Fluticasone Propionate
Generic: FLUTICASONE PROPIONATE
Basic Information
Manufacturer
Cosette Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
e7ef2aaf-749c-66c9-2bdf-7214ab00060e
Indications & Usage
1 INDICATIONS AND USAGE Fluticasone propionate ointment, USP 0.005% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.
Fluticasone propionate ointment, USP 0.005% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.
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Fluticasone propionate ointment, USP 0.005% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.
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Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • HPA Axis Suppression and Other Adverse Endocrine Effects [ see Warnings and Precautions ( 5.1 ) ] • Local Adverse Reactions [ see Warnings and Precautions ( 5.2 ) ] • Concomitant Skin Infections [ see Warnings and Precautions ( 5.3 ) ] The most common adverse reactions (<1%) were pruritus, burning, hypertrichosis, increased erythema, urticaria, irritation, and lightheadedness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals,Inc.
at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In controlled clinical trials, the total incidence of adverse reactions associated with the use of fluticasone propionate ointment, 0.005% was approximately 4%.
These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, urticaria, irritation, and lightheadedness.
Each of these events occurred individually in less than 1% of patients.
6.2 Postmarketing Experience The following local adverse reactions have been identified during post-approval use of fluticasone propionate ointment, 0.005%: acneiform dermatitis, edema, rash, hypoaesthesia, pustular psoriasis, skin atrophy.
The following systemic adverse reactions have been identified during post-approval use of fluticasone propionate cream and fluticasone propionate ointment, 0.005%: immunosuppression/ Pneumocystis jirovecii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).
The following local adverse reactions have also been reported with the use of topical corticosteroids: telangiectasia, striae, dryness, folliculitis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals,Inc.
at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In controlled clinical trials, the total incidence of adverse reactions associated with the use of fluticasone propionate ointment, 0.005% was approximately 4%.
These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, urticaria, irritation, and lightheadedness.
Each of these events occurred individually in less than 1% of patients.
6.2 Postmarketing Experience The following local adverse reactions have been identified during post-approval use of fluticasone propionate ointment, 0.005%: acneiform dermatitis, edema, rash, hypoaesthesia, pustular psoriasis, skin atrophy.
The following systemic adverse reactions have been identified during post-approval use of fluticasone propionate cream and fluticasone propionate ointment, 0.005%: immunosuppression/ Pneumocystis jirovecii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).
The following local adverse reactions have also been reported with the use of topical corticosteroids: telangiectasia, striae, dryness, folliculitis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.