Aclobet-N 15 gm cream

Aclobet-N cream

DESCRIPTION

Clobetasol Propionate is a highly active corticosteroid with topical antiinflammatory 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 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.

COMPOSITION

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.

INDICATIONS AND USAGE

 Eczema unresponsive to weak steroid cream or ointment.

 Other inflammatory skin disorders resistant to treatment with weaker steroid cream or ointment .

 Psoriasis.

 Any inflammatory skin disorders where secondary bacterial or candidal infection is present, suspected or likely to occur.

DOSAGE AND ADMINISTRATION

Adults and children above 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 antiinflammatory effect of this preparation 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 patients condition being reviewed.

 Repeated short courses of Aclobet - N 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.

SIDE EFFECTS

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.

CONTRAINDICATIONS

It is contraindicated in rosacea, acne vulgaris, perioral dermatitis, primary cutaneous viral infections (e.g herpes simplex, chickenpox), otitis externa with a perforated eardrum, hypersensitivity to the preparations.

PRECAUTIONS

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.

USE IN PREGNANCY & LACTATION

The safe use of this preparation during pregnancy & lactation has not been established.

DRUG INTERACTIONS

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.

SUPPLY

Aclobet-N Cream : Each pack contains 15 gm cream in a tube.

Aclobet-N Ointment : Each pack contains 15 gm ointment in a tube