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Look Up > Drugs > Fluticasone
Fluticasone
Pronunciation
U.S. Brand Names
Generic Available
Synonyms
Pharmacological Index
Use
Pregnancy Risk Factor
Contraindications
Warnings/Precautions
Adverse Reactions
Overdosage/Toxicology
Drug Interactions
Mechanism of Action
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
(floo TIK a sone)

U.S. Brand Names
Cutivate™; Flonase®; Flovent®

Generic Available

No


Synonyms
Fluticasone Propionate

Pharmacological Index

Corticosteroid, Oral Inhaler; Corticosteroid, Nasal


Use

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]


Pregnancy Risk Factor

C


Contraindications

Hypersensitivity to any component, bacterial infections, ophthalmic use


Warnings/Precautions

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.


Adverse Reactions

>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.


Overdosage/Toxicology

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

No data reported


Mechanism of Action

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.


Usual Dosage

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.


Mental Health: Effects on Mental Status

None reported


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

No effects or complications reported


Patient Information

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.


Nursing Implications

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


Dosage Forms

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 )


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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