Betamethasone valerate Chemical Structure: Bet amet hasone valerat e is 9-fluoro-11,21-dihydroxy-16-met hyl-3,20-dioxopregna-1,4- dien-17-yl pentanoate. The empirical formula is C27H37FO6. MW = 476.6
Celestone-M Cream contains betamethasone valerate equivalent to betamethasone 0.2mg, chlorocresol 1 mg/g as preservative, soft w hite paraffin, liquid paraffin, cetostearyl alcohol, cetomacrogol 1000, sodium phosphate monobasic, phosphoric acid and purified w ater. Celestone-M Ointment contains betamethasone valerate equivalent to betamethasone 0.2mg, soft w hite paraffin, liquid paraffin.
Betamethasone valerate is a topically-active corticosteroid ester w ith anti-inflammatory, antipruritic and vasoconstrictive actions.
Celestone-M is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as atopic eczema, infantile eczema, nummular eczema, anogenital and senile pruritus, contact dermatitis, seborrhoeic dermatitis, neurodermatitis, solar dermatitis, stasis dermatitis and psoriasis. Celestone-M is indicated for the maintenance therapy.
Hypersensitivity to betamethasone valerate, other corticosteroids or any components in Celestone-M. Like other topical corticosteriods, Celestone-M is contraindicated in most viral infections of the skin, such as vaccinia, varicella and Herpes simplex, also tuberculosis and acne rosacea.
Celestone-M should not be used in or near the eyes. If irritation or sensitisation develops w ith the use of Celestone-M, 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, Celestone-M should be discontinued until the infection has been controlled adequately. Any of the side effects that are reported follow ing systemic use of corticosteroids, including adrenal suppression, may also occur w ith topical corticosteroids, especially in infants and children. Systemic absorption of topical corticosteroids w ill be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or w hen long-term use is anticipated, particularly in infants and children.
Use in Children
Chronic corticosteroid therapy may interfere w ith the grow th and development of children. Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a larger skin surface area to body w eight ratio. HPA axis suppression, Cushing' s syndrome, linear grow th retardation, delayed w eight 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 bilaterial papilloedema.
Use in Pregnancy (Category A)
Topical corticosteroids should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.
Use in Lactation
Due to lack of dat a on the saf et y of bet amet hasone valerat e in lact at ion, care should be exercised to ensure that the potential benefits to the lactating mother outw eigh the possible hazards to the nursing infant.
The follow ing local adverse reactions have been reported w ith the use of topical corticosteroids: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. Rarely reported adverse effects include t ingling, prickly skin/tightening or cracking of skin, w arm feeling, laminar scaling and perilesional scaling, follicular rash, skin atrophy, erythema and t elangiect asia.
Apply a small amount to the affected area tw o or three times daily. Refractory lesions of psoriasis and other deep seated dermatoses, such as chronic lichen simplex, hypertrophic lichen planus, atopic dermatitis, chronic eczematous and lichenified hand eruptions, recalcitrant pustular eruptions of the palms and soles, respond better if occlusive dressings are used.
Occlusive Dressings
Apply a layer of medication over the entire lesion under a light gauze dressing, cover w ith a pliable transparent, impermeable plastic material w ell beyond the edges of the treated area. Seal the edges to normal skin by adhesive tape or other means. Leave the dressing in place for 1 to 3 days and repeat the procedure three or four times as needed. Occasionally, a miliary eruption or folliculitis develops in the skin beneath the dressing and should be treated by removing the plastic covering and applying a topical antibiotic.
Symptoms
Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency and produce manifestations of hypercorticism, including Cushing' s disease.
Treatment
Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow w ithdraw al of corticosteroids is advised.
Celestone-M Cream and Ointment, 0.02% (0.2 mg/g): 100g
Store below 25C
Prescription Only Medicine (Schedule 4)
Merck Sharp & Dohme (Australia) Pty Limited 54-68 Ferndell Street Granville NSW 2142 AUSTRALIA
This product information w as approved by the TGA on 14 August 1996. Date of most recent amendment: 21 October 2011