Gentriderm

Betamethasone dipropionate, clotrimazole, gentamicin sulfate.

Each gram contains: Betamethasone dipropionate 0.64mg, Clotrimazole 10.0mg, Gentamicin sulfate 1.0mg (Potency), Methylparaben (Preservative) 1.0mg, Propylparaben (Preservative) 0.5mg.

Pharmacology: GENTRIDERM is an effective topical dermatological preparation which provides a complete range of therapy in treating a large number of dermatologic conditions.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid and sustained response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy.
Gentamicin sulfate is a bactericidal antibiotic active against a wide variety of pathogenic gram-negative and gram-positive bacteria.
Clotrimazole is a broad-spectrum antifungal. It also exhibit activity against Trichomonas, Staphylococci, Streptococci and Bacteroides.
At a combination of 3 agents with distinct pharmacological effects, GENTRIDERM offers superior anti-inflammatory, antipruritic, bactericidal and fungicidal action for treatment of inflammatory and allergic dermatological conditions threatened or complicated by bacterial and/or common fungal infections.

Allergic inflammatory skin disease (Acute & chronic eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, chronic simple lichen, intertrigo, exfoliative dermatitis, papular urticaria, psoriasis, pruritus vulvae, pruritus ani, dermatitis solaris).
Skin mycosis (athlete's foot, trichophytia, etc.).
Tinea vesicolor.
Insect bite.
Skin disease by secondary bacterial infection.

Apply suitable amount of GENTRIDERM to the affected area as a thin film from one to several times daily.

Hypersensitivity to any of the ingredients.
Tuberculosis and most viral lesion of the skin particularly herpes simplex, vaccinia and varicella.

General Prescriptions: Similar effect to systemic steroid therapy may occur in large amount use or long term therapy by ODT (Occlusive Dressing Technique).
Local adverse effect such as skin atrophy, facial erythema may occur. Manifestations of hypersensitivity such as itching, flare, vesicle and urticaria may occur. Discontinue using GENTRIDERM if these reactions occur.
Do not use in overdosage or ODT (Occlusive Dressing Technique) prolonged period therapy.
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 disease such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Cautions in application: Do not use in the eyes. Propyleneglycol, which is an inactive ingredient of GENTRIDERM, can cause allergic reaction.
Others: Stop using in case of no improvements or worsenings.
Stop using as soon as possible improvements happen.
Use only for the purpose of medication.
Use in Children (including infants): Maldevelopment effect has been reported in overdosage, ODT prolonged period use.

Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of corticosteroid can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Continuous application without interruption may result in local atrophy of the skin, striae and superficial vascular dilation.
Rarely, patients may experience local mild burning or irritation.
Topical use of gentamicin may cause ototoxicity and/or nephrotoxicity when GENTRIDERM is applied to large burned areas or for extended periods of time, especially in patients with renal insufficiency or when administered concurrently with other drugs that are potentially ototoxic or nephrotoxic.
Vision, blurred.

Other potentially ototoxic or nephrotoxic drugs.

Incompatibility: No information is available.

Tight container, store at or below 25°C.
Use Term: 3 years from manufacturing date.

Topical Anti-Infectives with Corticosteroids

D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.

POM