Aclobet 0.05% Ointment 10 gm tube

Aclobet 0.05% Ointment 10 gm tube

COMPOSITION

Aclobet Ointment : Each gram contains Clobetasol Propionate BP 0.5 mg.

Aclobet Cream : Each gram contains Clobetasol Propionate BP 0.5 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 inflammed area. Clobetasol blocks the effect of macrophage migration inhibitory factor and decreases the activation of plasminogen to plasmin.

INDICATIONS

Aclobet is indicated in :

• Initial control of all forms of hyperacute eczema in all age groups (in children for no longer than a few days).

• Chronic hyperkeratotic eczema of the hands and feet and patches of chronic lichen simplex.

• Chronic hyperkeratotic psoriasis of any area of the body.

• Severe acute photosensitivity.

• Hypertrophic lichen planus.

• Localized bullous disorders.

• Keloid scarring.

• Pretibial myxoedema.

• Vitiligo.

• Suppression of reaction after cryotherapy.

DOSAGE AND ADMINISTRATION

Route of 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 patients condition being observed. Repeated short courses of Aclobet 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 effects of Aclobet 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.

CONTRAINDICATIONS AND PRECAUTION

Clobetasol Propionate is contraindicated in :

• Cutaneous infections such as impetigo, tinea corporis and herpes simplex.

• Infestations such as scabies.

• Neonates.

• Acne Vulgaris.

• Rosacea.

• 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 infant’s napkin might 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 EFFECTS

Common side effects : Provided the weekly dosage is less then 50 g in adults, any pituitary adrenal 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.

Rare side effects :

USE IN PREGNANCY & LACTATION

Clobetasol Propionate should be avoided in pregnant women. Mothers using large amounts of the drug should be aware of potential excretion in milk.

USE IN CHILDREN & ADOLESCENT

DRUG INTERACTION

With medicine :

With food & others :

OVER DOSE

Acute overdose is very unlikely to occur. However, in the case of chronic over dosage or misuse, the features of hypercorticisms may appear and in this situation topical steroids should be discontinued.

STORAGE

Store below 300 C and dry place, protected from light. Keep all medicines out of reach of children.

PACKING

Aclobet Ointment : Each pack contains 10 gm Ointment in tube.

Aclobet Cream : Each pack contains 10 gm Cream in tube.