NEO-SYNALAR- neomycin sulfate and fluocinolone acetonide
Medimetriks Pharmaceuticals
Rx Only
DESCRIPTION
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)]-,(6?,11?,16?)-, and the antibacterial neomycin sulfate. Fluocinolone acetonide. 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.
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. Neo-Synalar Indications and Usage
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). DOSAGE AND ADMINISTRATION
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.
