| Company Name |
| Memphis/Schering |
| | |
| Therapeutic Group |
| WITH ANTIBACT/ANTIFUNGALS |
| | |
| Pharmaceutical form |
| Cream |
| | |
| Package |
| Carton box containing an aluminium tube containing 15 g cream with an inner leaflet |
| | |
| Indications |
"QUADRIDERM Cream is indicated forthe 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 dermatosis, chronic dermatitis of the extremities, erythrasma,
balanoposthitis, herpes zoster, eczematiod dermatitis,contact dermatitis,follicular dermat itis,
dyshidrosis, paronychia, anal pruritus, seborrheic eczema, intertrigo, seborrheic dermatitis,
pustular acne, impetigo, neurodermatitis, angular stomatitis, photosensitivity dermatitis,
lichenified inguinal dermatophytosis and tinea infections such as tinea pedis, tinea cruris and
tinea corporis. |
| | |
| Warning & Precautions |
| "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 will be increased if extensive body sunace areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions orwhen long-term use is anticipated, particularly in infants and children. "" Systemic absorption of topically applied gentamicin may be increased if extensive bcdy 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 developes, treatment with QUADRIDERM Cream should be discontinued and appropriate therapy instituted. 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. Slight staining of linens or clothing due to clioquinol may occur. QUADRIDERM Cream is notforophthalmic use. Pediatric 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. Usage During Pregnancy and in nursing women: Since safety of the use of topical corticosteroid 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. |
| | |
|
|
| Product Type |
| Human |
| | |
| Dosage |
"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.ln cases of tinea pedis, longer therapy (2-4 weeks) may be necessary. |
| | |
| Adverse Reactions |
"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, stria and miliarie.
Rash, irritation and hypersensitivity have been reported with the topical usage of qentarnicin
sulfate, clioquinol and rarely with tolnafate. |
| | |
| Contra Indications |
QUADRIDERM Cream is contraindicated in those patients with a
history of sensitivity reactions to any of its components. |
| | |
| Drug Interactions |
|
| | |
|
No comments:
Post a Comment