NEO-SYNALAR- neomycin sulfate and fluocinolone acetonide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medimetriks Pharmaceuticals

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEO-SYNALAR- NEOMYCIN SULFATE AND FLUOCINOLONE ACETONIDE CREAM
MEDIMETRIKS PHARMACEUTICALS
----------
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