Diprogenta

Diprogenta

betamethasone + gentamicin

Manufacturer:

Merck Sharp & Dohme

Marketer:

Transfarma Medica Indah
Full Prescribing Info
Contents
Betamethasone dipropionate, gentamicin sulfate.
Description
Each gram of cream or ointment contains betamethasone dipropionate 0.64 mg equivalent to betamethasone 0.5 mg and gentamicin sulfate 1.7 mg equivalent to gentamicin base 1 mg.
Action
A combination of the corticosteroid betamethasone dipropionate and the antibiotic gentamicin sulfate with anti-inflammatory, antipruritic, vasoconstrictive and bactericidal properties, particularly against staphylococcal species.
Indications/Uses
Reduction of inflammatory manifestations of corticosteroid-responsive dermatoses when complicated by secondary infection, caused by organisms susceptible to gentamicin or when such infection is suspected.
Dosage/Direction for Use
A thin film should be applied to completely cover the affected area twice daily, in the morning and evening. Some patients may be maintained with less frequent application.
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.
Excessive prolonged use of topical gentamicin may lead to overgrowth of lesions by fungi or nonsusceptible bacteria.
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.
Appropriate antifungal or antibacterial therapy is indicated if overgrowth occurs.
Contraindications
Sensitivity to any ingredient of Diprogenta. Vaccinia, varicella and skin tuberculosis. Not to be used for infections caused by fungi and virus.
Special Precautions
Discontinue treatment if irritation or sensitization develops.
Any side effects reported following use of systemic corticosteroids may occur, especially in infants and children.
Systemic absorption of corticosteroids will increase if occlusive dressing is used or extensive areas are treated.
Overgrowth of nonsusceptible organisms may occur; should superinfection develop, discontinue treatment and initiate appropriate therapy.
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.
Not for ophthalmic use.
Not to be used for extensive body surface areas or for long-term use because of the nephrotoxic and ototoxic effects.
The use of this combination for >7 days have no greater benefit than using steroid alone.
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.
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 cortisal levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema.
Not to be used for children <2 years.
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
Use of topical corticosteroids have resulted in local adverse reactions: Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. Use of occlusive dressing may increase the incidence of skin maceration, secondary infection, skin atrophy, striae, miliaria.
Topical use of gentamicin has produced transient irritation (erythema and pruritus).
Storage
Store between 2°-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, 10 g. Oint 5 g, 10 g.
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