COMPOSITION :
STERNON – SF OINTMENT
Betamethasone 0.05% w/w
(as Dipropionate)
Salicylic Acid 6.0% w/w
In ointment base
Molecular Formula
Betamethasone Dipropionate C28H37FO7
Salicylic Acid C7H6O2
CLINICAL PHARMACOLOGY :
The primary therapeutic effect of Betamethasone dipropionate is due to the anti-inflammatory activity which is nonspecific. Topically applied glucocorticoids like Betamethasone dipropionate binds with receptor proteins in the cytoplasm of target cells. This ieads to the formation of phospholipase A2 inhibitory proteins, collectively called lipocortins. Phospholipase A2 is known to catalyse the conversion of membrane phospholipids to Arachidonic acid. Arachidonic acid binds with cyclo-oxygenase to form highly inflammation prostaglandins, PGE2. Lipocortins inhibits phopholipase A2, and thereby controls the biosynthesis of potent mediators of inflammatory like prostaglandin E2(PGE2) and leukotrienes, kinins, histamine, liposomal enzymes and the complement system. When applied to inflamed area of skin Betamethasone dipropionate inhibits the migration of leukocytes into the area by reversing vascular dilatation and permeability. The clinical result is a decrease in edema (swelling), erythema and pruritus. Betamethasone dipropionate falls under the category of very potent corticosteroids with a vasconstrictor potency index of 1660. Due to double esterification at positions 17&21, STERNON becomes very lipophilic thereby offering -better penetration
-more affinity to the cytosol receptors for potent action.
Salicylic Acid in STERNON –SF is a Keratolytic agent causing desquamation of stratum corneum, thereby ensuring better penetration of Betamethasone Dipropionate. The mechanism of action of topical salicylic acid may include two pathway, both leading to desquamation of corneocytes. Salicylic acid reduces intercellular cohesiveness of the horny cells by dissolving the intercellular cement material. Salicylic acid also reduces the pH of the stratum corneum, thereby increasing hydration and softening.
6% salicylic acid in STERNON –SF exerts a potent and rapid deep keratolytic effect and ultimately an exfoliative action.
6% salicylic acid enhances penetration of Betamethasone into deeper layers of epidermis.
6% salicylic acid produces no adverse effects on epidermis.
6% salicylic acid in STERNON –SF intended for rapid clearing of the toughest psoriatic plaques, especially of the palms and soles, in lichen simplex chronicus, lichen planus and neurodematitis.
INDICATIONS :
STERNON SF is indicated for the management of the very severe and toughest hyperkeratotic disorders like psoriasis with very thick scales, like psoriasis of palms and soles, lichen simplex chronicus, lichen planus, neurodermatitis & palmo plantar keratoderma.
DOSAGE AND ADMINISTRATION :
A thin film has to be applied to the affected area two or three times a day. Treatment should be limited to two weeks, and amounts greater than 50g. per week should not be used.
CONTRAINDICATIONS :
STERNON - SF is contraindicated in patients who are hypersensitive to Betamethasone Dipropionate, to other corticosteroids, or to any ingredients in these preparations.
WARNINGS AND PRECAUTIONS :
When applied to the eyelid or skin near the eyes, the drug may enter the eyes.
Pregnancy :
There are no adequate or well controlled studies in pregnant women. Therefore use during pregnancy only if potential benefits outweigh the potential hazards.
Lactation :
It is not known whether topical corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless caution to be exercised.
Children :
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic pituitary adrenal (HPA)-axis suppression and Cushing’s syndrome than adults because of a larger skin surface to body weight ratio. Limit administration to the least amount compatible with effective therapy.
ADVERSE REACTIONS :
Burning, itching, irritation, dryness, folliculitis, skin atrophy, erythema, numbness of fingers and telangiectasia occurs infrequently. If signs of hypersensitivity occur, treatment should be immediately stopped.
STORAGE INSTRUCTIONS :
Store in a cool, dry place.
