Novoter 0.05% Cream

Novoter 0.05% Cream is used for: Topical corticosteroids are generally indicated for symptomatic relief of acute and chronic skin eruptions, where anti-inflammatory, anti-allergenic and antipruritic activity is required; in the absence of infection. Fluocinonide is a potent (group III) topical corticosteroid generally used for lichenified and thickened areas of eczema on the body including the palm, sole, trunk, extremities, scalp and hairy skin areas. It is indicated for topical application in the following conditions: Atopic dermatitis (including infantile atopic dermatitis); Nummular dermatitis (discoid eczema); Prurigo nodularis; Psoriasis (excluding widespread plaque psoriasis); Lichen simplex chronicus (neurodermatitis) and lichen planus; Seborrhoeic dermatitis; Irritant or allergic contact dermatitis; Discoid lupus erythematosus; Insect bite reactions; otitis externa

Recommended for use on lichenified and thickened areas of eczema on the body Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs (in the more responsive conditions this may be within a few days), then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient. In more resistant lesions, especially where there is hyperkeratosis, the anti-inflammatory effect of fluocinonide can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually be maintained by application without occlusion. If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated. Therapy with fluocinonide should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy. Rebound of pre-existing dermatoses can occur with abrupt discontinuation of fluocinonide. Recalcitrant dermatoses: Once an acute episode has been treated effectively with a continuous course of topical corticosteroid, intermittent dosing (once daily, twice weekly, without occlusion) may be considered. This regimen should be combined with routine daily use of emollients and continued treatment must be re-evaluated on a regular basis. Application to the face: Courses should be limited to five days if possible and occlusion should not be used. Renal or Hepatic Impairment: In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit NOTE: For topical application only. Not for oral, ophthalmic, or intravaginal use Avoid abrupt discontinuation, Avoid contact with eyes. Wash hands after each application Do not use with occlusive dressing without medical supervision Cream is especially appropriate for moist or weeping surfaces while ointment is for dry, lichenified or scaly lesions

CHILD (>2 years), apply small quantity to the affected area 1–2 times daily until improvement occurs, then less frequently Pediatric use of topical corticosteroids: Some manufacturers recommend avoiding in children <2 years. In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects including HPA axis suppression and Cushing's syndrome. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults Hypothalmic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Generally, children require shorter courses and less potent agents than adults. The smaller the child the less you will need to use. Occlusion should be avoided. Duration of treatment should be limited if possible, to five days and reviewed weekly. Long-term continuous topical corticosteroid therapy should be avoided as this may interfere with the growth and development of children NOTE: For topical application only. Not for oral, ophthalmic, or intravaginal use Avoid abrupt discontinuation, Avoid contact with eyes. Wash hands after each application Do not use with occlusive dressing without medical supervision Cream is especially appropriate for moist or weeping surfaces while ointment is for dry, lichenified or scaly lesions

Renal or Hepatic Impairment: In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit

For topical administration. When practical, clean the affected area with mild soap and warm water and rinse thoroughly; gently dry by patting or blotting with toilet tissue or a soft cloth before applying. Application of cream in adults: - two fingertips of cream will cover both hands or one foot - three fingertips of cream will cover one arm - six fingertips of cream will cover one leg - fourteen fingertips of cream will cover the front and back of the body. - If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral, may be necessary. Application of cream in children: - The smaller the child the less you will need to use. - A child of 4 years needs about a third of the adult amount. - A course of treatment for a child should not normally last more than 5 days unless your doctor has told you to use it for longer. The doctor may want to see the child every week, whilst using the cream

Hypersensitivity to any of the ingredients or to other corticosteroids. Discontinue if irritation or sensitisation develops during use. Avoid in untreated tubercular, bacterial and fungal infections involving the skin and in certain viral diseases such as herpes simplex, chickenpox, and vaccinia due to concerns that immunosuppression may exacerbate the infection. Dermatoses in children under one year of age, including dermatitis and napkin eruptions Avoid use in or close to the eyes

