Mixderm

Mixderm

Mixderm
SIGMA
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Generic name:
Betamethasone valerate, Gentamicin sulphate, Tolnaftate and Clioquinol.
Composition:
Each I gram contains:
Active Ingredients:
Betamothasone valerate 0.6 mg equivalent to 0.5 mg betamethasone
Gontamicin sulphate 1.7 mg equivalent to 1.0 mg gentamicin
Tolnaflate 10 mg
Clioquinol (lodochiorhydroxyquln) 10mg
Inactive Ingredients:
Chiorocresol, TexoforAiP, Cetostearyl alcohol, White petrolatum, Sodium biphosphate, Mineral oil, Sodium
hydroxide and Purified water.
Pharmaceutical form:
Topical cream (for external use only)
Pharmacological action:
Mlxderm is a topical cream, It combines:
Betamethasone valerate: anti-inflammatory, anti-pruritic and vasoconstrictive agent.
- Gentan,icln sulphate: wide spectrum antibiotic that provides highly effective topical treatment in primary
and secondary bacterial infections of the skin.
- Tolnaftsto: fungicidal agent.
- Ciloqulnol: antibacterial and antifungal agent,
Indications:
Mixderm 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 infections is suspected.
Such disorders include: inguinal dermatosis, chronic dermatitis of extremities, erythrasrna, balanoposthitis, herpes zoster, eczematoid dermatitis, contact dermatitis, follicular dermatitis, dyshidrosis, paronychia, anal pruritus, seborrhelc eczema, intertrigo, seboirheic dermatitis, pustular acne, impetigo, neurodemiatitis. angular stornatitis. photosestivity dermatitis, lichenified inguinal dermatophytosis and tines infections such as tinea pedis, tinea cruris and tinea corporis
Dosage and administration;
A thin film of Mixderm 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 tines pedis longer therapy (2-4 weeks) may be necessary.
Overdosage
Symptoms: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting In secondary adrenal insufficiency, and produce manifestations of hyporcorticism, including Cushing’s disease.
A single overdose of genlamicin would not be expected to produce symptoms.
Excessive or prolonged use of topical antibiotics may lead to overgrowth of lesions by nonsusceptible organisms.
Systematically. tolnaftato 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 nonsusceptible organisms occurs, stop treatment with Mlxderm Cream and institute appropriate therapy.

Contraindications:
Mixderm cream is contraindicated in patients with a history of sensitivity reactions to any of its components,

Side effects:
Local side effects reported with the use of topical corticosteroids, especially, undor occlusive dressings, include: bumin, itching, irritation, dryness. fofliculitis, hypertrichosis, acneiforrn eruptions, hypopigmentalion, penoral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, stria and miliarie.
Rash, irntaUon and hypersensitivity have been reported with the topical usage of gentamicin sulfate, dioqulnol and rarely with tolnaflate.

Pregnancy and lactation:
Pregnancy Since safety of topical corticosteroid use in pregnant women has not been established, topical creams containing corticosteroid 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.
Lactation: 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.
Precautions and warnings:
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 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,
Systemic absorption of topicafly applied gentamicln may be increased if extensive body surface area Is treated, especially over prolonged time periods or in the presence of derrnal disruption. In these cases, the undesirable effects which occur following systemic use of gentamicin may potentially occur. Caution in use Is recommended under these conditions, particularly in infants and children. Prolonged use of topical antibiotics occasionally may result in overgrowth of non-susceptable organisms. If this occurs, or if irritation, sensitization or superinfection develops, treatment with Mixderm cream should be discontinued and appropriate therapy instituted.
Systemic absorption of clioquinol may interfere with thyroid function tests.
The ferric chloride test for phenylketonurla can yield a false-positive result if clioquinol is present In the urine.
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.
Patient instructions:
Mlxderm cream is for external use only.
Mixderm cream contains dioquinol, which may stains skin and clothing
Do not apply to irritated skin or if excessive irritation develops.
Mixderm cream is not for ophthalmic use, if eye contact occurs, immediately wash out the eye with water
or saline.
Keep out of reach of children.
Package and stora9e:
A carton box containing Aluminum collapsible tube of 15 g. cream, fitted with plastic cap.
Store at temperature not exceeding 30C.

Produced by SIGMA Pharmaceutical Industries , Egypt. S.A.E. 0412848