COMPOSITIONS :
Benoson-G® Cream, each gram contains : Betamethasone valerate equivalent to Betamethasone 0.1% and Gentamicin sulfate equivalent to Gentamicin 0.1%.
DESCRIPTIONS :
Benoson-G® contains Betamethasone valerate (equivalent to Betamethasone) and Gentamicin sulfate (equivalent to Gentamicin) as its active ingredients, available as cream dosage form 10 g.
INDICATIONS :
For topical treatment of corticosteroid-responsive dermatoses when complicated by secondary infection caused by organisms sensitive to Gentamicin or when the possibility of such infection is suspected.
DOSAGE AND ADMINISTRATIONS :
Apply a thin film to cover completely the affected area twice daily, in the morning and at night.
Frequency of application should be determined by the physician according to the severity of condition.
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 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 corticosteroid is advised. Appropriate antifungal or antibacterial therapy is indicated if overgrowth occurs.
CONTRAINDICATION :
Hypersensitivity to any ingredient of Benoson-G®.
WARNINGS AND PRECAUTIONS :
- If irritation or sensitization develops, treatment should be discontinued and appropriate therapy instituted.
- Any 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 and if the occlusive technique is used. Suitable precautions should be taken under these condition or when long-term use is anticipated, particularly in infants and children.
- 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.
- Use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms, including fungi. If this occurs or if irritation, sensitization or superinfection develops, treatment with Benoson-G® should be discontinued and appropriate therapy instituted.
- Not for ophthalmic 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 bulging fontanelle, headaches and bilateral papilledema.
- 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 amount 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.
DRUG INTERACTION :
No information provided.
ADVERSE REACTIONS :
The following local adverse reactions have been reported with the use of topical corticosteroids : Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis and allergic contact dermatitis.
The following may occur more frequently with occlusive dressings : Maceration of the skin, secondary infection, skin atrophy, stripes on the skin and miliaria.
Treatment with gentamicin has produced transient irritation (erythema and pruritus) that usually did not require discontinuance of treatment.
PRESENTATIONS :
Benoson-G® Cream 10 g Box, tube @ 10 gram Reg. No. : DKL 9602321629A1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
