Fluocinonide
Fluocinonide Prescribing Information
Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (
Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older.
Limitation of Use:
- Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
- Avoid use on the face, groin, or axillae.
- Avoid use in perioral dermatitis or rosacea.
Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.
Fluocinonide cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
Limitation of Use:
- Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. ()
1 INDICATIONS AND USAGEFluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older.
Limitation of Use:
- Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
- Avoid use on the face, groin, or axillae.
- Avoid use in perioral dermatitis or rosacea.
1.1 IndicationFluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [
seeUseinSpecificPopulations].1.2 Limitation of UseTreatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.
Fluocinonide cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
- Avoid use on the face, groin, or axillae. ()1.2 Limitation of Use
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.
Fluocinonide cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
- Avoid use in perioral dermatitis or rosacea.
For topical use only. Fluocinonide cream is not for ophthalmic, oral, or intravaginal use. (2)
For topical use only. Fluocinonide cream is not for ophthalmic, oral, or intravaginal use. (2)
For topical use only. Fluocinonide cream is not for ophthalmic, oral, or intravaginal use.
For psoriasis, apply a thin layer of fluocinonide cream once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.
For atopic dermatitis, apply a thin layer of fluocinonide cream once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [
For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of fluocinonide cream once or twice daily to the affected areas as directed by a physician.
For topical use only. Fluocinonide cream is not for ophthalmic, oral, or intravaginal use. (2)
For topical use only. Fluocinonide cream is not for ophthalmic, oral, or intravaginal use.
For psoriasis, apply a thin layer of fluocinonide cream once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.
For atopic dermatitis, apply a thin layer of fluocinonide cream once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [
For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of fluocinonide cream once or twice daily to the affected areas as directed by a physician.
For topical use only. Fluocinonide cream is not for ophthalmic, oral, or intravaginal use. (2)
For topical use only. Fluocinonide cream is not for ophthalmic, oral, or intravaginal use.
For psoriasis, apply a thin layer of fluocinonide cream once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.
For atopic dermatitis, apply a thin layer of fluocinonide cream once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [
For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of fluocinonide cream once or twice daily to the affected areas as directed by a physician.
Cream, 0.1% (
Cream, 0.1%
Each gram of fluocinonide cream, USP contains 1 mg of fluocinonide, USP.
Fluocinonide cream USP, 0.1% is white to off white cream, free from lumps and foreign matter with no phase separation.
Teratogenic Effects
There are no adequate and well-controlled studies in pregnant women. Therefore, fluocinonide cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
None (
None
None.
- Fluocinonide cream has been shown to suppress the HPA axis. Systemic absorption of fluocinonide cream may produce reversible hypothalamic- pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia and unmask latent diabetes ()5.1 Effect on Endocrine System
Systemic absorption of topical corticosteroids, including fluocinonide cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of fluocinonide cream for longer than 2 weeks may suppress the immune system [
seeNonclinicalToxicology].HPA axis suppression has been observed with fluocinonide cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis and 4 out of 123 pediatric patients with atopic dermatitis [
seeUseinSpecificPopulationandClinicalPharmacology].Because of the potential for systemic absorption, use of topical corticosteroids, including fluocinonide cream, may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.
Studies conducted in pediatric patients demonstrated reversible HPA axis suppression after use of fluocinonide cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of fluocinonide cream due to their larger skin surface-to-body-mass ratios [
SeeUseinSpecificPopulations]. - Systemic absorption may require evaluation for HPA axis suppression ()5.1 Effect on Endocrine System
Systemic absorption of topical corticosteroids, including fluocinonide cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of fluocinonide cream for longer than 2 weeks may suppress the immune system [
seeNonclinicalToxicology].HPA axis suppression has been observed with fluocinonide cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis and 4 out of 123 pediatric patients with atopic dermatitis [
seeUseinSpecificPopulationandClinicalPharmacology].Because of the potential for systemic absorption, use of topical corticosteroids, including fluocinonide cream, may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.
Studies conducted in pediatric patients demonstrated reversible HPA axis suppression after use of fluocinonide cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of fluocinonide cream due to their larger skin surface-to-body-mass ratios [
SeeUseinSpecificPopulations]. - Modify use should HPA axis suppression develop ()5.1 Effect on Endocrine System
Systemic absorption of topical corticosteroids, including fluocinonide cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of fluocinonide cream for longer than 2 weeks may suppress the immune system [
seeNonclinicalToxicology].HPA axis suppression has been observed with fluocinonide cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis and 4 out of 123 pediatric patients with atopic dermatitis [
seeUseinSpecificPopulationandClinicalPharmacology].Because of the potential for systemic absorption, use of topical corticosteroids, including fluocinonide cream, may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.
Studies conducted in pediatric patients demonstrated reversible HPA axis suppression after use of fluocinonide cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of fluocinonide cream due to their larger skin surface-to-body-mass ratios [
SeeUseinSpecificPopulations]. - Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption ()5.3 Concomitant Skin Infections
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of fluocinonide cream should be discontinued until the infection has been adequately controlled.
- Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids ()5.3 Concomitant Skin Infections
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of fluocinonide cream should be discontinued until the infection has been adequately controlled.
- Children may be more susceptible to systemic toxicity when treated with topical corticosteroids (,5.1 Effect on Endocrine System
Systemic absorption of topical corticosteroids, including fluocinonide cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of fluocinonide cream for longer than 2 weeks may suppress the immune system [
seeNonclinicalToxicology].HPA axis suppression has been observed with fluocinonide cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis and 4 out of 123 pediatric patients with atopic dermatitis [
seeUseinSpecificPopulationandClinicalPharmacology].Because of the potential for systemic absorption, use of topical corticosteroids, including fluocinonide cream, may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.
Studies conducted in pediatric patients demonstrated reversible HPA axis suppression after use of fluocinonide cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of fluocinonide cream due to their larger skin surface-to-body-mass ratios [
SeeUseinSpecificPopulations].)8.4 Pediatric UseSafety and efficacy of fluocinonide cream in pediatric patients younger than 12 years of age have not been established; therefore use in pediatric patients younger than 12 years of age is not recommended.
HPA axis suppression was studied in 4 sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area, treated once daily or twice daily with fluocinonide cream. The first cohort of 31 patients (mean 36.3% BSA) 12 to < 18 years old; the second cohort included 31 patients (mean 39.0% BSA) 6 to < 12 years old; the third cohort included 30 patients (mean 34.6% BSA) 2 to < 6 years old; the fourth cohort included 31 patients (mean 40.0% BSA) 3 months to < 2 years old. Fluocinonide cream caused HPA-axis suppression in 1 patient in the twice daily group in Cohort 1, 2 patients in the twice daily group in Cohort 2, and 1 patient in the twice daily group in Cohort 3. Follow-up testing 14 days after treatment discontinuation, available for all 4 suppressed patients, demonstrated a normally responsive HPA axis. Signs of skin atrophy were present at baseline and severity was not determined making it difficult to assess local skin safety. Therefore, the safety of fluocinonide cream in patients younger than 12 years of age has not been demonstrated [
seeWarningsandPrecautions].HPA axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age.
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
HPA-axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to cosyntropin (ACTH1-24) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.