Quadriderm

Quadriderm

Manufacturer:

Merck Sharp & Dohme

Distributor:

A. Menarini
Full Prescribing Info
Contents
Betamethasone, gentamicin, tolnaftate, clioquinol.
Description
Each gram contains: Betamethasone valerate 610 mcg (equivalent to 500 mcg of Betamethasone); Gentamicin Sulfate equivalent to 1 mg of Gentamicin base; Tolnaftate 10 mg; and Clioquinol 10 mg.
Action
Pharmacotherapeutic Group: Topical corticosteroid and anti-infectives in combination.
Pharmacology: Pharmacodynamics: Mechanism of Action: Betamethasone, Gentamicin, Tolnaftate, Clioquinol (QUADRIDERM) Cream combines the anti-inflammatory, antipruritic and vasoconstrictive agent betamethasone valerate, the wide-spectrum bactericidal antibiotic gentamicin sulfate, the fungicidal agent tolnaftate and clioquinol, an antibacterial and antifungal agent.
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, Gentamicin, Tolnaftate, Clioquinol (QUADRIDERM) 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.
Such disorders include: Chronic dermatitis of the extremities, erythrasma, balanoposthitis, herpes zoster, eczematoid dermatitis, contact dermatitis, follicular dermatitis, parakeratosis, paronychia, anal pruritus, intertrigo, impetigo, neurodermatitis, angular stomatitis, photosensitivity dermatitis, lichenified inguinal dermatophytosis and tinea infections such as tinea pedis, tinea cruris and tinea corporis.
Dosage/Direction for Use
Dose: A thin film of Betamethasone, Gentamicin, Tolnaftate, Clioquinol (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 by the physician according to the severity of the condition.
Duration of Treatment: Duration of therapy varies depending upon the extent and location of disease and patient response. In cases of tinea pedis, longer therapy (2-4 weeks) may be necessary. 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.
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 non-susceptible organisms.
Systemically, tolnaftate is pharmacologically inactive.
Clioquinol rarely produces iodism.
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 organisms occurs, stop treatment with Betamethasone, Gentamicin, Tolnaftate, Clioquinol (QUADRIDERM) Cream and institute appropriate therapy.
Contraindications
Betamethasone, Gentamicin, Tolnaftate, Clioquinol (QUADRIDERM) Cream 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, Gentamicin, Tolnaftate, Clioquinol (QUADRIDERM) Cream, 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.
Systemic absorption of Betamethasone, Gentamicin, Tolnaftate, Clioquinol (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.
Cross-allergenicity among aminoglycosides has been demonstrated.
Systemic absorption of topically applied gentamicin may be increased if extensive body surface areas are treated, especially over prolonged time periods or in the presence of dermal disruption. 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 organisms. If this occurs or if irritation, sensitization or superinfection develops, treatment with Betamethasone, Gentamicin, Tolnaftate, Clioquinol (QUADRIDERM) Cream should be discontinued and appropriate therapy instituted.
Slight staining of linens or clothing due to clioquinol may occur.
Betamethasone, Gentamicin, Tolnaftate, Clioquinol (QUADRIDERM) Cream 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 corticosteroids effects than mature patients because of greater absorption due to 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, Gentamicin, Tolnaftate, Clioquinol (QUADRIDERM) Cream therapy have been reported very rarely and include erythema, pruritus and skin discoloration.
Rash, irritation, and hypersensitivity have been reported with the topical usage of gentamicin sulfate, clioquinol and rarely with tolnaftate.
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.
Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
Drug Interactions
Interference with Laboratory Tests: Systemic absorption of clioquinol may interfere with thyroid function tests.
The ferric chloride test for phenylketonuria can yield a false positive result if clioquinol is present in the urine.
Storage
Store below 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
Cream 5 g.
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