COMPOSITIONS :
Benoson® N Cream, each g contains : Betamethasone valerate equivalent to Betamethasone 0.1% and Neomycin sulfate 0.5%.
DESCRIPTIONS :
Benoson® N Cream containing Betamethasone valerate (equivalent with Betamethasone) and Neomycin sulfate is available in 5 g and 15 g cream.
INDICATIONS :
Benoson® N Cream is indicated for the treatment of the following conditions where secondary bacterial infection is present, suspected, or likely to occur : Eczema in adults and children, including atopic and discoid eczemas; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses; seborrhoeic dermatitis; contact sensitivity reactions. Benoson® N preparations can also be used in the management of secondarily infected insect bites, anal and genital intertrigo.
DOSAGE AND ADMINISTRATIONS :
A small quantity of Benoson® N should be applied gently to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day or even less often.
OVERDOSAGE :
Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse the features of Cushing’s syndrome may appear. In this situation topical steroids should be discontinued gradually under medical supervision.
CONTRAINDICATIONS :
- Rosacea, acne vulgaris and perioral dermatitis.
- Peri-anal and genital pruritus.
- Primary cutaneous viral infections (e.g., herpes simplex, chickenpox).
- Hypersensitivity to any component of the preparation.
- Treatment of primary infected skin lesions caused by infections with fungi or bacteria; primary or secondary infections due to yeast; or secondary infections due to Pseudomonas or Proteus species.
- Dermatoses in children under 2 years of age, including dermatitis and napkin eruptions.
- Should not be used for the treatment of otitis externa when the ear-drum is perforated, because of the risk of ototoxicity.
- Due to the known ototoxic and nephrotoxic potential of Neomycin sulfate, the use of Benoson N® Cream in large quantities or on large areas for prolonged periods of time is not recommended.
- Not recommended in pregnancy or lactation.
WARNINGS AND PRECAUTIONS :
- Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression, with or without clinical features of Cushing’s syndrome.
- If infection persists, systemic chemotherapy is required.
- Avoid prolonged application to the face. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye.
- If used in psoriasis patient, supervision is important.
- Extended or recurrent application may increase the risk of contact sensitization.
- Extension of infection may occur due to the masking effect of the steroid.
- Following significant systemic absorption, Aminoglycosides such as Neomycin can cause irreversible ototoxycity, and Neomycin has nephrotoxic potential.
- In renal impairment the plasma clearance of Neomycin is reduced.
DRUGS INTERACTIONS :
Following significant systemic absorption, Neomycin sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.
ADVERSE REACTIONS :
- Prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce suppression of the HPA axis and the clinical features of Cushing’s syndrome.
- Skin burning, pruritus, pigmentation changes, allergic contact dermatitis and hypertrichosis.
- If signs of hypersensitivity appear, application should be stopped immediately.
- Exacerbation of symptoms may occur.
PRESENTATIONS :
Benoson® N Cream 5 g Box, tube @ 5 g Reg. No. DKL7202341229A1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
