66/68 Town Planning Way, Ilupeju, Lagos
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TP. Tempo Scan Pacific Tbk. JI. Let, Jen. Haryone MT 7, Jakata – Idonesia
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Cream (NRN: 04–7580), Clobetasol Propionate 0.05%
Pack size: Presented in a tube of 30 g.
Like other topical corticosteroids, Clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties.
The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Short-course treatment of more resistang dermatoses eg psoriasis, recalcitrant eczemas, lichen planus, discoid lupus erythematosus, and other condition which do not respond satisfactorily to less active steroids.
Rosacea, acne, and perioral dermatitis. Skin lesions caused by infection with viruses (e.g., herpes simplex, chickenpox). Fungi (e.g., candidiasis, tinea) or bacteria (e.g., impetigo).
Hypersensitivity to the preparation.
Long-term continuous therapy with Tempovate should be avoided, particularly in infants and children, in whom adrenal suppression occurs readily. If Tempovate is required for use in children, it is recommended that the treatment should be reviewed weekly. It should be noted that the infant’s napkin may act as an occlusive dressing.
The face, more than other areas of the body may exhibit atrophic chnges after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating facial conditions which warrant use of Tempovate, and frequent observation of the patient is important. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and institution of suitable systemic chemotherapy.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings and the skin should be cleansed before a fresh dressing is applied.
Topical administration of corticosteroid to pregnant animals can cause abnormalities od fetal developement. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e in large amount or for prolonged periods.
Provided the weekly dosage is less than 50 g in adult, 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 highly-active corticosteroid preparations may cause atrophic changes such as striae, thinning of the skin, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or where skin folds are involved. In rare instances, treatment of psoriasis with corticosteroid (or its withdrawal) is thought to have provoked the pustular form of the disease.
Tempovate is usually well-tolerated, but if signs of hypersensitivity appear, applications should be stopped immediately.
Dosage & Administration
Apply sparingly to the affected area once or twice daily until improvement occurs. As with other highly-active steroid preparation, therapy should be discontinued when control is achieved. In a more responsive conditions, this may be within a few days.
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 reviewd. Repeated short courses of Tempovate 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 Tempovate 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.
Store below 30ºC. Keep all medicine out of the reach of children.