Lidex NGN

Fluocinonide, neomycin sulfate, gramicidin, nystatin.

Each gram contains: Fluocinonide 0.5 mg, Neomycin sulfate 5.0 mg, Gramicidin 0.25 mg, Nystatin (in a water-washable emollient aqueous cream base) 100,000 IU.
The formulation does not contain lanolin, parabens, or phenolic compounds.

Fluocinonide, Neomycin sulfate, gramicidin and Nystatin (Lidex NGN) Emollient Cream is primarily effective because of the anti-inflammatory, antipruritic and vasoconstrictor actions of Fluocinonide, the broad-spectrum activities of Neomycin sulfate and Gramicidin, and the specific anti-candida activity of Nystatin.

For the treatment of cutaneous or skin infections caused by organisms sensitive to the antibiotic and antimycotic ingredients and when the anti-inflammatory and/or anti-allergic action of Fluocinonide is indicated, as in: burns, wounds and skin grafts; otitis externa; post-surgical procedures; other dermatologic conditions; atopic contact, stasis and infectious eczematoid dermatitis; neurodermatitis; eczema; anogenital pruritus. It may also be useful as an adjunct in certain pyodermas such as impetigo, during specific antibiotic therapy for these infections.

A small amount should be applied lightly to the affected skin area two to three times daily with gentle but thorough massage. When the condition is under control, the dosage should be decreased gradually.

Fluocinonide, Neomycin sulfate, gramicidin and Nystatin (Lidex NGN) Emollient Cream is contraindicated in those patients with a history of hypersensitivity to any of its components.

Because of the potential hazards of nephrotoxicity and ototoxicity of Neomycin, prolonged use or use of large amounts of this product should be avoided in the treatment of skin conditions following extensive burns, trophic ulceration and other conditions where absorption of Neomycin is possible.
In the presence of viral or fungal infection, the use of an appropriate agent should be instituted. If a favourable response does not occur promptly Fluocinonide, Nyomycin sulfate, gramicidin and Nystatin (Lidex NGN) Emollient Cream should be discontinued until the infection has been adequately controlled.
As with any antibiotic preparation, prolonged use may lead to overgrowth of non-susceptible and resistant organisms. Should this occur, other suitable antimicrobial therapy must be instituted.
Prolonged use of topical corticosteroid products may produce atrophy of the skin. When used on the face, this may occur even with short term use. Significant systemic absorption may result when steroids are applied over large areas of the body, even when occlusion is not used.
Administration of topical corticosteroids to children should be limited to a short period of time and to the smallest amount of product compatible with an effective therapeutic regimen.
This preparation is not intended for ophthalmic use.
Topical corticosteroids should be used with caution on lesions close to the eye.
It is recommended that Fluocinonide, Neomycin sulfate, gramicidin and Nystatin (Lidex NGN) Emollient Cream not be used under occlusive dressing.
Tight-fitting diapers or plastic pants on a child may also function as an occlusive dressing and increase absorption of topical corticosteroids by the underlying skin.
Patients (particularly children) receiving a large dose of topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated for evidence of hypothalmic-pituitary-adrenal (HPA) axis suppression. If HPA axis suppression is noted, the dose should be reduced or gradually discontinued.
In laboratory animals, increases in incidences of fetal abnormalities have been associated with exposure of gestating females to topical corticosteroids, in some cases at rather low dosage levels. Although topical corticosteroids have been reported to have an adverse effects on human pregnancy, the safety of their use in pregnant women has not been established absolutely. Therefore, drugs of this class should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time, especially during the first three months of pregnancy.

The following adverse skin reactions have been reported with the use of topical steroids: dryness, itching, burning, local irritation, striae, skin atrophy, telangiectasia, hypertrichosis, hypopigmentation, miliaria, and secondary infection. Adrenal suppression has also been reported following topical corticosteroid therapy.
Ototoxicity and nephrotoxicity have been reported with the topical use of Neomycin. Hypersensitivity to Neomycin, Gramicidin and Nystatin have been reported. Allergic cross-reactions may occur which could prevent future use of kanamycin, paromomycin and streptomycin.

Store at temperatures not exceeding 30°C.

Topical Anti-Infectives with Corticosteroids

D07CC05 - fluocinonide and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.

Rx