Salibet Ointment
Betamethasone + Salicylic acid
"0.5mg, 30mg/g"
Jamjoom Pharmaceuticals Company Ltd.
Pack size | 30g Tube |
---|---|
Dispensing mode | POM |
Source | SAUDI ARABIA |
Agent | Unicare for Medical Trading |
Retail Price | 20.00 AED |
Indications
Salibet Ointment is used for:
Topical treatment of hyperkeratotic and dry corticosteroid-responsive dermatoses where the cornified epithelium may resist penetration of the steroid. The descaling action of salicylic acid helps facilitate the steroid penetration into the dermis
Adult Dose
Ointment:
Apply a thin film of ointment to cover completely the affected areas of the skin usually twice daily, in the morning and at night. The ointment should be massaged gently and thoroughly into the skin.
For some patients, adequate maintenance therapy may be achieved with less frequent application.
It is recommended that prescribed amount be limited to 2 weeks, and that treatment is reviewed at that time.
The maximum weekly dose should not exceed 60 g.
Lotion:
Apply a thin film of lotion to cover completely the affected areas of the scalp usually twice daily
For some patients, adequate maintenance therapy may be achieved with less frequent application.
It is recommended that prescribed amount be limited to 2 weeks, and that treatment is reviewed at that time
Both lotion and ointment should not be used under occlusive dressing
NOTE:
For topical application only
Avoid contact with eyes. Wash hands after each application
Do not use with occlusive dressing
Child Dose
Dosage in children should be limited to 5 days
NOTE:
For topical application only
Avoid contact with eyes. Wash hands after each application
Do not use with occlusive dressing
Pediatric use of topical corticosteroids:
Some manufacturers recommend avoiding in children <2 years.
In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects including HPA axis suppression and Cushing's syndrome. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults
Hypothalmic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Generally, children require shorter courses and less potent agents than adults. The smaller the child the less you will need to use. Occlusion should be avoided.
Duration of treatment should be limited if possible, to five days and reviewed weekly. Long-term continuous topical corticosteroid therapy should be avoided as this may interfere with the growth and development of children
Renal Dose
Administration
Contra Indications
Hypersensitivity to any of the ingredients or to other corticosteroids or salicylates.
Discontinue if excessive dryness or increased skin irritation develops during use
Not recommended for the treatment of the following conditions: Rosacea; Acne vulgaris; Perioral dermatitis; Tuberculous and most viral lesions of the skin, particularly herpes simplex, vaccinia, varicella; Napkin eruptions; Fungal or bacterial skin infections without suitable concomitant anti-infective therapy
Children <2 years
Precautions
Prolonged use of topical corticosteroids on large areas of the skin may cause local and systemic toxicity. Occlusion must not be used, since under these circumstances the keratolytic action of salicylic acid may lead to enhanced absorption of the steroid
Use of topical corticosteroids in psoriasis may lead to tolerance and rebound relapses, increased risk of generalised pustular psoriasis, and local and systemic toxicity due to impaired barrier function of the skin
Monitor for corticosteroid-associated systemic adverse effects especially in children, including adrenal suppression, manifestation of Cushing’s syndrome, hyperglycemia, and glycosuria.
Application to the face: Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
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.
Use in children: In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
In children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression: Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. 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.
Skin features of hypothalamic-pituitary-adrenal (HPA) axis suppression include: skin thinning/skin atrophy skin wrinkling, skin dryness, striae, telangiectasias, pigmentation changes, alopecia, trichorrhexis
Risk factors for increased corticosteroidal systemic effects are: Potency and formulation of topical corticosteroid; Duration of exposure; Application to a large surface area; Use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings (napkins 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
Pregnancy and lactation
Pregnancy-Lactation
Interactions
Inhibitors of CYP3A4 (e.g. ritonavir, itraconazole): Co-administration can inhibit the metabolism of corticosteroids; the effect on the plasma levels of corticosteroids depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor
Adverse Effects
Side effects of Betamethasone + Salicylic acid :
Continuous application without interruption may result in local atrophy of the skin, striae and superficial vascular dilation, particularly on the face
Salicylic acid
Prolonged use of salicylic acid preparations may cause dermatitis
Betamethasone
Side effects associated with topical steroids include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hyperpigmentation, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae miliaria, capillary fragility (ecchymoses), blurred vision and sensitisation.
In children receiving topical corticosteroids, Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing's syndrome and intracranial hypertension have been reported
Mechanism of Action
Note
Salibet "0.5mg, 30mg/g" Ointment manufactured by Jamjoom Pharmaceuticals Company Ltd.. Its generic name is Betamethasone + Salicylic acid. Salibet is availble in United Arab Emirates.
Farmaco UAE drug index information on Salibet Ointment is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.