Prolonged use of topical corticosteroids on large areas of the skin may cause local and systemic toxicity. Occlusive dressing not recommended Use of topical corticosteroids in psoriasis may lead to tolerance and rebound relapses, increased risk of generalised pustular psoriasis, and local and systemic toxicity due to impaired barrier function of the skin Monitor for corticosteroid-associated systemic adverse effects especially in children, including adrenal suppression, manifestation of Cushing’s syndrome, hyperglycemia, and glycosuria Application to the face: Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes. Application to the eyelids: If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure. Use in children: In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults. In children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression: Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency. Skin features of hypothalamic-pituitary-adrenal (HPA) axis suppression include: skin thinning/skin atrophy skin wrinkling, skin dryness, striae, telangiectasias, pigmentation changes, alopecia, trichorrhexis Risk factors for increased corticosteroidal systemic effects are: Potency and formulation of topical corticosteroid; Duration of exposure; Application to a large surface area; Use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings (napkins may act as an occlusive dressing); Increasing hydration of the stratum corneum; Use on thin skin areas such as the face; Use on broken skin or other conditions where the skin barrier may be impaired Pregnancy and lactation

Inhibitors of CYP3A4 (e.g. ritonavir, itraconazole): Co-administration can inhibit the metabolism of corticosteroids; the effect on the plasma levels of corticosteroids depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor

Side effects of Fluocinonide (Topical) : Local adverse effects: Common and mostly occur on the face, in skin folds, and in areas that are treated over the long term - Transient burning or stinging — this is common, especially in the first 2 days of application on untreated, inflamed skin. - Worsening and spreading of untreated infection. - Thinning of the skin (atrophy) — the skin improves over a period after stopping treatment. - Permanent stretch marks or striae. Most common in the groin, axillae, and inner thigh areas. - Allergic contact dermatitis — due to the corticosteroid or the excipients. Lower potency agents like Hydrocortisone may be more allergenic. - Acne (or worsening of existing acne) or rosacea. Common in the face with high potency agents. - Hypopigmentation — More common in the blacks. May be reversible. - Excessive hair growth at the site of application (hypertrichosis). Reversible. Systemic adverse effects: Rare, but may occur more frequently in the presence of risk factors (see below) including infants and children - Adrenal suppression. - Cushing’s syndrome. - Hyperglycaemia. - Growth retardation in children. Risk factors for adverse effects: - Duration of treatment — long-term treatment is likely to result in systemic absorption. - Area of the skin being treated — treating large areas of skin increases the risk of absorption. - Condition of the skin — absorption is greatest in thin, inflamed skin. - Potency of the topical corticosteroid — the greater the potency, the greater the risk of absorption. - Occlusion — use of topical corticosteroids under occlusion increases the risk of systemic absorption. - Age — children and elderly people are more susceptible to the adverse effects of topical corticosteroids because they have a thinner epidermis. Minimizing adverse effects: Prescribe the least potent formulation which is fully effective (advise the person to apply it thinly to affected areas, no more than twice daily). Consider prescribing an appropriate quantity of an emollient for use alongside the topical corticosteroid (for moisturizing purposes). Avoid prescribing potent corticosteroids for use on the face. Unless under specialist supervision, the use of potent (such as betamethasone valerate 0.1%) and very potent (such as clobetasol propionate 0.1%) topical corticosteroids, should be limited to: - Use for up to 2 weeks, and - No more than 50 g each week. - Once-daily application is usually sufficient — maximum of twice daily. Avoid using occlusive dressings with topical corticosteroids (especially on large areas of the body). If a topical corticosteroid is needed for maintenance therapy, consider incorporating regular periods when they are withdrawn (for as long as possible) and emollients are used on their own. If the person is using large amounts of topical corticosteroid regularly, monitor them for signs of systemic adverse effects (such as adrenal suppression) and local adverse effects (such as areas of thin skin or striae). Monitor the height of children who are using large amounts of topical corticosteroid

Novoter 0.05% 0.5mg/g Cream manufactured by Cusi Laboratories. Its generic name is Fluocinonide (Topical). Novoter 0.05% is availble in United Arab Emirates. Farmaco UAE drug index information on Novoter 0.05% Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.