Fluocinonide Cream 10g

Fluocinonide Cream is a kind of adrenocortical hormone drug. It is used for allergic dermatitis, atopic dermatitis, contact dermatitis, seborrheic dermatitis, eczema, skin pruritus, psoriasis, neurodermatitis, etc.

[Indications] This product is a corticosteroid drug. Used for allergic dermatitis, atopic dermatitis, contact dermatitis, seborrheic dermatitis, eczema, pruritus, psoriasis, neurodermatitis, etc.

[Specifications] 10g: 2.5mg

[Packaging] Aluminum tube packaging for medicinal cream. 10g per tube, 1 tube per box.

[Validity period] 36 months.

COMPOSITION

Each tube contain Fluocinonide 2.5mg.

INDICATIONSAND USAGE

Local inflammatory,pruritic and allergic disorders of the skin and mucosa.It is indicatedfor topical application for its glucocorticoid activity in the treatment of various skindisorders such as allergic dermatitis,contact dermatitis,seborrhoeic dermatitis and eczema.

CONTRAINDICATIONS

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

DOSAGEAND ADMINISTRATION

A small amount of Fluocinonide cream should be applied gently to the affected

part ofthe body 2 to 3 times a day for one(1)week or as prescribed by the physician. The total amount should be not more than 50g weekly.

PRECAUTIONS

General:Systemic absorption of topical corticosteroids has produced reversible

hypothalamic-pituitary-adrenal(HPA)axis suppression,manifestations of CushinVg's syndrome,hyperglycemia,and glucosuria in some patients.Conditions which augment systemic absorption include the application of the more potent steroids,use over large surface area,prolonged use,and the addition of occlusive dressings.Therefore,patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests.If HPA axis suppression is noted,an attempt should be made to withdraw the drug,to reduce the frequency of application,or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.Infrequently,signs and symptoms of steroid withdrawal may occur,requiring supplemental systemic corticosteroids.Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.(See PRECAUTIONS-Pediatric Use.)If irritation develops,topical corticosteroids should be discontinued and appropriate therapy instituted.

As with any topical corticosteroid product,prolonged use may produce atrophy of the skin and subcutaneous tissues.When used on intertriginous or flexor areas,or on the face,this may occur even with short-term use.In the presence of dermatological

infections,the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly,the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient:Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician.It is for external use only. Avoid contact with the eyes.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a physician.Patients should report any signs of local

adverse reactions especially under occlusive dressing.

Parents ofpediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area,as these garments may constitute

occlusive dressings.Laboratory Tests:The following tests may be helpful in evaluating the HPA axis suppression:Urinary free cortisol test;ACTH stimulation test.

Carcinogenesis,Mutagenesis,Impairment of Fertility:Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.Studies to determine mutagenicity with prednisolone and

hydrocortisone have revealed negative results.

Pregnancy:Teratogenic Effects:Pregnancy Category C.Corticosteroids are generally

teratogenic in laboratory animals when administered systemically at relatively low

dosage levels.The more potent corticosteroids have been shown to be teratogenic after

dermal application in laboratory animals.There are no adequate and well-controlled

studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore,topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Drugs of this class should not be used

extensively on pregnant patients,in large amounts,or for prolonged periods of time.

Nursing Mothers:It is not known whether topical administration ofcorticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant.Nevertheless,caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use:Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal(HPA)axis suppression,Cushing's syndrome,and

intracranial hypertension have been reported in children receiving topical

corticosteroids.Manifestations of adrenal suppression in children include linear growth retardation,delayed weight gain,low plasma cortisol levels,and absence of response to ACTH stimulation.Manifestations of intracranial hypertension include bulging fontanelles,headaches,and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen.Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS

The following local adverse reactions are reported infrequently with topical

corticosteroids,but may occur more frequently with the use of occlusive dressings.

These reactions are listed in an approximate decreasing order of occurrence:burning, itching,irritation,dryness,folliculitis,hypertrichosis,acneiform eruptions,

hypopigmentation,perioral dermatitis,allergic contact dermatitis,maceration of the skin,secondary infection,skin atrophy,striae,miliaria.