UNIFLEX 0.1% Cream

Therapeutic Class

Topical Corticosteroids

Indications

For the relief of Inflammatory manifestations of cortrcosterord-responslve dermatoses such as In eczema, Infantile eczema, atoptc dermatitis dermatitis herpetlformls, contact dermatitis, seborrheic dermatitis:neurodermatitis, some form of psoriasis and intertrigo.

Chemical Composition

Betamethasone 0.1 % w/w

Packaging

15 g / Tube

Dosage & Administration

For external use only. Apply sparingly onto the. affecte area 3 to 2 times a day. When a favourable response rs obtamed, reduce application gradually and eventually discontinue.

Contraindications

Unless under medical supervision, Unlflex should not be used for rosacea or on areas around the mouth. Uniflex should not be used for acne, viral skin infections e.g. herpes simplex (cold sores) and chicken pox; fungal infections e.g. candidiasis; bacterial infections; in patients with a history of sensitivity to any of its components. Do not use in children under one year of age, incl uding dermatitis and napkin eruptions.

Warning & Precautions

If irritation develops with the use of Uniflex, treatment should be discontinued and appropriate therapy instituted. Prolonged therapy should be avoided where possible. Any of the side effects reported following systemic use of corticosteroids including adrenal suppression, may also occur following their topical use especially in children and infants. Systemic absorption will be increased if extensive body surfaces are treated or if occlusive dressing is used. Although topical steroids have not been reported to have adverse effect on human pregnancy, their safe use in pregnant women has not been absolutely established and should not be used in large amounts or for prolonged periods in pregnant women. Avoid prolonged use or over large areas of the body particularly in areas where the skin is thinner or with occlusive dressing present. Unless under medical supervision, do not use on the face. Do not use on eyes, in the ano-genital region and on broken or infected skin including cold sores, acne and athletes foot. Use in children and babies may increase risk of systemic absorption which may lead to side effects such as adrenal suppression. Indiscriminate use in pruritus may cause a rebound exacerbation of the condition and may occur when treatment is stopped.

Side Effects

Uniflex Is generally well tolerated when used for short durations and over small areas.If application of more than 1OOg per week is used, betamethasone ester, being a potent corticosteroid, is likely to produce the severe side-effects associated with steroid use such as pituitary­ adrenal-axis suppression. As with other topical corticosteroids, prolonged use of large amount or treatment of extensive areas can result insufficient systemic absorption to produce the features of hypercorticism and suppression of HPA axis. These effects are likely to occur in infants and children, and if occlusive dressings is used. Local side-effects may include spread of local infections, thinning of the skin,irreversible striae atrophicae, increased hair growth, acne, mild depigmentation and growth of vellus hair and perioral dermatitis in young women.

Drug Interaction

Topical application of Unflilex Is not likely to produce s1gn1ficant drug Interactions Concurrent use of barbiturates, phenytoin, or rifampicin may enhance the metabolism and decrease the effect of corticost-roids.