Triderm

Triderm

Manufacturer:

Merck Sharp & Dohme

Distributor:

A. Menarini
Full Prescribing Info
Contents
Betamethasone dipropionate, clotrimazole, gentamicin sulfate.
Description
Each gram contains: Betamethasone dipropionate 643 mcg (Equivalent to 500 mcg of Betamethasone), Clotrimazole 10 mg, Gentamicin Sulfate equivalent to 1 mg of Gentamicin base.
Action
Pharmacotherapeutic Group: Topical corticosteroid and anti-infective in combination.
Pharmacology: Pharmacodynamics: Mechanism of Action: Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment combines the sustained anti-inflammatory, antipruritic and vasoconstrictive actions of betamethasone dipropionate with the broad spectrum antifungal activity of clotrimazole and the wide-spectrum bactericidal 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.
Pharmacodynamic Effects: Bacteria susceptible to gentamicin include sensitive strains of 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.
Indications/Uses
Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment 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 (Pityrosporum obiculare).
Dosage/Direction for Use
A thin film of Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment 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, Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment should be applied regularly.
Duration of Treatment: Duration of therapy varies depending upon the extent and location of disease and patient response. However, if clinical improvement is not achieved by three to four weeks, diagnosis should be reviewed.
Method of Administration: FOR DERMATOLOGIC USE ONLY.
Overdosage
Symptoms: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency and produce manifestations of hypercorticism, including Cushing's disease.
Since application of 14C labeled clotrimazole to intact or diseased skin under occlusive dressing for six hours did not yield measurable quantities (lower detection limit 0.001 mcg/ml) of radioactive material in the sera of human subjects, overdosage by topical clotrimazole administration is highly improbable.
A single overdose of gentamicin would not be expected to produce symptoms. Excessive or prolonged use of topical gentamicin may lead to overgrowth of lesions by non-susceptible microorganisms.
Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.
If overgrowth by non-susceptible microorganisms occurs, stop treatment with Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment and institute appropriate therapy.
Contraindications
Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment is contraindicated in those patients with a history of sensitivity reactions to any of its components.
Special Precautions
If irritation or sensitization develops with the use of Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment, treatment should be discontinued and appropriate therapy instituted.
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.
Cross-allergenicity among aminoglycosides has been demonstrated.
Systemic absorption of topical corticosteroids or gentamicin will be increased if extensive body surface areas are treated or if occlusive dressings are used, especially over prolonged time periods or in the presence of dermal disruption. Application of gentamicin to open wounds or damaged skin should be avoided. In these cases, the undesirable effects which occur following systemic use of gentamicin may potentially occur. Cautious use is recommended under these conditions, particularly in infants and children.
Prolonged use of topical antibiotics occasionally may result in overgrowth of non-susceptible microorganisms. If this occurs or if irritation, sensitization or superinfection develops, treatment with Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment should be discontinued and appropriate therapy instituted.
Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment is not for ophthalmic use.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) 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 of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Use in children: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema.
Use In Pregnancy & Lactation
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 corticosteroids 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.
Adverse Reactions
Adverse reactions to Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment therapy have been reported very rarely and include skin discoloration, hypochromia, burning, erythema, exudation and pruritus.
Of almost 1000 patients who received clotrimazole therapy topically for indicated dermatomycoses, 95% showed excellent local tolerance. Reported adverse reactions include, stinging, blistering, peeling, edema, urticaria and general irritation of the skin.
Treatment with gentamicin has produced transient irritation that usually did not require discontinuance of treatment.
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.
Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
Storage
Ointment: Store at temperatures not exceeding 30°C.
ATC Classification
D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.
Presentation/Packing
Oint 5 g.
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