Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

teligent pharma, inc. - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - fluocinonide  cream, 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 [see use in specific populations (8.4) ]. 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. none. teratogenic effects: there are no adequate and well-controlled studies in pregnant women. therefore, fluocinonide cream should be used d

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - fluocinonide cream, 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 [see use in specific populations (8.4)] . 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, 0.1% 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, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. none. teratogenic effects: pregnancy category c 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. systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. safety 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 [see warnings and precautions (5.2)] . 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. clinical studies of fluocinonide cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - 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 [see use in specific populations (8.4) ]. 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 usp, 0.1% 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 usp, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. none. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregnant women. th

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (bsa) in patients 18 years of age or older. patients should be instructed to use clobetasol propionate spray, 0.05% for the minimum amount of time necessary to achieve the desired results [ see dosage and administration (2)] . use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of hpa axis suppression were seen with other clobetasol propionate topical formulations. [see  use in specific populations (8.4) ]. clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin. clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.    none. risk summary there are no available d

Malta - engleză - Medicines Authority

leo pharma a/s industriparken 55, 2750-dk ballerup, denmark - methylprednisolone aceponate - cream - methylprednisolone aceponate 1 mg/g - corticosteroids, dermatological preparations

Malta - engleză - Medicines Authority

leo pharma a/s industriparken 55, 2750-dk ballerup, denmark - methylprednisolone aceponate - ointment - methylprednisolone aceponate 1 mg/g - corticosteroids, dermatological preparations

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - 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 [see use in specific populations (8.4) ]. 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 usp, 0.1% 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 usp, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. none. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregnant women. th

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

puretek corporation - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - highlights of prescribing information these highlights do not include all the information needed to use fluocinonide cream usp, 0.1% safely and effectively. see full prescribing information for fluocinonide cream usp, 0.1%. fluocinonide cream usp, 0.1% for topical use initial u.s. approval: 1971 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. (1) - avoid use on the face, groin, or axillae. (1.2) - 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

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

viona pharmaceuticals inc - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - 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 [see  use  in  specific  populations  (8.4) ]. 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. none. teratogenic effects pregnancy  category  c there are no adequate and well-controlled studies in pregnant women. therefore, fluoc

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - 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 [see use in specific populations (8.4) ]. 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 usp, 0.1% 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 usp, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. none. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregnant women. th