Version May 2024
Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time. Therapy should be discontinued when control is achieved.
Corticosteroid-responsive dermatoses: Topical: Apply a thin film to affected area 2 to 4 times daily depending on severity of condition.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time. Therapy should be discontinued when control is achieved.
Corticosteroid-responsive dermatoses: Topical: Children and Adolescents: Refer to adult dosing.
See individual agents.
Hypersensitivity to fluocinolone, neomycin, or any component of the formulation; use in external auditory canal if eardrum is perforated
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Local effects: Local adverse reactions may occur (eg, skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection miliaria); may be irreversible. Local adverse reactions are more likely to occur with occlusive and/or prolonged use. If irritation develops, discontinue use and institute appropriate therapy.
• Ototoxicity: Neomycin may increase the risk of ototoxicity with extended use. Do not use in any patient with a perforated tympanic membrane.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Special populations:
• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Other warnings/precautions:
• Appropriate use: Not for oral use. Unless otherwise directed by healthcare professional, do not use with occlusive dressing; do not use on children's skin covered by diapers or plastic pants.
Neo-Synalar kit contains Karadan emollient cream (255 g).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Neo-Synalar: Neomycin sulfate 0.5% and fluocinolone acetonide 0.025% (60 g) [contains cetyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]
Kit, External:
Neo-Synalar: Neomycin sulfate 0.35% and fluocinolone acetonide 0.025% [DSC] [contains cetyl alcohol, edetate (edta) disodium, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]
No
Cream (Neo-Synalar External)
0.5-0.025% (per gram): $18.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical: For external use only; not for oral use. Unless otherwise directed by health care professional, do not use with occlusive dressing.
Topical: For external use only; not for oral use. Unless otherwise directed by health care professional, do not use with occlusive dressing; do not use on children's skin covered by diapers or plastic pants. Discontinue treatment if irritation develops.
Corticosteroid-responsive dermatoses with secondary infection: Treatment of corticosteroid-responsive dermatoses with secondary infection. Use of this combination has not shown greater benefit than the steroid component alone after 7 days of treatment.
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
None known.
There are no known significant interactions.
Adverse events have been observed with corticosteroids in animal reproduction studies.
Systemic corticosteroids are excreted in human milk. It is not known if sufficient quantities of fluocinolone are absorbed following topical administration to produce detectable amounts in breast milk. The manufacturer recommends that caution be exercised when administering fluocinolone to breastfeeding women. Refer to individual monographs.
Growth in pediatric patients; HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test); signs of bacterial or fungal infection
Neomycin interferes with bacterial protein synthesis by binding to 30S ribosomal subunits.
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Fluocinolone has low to intermediate range potency (dosage-form dependent).
See individual agents.
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