| CLOBESOL Cream
Clobetasol Propionate USP 0.05%
Description:
Clobesol Cream
contains the compound Clobetasol Propionate USP an analog of
prednisolone, has a high degree of glucocorticoid activity and
a slight degree of mineralocorticoid activity.
Composition:
Each gram cream
contains Clobetasol Propionate USP 0.5 mg.
Pharmacology:
Clobesol has
both local anti-inflammatory and immunosuppressive activity.
Thus Clobesol inhibits the adherence of neutrophils and
monocyte-macrophages to the capillary endothelial cells of the
inflammed area. The drug blocks the effect of macrophage migration
inhibitory factor and decreases the activation of plasminogen
to plasmin. Clobesol also reduces the number of human
leukocyte antigen-DR+/T6+. By inhibition
of phospholipase A2 activity via formation of lipocortin.
Clobetasol reduces the formation of prostaglandins and leucotrienes
in the local tissues.
Indications:
ˇ Initial control
of all forms of hyperacute eczema in all age groups ˇ Chronic
hyperkeratotic eczema of the hands and feet and patches of chronic
lichen simplex ˇ Chronic hyperkeratotic psoriasis of any area
of the body ˇ Severe acute photosensitivity ˇ Acute contact
dermatitis ˇ Hypertropic lichen planus ˇ Localized bollous disorders
ˇ Keloid scarring ˇ Pretiable myxoedema ˇ Vitiligo ˇ Suppression
of reactions after cryotherapy.
Dosage and Application:
Clobesol
should be applied with gentle rubbing to the affected skin areas
twice daily. Once absorbed through the skin, topical corticosteroids
enter pharmacokinetic pathways similarly to systemically administered
corticosteroids. For acute dermatitis twice daily application
may be appropriate for short periods of time e.g. 1-2 weeks,
although evidence now suggests that once daily application is
sufficient. Long treatment should probably be limited to intermittent
plus therapy as skin atrophy has been shown to persist for 3
days after single application.
Dosage should not
normally exceed 50 g per week and the duration of a course should
not be more than 4 weeks. The potency can further enhanced by
the use of occlusive dressing.
Side-effects:
The use of large
amounts of cream for a long period of time over very large areas
of the body can lead to produce adrenal suppression, cushing
syndrome; hypercorticism; pigmentation; atrophic changes, such
as thinning, striae; etc.
Contraindications:
Cutaneous infections
such as impetigo, tinea corporis and herpes simplex Infestations
such as scabies Acne vulgaris Children under 1 year Hypersensitivity
Rosacea Gravitational ulceration Perioral dermatitis.
Precaution:
Avoid long-term
therapy particularly in children, in whom adrenal suppression
occurs readily. If Clobesol is required for use in children,
it is recommended that the treatment should be weekly reviewed.
Avoid prolonged application to face because the face than other
area of the body exhibits more atrophic changes with potent
corticosteroids.
Discontinue the
use if there is spread of infection. Avoid contact with eyes.
Use in pregnancy:
Clobesol
should be avoided in pregnant women.
Use in lactation:
Mothers using large
amounts of the drug should be aware of potential excretion in
milk.
Paediatric use:
The drug may be
used in paediatric patients in appropriate doses, but large
quantities for prolonged period should be avoided. It is contraindicated
in children under 1 year.
Drug Interaction:
No hazardous interactions
have been found.
Information
for patients:
1.
This medication is to be used as directly by the physician
and should not be used longer than the prescribed time period.
It is for external use only. Avoid contact with eyes.
2.
The treated skin should not be bandaged or otherwise
covered or wrapped so as to be occlusive.
3.
This medication should not be used for any disorder other
than that for which it was prescribed.
4.
Patients should report any signs of local adverse reactions
to the physicians.
Storage:
1.
Keep in cool (below 25ēC) & dry place.
2.
Close the mouth of tube well after each application.
3.
Do not freeze.
Packing:
Collapsible aluminum
tube containing 10 g cream. |
