Dermasol-N® Cream: Each gram cream contains Clobetasol Propionate BP 0.5 mg, Neomycin Sulphate BP 5 mg and Nystatin BP 100,000 I.U.
Dermasol-N® Ointment: Each gram ointment contains Clobetasol Propionate BP 0.5 mg, Neomycin Sulphate BP 5 mg and Nystatin BP 100,000 I.U.
Dermasol-N® contains three active ingredients- Clobetasol Propionate, Neomycin Sulphate, and Nystatin. Clobetasol Propionate is a very potent corticosteroid. It is prescribed to treat severe inflammatory skin disorders such as eczema and psoriasis that have not responded to weaker corticosteroids. Neomycin Sulphate is an antibiotic of the aminoglycoside type and is used to treat infections with bacteria. Nystatin is an antifungal that kills fungi and yeasts by interfering with their cell membranes. The mechanism of the topical steroids like Clobetasol, in general, is unclear. However, Clobetasol Propionate is highly active corticosteroid with topical anti-inflammatory activity. The major effect of Clobetasol Propionate on skin is a nonspecific anti-inflammatory response, partially due to vasoconstriction and decrease in collagen synthesis. Neomycin binds to the ribosomal 30s and 50s sub-units of susceptible bacteria and inhibits protein synthesis. Neomycin also causes a misreading of the genetic codes of the mRNA template and this causes incorrect amino acids to be incorporated into the growing polypeptide chain. Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components.
Dermasol-N® is indicated in:
Adults: Apply sparingly to the affected area once or twice daily until improvement occurs. In very resistant lesion, specially where there is hyperkeratosis, the anti-inflammatory effect of Dermasol-N® can be enhanced (if necessary) by occluding the treatment area with polythene. Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient’s condition being reviewed.
Elderly: Dermasol-N® is suitable for use in elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of Neomycin Sulphate may occur.
Children: Dermasol-N® is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Dermasol-N® is not recommended for use in neonates and infants (younger than 2 years).
There is little information to demonstrate the possible effect of topically applied Neomycin in pregnancy and lactation. However, Neomycin present in the maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus the use of the preparation is not recommended in pregnancy and lactation. The safety of Clobetasol Propionate has not been established in lactating mothers.
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 applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. If this medication does enter the eye, the affected eye should be thoroughly washed with copious amount of water.