Label: SYNALAR- fluocinolone acetonide cream
SYNALAR- fluocinolone acetonide kit
- NDC Code(s): 43538-900-12, 43538-900-99, 43538-901-12
- Packager: Medimetriks Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated November 29, 2018
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- SPL UNCLASSIFIED SECTION
SYNALAR® (fluocinolone acetonide) Cream 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® Cream contains fluocinolone acetonide 0.25 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white beeswax.
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.
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 bile.
- INDICATIONS AND USAGE
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, 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 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.
The following tests may be helpful in evaluating the HPA axis suppression:
- Urinary free cortisol test
- ACTH stimulation test
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.
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.
It is not known whether topical administration of corticosteroids 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 a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced 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.
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
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION
SYNALAR® Cream 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.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 120 g Tube Carton
- PRINCIPAL DISPLAY PANEL - Kit Carton
INGREDIENTS AND APPEARANCE
fluocinolone acetonide cream
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-900 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M) fluocinolone acetonide 0.25 mg in 1 g Inactive Ingredients Ingredient Name Strength butylated hydroxytoluene (UNII: 1P9D0Z171K) cetyl alcohol (UNII: 936JST6JCN) anhydrous citric acid (UNII: XF417D3PSL) edetate disodium (UNII: 7FLD91C86K) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) mineral oil (UNII: T5L8T28FGP) polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY) propylene glycol (UNII: 6DC9Q167V3) stearyl alcohol (UNII: 2KR89I4H1Y) water (UNII: 059QF0KO0R) white wax (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43538-900-99 6 in 1 CARTON 09/27/2012 1 3 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:43538-900-12 1 in 1 CARTON 09/27/2012 2 120 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA012787 09/27/2012 SYNALAR
fluocinolone acetonide kit
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-901 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43538-901-12 1 in 1 CARTON 12/15/2012 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 120 g Part 2 1 TUBE 255 g Part 1 of 2 SYNALAR
fluocinolone acetonide cream
Product Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M) fluocinolone acetonide 0.25 mg in 1 g Inactive Ingredients Ingredient Name Strength butylated hydroxytoluene (UNII: 1P9D0Z171K) cetyl alcohol (UNII: 936JST6JCN) anhydrous citric acid (UNII: XF417D3PSL) edetate disodium (UNII: 7FLD91C86K) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) mineral oil (UNII: T5L8T28FGP) polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY) propylene glycol (UNII: 6DC9Q167V3) stearyl alcohol (UNII: 2KR89I4H1Y) water (UNII: 059QF0KO0R) white wax (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 120 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA012787 12/15/2012 Part 2 of 2 KERADAN
Product Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR water (UNII: 059QF0KO0R) INGR cetostearyl alcohol (UNII: 2DMT128M1S) INGR medium-chain triglycerides (UNII: C9H2L21V7U) INGR glycerin (UNII: PDC6A3C0OX) INGR cetyl alcohol (UNII: 936JST6JCN) INGR petrolatum (UNII: 4T6H12BN9U) INGR polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY) INGR caprylyl trisiloxane (UNII: Q95M2P1KJL) INGR cyclomethicone 5 (UNII: 0THT5PCI0R) INGR cyclomethicone 4 (UNII: CZ227117JE) INGR stearic acid (UNII: 4ELV7Z65AP) INGR paraffin (UNII: I9O0E3H2ZE) INGR polysorbate 20 (UNII: 7T1F30V5YH) INGR phenoxyethanol (UNII: HIE492ZZ3T) INGR xanthan gum (UNII: TTV12P4NEE) INGR cholesterol (UNII: 97C5T2UQ7J) INGR allantoin (UNII: 344S277G0Z) INGR yellow wax (UNII: 2ZA36H0S2V) INGR methylparaben (UNII: A2I8C7HI9T) INGR linoleic acid (UNII: 9KJL21T0QJ) INGR trolamine (UNII: 9O3K93S3TK) INGR edetate disodium (UNII: 7FLD91C86K) INGR squalane (UNII: GW89575KF9) INGR .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) INGR microcrystalline wax (UNII: XOF597Q3KY) INGR olive oil (UNII: 6UYK2W1W1E) INGR aluminum acetate (UNII: 80EHD8I43D) INGR aluminum sulfate (UNII: 34S289N54E) INGR calcium acetate (UNII: Y882YXF34X) INGR sodium lauroyl lactylate (UNII: 7243K85WFO) INGR linolenic acid (UNII: 0RBV727H71) INGR hyaluronate sodium (UNII: YSE9PPT4TH) INGR ceramide 3 (UNII: 4370DF050B) INGR ceramide 6 II (UNII: F1X8L2B00J) INGR tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 255 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 06/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA012787 12/15/2012 Labeler - Medimetriks Pharmaceuticals, Inc. (019903816) Establishment Name Address ID/FEI Business Operations Teligent Inc 011036910 MANUFACTURE(43538-900, 43538-901)