Neoderm

Neoderm

Manufacturer:

Tai Guk Pharm

Distributor:

Polymedic
Full Prescribing Info
Contents
Betamethasone dipropionate, clotrimazole, gentamicin sulfate.
Description
Each gram of Neoderm Cream contains 0.64 mg betamethasone dipropionate, equivalent to 0.5mg betamethasone, 10mg clotrimazole, and gentamicin sulfate equivalent to 1.0 mg of gentamicin base.
Action
Neoderm Cream combines the sustained anti-inflammatory, antipruritic and vaso-constrictive actions of betamethasone dipropionate with the broad spectrum antifungal activity of clotrimazole and the wide-spectrum antibiotic activity of gentamicin sulfate. Clotrimazole appears to act on the fungal cell membrane, causing leakage of cell contents. Gentamicin provides highly effective topical treatment in primary and secondary bacterial infections of the skin.
Indications/Uses
Neoderm Cream is indicated for the relief of the inflammatory manifestations of corticosteroid-responsive dermatoses when complicated by secondary infection caused by organisms sensitive to the components of this dermatologic preparation or when the possibility of such infection is suspected.
Clotrimazole has been shown to be effective in the treatment of tinea pedis, tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis due to Candida albicans; and tinea versicolor caused by Malassezia furfur.
Bacteria susceptible to gentamicin include sensitive strains of Streptococci (group A beta hemolytic, alpha hemolytic), Staphylococcus aureus (coagulase positive, coagulase negative and some penicillinase-producing strains) and the gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.
Dosage/Direction for Use
A thin film of Neoderm Cream should be applied to cover completely the affected and surrounding skin areas twice daily, in the morning and at night. For treatment to be effective, Neoderm Cream should be applied regularly.
Duration of therapy varies and depends upon the extent and location of the disease.
Contraindications
Neoderm cream is contraindicated in those patients with a history of sensitivity reactions to any of its components.
Special Precautions
Prolonged use of topical antibiotics occasionally may result in overgrowth of nonsusceptible micro-organisms. lf this occurs or if irritation, sensitization or superinfection develops with the use of Neoderm Cream, treatment should be discontinued and appropriate therapy instituted.
Cross-allergenicity among aminoglycosides has been demonstrated.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Systemic absorption of topical corticosteroids or gentamicin will be increased if extensive body surface areas are treated or if occlusive dressings are used. Application of gentamicin to open wounds or damaged skin should be avoided. Suitable precautions should be taken under these conditions, particularly in infants and children.
Long term use of gentamicin is not recommended.
Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serious chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Neoderm Cream is not for ophthalmic use.
Use In Pregnancy & Lactation
Usage in Pregnancy: Since safety of the use of Neoderm Cream in pregnant women has not been established, it should not be used on pregnant patients in large amounts or for prolonged periods of time. It should be used in the first trimester of pregnancy only when considered essential to the welfare of the patient.
Usage in Nursing Mothers: Caution should be exercised when Neoderm Cream is applied to a nursing mother.
Adverse Reactions
The following local adverse reactions have been reported with the use of topical corticosteroids especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Of almost 1000 patients who received clotrimazole therapy topically for indicated dermatomycoses, 95% showed excellent local tolerance. Reported adverse reactions include erythema, stinging, blistering, peeling, edema, pruritus, urticaria and general irritation of the skin.
Treatment with gentamicin has produced transient irritation (erythema and pruritus) that usually did not require discontinuance of treatment.
Vision, blurred.
Storage
Store between 2°C and 30°C.
ATC Classification
S01CA05 - betamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases.
Presentation/Packing
Cream 15 g, 500 g.
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