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Pronunciation |
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(floo
TIK a
sone) |
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U.S. Brand
Names |
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Cutivate™; Flonase®;
Flovent® |
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Generic
Available |
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No |
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Synonyms |
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Fluticasone Propionate |
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Pharmacological Index |
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Corticosteroid, Oral Inhaler; Corticosteroid, Nasal |
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Use |
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Inhalation: Maintenance treatment of asthma as prophylactic therapy. It is
also indicated for patients requiring oral corticosteroid therapy for asthma to
assist in total discontinuation or reduction of total oral dose. NOT indicated
for the relief of acute bronchospasm.
Intranasal: Management of seasonal and perennial allergic rhinitis in
patients greater than or equal to 12 years of age
Topical: Relief of inflammation and pruritus associated with
corticosteroid-responsive dermatoses [medium potency topical corticosteroid]
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Hypersensitivity to any component, bacterial infections, ophthalmic
use |
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Warnings/Precautions |
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Adverse systemic effects may occur when used on large areas of the body,
denuded areas, for prolonged periods of time, with an occlusive dressing, and/or
in infants or small children. 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. Use in pediatric patients longer than 4
weeks has not been established.
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.
Use of topical fluticasone in patients <4 years of age has not been
established.
Rare cases of vasculitis (Churg-Strauss syndrome) can occur.
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Adverse
Reactions |
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>10%: Oral inhalation:
Central nervous system: Headache
Respiratory: Respiratory infection, pharyngitis, nasal congestion
1% to 10%: Oral Inhalation:
Central nervous system: Dysphonia
Gastrointestinal: Oral candidiasis
Respiratory: Sinusitis
<1%: Acne, hypopigmentation, allergic dermatitis, maceration of the skin,
skin atrophy, folliculitis, hypertrichosis, itching, dry skin, HPA suppression,
Cushing's syndrome, growth retardation, burning, irritation, secondary
infection, Churg-Strauss syndrome. |
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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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No data reported |
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Mechanism of
Action |
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Fluticasone belongs to a new group of corticosteroids which utilizes a
fluorocarbothioate ester linkage at the 17 carbon position; extremely potent
vasoconstrictive and anti-inflammatory activity; has a weak hypothalamic
-pituitary- adrenocortical axis (HPA) inhibitory potency when applied topically,
which gives the drug a high therapeutic index. The mechanism of action for all
topical corticosteroids is believed to be a combination of three important
properties: anti-inflammatory activity, immunosuppressive properties, and
antiproliferative actions. |
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Usual Dosage |
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Flovent® Rotadisk can now be used in children greater
than or equal to 4 years; Flovent® is still indicated for
use greater than or equal to 12 years of age; topical product
(Cutivate®) approved for use in pediatric patients 3
months of age and older
Intranasal: Initially 1 spray (50 mcg/spray) per nostril once daily. Patients
not adequately responding or patients with more severe symptoms may use 2 sprays
(100 mcg) per nostril. Depending on response, dosage may be reduced to 100 mcg
daily. Total daily dosage should not exceed 2 sprays in each nostril (200
mcg)/day.
Adults:
Inhalation, Oral: Dosing based on previous therapy:
Bronchodilator alone:
Recommended starting dose: 88 mcg twice daily; highest recommended dose: 440
mcg twice daily
Inhaled corticosteroids:
Recommended starting dose: 88-220 mcg twice daily; highest recommended dose:
440 mcg twice daily
Oral corticosteroids:
Recommended starting dose: 880 mcg twice daily; highest recommended dose: 880
mcg twice daily
Intranasal: Initial: 2 sprays (50 mcg/spray) per nostril once daily; after
the first few days, dosage may be reduced to 1 spray per nostril once daily for
maintenance therapy; maximum total daily dose should not exceed 4 sprays (200
mcg)/day
Adults and Children > 3 months of age:
Topical: Apply sparingly in a thin film twice daily. Therapy should be
discontinued when control is achieved. If no improvement is seen, reassessment
of diagnosis may be necessary. |
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Mental Health: Effects
on Mental Status |
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None reported |
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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 overuse and use only for length of time prescribed.
Pregnancy/breast-feeding precautions: Inform prescriber if you are or
intend to be pregnant. Consult prescriber if breast-feeding.
Nasal spray: Shake gently before use. Use at regular intervals, no more
frequently than directed. Report unusual cough or spasm; persistent nasal
bleeding, burning, or irritation; or worsening of condition.
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Nursing
Implications |
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A thin film of cream or ointment is effective; do not overuse; do not use
tight-fitting diapers or plastic pants on children being treated in the diaper
area; use only as prescribed, and for no longer than the period prescribed;
apply sparingly in light film; rub in lightly; avoid contact with eyes; notify
physician if condition being treated persists or worsens |
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Dosage Forms |
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Spray, aerosol, oral inhalation (Flovent®): 44
mcg/actuation (7.9 g = 60 actuations or 13 g = 120 actuations), 110
mcg/actuation (13 g = 120 actuations); 220 mcg/actuation (13 g = 120 actuations)
Spray, intranasal (Flonase®): 50 mcg/actuation (16 g =
120 actuations)
Topical (Cutivate™):
Cream: 0.05% (15 g, 30 g, 60 g)
Ointment: 0.005% (15 g, 60 g ) |
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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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