INDICATION
Diprobet ® (Betamethasone Dipropionate) cream and ointment are indicated for the relief
of the inflammatory and pruritic manifestations of resistant or severe corticosteroidresponsive
dermatoses. These include-
atopic eczema
nummular eczema
contact dermatitis
neurodermatitis
anogenital and senile pruritus
lichen planus and
psoriasis.
DOSAGE AND ADMINISTRATION
Apply a thin film once or twice daily to cover completely the affected area. Patients with
chronic psoriasis who have achieved at least a marked improvement in their psoriatic
lesion (i.e., approximately 80% improvement) with Betamethasone Dipropionate may be
maintained in remission with a pulse dosing regimen consisting of three consecutive
applications of up to 3.5 g each of Betamethasone Dipropionate cream and ointment,
twelve hours apart (e.g., morning, evening, following morning) to the previously affected
areas once each week. For this purpose, Betamethasone Dipropionate cream and ointment
should be applied to the lesion sites previously affected and treated. Patients on this pulse
dose regimen who relapse should be reverted back to the conventional dosing regimen.
CONTRAINDICATION
Hypersensitivity to Betamethasone Dipropionate, other corticosteroids or any
components in this preparation. Like other topical corticosteroids, Betamethasone
Dipropionate is contraindicated in viral infections of the skin, such as vaccinia, varicella
and Herpes simplex, also tuberculosis, acne rosacea, fungal skin infections (moniliasis),
perioral dermatitis and ulcerative conditions.
PRECAUTIONS
Betamethasone Dipropionate should not be used in or near the eyes, as there is a potential
risk of developing glaucoma and cataract. If irritation or sensitisation develops with the
use of Betamethasone Dipropionate, treatment should be discontinued and appropriate
therapy instituted. In the presence of an infection, an appropriate antifungal or
antibacterial agent should be administered. If a favourable response does not occur
promptly, Betamethasone Dipropionate should be discontinued until the infection has
been controlled adequately.
Corticosteroids are known to be absorbed percutaneously, therefore in patients under
prolonged and extensive topical treatment, the possibility of systemic effects should be
kept in mind. Betamethasone Dipropionate is not intended for use under occlusive
dressings since this will also increase systemic absorption of the corticosteroid. In infants
the napkin may act as an occlusive dressing and increase absorption. Suitable precautions
should be taken when using topical corticosteroids in patients with stasis dermatitis and
other skin diseases with impaired circulation. Prolonged use of topical corticosteroid
preparations may produce striae or atrophy of the skin or subcutaneous tissue. If this
occurs, treatment should be discontinued.
SIDE EFFECTS
The most frequent side effects reported with Betamethasone Dipropionate are mild to
moderate transient burning/stinging, dry skin, pruritus, irritation and folliculitis. Rarely
reported adverse effects include tingling, prickly skin/tightening or cracking of skin,
warm feeling, laminar scaling and perilesional scaling, follicular rash, skin atrophy,
erythema, urticaria, vesiculation, telangiectasia, acneiform papules and hyperaesthesia.
Adverse reactions reported with the use of the Betamethasone Dipropionate ointment
pulse dose regimen were mild intermittent hypertension and paraesthesia. Other local
adverse reactions that have been reported with the use of topical corticosteroids include:
itching, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis,
maceration of the skin, secondary infection, striae, miliaria and exacerbation of untreated
infections.
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