Neo-Synalar
(fluocinolone acetonide)Neo-Synalar Prescribing Information
NEO-SYNALAR® cream is indicated for the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment (see WARNINGS section).
NEO-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.
Since NEO-SYNALAR® cream is a water-washable vanishing cream, it is easily applied and leaves no traces.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product should not be used in the external auditory canal if the eardrum is perforated.
The following local adverse reactions are reported infrequently with topical corticosteroids. 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 |
The following adverse reactions have been reported with the topical use of neomycin:
| Ototoxicity | Nephrotoxicity |
NEO-SYNALAR® cream 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)-, and the antibacterial neomycin sulfate. Fluocinolone acetonide has the following chemical structure:
The cream contains neomycin sulfate 5 mg/g (3.5 mg/g neomycin base) and 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 wax.
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.
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.
NEO-SYNALAR® [neomycin sulfate 0.5% (0.35% neomycin base), fluocinolone acetonide 0.025%] Cream is supplied in
- 60 g Tube – NDC 43538-940-60
STORAGE
Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).
If local infection should continue or become severe, or in the presence of systemic infection, appropriate systemic antibacterial therapy, based on susceptibility testing, should be considered.
Because of the concern of nephrotoxicity and ototoxicity associated with neomycin, this combination product should not be used over a wide area or for extended periods of time.
There are articles in the current medical literature that indicate an increase in the prevalence of persons sensitive to neomycin.