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LYDERM is a brand name for Fluocinonide, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LYDERM (fluocinonide) is indicated for topical therapy of corticosteroid responsive acute and chronic skin eruptions where an anti-inflammatory, anti-allergenic and anti-pruritic activity in the topical management is required.
Verbatim from this product's HC label. Tap a section to expand.
1 Recommended Dose and Dosage Adjustment The cream is recommended for moist, weeping lesions, the ointment is suitable when an emollient effect is desired, and the gel may be more appropriate for lesions of the scalp. A small amount of LYDERM should be applied gently on the affected skin area, two to four times daily, depending on the severity of the condition.
It is recommended that LYDERM not be used under occlusive conditions.
1 Adverse Reaction Overview The following adverse skin reactions have been reported with the use of topical corticosteroids: dryness, burning, itching, local irritation, folliculitis, acneiform eruptions, striae, skin atrophy, atrophy of subcutaneous tissues, perioral dermatitis, telangiectasia, allergic contact dermatitis, leukoderma, maceration of the skin, hypertrichosis, change in pigmentation and secondary infection.
Adrenal suppression has also been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids. Systemic absorption of corticosteroids has produced manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Hypertension and gastroenteritis, although uncommon, has been observed. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have provoked the pustular form of the disease. 2 Post-Market Adverse Reactions LYDERM Product Monograph Page 9 of 22 The following adverse skin reactions have been reported with the use of topical corticosteroids and may occur more frequently with potent corticosteroids such as LYDERM (Fluocinonide) cream.
These reactions are listed in an approximately decreasing order of occurrence: 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.
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have provoked the pustular form of the disease.
1 General Patients should be advised to inform subsequent physicians of the prior use of corticosteroids. Significant systemic absorption may result when steroids are applied over large areas of the body. To minimize the possibility, when long-term therapy is anticipated, interrupt treatment periodically or treat one area of the body at a time.
If a symptomatic response is not noted within a few days to a week, the local application of corticosteroids should be discontinued, and the patient re-evaluated. 2 Endocrine and Metabolism Systemic effects of topical corticosteroids may include reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency.
This may occur during treatment or upon withdrawal of treatment with the topical corticosteroid. Because of the potential for systemic absorption, use of topical corticosteroids, including LYDERM Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression.
Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, occlusive use, and use on an altered skin barrier, concomitant use of multiple corticosteroid - containing products, liver failure, and young age.
If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface -to-body mass ratios.
3 Ophthalmic These products are not for ophthalmic use. Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in post -marketing experience with the use of topical corticosteroid products.
Topical corticosteroids are contraindicated in untreated bacterial, tubercular, fungal and most viral lesions of the skin (including herpes simplex, vaccinia and varicella). They are also contraindicated in individuals with a history of hypersensitivity to its components.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. Apply cautiously on lesions close to the eye. Severe irritation is possible if these formulations contact the eye. Should this occur, immediate flushing of the eye with a large volume of water is recommended.
4 Hepatic As corticosteroids undergo hepatic metabolism, LYDERM should be used with caution in patients with hepatic impairment. 5 Immune Hypersensitivity reactions have been rare been observed with topically applied steroid products.
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing.
Discontinue LYDERM if allergic contact dermatitis occurs. 6 Infections During the use of topical corticosteroids secondary infections may occur. In cases of bacterial infections of the skin, appropriate antibacterial agents should be used as primary therapy.
If it is considered necessary, the topical corticosteroid product may be used as an adjunct to control inflammation, erythema and itching. If a favorable response to an appropriate antimicrobial agent does not occur promptly, discontinue use of LYDERM (Fluocinonide) until the infection has been adequately treated.
7 Skin Prolonged use of topical corticosteroid products may produce atrophy of the skin and of subcutaneous tissues, particularly on flexor surfaces and on the face. If this is noted, discontinue the use of this product. Topical corticosteroids should be used with caution in patients with stasis dermatitis and other skin diseases associated with impaired circulation.
These products are not recommended for use under occlusive dressings. 1 Pregnancy and Lactation The safety of topical corticosteroids during pregnancy or lactation has not been established. There are no available data on fluocinonide use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. There are no data on the presence of fluocinonide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after treatment with fluocinonide.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LYDERM. Advise breastfeeding women not to apply LYDERM directly to the nipple and areola to avoid direct infant exposure.
LYDERM Product Monograph Page 8 of 22 The potential benefit of topical corticosteroids, if used during pregnancy or lactation, should be weighed against possible hazard to the fetus or the nursing infant. 2 Pediatrics Safety and effectiveness of fluocinonide in pediatric patients under the age of 18 years have not been evaluated.
Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment.
Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism). HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to […]