Aclobet-N Cream: Each gram contains Clobetasol Propionate BP 0.5 mg, Neomycin Sulphate USP 5 mg and Nystatin USP 100000 units.
Aclobet-N Ointment: Each gram contains Clobetasol Propionate BP 0.5 mg, Neomycin Sulphate USP 5 mg and Nystatin USP 100000 units.
Clobetasol Propionate is a highly active corticosteroid with topical anti-inflammatory activity. The major effect of Clobetasol Propionate on skin is a non specific anti-inflammatory response, partially due to vasoconstriction and decrease in collagen synthesis.
Neomycin Sulphate is a broad spectrum antibiotic of the aminoglycoside type and is used to treat infections with bacteria. Nystatin is an antifungal medicine that kills fungi and yeasts by interfering with their cell membranes.
The principle action of the preparation is based on the anti-inflammatory activity of the corticosteroid. The broad spectrum antibacterial and anti-candidal activity provided by the combination of Neomycin and Nystatin allow this effect to be utilized in the treatment of conditions which are or are likely to become infected.
Adults and children above 2 years:
Elderly:
This preparation is suitable for use in the elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulphate may occur.
Children:
Under 2 years this preparation is not recommended.
Neomycin sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents following significant systemic absorption. If used in accordance with the recommendations systemic exposure to Neomycin Sulphate is expected to be minimal and drug interactions are unlikely to be significant. No hazardous interactions have been reported with use of Clobetasol Propionate or Nystatin.
Over Dose:
Acute over dosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may appear and in this situation topical steroids should be discontinued gradually. Also, consideration should be given to significant systemic absorption of Neomycin Sulphate. If this is suspected, use of the product should be stopped and the patient’s general status, hearing acuity, renal and neuromuscular functions should be monitored. Haemodialysis may reduce the serum level of Neomycin Sulphate.
The safe use of this preparation during pregnancy & lactation has not been established.
Long term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion. If use in childhood, or on the face, courses should be limited to 5 days and occlusion should not be used. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye. If used in psoriasis careful patient supervision is important.
Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.