Dermasol Cream 20g Clobetasol Propionate

>

COMPOSITION
Dermasol®
0.05% cream: Each 20 gm cream contains Clobetasol
Propionate BP 5 mg.

PHARMACOLOGY
Clobetasol Propionate is a highly potent topical steroid. It has both local
anti inflammatory and immunosuppressive activity. Clobetasol, as the
Propionate salt, is only used topically on the skin and its effects are
limited to the local anti inflammatory activity. When given systemically it
has standard glucocorticoid activity and binds with high affinity to the
glucocorticoid receptor. Clobetasol Propionate inhibits the adherence of
neutrophils and monocyte-macrophages; to the capillary endothelial
cells of inflammed area. Clobetasol blocks the effect of macrophage
migration inhibitory factor and decreases the activation of plasminogen
to plasmin.

INDICATION
is indicated in:
1. Initial control of all forms of hyperacute eczema in all age groups 2.
Chronic hyperkeratotic eczema of the hands and feet and patches of
chronic lichen simplex 3. Chronic hyperkeratotic psoriasis of any area of
the body 4. Severe acute photosensitivity 5. Hypertrophic lichen planus 6.
Localized bullous disorders 7. Keloid scarring 8. Pretibial myxoedema 9.
Vitiligo 10. Suppression of reaction after cryotherapy

DOSAGE AND ADMINISTRATION
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.
If a longer course is necessary, it is recommended that treatment should
not be continued for more than four weeks without the patient;s
condition being observed. Repeated short courses of Dermasol®
may be
used to control exacerbations. If continuous steroid treatment is
necessary, a less potent preparation should be used. In very resistant
lesions, especially where there is hyperkeratosis, the anti-inflammatory
effect of Dermasol®
can be enhanced, if necessary, by occluding the
treatment area with polythene film. Only overnight occlusion is usually
adequate to bring about a satisfactory response. Thereafter,
improvement can usually be maintained by application without
occlusion.

CONTRAINDICATION AND PRECAUTION
Clobetasol Propionate is contraindicated in:
1. Cutaneous infections such as impetigo, tinea corporis and Herpes
simplex 2. Infestations such as scabies 3. Neonates (Children less than one
year old) 4. Acne vulgaris 5. Rosacea 6. Gravitational ulceration Long term
continuous therapy with Clobetasol Propionate should be avoided,
particularly in infants and children, in whom adrenal suppression occurs
readily. If Clobetasol Propionate is required for use in children, it is
recommended that the treatment should be reviewed on weekly basis. It
should be noted that the infants napkin may act as occlusive dressing.
The face more than other area of the body, may exhibit atrophic changes
after prolonged treatment with potent topical corticosteroids. This must
be borne in mind when treating facial conditions which warrants use of
Clobetasol Propionate and frequent observation of the patient is
important.

SIDE EFFECT
Provided the weekly dosage is less than 50g in adults, any pituitaryadrenal
suppression is likely to be transient with a rapid return to normal values
once the short course of steroid therapy has ceased. The same applies to
children given proportionate dosage. Use of occlusive dressings
increases the absorption of topical corticosteroids. Prolonged and
intensive treatment with a highly active corticosteroid preparation may
cause atrophic changes, such as thinning, striae and dilatation of the
superficial blood vessels, particularly when occlusive dressings are used
or where skin folds are involved.

USE IN PREGNANCY AND LACTATION
Clobetasol Propionate should be avoided in pregnant women. Mothers
using large amounts of the drug should be aware of potential excretion
in milk.
OVERDOSE
Acute overdose is very unlikely to occur. However, in the case of chronic
overclosage or misuse, the features of hypercorticism may appear and in
this situation topical steroids should be discontinued.
PHARMACEUTICAL PRECAUTION
Store in a cool and dry place, away from light. Keep out of reach of
children.

HOW SUPPLIED
Dermasol®
10 gm cream: Each pack has a tube containing 10 gm of the
cream.