Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically
and produces a rapid and sustained response in those inflammatory dermatoses that are
normally responsive to topical corticosteroid therapy, and it is also effective in the less
responsive conditions, such as psoriasis of the scalp, chronic plaque psoriasis of the hands
and feet, but excluding widespread plaque psoriasis.
Topical salicylic acid softens keratin, loosens cornified epithelium and desquamates the
epidermis.
Salibet presentations are therefore indicated for the treatment of hyperkeratotic and dry
corticosteroid-responsive dermatoses where the cornified epithelium may resist penetration
of the steroid. The salicylic acid constituent of Salibet preparations, as a result of its
descaling action, allows access of the dermis more rapidly than by applying steroid alone.

Adults :
Once to twice daily. In most cases a thin film should be applied to cover the affected area
twice daily.
For some patients adequate maintenance therapy may be achieved with less frequent
application.

It is recommended that Salibet preparations are prescribed for two weeks, and that treatment
is reviewed at that time. The maximum weekly dose should not exceed 60g.
Children:
Dosage in children should be limited to 5 days.

Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the Salibet presentations contra-indicates their use as does tuberculous and most viral lesions of the skin, particularly herpes simplex, vacinia, varicella. Salibet should not be used in napkin eruptions, fungal or bacterial skin infections without suitable concomitant anti-infective therapy.

Occlusion must not be used, since under these circumstances the keratolytic action of
salicylic acid may lead to enhanced absorption of the steroid.
Local and systemic toxicity is common, especially following long continuous use on large
areas of damaged skin, in flexures or with polythene occlusion. If used in children or on the
face courses should be limited to 5 days. Long term continuous therapy should be avoided in
all patients irrespective of age.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons, including
rebound relapses following development of tolerance, risk of generalised pustular psoriasis
and local systemic toxicity due to impaired barrier function of the skin. Careful patient
supervision is important.
It is dangerous if Salibet presentations come into contact with the eyes. Avoid contact with
the eyes and mucous membranes.
The systemic absorption of betamethasone dipropionate and salicylic acid may be increased
if extensive body surface areas or skin folds are treated for prolonged periods or with
excessive amounts of steroids. Suitable precautions should be taken in these circumstances,
particularly with infants and children.

If irritation or sensitization develops with the use of Salibet Ointment and Lotion, treatment
should be discontinued.
Any side effects that are reported following systemic use of corticosteroids, including
adrenal suppression, may also occur with topical corticosteroids, especially in infants and
children.
If excessive dryness or increased skin irritation develops, discontinue use of this preparation.
Peadiatric Use: Peadiatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced hypothalamic-pituary-adrenal (HPA) axis suppression and to
exogenous corticosteroid effects than mature patients because of greater absorption due to a
large skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain,
and intracranial hypertension have been reported in children receiving topical
corticosteroids. Manifestations of adrenal suppression in children include low plasma
cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial
hypertension include a bulging fontanelle, headaches and bilateral papilledema.

 

None stated

Since safety of topical corticosteroid use in pregnant women has not been established, drugs
of this class should be used during pregnancy only if the potential benefit justifies the
potential risk to the foetus. Drugs of this class should not be used extensively in large
amounts or for prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of corticosteroids can result in
sufficient systemic absorption to produce detectable quantities in breast milk, a decision
should be made to discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.

None stated

Salibet skin preparations are generally well tolerated and side-effects are rare.
Continuous application without interruption may result in local atrophy of the skin, striae
and superficial vascular dilation, particularly on the face.
Adverse reactions that have been reported with the use of topical corticosteroids include:
burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions,
hypopigmentation, perioral dermatitis and allergic contact dermatitis.
The following may occur more frequently with the use of occlusive dressings: maceration of
the skin, secondary infection, skin atrophy, striae and miliaria.
In addition, prolonged use of salicylic acid preparations may cause dermatitis.
To reports any side effect(s):
 Saudi arabia
-The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
 

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions
resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism,
including Cushing's disease.
Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms
are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity,
slow withdrawal of corticosteroids is advised.
With topical preparations containing salicylic acid excessive prolonged use may result in
symptoms of salicyclism. Treatment is symptomatic. Measures should be taken to rid the body rapidly of salicylate. Adminster oral sodium bicarbonate to alkalinize the urine and
force diuresis.
The steroid content of each tube is so low as to have little or no toxic effect in the unlikely
event of accidental oral ingestion.

Salibet preparations contain the dipropionate ester of betamethasone which is a
glucocorticoid exhibiting the general properties of corticosteroids, and salicylic acid which
has keratolytic properties.
Salicylic acid is applied topically in the treatment of hyperkeratotic and scaling conditions
where its keratolytic action facilitates penetration of the corticosteroid.
In pharmacological doses, corticosteroids are used primarily for their anti-inflammatory
and/or immune suppressive effects.
Topical corticosteroids such as betamethasone dipropionate are effective in the treatment of
a range of dermatoses because of their anti-inflammatory, anti-pruritic and vasoconstrictive
actions. However, while the physiologic, pharmacologic and clinical effects of the
corticosteroids are well known, the exact mechanisms of their action in each disease are
uncertain.

Salicylic acid exerts only local action after topical application.
The extent of percutaneous absorption of topical corticosteroids is determined by many
factors including vehicle, integrity of the epidermal barrier and the use of occlusive
dressings.
Topical corticosteroids can be absorbed through intact, normal skin. Inflammation and/or
other disease processes in the skin may increase percutaneous absorption.

Occlusive dressings substantially increase the percutaneous absorption of topical
corticosteroids.
Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids are bound to plasma
proteins in varying degrees, are metabolised primarily in the liver and excreted by the
kidneys. Some of the topical corticosteroids and their metabolites are also excreted in the
bile.

There are no pre-clinical data of relevance to the prescriber which are additional to that
already included in other sections of the SPC.

Liquid Paraffin
White Soft Paraffin

None Stated.

2 years

Do not store above 30°C.

Immediate Container: 30g collapsible aluminum tube 25 mm diameters, double
lacquered, latex end seal, membrane nozzle.
Cap: High Density (HDPE) with piercing end.
Outer Individual Carton: 280 g/m2 grammage paper, dimension 43.0 mm x 31.5 mm x 138
mm, printed.
Insert/Leaflet: 50-60 g/m2 paper, dimension 140 x 120 mm, both sides printed.

For external use only.
Avoid contact with eye and mouth.
Advice to be used within 3 months of tube opening.