cirrhosis, hypertension,
congestive heart failure, ulcerative colitis, thromboembolic disorders; do not
stop medication abruptly if on prolonged therapy; fatalities have occurred due
to adrenal insufficiency in asthmatic patients during and after transfer from
systemic corticosteroids to aerosol steroids; several months may be required for
recovery of this syndrome; during this period, aerosol steroids do not
provide the systemic steroid needed to treat patients having trauma, surgery or
infections. When consumed in excessive quantities, systemic hypercorticism and
adrenal suppression may occur; withdrawal and discontinuation of the
corticosteroid should be done carefully. 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: Dizziness, headache, nervousness
Dermatologic: Itching, rash
Endocrine & metabolic: Adrenal suppression, menstrual problems
Gastrointestinal: GI irritation, anorexia, sore throat, bitter taste
Local: Nasal burning, Candida infections of the nose or pharynx,
atrophic rhinitis
Respiratory: Sneezing, coughing, upper respiratory tract infection,
bronchitis, nasal congestion, nasal dryness
Miscellaneous: Increased susceptibility to infections
1% to 10%:
Central nervous system: Insomnia, psychic changes
Dermatologic: Acne, urticaria
Gastrointestinal: Increase in appetite, xerostomia, dry throat, loss of taste
perception
Ocular: Cataracts
Respiratory: Epistaxis
Miscellaneous: Diaphoresis, loss of smell
<1%: Abdominal fullness, bronchospasm, shortness of breath
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Overdosage/Toxicology |
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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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Expected interactions similar to other corticosteroids |
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Mechanism of
Action |
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Decreases inflammation by suppression of migration of polymorphonuclear
leukocytes and reversal of increased capillary permeability; does not depress
hypothalamus |
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Pharmacodynamics/Kinetics |
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Absorption: Nasal inhalation: ~50%
Metabolism: Rapidly in the liver to active metabolites
Half-life: 1.8 hours
Elimination: Equally in urine and feces |
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Usual Dosage |
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Children >6 years:
Oral inhalation: 2 inhalations twice daily (morning and evening) up to 4
inhalations/day
Nasal: 1 spray each nostril twice daily (morning and evening), not to exceed
4 sprays/day each nostril
Adults:
Oral inhalation: 2 inhalations twice daily (morning and evening) up to 8
inhalations/day maximum
Nasal: 2 sprays each nostril twice daily (morning and evening); maximum dose:
8 sprays/day in each nostril |
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Mental Health: Effects
on Mental Status |
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Dizziness and nervousness are common; may cause 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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No effects or complications reported |
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Patient
Information |
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Use as directed; do not use nasal preparations for oral inhalation. Do not
increase dosage or discontinue abruptly without consulting prescriber. Review
use of inhaler or spray with prescriber or follow package insert for directions.
Keep oral inhaler clean and unobstructed. Always rinse mouth and throat after
use of inhaler to prevent opportunistic infection. 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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Shake well before giving; do not use Nasalide® orally;
throw out product after it has been opened for 3 months |
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Dosage Forms |
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Inhalant:
Nasal (Nasalide®, Nasarel™): 25
mcg/actuation [200 sprays] (25 mL)
Oral:
AeroBid®: 250 mcg/actuation [100 metered doses] (7 g)
AeroBid-M® (menthol flavor): 250 mcg/actuation [100
metered doses] (7 g)
Solution, spray: 0.025% [200 actuations] (25 mL) |
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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.
Expert Panel Report, National Asthma Education Program,
"National Heart, Lung and Blood Institute: Guidelines for the Diagnosis and Management of Asthma,"
J Allergy Clin Immunol, 1991, 88(3 pt 2):425-534.
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