Product Elements:
Halcinonide halcinonide cetyl alcohol dimethicone 350 glyceryl monostearate isopropyl palmitate polysorbate 60 propylene glycol water titanium dioxide halcinonide halcinonide
Indications and Usage:
Indications and usage halcinonide cream usp, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration:
Dosage and administration apply the 0.1% halcinonide cream to the affected area two to three times daily. rub in gently. occlusive dressing technique occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. gently rub a small amount of cream into the lesion until it disappears. reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. if needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. the frequency of changing dressings is best determined on an individual basis. it may be convenient to apply halcinonide cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). when utilizing the 12-hour occlusion regimen, additional cream should be applied, w
Read more...ithout occlusion, during the day. reapplication is essential at each dressing change. if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Contraindications:
Contraindications topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Adverse Reactions:
Adverse reactions the following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (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, and miliaria.
Use in Pregnancy:
Pregnancy teratogenic effects 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.
Pediatric Use:
Pediatric use pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hpa axis suppression and cushingâs syndrome than mature patients because of a larger skin surface area to body weight ratio. hpa axis suppression, cushingâs 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.
Geriatric Use:
Geriatric use of approximately 3000 patients included in clinical studies of 0.1% halcinonide cream, 14% were 60 years or older, while 4% were 70 years or older. no overall differences in safety were observed between these patients and younger patients. efficacy data have not been evaluated for differences between elderly and younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions: general).
Description:
Description the topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. the steroids in this class include halcinonide. halcinonide is designated chemically as 21-chloro-9-fluoro-11β,16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. graphic formula: each gram of halcinonide cream usp, 0.1% contains 1 mg halcinonide in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, mono and diglycerides, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide. structure
Clinical Pharmacology:
Clinical pharmacology topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. the mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. there is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. thus, occlusive dressings may be
Read more...a valuable therapeutic adjunct for treatment of resistant dermatoses (see dosage and administration). once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile.
Pharmacokinetics:
Pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see dosage and administration). once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bi
Read more...le.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, and 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 showed negative results.
How Supplied:
How supplied halcinonide cream usp, 0.1% is supplied as: ndc 71428-011-30 tubes containing 30 g of cream ndc 71428-011-60 tubes containing 60 g of cream storage store at room temperature; avoid excessive heat (104° f).
Information for Patients:
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 dermatologic 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 the physician. patients should report any signs of local adverse reactions especially under occlusive dressing. parents of pediatric 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.
Package Label Principal Display Panel:
Halcinonide cream usp, 0.1% rx only for topical use only. not for ophthalmic, oral or intravaginal use. ndc 71428-011-60 glasshouse-carton-60g-g