NEO-SYNALAR- neomycin sulfate and fluocinolone acetonide kit

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297), fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)

Disponible desde:

Medimetriks Pharmaceuticals

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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) . 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.

Resumen del producto:

NEO-SYNALAR® [neomycin sulfate 0.5% (0.35% neomycin base), fluocinolone acetonide 0.025%] Cream is supplied in Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

NEO-SYNALAR- NEOMYCIN SULFATE AND FLUOCINOLONE ACETONIDE
MEDIMETRIKS PHARMACEUTICALS
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NEO-SYNALAR
[NEOMYCIN SULFATE 0.5% (0.35% NEOMYCIN BASE), FLUOCINOLONE ACETONIDE
0.025%] CREAM
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)]-,(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.
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.
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways
similar to sy