COMPOSITION :
Bersol® Cream 0.05%, each gram contains : Clobetasol propionate 0.05%.
DESCRIPTIONS :
Bersol® Cream containing Clobetasol propionate is available in 5 gram and 15 gram tubes.
INDICATIONS :
For short courses for the treatment of the more resistant dermatoses such as psoriasis (excluding widespread plaque psoriasis), recalcitrant eczema, lichen planus, discoid lupus erythematosus and other conditions which do not respond satisfactorily to less active steroids.
DOSAGE AND ADMINISTRATION :
Creams are especially appropriate for moist or weeping surfaces.
Adults, elderly and children over 1 year
Apply sparingly to the affected area once or twice daily until improvement occurs and discontinue when control is achieved. In the more responsive conditions this may be within a few days. Treatment should not be continued for more than four weeks without the patient’s condition being reviewed. Repeated short courses of Bersol® 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 effect of Bersol® 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.
OVERDOSAGE :
Symptoms and signs
Topically applied Clobetasol propionate may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may occur (see ADVERSE REACTION).
Treatment
In the event of overdosage, Clobetasol propionate should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
CONTRAINDICATIONS :
- Untreated cutaneous infections.
- Rosacea.
- Acne vulgaris.
- Pruritus without inflammation.
- Perianal and genital pruritus.
- Perioral dermatitis.
Clobetasol propionate is contraindicated in dermatoses in children under 1 year of age, including dermatitis.
WARNINGS AND PRECAUTIONS :
Clobetasol propionate should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see ADVERSE REACTION) may resemble symptoms of the condition under treatment.
Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glococorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids. If either of the above are observed, withdraw the drug gradually by reducing the frequency of application or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see ADVERSE REACTION).
Risk factor for increased systemic effects are :
- Potency and formulation of topical steroid.
- Duration of exposure.
- Application to a large surface area.
- Use on occluded areas of skin (e.g., on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing).
- Increasing hydration of the stratum corneum.
- Use on thin skin areas such as the face.
- Use on broken skin or other conditions where the skin barrier may be impaired.
- In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effect. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
Children
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
Children are more susceptible to develop atrophic changes with the use of topical corticosteroids.
If Clobetasol propionate is required for use in children, it is recommended that the treatment should be limited to only a few days and reviewed weekly.
Infection risk with occlusion
Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Use in psoriasis
Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development to tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis careful patient supervision is important.
Concomitant infection
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 administration of appropriate antimicrobial therapy.
Application to the face
Application to the face is undesirable as this area is more susceptible to atrophic changes. If used on the face, treatment should be limited to only 5 days.
Application to the eyelids
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure.
Pregnancy and lactation
Fertility : There are no data in human to evaluate the effect of topical corticosteroids on fertility. Clobetasol administered subcutaneously to rats had no effect upon mating performance; however, fertility was decreased at the highest dose.
Pregnancy : There are limited data from the use of Clobetasol propionate in pregnant woman. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development.
The relevance of this finding to humans has not been established. Administration of Clobetasol propionate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum duration.
Lactation : The safe use of topical corticosteroids during lactation has not been established. It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Administration of Clobetasol propionate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation Clobetasol propionate should not be applied to the breasts to avoid accidental ingestion by the infant.
Effect on ability to drive and use machines
There have been no studies to investigate the effect of Clobetasol propionate on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical Clobetasol propionate.
DRUG INTERACTIONS :
Co-administered drugs that can inhibit CYP3A4 (e.g., Ritonavir and Itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.
ADVERSE REACTIONS :
Infections and infestations
Very rare : Opportunistic infection
Immune system disorders
Very rare : Local hypersensitivity
Endocrine disorders
Very rare : Hypothalamic-pituitary adrenal (HPA) axis suppression :
Cushingoid features : (e.g., moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis.
Skin and subcutaneous tissue disorders
Common : Pruritus, local skin burning/skin pain.
Uncommon : Skin atrophy*, striae*, telangiectasias*.
Very rare : Skin thinning*, skin wrinkling*, skin dryness*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne.
General disorders and administration site conditions
Very rare : Application site irritation/pain.
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
PRESENTATIONS :
Bersol® Cream 0.05%Box, tube @ 15 gramReg. No. DKL9602323129A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
