GMP Ketoconazole Complex Cream 1% 15g

ISOCORT Cream is for use in adults.

For Tinea pedis:

ISOCORT cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse.

For other infections:

ISOCORT cream should be applied to the affected areas once or twice daily, depending on the severity of the infection. The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment is: tinea versicolor 2–3 weeks, tinea corporis 3–4 weeks.

The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection. Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.

Method of administration: Cutaneous administration.

There are limited data on the use of ISOCORT cream in paediatric patients. Route of

Administration: Cutaneous

Creams are especially appropriate for moist or weeping surfaces.

Adults, Elderly and Children over 1 year :

Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs (in the more responsive conditions this may be within a few days), then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient. Repeated short courses of ISOCORT Cream may be used to control exacerbations.

In more resistant lesions, especially where there is hyperkeratosis, the effect of clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually be maintained by application without occlusion. If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated.

Treatment should not be continued for more than 4 weeks. If continuous treatment is necessary, a less potent preparation should be used.

Therapy with clobetasol should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy. Rebound of pre-existing Clobetasol Propionate can occur with abrupt discontinuation of clobetasol.

Recalcitrant ISOCORT Cream  : Patients who frequently relapse Once an acute episode has been treated effectively with a continuous course of topical corticosteroid, intermittent dosing (once daily, twice weekly, without occlusion) may be considered. This has been shown to be helpful in reducing the frequency of relapse.

Application should be continued to all previously affected sites or to known sites of potential relapse. This regimen should be combined with routine daily use of emollients. The condition and the benefits and risks of continued treatment must be re-evaluated on a regular basis.

Paediatric population:

ISOCORT Cream contraindicated in children under one year of age. Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults. Care should be taken when using cream include clobetasol propionate to ensure the amount applied is the minimum that provides therapeutic benefit.

Duration of treatment for children and infants Courses should be limited if possible to five days and reviewed weekly. Occlusion should not be

used.

Application to the face Courses should be limited to five days if possible and occlusion should not be used.

Elderly Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Renal / Hepatic Impairment In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

For nasal application only. A small amount of Neomycin sulfate is placed on the little finger and applied to the inside of each nostril.

For prophylaxis: Neomycin sulfate is applied as above, twice daily, to prevent patients from becoming carriers and to inhibit the dispersion of Staphylococci.

For eradication of infection: Neomycin sulfate is applied four times daily for 10 days to eliminate organisms from the nares.

Children and elderly patients:  There are no special  dosage recommendations  for either children or elderly patients.