Product Elements:
Synalar fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide petrolatum synalar fluocinolone acetonide synalar fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide petrolatum keradan inert water cetostearyl alcohol medium-chain triglycerides glycerin cetyl alcohol petrolatum polyoxyl 20 cetostearyl ether caprylyl trisiloxane cyclomethicone 5 cyclomethicone 4 stearic acid paraffin polysorbate 20 phenoxyethanol xanthan gum cholesterol allantoin yellow wax methylparaben linoleic acid trolamine edetate disodium squalane .alpha.-tocopherol acetate microcrystalline wax olive oil aluminum acetate aluminum sulfate calcium acetate sodium lauroyl lactylate linolenic acid hyaluronate sodium ceramide 3 ceramide 6 ii tocopherol
Indications and Usage:
Indications and usage synalar ® ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
General Precautions:
General systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (hpa) axis suppression, manifestations of cushing'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 areas, 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, requ
Read more...iring supplemental systemic corticosteroids. children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see precautionsâpediatric 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.
Dosage and Administration:
Dosage and administration synalar ® ointment is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. in hairy sites, the hair should be parted to allow direct contact with the lesion. occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. some plastic films may be flammable and due care should be exercised in their use. similarly, caution should be employed when such films are used on children or left in their proximity, to avoid the possibility of accidental suffocation. if an infection develops, the use of the 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 preparation.
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. these reactions are listed in an approximate decreasing order of occurrence: burning hypertrichosis maceration of the skin itching acneiform eruptions secondary infection irritation hypopigmentation skin atrophy dryness perioral dermatitis striae folliculitis allergic contact dermatitis miliaria
Adverse Reactions Table:
| Burning | Hypertrichosis | Maceration of the skin |
| Itching | Acneiform eruptions | Secondary infection |
| Irritation | Hypopigmentation | Skin atrophy |
| Dryness | Perioral dermatitis | Striae |
| Folliculitis | Allergic contact dermatitis | Miliaria |
Use in Pregnancy:
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.
Pediatric Use:
Pediatric use pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalmic-pituitary-adrenal (hpa) axis suppression and cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. 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.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions ) .
Description:
Description synalar ® (fluocinolone acetonide) ointment 0.025% is intended for topical administration. the active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. it has the following chemical structure: synalar ® ointment contains fluocinolone acetonide 0.25 mg/g in a white petrolatum usp vehicle. chemical structure
Clinical Pharmacology:
Clinical pharmacology topical corticosteroids share anti-inflammatory, anti-pruritic 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
Read more...bile.
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 have revealed negative results.
How Supplied:
How supplied synalar ® (fluocinolone acetonide) ointment 0.025% is supplied in 60 g tube â ndc 43538-910-60 120 g tube â ndc 43538-910-12 storage store at room temperature 15-25°c (59-77°f); avoid freezing and excessive heat above 40°c (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 external use only. avoid contact with the eyes. patients should be advised not to use this medication for any disorder other than that 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:
Principal display panel - 120 g tube carton r x only ndc 43538-910-12 synalar ® (fluocinolone acetonide) ointment, 0.025% for topical use only not for ophthalmic use 120 g medimetriks pharmaceuticals, inc. principal display panel - 120 g tube carton
Principal display panel - kit carton ndc 43538-911-12 for topical use only not for ophthalmic use 120 g r x only synalar ® (fluocinolone acetonide) ointment, 0.025% ointment kit kit contains: 1 - synalar ® (fluocinolone acetonide) ointment, 0.025% 120 g tube 1 - keradan ® cream net wt. 9 oz. (255 g) tube medimetriks pharmaceuticals, inc. principal display panel - kit carton