Dosage Form: Cream
Description: Topical corticosteroid, antibacterial and antifungal agent
Each gram contains:
Betamethasone valerate…………………………..0.5 mg
Gentamicin sulfate…………………………………..1.0 mg
Clioquinol (iodochlorhydroxyquin)…………….10 mg
In a paraben- and lanolin-free water washable cream base containing 0.1% chlorocresol as a preservative.
The cream base is composed of: chlorocresol, monocetyl ether of polyethylene glycol, white petrolatum, sodium phosphate, and purified water
Quadriderm cream combines the anti-inflammatory, antipruritic and vasoconstrictive agent betamethasone valerate, the wide-spectrum antibiotic gentamicin suifate, the fungicidal agent tolnaftate and clioquinol, an antibacterial and antifungal agent.
Clinical studies have demonstrated the efficacy of betamethasone valerate in the treatment of corticosteroid-responsive dermatoses.
When betamethasone valerate was subjected to the Draize patch test, no primary irritation or potential for allergic contact dermatitis occurred.
In vitro antibacterial activity of gentamicin showed it to be bacericidal against a wide variety of gram-positive and gram-negative bacteria. At concentrations of 4 mcg/ml or less, gentamicin inhibited 95% of strains of Staphylocoecus aureus and 70-90% of strains of Escherichia coli and Aerobacter aerogenes.
Toxicity studies in animals and man revealed no evidence of skin irritation after local application of gentamicin in concentrations higher than that formulated for therapeutic use.
Results of the Draize cutaneous patch test in 100 patients indicated that gentamicin was not a primary irritant; furthermore, gentamicin has a low index of skin sensitization.
Tolnaftate-is a potent fungicicial agent against Trichophyton mentagrophytes, Trichophyton rubrum, Microsporum canis, Epidermophyton floccosum and Malassezia furfur. Clinical studies have shown the excellent fungicidal effect of tolnaftate in a large number of patients with superficial fungal infections. Therapy with tolnaftate has been notable for lack of recurrence. Tests of skin sensitivity have shown no signs of local irritation 24 and 48 hours after medication was applied.
Clioquinol is effective topical therapy for bacterial and/or candidial (monilial) infections. Inhibition of Candida albicans was obtained with concentrations of 25 µg/ml. At concentrations of 50 mcg/ml clioquinol completely inhibited all four strains of Candida albicans tested.
Each component of Quadriderm cream makes a significant contribution to the efficacy of the product in treating infections of mixed etiology.
Quadriderm crearn 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.
Such disorders include:
- Inguinal dermatoses
- Chronic dermatitis of the extremities
- Herpes zoster
- Eczematiod dermatitis
- Contact dermtitis
- Follicular dermatitis
- Anal pruritus
- Seborrheic eczema
- Seborrheic dermatitis
- Pustular acne
- Angular stomatitis
- Photosensitivity dermatitis
- Lichenified inguinal dermatophytosis
- Tinea infections such as tinea pedis
- Tinea cruris
- Tinea corpori
Quadriderm cream is contraindicated in those patients with a history of sensitivity reactions to any of its components.
Local adverse reactions reported with the use of topical corticosteroids, especially under occlusive dressings, include: 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.
Rash, irritation and hypersensitivity have been reported with the topical usage of gentamicin sulfate, clioquinol and rarely with tolnaftate.
Dosage and Administration:
A thin film of Quadriderm cream should be applied to cover completely the affected area two or three times daily, or as prescribed by the physician. Frequency of application should be determined according to severity of the condition. Duration of therapy should be determined by patient response.In cases of tinea pedis, longer therapy (2-4 weeks) may be necessary.
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.
A single overdose of gentamicin would not be expected to produce symptoms. Excessive or prolonged use of topical antibiotics may lead to overgrowth of lesions by nonsusceptible organisms. Systemically, tolnaftate is pharmacologically inactive.
Ciloquinol rarely produces iodism.
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 organisms occurs, stop treatment with Quadriderm cream and institute appropriate therapy.
Pregnancy and 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.
Any of the side effects that are reported following systemic use of corticosteroids. um including adrenal suppression, may also occur with topical corticosteroids. especially in infants and children.
Systemic absorption of Quadriderm cream will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
Prolonged use of topical antibiotics occasionally may result in overgrowth of non-susceptible organisms.lf this occurs or if irritation, sensitization or superinfection develops, treatment with Quadriderm cream should be discontinued and appropriate therapy instituted.
Systemic absorption of clioquinol may interfere with thyroid function tests. Therapy should be discontinued one month before these tests are conducted. The ferric chloride test for phenylketonuria can yield a false-positive result if clioquinol is present in the urine.
Slight staining of linens or clothing due to clioquinol may occur.
Quadriderm cream is not for ophthalmic use.
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.
Tube of 15 g.
Store at room temperature, below 25°C.