ACME LABORATORIES LTD.
CLOBETASOL PROPIONATE + NEOMYCIN SULPHATE + NYSTATIN
This is indicated in: Short courses treatment of recalcitrant eczemas, Neurodermatoses, Psoriasis (excluding widespread plaque psoriasis) where secondary bacterial infection or fungal infection is present, suspected or likely to occur. Other inflammatory conditions which do not respond satisfactorily to less active steroids.
Clobetasol / Clobetasone & Combined Preparations
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. It 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 is an antifungal medicine that kills fungi and yeasts by interfering with their cell membranes. The principle action of this 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 over 2 years: Apply sparingly to the affected area once or twice daily until improvement occurs. As with other highly active topical steroid preparations therapy should be discontinued when control is achieved. In very resistant lesions, especially where there is hyperkeratosis, the anti-inflammatory effect of this preparaton 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. Repeated short courses of this preparation may be used to control exacerbations 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. However, 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.d
This medication is contraindicated in rosacea, acne vulgaris and perioral dermatitis, primary cutaneous viral infection (eg-Herpes simplex, chicken pox) and hypersensitivity to the preparation.
Generally this preparation is well tolerated. However, few side effects after prolonged and intensive treatment may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used, or when skin folds are involved.ds
Pregnancy category C. The safe use of this preparation during pregnancy & lactation has not been established.
Acute overdosage is very unlikely to occur. No overdose related problem yet reported. 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.
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.
Store below 258 C temperature. Do not freeze. Keep out of reach of children.