Diprogenta

Diprogenta® Cream and Ointment
Betamethasone dipropionate
Gentamicin sulfate

COMPOSITION
Each gram contains 0.64 mg betamethasone dipropionete equivalent to 0.5 mg betamethasone and 1.7 mg gentamicin sulfate equivalent to 1 mg gentamicin base.

DESCRIPTION
A combination of the corticosteroid betamethasone dipropionate and the antibiotic gentamacin sulfate with anti-inflammatory, antipruritic, vasoconstrictive and bactericidal properties, particularly against staphylococcal species.

INDICATIONS
For the reduce 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 AND ADMINISTRATION
A thin film should be applied to cover completely the affected area twice daily, in the morning and evening. Some patients may be maintained with less frequent application.

PRECAUTIONS
Discontinue treatment if irritation or sensitization develops.
Any side-effect 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 non-susceptible organisms may occur, should super-infection 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 nephrotoxicity and ototoxicity effect. The used of this combination more than seven days have no greater benefit than using steroid alone.
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 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 under 2 years of age.
Use during pregnancy and in nursing women: 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 insufficient 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 10 the mother.
Over dosage: 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 non susceptible 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 anti fungal or antibacterial therapy is indicated if overgrowth occurs.

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).

CONTRA INDICATIONS
Sensitivity to any ingredient.
Vaccinia, varicelia, skin tuberculosis.
Not to be used for infections caused by fungi and virus.

PRESENTATIONS
DIPROGENTA Cream, tube of 5 gram; Reg. No.: DKL7606605429A1
DIPROGENTA Cream, tube of 10 gram; Reg. No.: DKL 7606605429A1
DIPROGENTA Ointment, tube of   5 gram; Reg. No.: DKL 7606605530A1
DIPROGENTA Ointment, tube of 10 gram; Reg. No.: DKL 7606605530Al

HARUS DENGAN RESEP DOKTER
ON DOCTOR'S PRESCRIPTION ONLY

Store below 30°C.

Manufactured by
PT Schering-Plough Indonesia Tbk,
Pandaan, Jawa- Timur,
a subsidiary of
Schering-Plough Corporation, USA.

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