ARTG Entry
DIPROSONE
ARTG entry for DIPROSONE (betamethasone), ARTG 18823 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Organon Pharma
- Active ingredient: betamethasone
- Therapeutic area: Dermatology
What it is
DIPROSONE is betamethasone dipropionate, supplied as cream, ointment and lotion at 0.05% w/w strength. Betamethasone dipropionate is a potent topically-active corticosteroid producing prompt, marked and prolonged anti-inflammatory, anti-pruritic and vasoconstrictive effects.
Approved indications —
Relief of inflammatory and pruritic manifestations of atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis. — Treatment of corticosteroid-responsive dermatoses on the scalp, chest and underarms where hair impedes access to the skin, including seborrhoea and psoriasis of the scalp (lotion formulation).
Dosing overview
DIPROSONE Cream and Ointment: apply a small amount to the affected area twice daily, though adequate maintenance therapy may be achieved with once daily application in some patients. DIPROSONE Lotion: apply twice daily by parting the hair with a comb and applying directly onto the scalp with the nozzle, squeezing the bottle gently. In most cases, four weeks continuous treatment should be considered the maximum.
Key safety warnings
DIPROSONE preparations should not be used in or near the eyes. Corticosteroids are known to be absorbed percutaneously; therefore, in patients under prolonged and extensive topical treatment, particularly when using occlusive dressing technique, the possibility of systemic effects should be kept in mind, and suitable precautions should be taken, particularly in infants and children. Any of the side effects reported following systemic use of corticosteroids, including adrenal suppression, may occur with topical corticosteroids, especially in infants and children; patients applying large doses over large body surface areas should be evaluated periodically for evidence of HPA axis suppression. Patients applying doses of DIPROSONE in excess of 15 g per day should be carefully monitored. Visual disturbance may be reported with topical corticosteroid use; patients presenting with symptoms such as blurred vision or other visual disturbances should be considered for referral to an ophthalmologist for evaluation of possible causes including cataract, glaucoma or central serous chorioretinopathy. Topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue; if this occurs, treatment should be discontinued.
Contraindications
DIPROSONE is contraindicated in hypersensitivity to betamethasone dipropionate, other corticosteroids or any components in DIPROSONE. Like other topical corticosteroids, DIPROSONE preparations are contraindicated in most viral infections of the skin, such as vaccinia, varicella, Herpes simplex, and also tuberculosis and acne rosacea.
Regulatory history
DIPROSONE Cream and DIPROSONE Lotion were first registered on the ARTG on 8 October 1991. DIPROSONE Ointment was registered on the ARTG on 12 November 2007.